Additional Measles Vaccine at 4 Months of Age

Phase 4

• Conditions: Measles Infection

• Registration Number: NCT01486355
• Lead Sponsor: Bandim Health Project

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 Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2011-08-03
• Study First Submitted QC: 2011-12-05
• Study First Posted: 2011-12-06
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-14
• Last Update Posted: 2013-11-15
• Primary Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality		Differences in mortality rates between the intervention and control groups

Secondary Outcome Measures

Name	Time	Method
Morbidity		Symptoms of infection
Hospitalisations/consultations		Visits to health center for consultation due to illness, hospitalisation
Growth		Weight, length, arm circumference
Measles infection		Measles infection assessed by medical doctor and/or verified by blood samples

Trial Locations

Locations (1)

Bandim Health Project; 🇬🇼 Bissau, Guinea-Bissau