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Proposal 1629

Title of the Proposed Research

Sex-differences in immunogenicity, reactogenicity and efficacy in response to vaccines in infants and young children.

Lead Researcher

Merryn Voysey

Affiliation

University of Oxford

Funding Source

Funding is available from my NIHR Doctoral Research Fellowship (NIHR-2015-08-048) until September 2019.

Potential Conflicts of Interest

AJP has previously conducted studies on behalf of Oxford University funded by vaccine manufacturers, but currently does not undertake industry funded clinical trials.

Data Sharing Agreement Date

26 Sept 2016

Lay Summary

Males and females have different levels of risk for certain diseases. Men are more prone to suffer heart attacks and strokes than women. Women are more likely to develop multiple sclerosis than men. In young children, pneumonia and meningitis more often occur in boys than girls. In the same way that some infectious diseases are more common in males than females, difference can also occur in their immune responses to vaccination. The biological mechanisms by which males and females respond differently to vaccines is multifactorial and not well understood. Females have two X chromosomes which contain many genes related to immune mechanisms. Males and females also have different hormone levels which, additionally, change over time, further affecting a person’s ability to respond to a vaccine or other source of immune challenge. Differences between males and females in response to vaccination have been mostly observed for viral vaccines and mostly in adults. Little information is available as to whether young boys and girls respond differently to their vaccinations even though the majority of all vaccines are received in these early years.

In this project we will assess sex-differences in response to vaccines administered to infants and toddlers. In addition, we will assess the timing and spacing at which vaccines are administered as these can have important effects on the immune response to vaccine.

Data from randomised controlled trials of vaccines will be combined (meta-analysed) to assess the impact of key variables on antibody responses. Studies will include all randomised controlled trials assessing the immune response to vaccines in infants and healthy young children. The vaccines of interest include diphtheria, tetanus, pertussis, meningococcal, pneumococcal, measles, mumps, rubella, varicella and rotavirus vaccines.

The findings of this research will provide important insights into immune mechanisms and which will be important in planning of future clinical trials of vaccines and optimising vaccine schedules.

