Trial of Additional Measles Vaccine to Reduce Child Mortality

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

3750 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2016-10-31

Brief Summary

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Background: All observational studies and a few randomised controlled trials (RCT) suggest that early measles vaccine (MV), in particular an early two-dose strategy, has a much better effect on overall mortality than later MV. These results suggest that MV has a non-measles related beneficial effect on child survival.

Objective: To evaluate in a two-site RCT the effect on child survival and other health indicators of a two-dose measles vaccination schedule by providing an additional dose of Edmonston-Zagreb (EZ) MV as soon as possible after 4 months of age as well as the standard measles vaccine at 9 months of age. The trials are planned in Guinea-Bissau and Burkina Faso. The investigators will test a 40-43% reduction of mortality at each site separately and a 32% reduction overall. Based on the results from the RCT, the investigators will assess the cost-effectiveness of the intervention.

Design, Guinea-Bissau: Newborns are followed through the Health and Demographic Surveillance System (HDSS) of the Bandim Health Project. Information on routine and campaign vaccinations will be collected regularly through home visits and health centre registers. Four weeks after having received the third dose of pentavalent vaccine (Penta3), the children will be eligible for enrollment in the trial if they are not severely ill. Eligible children will be invited to take part in the trial. Provided parental informed consent is given, the children will be randomised to MV at 4 and 9 months of age or only at 9 months. Cost estimates will be based on consumption of services and average cost per unit. The incremental cost effectiveness ratio will be calculated.

Sample size, follow-up and analyses: To detect a 40% reduction in overall mortality at each site the investigators intend to enroll at least 3,750 children in Guinea-Bissau. The children will be followed for survival and hospitalisations to 3 years of age or to the end of the study after three years. The investigators will analyse the effects by site and combined; by sex and season; possible interactions with other interventions like campaigns with drugs, vaccines or micronutrients will be explored.

Antibody study: 450 children will be enrolled in a subgroup study to examine the effect of maternal antibody levels on subsequent antibody responses to MV. The children will be followed to 24 months of age and samples collected at 4, 9 and 24 months of age.

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Detailed Description

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Conditions

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Measles Vaccine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Early measles vaccine

An additional measles vaccine at 4 months of age, at least 28 days after the third dose of pentavalent vaccine

Group Type EXPERIMENTAL

Early measles vaccine

Intervention Type BIOLOGICAL

Standard Edmonston-Zagreb measles vaccine

Control

Follows the normal vaccination schedule

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Early measles vaccine

Standard Edmonston-Zagreb measles vaccine

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

Children who

* received the third dose of pentavalent vaccine at least 28 days before enrolment
* are between 4 and 6 months old
* belong to households of the existing HDSS

Exclusion Criteria

Children

* with serious malformation
* who are severely sick (needing hospitalisation)
* with high fever (\>38.5 C axillary temperature)
* who are severely malnourished (mid-upper-arm-circumference (MUAC) \< 110 mm and/or bilateral peripheral oedema)
* who have received neonatal vitamin A supplementation
* whose parents/guardians state that they intend to permanently move out of the study area before the child reaches 9 months of age

Minimum Eligible Age

4 Months

Maximum Eligible Age

6 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

No