Additional Measles Vaccine at 4 Months of Age

Phase 4

• Conditions: Measles Infection
• Interventions: Biological: Measles vaccine

• 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

Arm && Interventions

Group	Intervention	Description
Early measles vaccine	Measles vaccine	Receives an early measles vaccine in addition to the standard measles vaccine at 9 months of age

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