Study Data Provided

GSK-110058: Immunogenicity of GlaxoSmithKline Biologicals' MMRV vaccine (208136) vs. ProQuad®, when coadministered with hepatitis A and pneumococcal conjugate vaccines to children 12-14 months of age.
GSK-110876: Immunogenicity & safety study of GSK Biologicals’ combined measles-mumps-rubella-varicella vaccine 208136
GSK-109995: A phase IIIb, open, randomised, multicentre, primary study in healthy children, to establish the non-inferiority of GlaxoSmithKline (GSK) Biologicals’ MeMuRu-OKA vaccine (administered at 9 and 15 months of age) versus Priorix™ (9 months of age) and Priorix™ co-administered with Varilrix™ at 15 months of age (comparator) and also to evaluate the non-inferiority of Priorix™ (9 months of age) and MeMuRu-OKA vaccine (15 months of age) versus the comparator, all administered subcutaneously as two-dose primary vaccination course
GSK-109375: Study to assess immunogenicity, reactogenicity and safety of primary vaccination with GSK Biologicals' MenACWY vaccine (GSK134612) given as 1 or 2 doses to healthy toddlers 9-12 months of age
GSK-109835: Co-Administration of GSK Biologicals' Meningococcal Vaccine GSK134612 With Infanrix hexa™, Compared to Individual Administration of Each Vaccine, in Healthy 12- Through 23-Month-Old Children
GSK-109670: Immunogenicity & Safety Study of GSK Biologicals' Meningococcal Vaccine GSK134612 When co-Administered With GSK Biologicals' MMRV Vaccine (Priorix-Tetra™) in Healthy 12 to 23-Month-Old Children
GSK-110870: Immunogenicity & safety study of a booster dose of GSK Biologicals’ meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in primed healthy toddlers.
GSK-111393: Immunogenicity & safety study of GSK Biologicals’ meningococcal vaccine GSK134612 when co-administered with GSK Biologicals’ pneumococcal vaccine GSK1024850A in healthy 12-23-month-old children previously primed with GSK1024850A
GSK-107137: Prophylactic antipyretic treatment in children receiving booster dose of pneumococcal vaccine GSK1024850A and DTPa-HBV-IPV/Hib vaccine (Infanrix hexa) and assessment of impact of pneumococcal vaccination on nasopharyngeal carriage
GSK-110808: Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A or Prevenar™ co-administered with Hiberix™
GSK-111188: Primary vaccination course in healthy children receiving the pneumococcal vaccine GSK 1024850A co-administered with Tritanrix™-HepB/Hib at 6, 10 and 14 weeks of age
GSK-111442: Evaluation of effectiveness of GSK Biologicals’ pneumococcal conjugate vaccine 1024850A against invasive disease
GSK-112801: Vaccination course in children primed and boosted with pneumococcal vaccine GSK 1024850A and in age-matched unprimed children
GSK-112933: Booster vaccination with pneumococcal vaccine GSK1024850A or Prevenar™ co-administered with Hiberix™ in children primed with the same vaccines
GSK-113266: Evaluation of immunological persistence following 3-dose priming with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine in study NCT00808444 and safety and immunogenicity following a booster dose of the same vaccine
GSK-107625: Efficacy, safety, reactogenicity and immunogenicity study of the lyophilised formulation of Rotarix vaccine in healthy Japanese infants
GSK-109216: Immunogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) liquid vaccine (GSK 357941A) in healthy infants.
GSK-109861: Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A, Infanrix hexa and Rotarix
GSK-111654: Non-inferiority of a commercial lot of the pneumococcal vaccine GSK1024850A compared to a clinical lot.
GSK-112269: Immunogenicity, reactogenicity and safety study to evaluate two doses of the lyophilised formulation of the human rotavirus (HRV) vaccine when administered to healthy Korean infants previously uninfected with HRV
GSK-105555: A phase II, multicentre booster study to evaluate booster vaccination with GSK Biologicals’ 10-valent pneumococcal conjugate vaccine or to evaluate the immune memory following the administration of a single dose of 23-valent plain polysaccharide vaccine in healthy children, previously vaccinated in infancy in the primary study 11PN-PD-DIT-002 (103488)
GSK-105554: Phase IIIa randomized, controlled study to assess the immunogenicity of GlaxoSmithKline (GSK) Biologicals’ 10-valent pneumococcal conjugate vaccine, when administered as a 3-dose primary immunization course before 6 months of age
GSK-106623: Multicentre immune memory study in healthy children following a 3 dose primary vaccination with Prevenar or GSK Biologicals' pneumococcal conjugate vaccine via the administration of a single booster dose of Pneumovax 23
GSK-107058: Evaluate immunogenicity, safety & reactogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine given as catch-up immunization in children older than 7 mo of age or as 3-dose primary immunization in children before 6 mo of age
GSK-111736: Vaccination course in children primed and boosted with pneumococcal vaccine GSK 1024850A and in age-matched unprimed children
GSK-112807: Vaccination with the pneumococcal vaccine GSK 1024850A or Prevenar™ at approximately 4 years of age in children primed with 3 doses of GSK 1024850A vaccine or Prevenar™ and boosted with 23-valent pneumococcal plain polysaccharide vaccine
GSK-113151: Primary vaccination course with the pneumococcal vaccine GSK 1024850A, in healthy infants in Vietnam when co-administered with GSK Biologicals’ Infanrix hexa™ (DTPa-HBV-IPV/Hib) vaccine
GSK-444563/023: A placebo-controlled, multi-country & multi-center study to assess the efficacy, safety & immunogenicity of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants
GSK-101555: A phase II, double-blind, randomized, placebo-controlled study to compare the immunogenicity, reactogenicity and safety of 2 different formulations of GSK Biologicals’ live attenuated human rotavirus (HRV) vaccine given as a two-dose primary vaccination in healthy infants previously uninfected with HRV
