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 multi-center 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. Three trials are planned in Guinea-Bissau, Ghana 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, Burkina Faso: Newborns are followed through the Health and Demographic Surveillance
System (HDSS) of the Centre de Recherche en Sante de Nouna. 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 43% reduction in overall mortality at each
site the investigators intend to enroll at least 4050 children in Burkina Faso. 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.
| Status | Recruiting |
| Enrollment | 4050 |
| Est. completion date | March 2016 |
| Est. primary completion date | December 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 4 Months to 6 Months |
| Eligibility |
Inclusion Criteria: Children who - received the third dose of pentavalent vaccine at least 28 days before enrolment - are between 4 and 6 months old - belong to households of the existing HDSS Exclusion Criteria: Children - with serious malformation - who are severely sick (needing hospitalisation) - with high fever (>38.5 C axillary temperature) - who are severely malnourished (mid-upper-arm-circumference (MUAC) < 110 mm and/or bilateral peripheral oedema) - who have received neonatal vitamin A supplementation - whose parents/guardians state that they intend to permanently move out of the study area before the child reaches 9 months of age |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Burkina Faso | Centre de Recherche en Sante de Nouna | Nouna |
| Lead Sponsor | Collaborator |
|---|---|
| Bandim Health Project | Centre de Recherche en Sante de Nouna, Burkina Faso, Heidelberg University, National Institute for Public Health and the Environment, RIVM, Holland, Navrongo Health Research Centre, Ghana |
Burkina Faso,
Aaby P, Martins CL, Garly ML, Balé C, Andersen A, Rodrigues A, Ravn H, Lisse IM, Benn CS, Whittle HC. Non-specific effects of standard measles vaccine at 4.5 and 9 months of age on childhood mortality: randomised controlled trial. BMJ. 2010 Nov 30;341:c6495. doi: 10.1136/bmj.c6495. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Immunological markers | Provided funding becomes available | 9 months to 3 years of age | No |
| Primary | Mortality | 4 months - 3 years | Yes | |
| Secondary | Mortality | 4 to 9 months of age and from 9 months to 3 years of age | Yes | |
| Secondary | Morbidity | 4 months - 3 years of age | Yes | |
| Secondary | Growth | 4 months to 3 years of age | No | |
| Secondary | Antibody titres | 9 months to 3 years of age | No |
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