Data management for an efficacy trial of a vaccine in the Gambia
G P Lahai1, E K Mulholland, S Hilton
1Medical Research Council Laboratories, Fajara, The Gambia. glahai@gam.healthnet.org
Insights
This study evaluated the efficacy of the PRP-T Hib conjugate vaccine in Gambian children. Data management ensured accurate tracking of vaccine administration and confirmed Hib disease cases.
Area of Science:
- Immunology
- Vaccinology
- Pediatrics
Background:
- Haemophilus influenzae type b (Hib) remains a significant cause of childhood illness globally.
- Effective conjugate vaccines are crucial for Hib disease prevention in endemic regions.
Purpose of the Study:
- To assess the efficacy of the PRP-T Hib conjugate vaccine in preventing Hib disease.
- To evaluate the data management procedures for a large-scale individually randomized controlled trial.
Main Methods:
- An individually randomized, double-blind trial involving 42,848 children in The Gambia (1993-1995).
- Participants were assigned to vaccine or placebo groups, with detailed recording of all vaccine doses administered.
- Clinical data were collected for 2,681 suspected Hib disease episodes, leading to 50 confirmed cases.
Main Results:
- The study successfully collected and managed extensive demographic, vaccination, and clinical data.
- Data integrity was confirmed by matching home-based health card records with the central vaccination database for all confirmed Hib cases.
- The trial design and data management procedures supported the final efficacy analysis.
Conclusions:
- Robust data management is essential for the reliable assessment of vaccine efficacy in large clinical trials.
- The study established a foundation for evaluating the PRP-T Hib conjugate vaccine's impact on Hib disease incidence.
Abstract:
An individually randomised double-blind trial of PRP-T Hib conjugate vaccine was conducted in the Gambia between 1993 and 1995, in which 42,848 children were randomised into one of 10 groups, five corresponding to vaccine and five to placebo. Basic demographic data were collected on all children, and administration details of all doses of EPI vaccines were recorded. In addition, details on all doses of vaccines were recorded on each child's home-based health card; 2,681 episodes of possible Hib disease were investigated and for each episode detailed clinical data were collected. These investigations yielded 50 cases of confirmed Hib disease, which formed the basis of the final efficacy results. In all 50 cases, the data on the children's health card, describing the doses of study vaccine received exactly, matched the vaccination database which was filled with data returned from the clinics. The data-management procedures are described in detail in this paper.