GSK-444563/013: A phase II, randomized, double-blind, placebo-controlled study of safety, reactogenicity and immunogenicity of 2 or 3 doses of GSK Biologicals’ oral live attenuated human rotavirus vaccine at 10E6.5 CCID50 viral concentration in healthy infants (approximately 5-10 weeks old) in the Republic of South Africa
GSK-444563/022: A phase II, double-blind, randomized, placebo-controlled study to assess the safety, reactogenicity and immunogenicity of three doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine administered to human immunodeficiency virus (HIV) infected infants at 6, 10 and 14 weeks of age in South Africa.
GSK-444563/024: A multi-country & multi-center study to assess the efficacy, immunogenicity & safety of two doses of GSK Biologicals' oral live attenuated HRV vaccine given concomitantly with routine EPI vaccinations including OPV in healthy infants
GSK-444563/028: A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants
GSK-107070: A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy and safety of two doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine in healthy infants.
GSK-444563/029: A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants
GSK-107072: A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy and safety of two doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine in healthy infants.
GSK-444563/030: A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy and safety of two doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants
GSK-107076: A phase III, double-blind, randomized, placebo-controlled, multi-country and multi-center study to assess the efficacy and safety of two doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine in healthy infants.
GSK-444563/033: Study to assess the clinical consistency of three production lots of GSK Biologicals’ HRV vaccine in terms of immunogenicity and safety when given to healthy infants at 2 and 4 months of age
GSK-102247: A multi-country & multi-center study to assess the efficacy, safety & immunogenicity of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants in co-administration with specific childhood vaccines
GSK-109810: To assess long-term efficacy & safety of subjects approximately 3 years after priming with 2 doses of GlaxoSmithKline (GSK) Biologicals’ oral live attenuated human rotavirus (HRV) vaccine (Rotarix) in the primary vaccination study (102247).
GSK-102248: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants
GSK-111274: Multi-Center Study to Assess the Efficacy, Safety and Immunogenicity of 2 or 3 Doses of GSK Biologicals' Oral Live Attenuated Human Rotavirus (HRV) Vaccine Given Concomitantly With Routine EPI Vaccinations in Healthy Infants
GSK-103477: Study to assess the immunogenicity, reactogenicity and safety of GlaxoSmithKline Biologicals’ oral live attenuated human rotavirus (HRV) vaccine following a 0, 2 month schedule, in healthy infants previously uninfected with human rotavirus
GSK-103478: Assess the immunogenicity, safety & reactogenicity of 2 doses of GSK Biologicals’ oral live attenuated human rotavirus (HRV) vaccine in healthy infants (6-12 weeks of age at first dose) previously uninfected with human rotavirus
GSK-103992: Evaluate immunogenicity, reactogenicity & safety of 2 doses of GSK Biologicals’ oral live attenuated HRV vaccine (RIX4414 at 106.5 CCID50) when given concomitantly with OPV versus given alone (HRV vaccine dose given 15 days after the OPV dose) in healthy infants in Bangladesh
GSK-104480: Compare the immunogenicity, reactogenicity & safety of 2 different formulations of GSK Biologicals’ live attenuated human rotavirus (HRV) vaccine given as a two-dose primary vaccination in healthy infants previously uninfected with HRV the efficacy and safety of two doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) vaccine in healthy infants.
GSK-105722: A placebo-controlled study to evaluate the immunogenicity, reactogenicity and safety of two doses of GSK Biologicals' oral live attenuated human rotavirus (HRV) liquid vaccine, when given to healthy infants, in Vietnam
GSK-107077: A study to assess the immunogenicity, reactogenicity and safety of 2 different formulations of GSK Biologicals' live attenuated HRV vaccine, given as a two-dose primary vaccination, in healthy infants previously uninfected with HRV
GSK-107531: Assess the immunogenicity of 3 doses of Pediarix®, Prevnar® & ActHIB® given to healthy infants when administered with GSK Biologicals’ 2 dose oral live attenuated human rotavirus vaccine given during the same vaccination visit or separately
GSK-107876: Study to evaluate clinical consistency of the liquid formulation of GSK Biologicals' HRV vaccine and to evaluate liquid formulation compared to lyophilised formulation of the HRV vaccine administered as a two-dose primary vaccination.
GSK-113808: Efficacy, immunogenicity and safety of two doses of GlaxoSmithKline (GSK) Biologicals' Oral Live Attenuated Liquid Human Rotavirus (HRV) Vaccine (444563), in healthy infants
GSK-103533: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years
GSK-103534: Evaluate the immunogenicity, reactogenicity, safety of 4 different formulations of GSK Biologicals' conjugate vaccine (MenACWY) vs 1 dose of MenC-CRM197 or Mencevax™ ACWY in children aged 12-14 months & 3-5 years
GSK-104703: A Phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of investigational vaccination regimens versus MENINGITEC™ or MENCEVAX™ ACWY when given as one dose to children aged 12 to 14 months and 3 to 5 years old
GSK-104704: A Phase II, open (partially double-blind), randomized, controlled dose-range study to evaluate the immunogenicity, reactogenicity and safety of investigational vaccination regimens versus MENINGITEC™ or MENCEVAX™ ACWY when given as one dose to children aged 12 to 14 months and 3 to 5 years old
