Measles Vaccine Clinical Trial
Official title:
A Two-site Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality in Rural Areas of Burkina Faso and Guinea-Bissau
Background: All observational studies and a few randomised controlled trials (RCT) suggest
that early measles vaccine (MV), in particular an early two-dose strategy, has a much better
effect on overall mortality than later MV. These results suggest that MV has a non-measles
related beneficial effect on child survival.
Objective: To evaluate in a two-site RCT the effect on child survival and other health
indicators of a two-dose measles vaccination schedule by providing an additional dose of
Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard
measles vaccine at 9 months of age. The trials are planned in Guinea-Bissau and Burkina
Faso. The investigators will test a 40-43% reduction of mortality at each site separately
and a 32% reduction overall. Based on the results from the RCT, the investigators will
assess the cost-effectiveness of the intervention.
Design, Guinea-Bissau: Newborns are followed through the Health and Demographic Surveillance
System (HDSS) of the Bandim Health Project. Information on routine and campaign vaccinations
will be collected regularly through home visits and health centre registers. Four weeks
after having received the third dose of pentavalent vaccine (Penta3), the children will be
eligible for enrollment in the trial if they are not severely ill. Eligible children will be
invited to take part in the trial. Provided parental informed consent is given, the children
will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will
be based on consumption of services and average cost per unit. The incremental cost
effectiveness ratio will be calculated.
Sample size, follow-up and analyses: To detect a 40% reduction in overall mortality at each
site the investigators intend to enroll at least 3,750 children in Guinea-Bissau. The
children will be followed for survival and hospitalisations to 3 years of age or to the end
of the study after three years. The investigators will analyse the effects by site and
combined; by sex and season; possible interactions with other interventions like campaigns
with drugs, vaccines or micronutrients will be explored.
Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of
maternal antibody levels on subsequent antibody responses to MV. The children will be
followed to 24 months of age and samples collected at 4, 9 and 24 months of age.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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Phase 4 | |
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