A Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality and to Explore the Role of Maternal Measles Antibodies for the Beneficial Non-specific Effects of Measles Vaccine
Trial Snapshot
- Phase
- Phase 4
- Sponsor
- Bandim Health Project
- Locations
- 1
- Primary Endpoint
- Mortality
Study Overview
Brief Summary
Overall objective: To conduct a randomised controlled trial (RCT) to examine whether an early two-dose measles vaccination (MV) strategy at 4 and 9 months will reduce child mortality compared with the WHO strategy of one dose of MV at 9 months.
Specific hypotheses Hypothesis I) Two doses of MV at 4 and 9 months compared with the standard dose of MV at 9 months will reduce mortality by 30% between 4 months and 5 years of age1. As in a previous trial it is expected that the beneficial effect is strongest for girls.
Hypothesis II) Children receiving MV at 4 months in the presence of maternal measles antibodies (MatAb) will have 35% lower mortality between 4 months and 5 years of age than children receiving MV at 4 months with no detectable MatAb.
Implications: These hypotheses are based on a previous RCT showing strong beneficial effects of providing an early measles vaccine, in particular among children with MatAb.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Primary Purpose
- Prevention
Eligibility Criteria
- Ages
- 4 Months to 7 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Children aged 4 to 7 months who received the third dose of pentavalent vaccine at least 4 weeks earlier
Exclusion Criteria
- •Malformations
- •Severely ill
- •Severely malnourished
Arms & Interventions
No early measles vaccine
Receives only the standard measles vaccine at 9 months of age
Early measles vaccine
Receives an early measles vaccine in addition to the standard measles vaccine at 9 months of age
Intervention: Measles vaccine (Biological)
Outcomes
Primary Outcomes
Mortality
Differences in mortality rates between the intervention and control groups
Secondary Outcomes
- Morbidity
- Hospitalisations/consultations
- Growth
- Measles infection