GSK-103388: Blinded, randomized study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella candidate vaccine given to healthy children during the second year of life
GSK-104020: Blinded, randomised study to assess the immunogenicity and safety of GlaxoSmithKline (GSK) Biologicals’ live attenuated measles-mumps-rubella-varicella candidate vaccine when given to healthy children in their second year of life
GSK-104389: Blinded, randomised, controlled study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella candidate vaccine given to healthy children in their second year of life
GSK-105908: Comparative study evaluating the immunogenicity and safety of MeMuRu-OKA vaccine and measles-mumps-rubella vaccine (Priorix™) co-administered with varicella vaccine (Varilrix™) in children primed with measles-mumps-rubella vaccine
GSK-105909: Comparative study evaluating the immunogenicity & safety of MeMuRu-OKA vaccine & measles-mumps-rubella vaccine (Priorix™) co-administered with varicella vaccine (Varilrix™) in children primed with both measles-mumps-rubella & varicella vaccines
GSK-104730: A phase III, multicentre booster vaccination study to assess the immunogenicity, safety and reactogenicity a dose of Mencevax™ ACWY at 24 to 30 months of age in subjects primed with an investigational vaccination regimen in study 100480 and boosted at 15 to 24 months of age in study 104727.
GSK-104756: Booster Vaccination Study to Assess Safety & Reactogenicity of a Dose of DTPw-HBV/Hib Vaccine and to Assess the Immunogenicity, Safety & Reactogenicity of a Dose of Mencevax™ ACW in Subjects Primed in Study 759346/007
GSK-105239: Booster Vaccination Study to Assess Immunogenicity & Safety of a Dose of GSK Biologicals' Mencevax™ ACWY & 1/5th of a Dose of Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
GSK-105245: Booster Vaccination Study to Assess Immunogenicity & Safety of a Dose of GSK Biologicals' Mencevax™ ACWY & 1/5th of a Dose of Mencevax™ ACWY in Subjects Primed in the DTPW-HBV=HIB-MENAC-TT-011 Study
GSK-111345: Long-term follow-up study to assess antibody persistence in children previously vaccinated with four doses of pneumococcal conjugate vaccine in primary vaccination study (105553) and booster vaccination study (107046)
GSK-109705: Study of two formulations of GSK Biologicals' varicella vaccine given as a 2-dose course in the second year of life
GSK-208136/039: Follow-up to evaluate the the immunogenicity & safety of GSK Biologicals’ MMRV vaccine given as a two-dose schedule in the second year of life, as compared to separate administration of GSK Biologicals’ Priorix® & Varilrix®.
GSK-208136/040: Study to evaluate immunogenicity and safety of three production lots of GSK Biologicals' combined MeMuRu-OKA candidate vaccine given on a two-dose schedule to healthy children, as compared to separate administration of GSK Biologicals' Priorix® and Varilrix® vaccines
GSK-208136/041: Study to evaluate immunogenicity and safety of three production lots of GSK Biologicals' combined MeMuRu-OKA candidate vaccine given on a two-dose schedule to healthy children, as compared to separate administration of GSK Biologicals' Priorix® and Varilrix® vaccines
GSK-108760: Immunogenicity & safety study of GSK Biologicals’ 208136 vaccine formulated with new measles and rubella working seeds
GSK-208136/038: Study to evaluate immunogenicity and safety of three production lots of GSK Biologicals' combined MeMuRu-OKA candidate vaccine given on a two-dose schedule to healthy children in their second year of life, as compared to separate administration of GSK Biologicals' Priorix™ and Varilrix™ vaccines
GSK-208109/231: Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 Months of Age
GSK-112036: Persistence of antibodies after GSK Biologicals’ meningococcal vaccine GSK134612 in toddlers
GSK-112021: The long term antibody persistence study of GSK Biologicals’ meningococcal vaccine GSK 134612 administered as 1 or 2 doses to healthy toddlers at 9-12 months of age and as a booster dose at 5 years post-primary vaccination
GSK-109563: COMPAS: A phase III study to demonstrate efficacy of GSK Biologicals' 10-valent pneumococcal vaccine (GSK1024850A) against Community Acquired Pneumonia and Acute Otitis Media
GSK-111346: Assessment of long-term antibody persistence and immunological memory in children previously vaccinated with four pneumococcal conjugate vaccine doses and assessment of pneumococcal catch-up vaccination with GSK1024850A at 5 years of age
GSK-111347: Assessment of long-term antibody persistence and immunological memory in children previously vaccinated with four pneumococcal conjugate vaccine doses and assessment of pneumococcal catch-up vaccination with GSK1024850A at 5 years of age.
GSK-112640: Immunogenicity, safety and reactogenicity of GlaxoSmithKline Biologicals’ pneumococcal vaccine GSK1024850A following primary and booster vaccination of healthy Japanese children
GSK-112909: Booster vaccination with pneumococcal vaccine GSK1024850A in primed children and catch-up vaccination in unprimed children
GSK-100388: Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (Varilrix™) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella
GSK-100478: Study to show non-inferiority of Tritanrix™-HepB/Hib-MenAC (+/- hepatitis B vaccine at birth) versus Tritanrix™-HepB/Hiberix™ without hepatitis B vacc. at birth for antibody response to all vaccine antigens given in healthy infants
GSK-100480: Study to show lot-to-lot consistency of Hib-MenAC mixed with Tritanrix™-HBV, its non-inferiority to Tritanrix™-HBV/Hiberix™ with or without Meningitec™, and MenA response in 2, 4, 6 month infants with hepatitis B birth dose
