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Proposal 651

Title of the Proposed Research

Descriptive evaluation of SAE reporting rates in vaccine clinical trials among Latin American children

Lead Researcher

Thomas Verstraeten

Affiliation

P95 Pharmacovigilance and Epidemiology Services
Leuven, BE

Funding Source

The research will be funded as part of a consultancy agreement between P95 and FIDEC – Fighting Infectious Diseases in Emerging Countries who are sponsoring the polio trials in Latin America with grant support from the Bill and Melinda Gates Foundation.

Potential Conflicts of Interest

Thomas Verstraeten has performed or is involved in consultancies for GSK and other pharmaceutical companies involved in the development of vaccines.

Disclosure of potential conflicts will be part of any publication of the results. In addition, since this concerns a purely descriptive analysis, without any conclusions on the properties of the vaccines used in the study, there is no concern on the analyses being unduly influenced.

Data Sharing Agreement Date

11 March 2014

Lay Summary

The background to the research:
As part of the worldwide effort to eliminate polio, a number of clinical trials are ongoing in Latin America to enable the transition from oral polio vaccines to injected polio vaccines. One of the critical elements to monitor the safety of the subjects enrolled in these studies is the rate of Serious Adverse Events (SAEs) that occur after immunization. SAEs are events that lead to hospitalization, death or permanent disability. The rate of these SAEs is monitored during clinical studies as a way of checking that there is no unexpected problem with the vaccine that is being tested. To understand the importance of the SAEs reported, it is very helpful to know beforehand what can be expected based on studies carried out before in a similar population. GSK has carried out one of the largest vaccine trials in Latin America to assess the safety and efficacy of its Rotavirus vaccine. We are therefore requesting access to these data to be able to compare the SAE rates observed in the current studies to those in the rotavirus study. We request detailed data since the published information does not contain sufficient details.

How the research will add to medical science or improve patient care
The research we are proposing will help researchers involved in the current trials as well future trials among Latin American infants to better prepare for the workload that can be expected and to better monitor the safety of the children that will be enrolled.

The aims and objectives of the research
The aim of the research is to describe in details the SAE rates that can be expected to occur among Latin American infants.

The first objective is to estimate the overall reporting rate of any SAEs and specific SAEs among Latin American infants.

A second objective is to estimate the reporting rate of any SAEs and specific SAEs among Latin American infants, by country, season, gender, age, and vaccine dose.

How the research will be conducted
The research will be conducted by doing an analysis of the data already collected in the study 023. The reporting rates will be calculated by dividing the number of SAEs in certain groups, by the total number of years that these children were included in the study.

The rates that are calculated will be compared in a descriptive way between the countries (we do not expect to show for example that one country or one gender is significantly different from the other).

How the findings will be interpreted and communicated
The findings will be interpreted in a descriptive manner. By this we mean that we will not try to make far-reaching conclusion on the differences we observe, but will use this as information that is useful for others to compare their results to. We intend to report the rates that we will calculate in a publication in a peer-reviewed journal.

Study Data Provided

Study 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

Statistical Analysis Plan

Publication Citation

Baay M, Bollaerts K, Struchiner C, Verstraeten T. Background rates of disease in Latin American children from a rotavirus vaccine study. Hum Vaccin Immunother. 2017 Apr 25:1-5. doi: 10.1080/21645515.2017.1320007. PMID: 28441094

Summary Results

Results summary or link will be posted when available.