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Clinical Trials/NCT01486355
NCT01486355UnknownPhase 4

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

Bandim Health Project1 site in 1 countryStarted: August 1, 2011Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Phase 4
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

No Intervention

Receives only the standard measles vaccine at 9 months of age

Early measles vaccine

Experimental

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

Investigators

Sponsor Class
Other

Study Sites (1)

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