GSK-101197 (DTPa -127): An open, multicentric, phase IV clinical trial to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ combined diphtheria-tetanus-acellular pertussis vaccine (Infanrix™) administered to healthy infants at 2, 4 and 6 months of age.
GSK-101222: Study to demonstrate the non-inferiority of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine compared to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine and to separate administration of DTPw-HBV Kft. and Hiberix™ vaccines with respect to the immunogenicity of all antigens, when administered to healthy infants.
GSK-759346/007: Demonstrate non-inferiority of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ with respect to anti-HBs immune response, when given to healthy infants at 6,10 & 14 weeks age, after a birth dose of hepatitis B vaccine
GSK-444563/007 (rota-007): Study to assess efficacy, immunogenicity, reactogenicity and safety of two doses of GSK Biologicals' oral live attenuated human rotavirus vaccine at different viral concentrations in healthy infants previously uninfected with human rotavirus and approximately 3 months of age
GSK-104420: A phase II study to evaluate the persistence of measles, mumps and rubella antibodies two years after the single dose primary vaccination in study 209762/151.
GSK-209762/136 (MeMuRu-136): A phase III, blinded, randomized, multicenter U.S. study evaluating the clinical consistency of three production lots of SmithKline Beecham Biologicals' MMR vaccine (PRIORIX) and comparability of PRIORIX with Merck's M-M-R IIvaccine, administered to healthy children 12 to 18 months of age
GSK-209762/147 (MeMuRu-147): Phase IV open study to assess the safety, reactogenicity and immunogenicity of GlaxoSmithKline (GSK)Biologicals live attenuated Measles-Mumps-Rubella (MMR) vaccine when given to healthy children at the age of 12 to 18months in Singapore.
GSK-209762/148: Phase II, double blind, randomized sequential study to compare immunogenicity and reactogenicity of the current formulations of GSK Biologicals’ measles-mumps-rubella vaccine and GSK Biologicals’ varicella vaccine containing human serum albumin with the modified formulations which do not contain HSA
GSK-209762/150: Double blind, randomized sequential study to compare immunogenicity and reactogenicity of current formulations of GSK Biologicals’ measles-mumps-rubella vaccine and GSK Biologicals’ varicella vaccine to investigational vaccination regimens
GSK-209762/151: Phase II study to evaluate immunogenicity, reactogenicity and safety of GSK Biologicals’ investigational vaccination regimen compared to the currently licensed GSK Biologicals’ Priorix™ and Merck and Co.’s M-M-R®II vaccines when administered as a primary vaccination to healthy children aged 12-24 months
GSK-404286/006 A phase II, open, randomized, controlled study to assess the immune memory induced by an investigational vaccination regimen and the safety, reactogenicity and immunogenicity of a booster dose of an investigational vaccination regimen in toddlers primed in study 404286/001.
GSK-711202/001: Evaluate immunogenicity, reactogenicity, safety of GSK Biologicals’ MenC-TT vaccine (2 formulations) given with Infanrix hexa® + GSK Biologicals’ Hib MenC-TT vaccine (2 formulations) given with Infanrix penta® to infants in mths 3,4,5 of life
GSK-711202/008: Evaluate the persistence and immune memory induced by a primary vaccination course with GSK Biologicals’ MenC-TT (1 formulation) & GSK Biologicals’ Hib-MenC-TT (2 formulations) or Meningitec™ in healthy toddlers aged 12-15 mths primed in study 711202/001
GSK-811936/001 (Hib-MenC-TT-001): Phase 2, open, randomized, controlled study to demonstrate the non-inferiority of the meningococcal serogroup C immune response and the superiority of the Hib immune response of GSK Biologicals’ Haemophilus influenzae type b-meningococcal C-TT conjugate vaccine administered with Infanrix™ penta versus Meningitec™ administered with Infanrix™
GSK-444563/003 (rota-003): A phase II, double-blind, randomized, placebo-controlled, dose-escalating, stepwise study to assess safety, reactogenicity and immunogenicity of GlaxoSmithKline Biologicals’ live attenuated human rotavirus (HRV) vaccine in healthy infants previously uninfected with human rotavirus.
GSK-444563/004: A study to assess the efficacy, immunogenicity and safety of two doses of oral live attenuated human rotavirus (HRV) vaccine (Rotarix) in healthy infants.
GSK-444563/005: (rota-005): Phase II, double-blind, randomized, placebo-controlled study of 2 doses of GSK Biologicals’ live attenuated human rotavirus vaccine at different virus concentrations (10 5.2 and 10 6.4 ffu) in healthy infants following a 0, 2 month schedule and previously uninfected with human rotavirus
GSK-444563/006: To assess the efficacy, immuno & safety of 2 doses of GSK HRV vaccine at different virus concentrations in healthy infants aged 2 months & previously uninfected with HRV, concurrently given with DTPw-HBV, Hib.
GSK-444563/014 (Rota-014): Study of safety, reactogenicity and immunogenicity of two doses of GSK Biologicals' oral live attenuated human rotavirus vaccine co-administered with either oral polio vaccine (OPV) or inactivated polio vaccine (IPV) in healthy infants in South Africa
GSK-444563/020: Phase II, double-blind randomised, placebo controlled clinical dose-range study to assess immunogenicity and reactogenicity of an investigational vaccination regimen, and to assess immunogenicity of OPV orally co-administered to healthy infants at 2, 4 and 6 months of age
GSK-444563/021: Phase II, double-blind, randomized, placebo-controlled clinical study to assess immunogenicity and reactogenicity of doses of a modified vaccine formulation versus GSK Biologicals’ live attenuated human rotavirus vaccine when orally administered to healthy infants at 2, 4 and 6 months of age
