Clinical Trial: Additional Measles Vaccine at 4 Months of Age
Study Status: Completed
Recruit Status: Unknown status
Study Type: Interventional
Official Title: 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 A
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.
Detailed Summary:
Sponsor: Bandim Health Project
Current Primary Outcome: Mortality
Original Primary Outcome: Same as current
Current Secondary Outcome:
- MorbiditySymptoms of infection
- Hospitalisations/consultationsVisits to health center for consultation due to illness, hospitalisation
- GrowthWeight, length, arm circumference
- Measles infectionMeasles infection assessed by medical doctor and/or verified by blood samples
Original Secondary Outcome: Same as current
Information By: Bandim Health Project
Dates:
Date Received: August 3, 2011
Date Started: August 2011
Date Completion:
Last Updated: November 14, 2013
Last Verified: November 2013