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Additional Measles Vaccine at 4 Months of Age

NCT01486355 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2013-11-15

No results posted yet for this study

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

BIOLOGICAL

Measles vaccine

Edmonston-Zagreb measles vaccine

Sponsors & Collaborators

  • Bandim Health Project

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION

Eligibility

Min Age
4 Months
Max Age
7 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-08-31
Primary Completion
2016-07-31

Countries

  • Guinea-Bissau

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01486355 on ClinicalTrials.gov