GSK-104690: Blinded, randomized study to evaluate the immunogenicity and safety of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella candidate vaccine given to healthy children during the second year of life
GSK-208136/006 (MeMuRu-OKA-006): A phase II, open, randomized, multicentre study evaluating in healthy children 12-24 months of age, the safety and immunogenicity of GlaxoSmithKline Biologicals' combined Measles-Mumps-Rubella-Varicella vaccine (MeMuRu-OKA), compared to GlaxoSmithKline Biologicals' Varicella vaccine
GSK-208136/013 (MeMuRu-OKA-013): Study to assess immunogenicity and safety of one dose of GSK Biologicals’ live attenuated MMRV vaccine, co-administered with a booster dose of the GSK Biologicals’ combined diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated polio-Haemophilus influenzae type b conjugate vaccine
GSK-208136/017 (MeMuRu-OKA-017): Study to assess immunogenicity, reactogenicity and safety of a 2nd dose of GlaxoSmithKline Biologicals’ measles-mumps-rubella-varicella (MeMuRu-OKA) vaccine given in healthy children of 5 to 6 years of age
GSK-208136/018 (MeMuRu-OKA-018): Study to evaluate immunogenicity and safety of GSK Biologicals’ MeMuRu-OKA vaccine compared to concomitant administrations of GSK Biologicals’ Priorix™ and Varilrix™ vaccines
GSK-208136/019 (MeMuRu-OKA-019): Study to evaluate immunogenicity and safety of one dose of GSK Biologicals’ measles-mumps-rubella-varicella vaccine given to healthy children previously primed with one dose of measles-mumps-rubella vaccine
GSK-111870: A phase II, randomized, observer blind, controlled, multicenter study to assess immunogenicity and antibody persistence following vaccination with GSK's candidate combined measles, mumps, and rubella vaccine (MMR) versus M-M-R® II as a first dose, both administered subcutaneously at 12-15 months of age, concomitantly with hepatitis A vaccine (HAV), varicella vaccine (VV) and pneumococcal conjugate vaccine (PCV) but at separate sites.
GSK-208136/007 (MeMuRu-OKA-007): Study to assess consistency of 3 production lots of GSK Biologicals' combined measles-mumps-rubella-varicella vaccine in terms of immunogenicity and safety, compared to administration of GSK Biologicals' measles-mumps-rubella vaccine and varicella vaccine in healthy children in their second year of life
GSK-101223: Study to assess the lot-to-lot consistency of the production method of GSK Biologicals' DTPw-HBV/ Hib Kft. vaccine and to compare to GSK Biologicals' Tritanrix™-HepB/Hiberix™ vaccine, when administered as a primary vaccination course.
GSK-101518 (DTPa-HBV-IPV-103): A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix-hexa) given as a booster at 18-24 months of age to children who have received a three-dose primary immunisation course with the same vaccine in a previous study
GSK-103488: A randomized, controlled, phase II study to evaluate the safety and immunogenicity of different formulations of GlaxoSmithKline Biologicals’ 11-valent pneumococcal conjugate vaccine, when administered intramuscularly as a 3-dose primary immunization (2-3-4 month schedule) before 6 months of age
GSK-103494: Blinded, randomised, controlled, multicenter study to evaluate the clinical efficacy against varicella disease of GlaxoSmithKline Biologicals’ live attenuated varicella vaccine (Varilrix™) given on a one-dose schedule and of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella vaccine (Priorix™-Tetra) given on a two-dose schedule in healthy children during the second year of life
GSK-104065: Immune memory of GSK's DTPw-HBV/Hib vaccine by giving Plain PRP polysaccharide at 10 mths. Immunogenicity & reactogenicity of a booster dose of DTPw-HBV/Hib or DTPw-HBV or DTPw-HBV+Hib at 15-18 mths in infants previously primed with DTPw-HBV/Hib
GSK-104105:Blinded, randomised, controlled, multicenter study to evaluate the clinical efficacy against varicella disease of GlaxoSmithKline Biologicals’ live attenuated varicella vaccine (Varilrix™) given on a one-dose schedule and of GlaxoSmithKline Biologicals’ combined measles-mumps-rubella-varicella vaccine (Priorix™-Tetra) given on a two-dose schedule in healthy children during the second year of life
GSK-104489: Study to assess immunogenicity and safety of GlaxoSmithKline Biologicals Kft’s DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft and vs concomitant administration of CSL’s Triple Antigen and GlaxoSmithKline Biologicals’ Hiberix, to infants at 2, 4, 6 months of age, after a birth dose of hepatitis B
GSK-104567: Phase IIIb, multicentre study to assess safety & immunogenicity of GSK Biologicals’ combined DTPa/Hib (Infanrix/Hib) vaccine vs separate administration of DTPa (Infanrix) & Hib (Hiberix) vaccines in healthy infants 3,4,&5 months of age as compared with the separate administration of DTPa and Hib vaccines at different injection sites.
GSK-104727: Assess immunogenicity, safety & reactogenicity of a 4th dose of GSK Biologicals’ Tritanrix™-HepB/Hib-MenAC at 15-24 months & of a dose of Mencevax™ ACWY at 24-30 months in subjects primed with 3 doses of Tritanrix™-HepB/Hib-MenAC
GSK-104871: A multicentric study to compare the immunogenicity, safety & reactogenicity of GSK Biologicals' DTPa-IPV vaccine vs. co-administration of GSK's DTPa vaccine & Sanofi-Pasteurs' IPV vaccine at different injection sites, to healthy children
GSK-105539: An open, randomized, phase IIIa study to evaluate the safety and immunogenicity of GSK Biologicals' 10-valent pneumococcal conjugate vaccine, when administered intramuscularly according to a 2-4-11 months vaccination schedule
GSK-105553: Assess lot-to-lot consistency of 3 lots (double blind design) of GlaxoSmithKline Biologicals' 10-valent pneumococcal vaccine and evaluate non-inferiority to Prevenar™ (single blind design) when administered as 3-dose primary immunization course before 6 months of age
