Methods Inf Med 1997; 36(03): 214-20 DOI: 10.1055/s-0038-1636828
Original Article
Schattauer GmbH
Data Management for an Efficacy Trial of a Vaccine in the Gambia
G. P. Lahai
1
Medical Research Council Laboratories, Fajara, The Gambia
,
E. K. Mulholland
1
Medical Research Council Laboratories, Fajara, The Gambia
,
S. Hilton
1
Medical Research Council Laboratories, Fajara, The Gambia
,
G. Fegan
1
Medical Research Council Laboratories, Fajara, The Gambia
,
G. Inskip
2
MRC Environmental Epidemiology Unit, Southampton General Hospital, Southampton, UK
,
O. Yuuni
1
Medical Research Council Laboratories, Fajara, The Gambia
,
J. E. Bangali
1
Medical Research Council Laboratories, Fajara, The Gambia
,
B. M. Greenwood
1
Medical Research Council Laboratories, Fajara, The Gambia
› Author AffiliationsWe would like to acknowledge the individuals who contributed in various ways to the successful management of data in this trial. Many thanks go to Mrs Haddy Kanyi, Mr Bakary Kijera, Mrs Binta Jammeh and Mr Yankuba Ceesay for their untiring effort in maintaining the computer entry of all study data up to date. We are also grateful to Mr Boi Sawaneh for his exellent field supervision and to the many field workers who worked so hard at collecting high quality data. Special thanks go to staff of The Gambia Expanded Programme on Immunisation (EPI) for their support throughout the trial and to the study children for making it all possible.
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.
Keywords
Haemophilus Influenzae
-
Randomised -
Data Management -
The Gambia -
Data Quality
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