Additional Measles Vaccine at 4 Months of Age

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Measles Infection

Intervention / Treatment
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* Biological: Measles vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 4 Months
Maximum Age: 7 Months

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early measles vaccine<br>Receives an early measles vaccine in addition to the standard measles vaccine at 9 months of age | Biological: Measles vaccine<br>* Edmonston-Zagreb measles vaccine<br>|
| No Intervention: No early measles vaccine<br>Receives only the standard measles vaccine at 9 months of age | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Differences in mortality rates between the intervention and control groups |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mortality, Morbidity, Hospitalisations/consultations, Growth, Measles infection