GSK-105910: Compare immunogenicity & reactogenicity of 2 formulations of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (new vs current) given in healthy infants. The DTPa-HBV-IPV vaccine (new formulation) will also be assessed in a 3rd group of subjects
GSK-106208: To assess reactogenicity and immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix™ hexa) at 2, 4 and 6 months of age.
GSK-106602: Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals’ DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals’ DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.
GSK-106786: A study to evaluate the immunogenicity and safety of a new formulation of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine as compared to the currently licensed Infanrix hexa in healthy infants (2,3,4 M)
GSK-107005: To assess safety, reactogenicity and immunogenicity of GSK Biologicals’ 10-valent pneumococcal conjugate vaccine, when co-administered with DTPa-combined vaccines and MenC or Hib-MenC vaccines during the first 6 months of age.
GSK-107007: To assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™, co-administered with DTPw-HBV/Hib & OPV or IPV vaccines as a 3-dose primary immunization course during the first 6 months of age
GSK-107017: Multicentre study to assess the effect of prophylactic antipyretic treatment on the rate of febrile reactions following concomitant administration of GSK Biologicals’ 10-valent pneumococcal conjugate, Infanrix hexa and Rotarix vaccines
GSK-107046: To assess the safety, reactogenicity & immunogenicity of a 4th dose of GSK Biologicals’ pneumococcal vaccine or Prevenar™ in children (12-18 months) previously vaccinated in the primary study 105553 with either pneumococcal vaccine or Prevenar™
GSK-107706: To assess safety, reactogenicity & immunogenicity of a booster dose of pneumococcal conjugate vaccine, co-admin with GSK Biologicals’ MMRV vaccine in children (2nd yr of life) primed with the pneumococcal conjugate vaccine in study 105553.
GSK-107737: Study to assess the safety and immunogenicity of GSK Biologicals 10-valent pneumococcal conjugate vaccine when Co-administered with DTPa-HBV-IPV/Hib (Infanrix-Hexa) vaccine in preterm infants as a 3-dose primary immunization course during the first 6 months of life.
GSK-109507: Booster Vaccination With Pneumococcal Vaccine GSK1024850A, a DTPa-Combined and MenC or Hib-MenC Vaccines
GSK-109509: Booster vaccination course with the pneumococcal vaccine GSK 1024850A, DTPw-HBV/Hib and OPV or IPV in children who completed the primary vaccination course in study 107007
GSK-109661: Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A, Infanrix hexa and Rotarix
GSK-110031: Phase II, observer-blind follow-up study to assess reacto-and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine (GSK1024850A), when given as booster in primed children or as 2-dose catch-up in unprimed children.
GSK-110142: Non-inferiority of co-administration of GSK Biologicals’pneumococcal conjugate vaccine GSK1024850A with DTPa-IPV-Hib versus co-administration with DTPa-HBV-IPV/Hib.
GSK-110871: Immunogenicity & safety study of a booster dose of GSK Biologic als’ meningococcal vaccine 134612 given at 12-15 months of age or at 15-18 months of age (co-administered with Infanrix®) in primed healthy toddlers.
GSK-110478: Immunogenicity and reactogenicity study of a new formulation of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine administered as a booster dose to 18-23 months old children
GSK-110521: Primary vaccination course in children receiving the pneumococcal vaccine GSK 1024850A co-administered with Zilbrix™ Hib and Polio Sabin™
GSK-111053: Non-inferiority of co-administration of GSK Biologicals’pneumococcal conjugate vaccine GSK1024850A with DTPa-IPV-Hib versus co-administration with DTPa-HBV-IPV/Hib.
GSK-111344: Immunogenicity and reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine when given as a booster dose.
GSK-111535: Immunogenicity and reactogenicity study of GlaxoSmithKline Biologicals' Infanrix™/Hib vaccine administered as a booster dose to 18-24 months old children
GSK-112157: Immunogenicity and safety study of GlaxoSmithKline Biologicals’ GSK2202083A vaccine in healthy infants at 2, 3 and 4 months of age
GSK-112595: Impact on nasopharyngeal carriage, acute otitis media, immunogenicity and safety of GSK Biologicals’ pneumococcal conjugate vaccine 1024850A
GSK-113166: Safety, reactogenicity and immunogenicity study of GSK Biologicals’ pneumococcal vaccine GSK1024850A, given either as a booster dose or as a 2-dose catch-up immunization in healthy Malian children
GSK-113199: Safety, reactogenicity and immunogenicity study of GSK Biologicals’ pneumococcal vaccine GSK1024850A, given either as a booster dose or as a 2-dose catch-up immunization in healthy Nigerian children
GSK-113978: Immunogenicity and safety study of GlaxoSmithKline Biologicals’ GSK2202083A vaccine administered as a booster dose in 12-18 months old healthy children
GSK-V72P12: A Phase 2b, Open Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered With or Without Routine Infant Vaccinations to Healthy Infants According to Different Immunization Schedules.
GSK-V72P13: A Phase 3, Partially Blinded, Randomized, Multi-Center, Controlled Study to Evaluate Immunogenicity, Safety and Lot to Lot Consistency of Novartis Meningococcal B Recombinant Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants
GSK-V72P13E1: A Phase 3, Open Label, Multi-Center, Extension Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered as a Booster at 12 Months of Age or as a Two-dose Catch-up to Healthy Toddlers Who Participated in Study V72P13
GSK-208355/125 (APV-125): A phase III, open, multicenter study of the safety of Infanrix® when administered as a booster dose at 15 to 18 months of age following primary immunization in studies 217744/084 and 217744/085 (Subjects from DTaP-HepB-IPV-084 and DTaP-HepB-IPV-085)
