NCT01486355

Additional Measles Vaccine at 4 Months of Age

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: —
• Sponsor: Bandim Health Project · Academic / Other
• Sex: All
• Age: 4 Months – 7 Months
• Healthy volunteers: —

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.

Conditions

• Measles Infection

Interventions

Type	Name	Description
BIOLOGICAL	Measles vaccine	Edmonston-Zagreb measles vaccine

Timeline

• Start date: 2011-08-01
• Primary completion: 2016-07-01
• First posted: 2011-12-06
• Last updated: 2013-11-15

Locations

1 site across 1 country: Guinea-Bissau