GSK-217744/070 (DTPa-HBV-IPV-070): An open clinical study to assess the immunogenicity and safety of GSK Biologicals' DTPa-HBV-IPV vaccine mixed in one syringe with Hib vaccine, as a primary vaccination course to pre-term infants (<37 weeks) at 2, 4 and 6 months of age in comparison with infants born after normal gestation period
GSK-217744/076 (DTPa-HBV-IPV-076): An open, multicenter, phase IV clinical trial to assess the immunogenicity and reactogenicity of three doses of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine in healthy infants at 2, 4 and 6 months of age, when co-administered with Wyeth-Lederle’s meningococcal group C conjugate vaccine.
GSK-217744/077 (DTPa-HBV-IPV-077): A phase III, double-blind, randomized, multicenter primary vaccination study to bridge the DTPa-HBV-IPV vaccine manufactured according to the large scale manufacturing process with the DTPa-HBV-IPV vaccine manufactured by the small scale manufacturing process when administered intramuscularly to infants at 2, 4 and 6 months of age, co-administered with Merck's Hib conjugate vaccine (Liquid PedvaxHIB®) in a separate injection at 2 and 4 months of age
GSK-217744/078 (DTPa-HBV-IPV-078): An open, multicentre, phase IV clinical trial to assess the immunogenicity and reactogenicity of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine, when co-administered at 3-4-5 Mth of age with Wyeth-Lederle's seven-valent pneumococcal conjugate vaccine at a different injection site during the same visit
GSK-217744/081 (DTPa-HBV-IPV-081): An open, multicentre, phase IV booster vaccination study to assess the immunogenicity and reactogenicity of a 4th dose of GSK Biologicals’ combined DTPa-HBV-IPV/Hib vaccine, co-administered with Wyeth's seven-valent Pneumococcal conjugate vaccine at a different injection site during the same visit in healthy children
GSK-217744/083 (DTPa-HBV-IPV-083): Study to assess immunogenicity and reactogenicity of GSK Bio’s combined DTPa-HBV-IPV/Hib vaccine in pre-term infants in comparison with term infants, administered as a booster dose to children who previously were primed with 3 doses of GSK Biologicals combined DTPa-HBV-IPV/Hib vaccine
GSK-217744/084 (DTPa-Hep B-IPV-084): A phase III, open labeled, randomized, multicenter, clinical study of the safety of a primary series of GlaxoSmithKline Biologicals' (GSK Biologicals') DTaP-HepB-IPV combined candidate vaccine coadministered with HibTITER® and Prevnar® to healthy infants at 2, 4, and 6 months of age as compared to the separate administration of Infanrix® + Engerix-B®+ IPOL® + HibTITER + Prevnar
GSK-217744/085 (DTPa-Hep B-IPV-085): A phase III, open labeled, randomized, multicenter, clinical study of the safety and immunogenicity of a primary series of GlaxoSmithKline Biologicals' (GSK Biologicals') DTaP-HepBIPV candidate vaccine coadministered with HibTITER® and Prevnar® to healthy infants at 2, 4, and 6 months of age as compared to the separate administration of Infanrix® + Engerix-B® + IPOL® + HibTITER + Prevnar and to GSK Biologicals' DTaP-HepB-IPV candidate vaccine coadministered with HibTITER
GSK-217744/086 (DTPa-HBV-IPV-086): Single-blind, multicentre, phase IV clinical trial to assess and compare the immunogenicity and reactogenicity of GSK Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa™) and Aventis Pasteur’s DTPa-HBV-IPV-Hib vaccine (Hexavac™) given as a primary vaccination course at 2, 4 and 6 months of age.
GSK-217744/090 (DTPa-HBV-IPV-090): A phase IV, open, multicentre study to assess the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (Infanrix hexa() given as a primary vaccination course at 2, 4 and 6 months of age to pre-term infants.
GSK-217744/094: Study to assess and compare the immunogenicity and reactogenicity of GlaxoSmithKline Biologicals’ DTPa-HBV-IPV/Hib vaccine (INFANRIX™ HEXA) and Aventis Pasteur MSD’s DTPa-HBV-IPV-Hib vaccine (HEXAVAC™) given at 3, 5 and 11-12 months of age
GSK-217744/095 (DTPa-HBV-IPV-095): Study to assess immunogenicity and reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine when given as a booster dose to children previously primed at 2-4-6 months of age either with Aventis Pasteurs' DTPa-HBV-IPV-Hib vaccine or GSK Biologicals' DTPa-HBV-IPV/Hib vaccine in study DTPa-HBV-IPV-086
GSK-217744/097 (DTPa-HBV-IPV-097): Study to assess immunogenicity and reactogenicity of three doses of GSK Bio’s combined Hib-MenC vaccine co-admind with GSK Bio’s DTPa-HBV-IPV vaccine and of two doses of Baxters meningococcal C conjugate vaccine co-admind with GSK Bio’s DTPa-HBV-IPV/Hib vaccine
GSK-404286/001: Feasibility Double-blindDTPa-HBV-IPV/HIB-MenC control : DTPa-HBV-IPV + HiberixLot D21798A2;D21799B2;DCH002A46;DCH003A46;Hib400A47/MInfants 2-3 months
GSK-208136/014 (MeMuRu-OKA-014): Study to evaluate immunogenicity and safety of one dose of GSK Biologicals' combined measles-mumps-rubella-varicella vaccine given to healthy children previously primed with one dose of measles-mumps-rubella vaccine in their second year of life and presumed seronegative for varicella
GSK-208136/016 (MeMuRu-OKA-016): Study to assess immunogenicity and safety of two lots of GSK Biologicals' live attenuated measles-mumps-rubella-varicella vaccine, at two different titres, given as a single injection to healthy children with Biologicals' measles-mumps-rubella vaccine as control group
GSK-208136/022 (MeMuRu-OKA-022): Study to evaluate immunogenicity and safety of one dose of GSK Biologicals' combined measles-mumps-rubella-varicella vaccine compared to concomitant administrations of GSK Biologicals' measles-mumps-rubella vaccine and varicella vaccine

Statistical Analysis Plan

Publication Citation

https://doi.org/10.1016/j.vaccine.2017.09.002

Summary Results

Results summary or link will be posted when available.