- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01644721
Trial of Additional Measles Vaccine to Reduce Child Mortality
A Two-site Randomised Trial of an Additional Measles Vaccine at 4 Months of Age to Reduce Child Mortality in Rural Areas of Burkina Faso and Guinea-Bissau
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Cesario Martins, MD, PhD
- Email: c.martins@bandim.org
Study Locations
-
-
-
Bissau, Guinea-Bissau
- Recruiting
- Bandim Health Project
-
Contact:
- Cesario Martins, MD, PhD
- Email: c.martins@bandim.org
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Early measles vaccine
An additional measles vaccine at 4 months of age, at least 28 days after the third dose of pentavalent vaccine
|
Standard Edmonston-Zagreb measles vaccine
|
NO_INTERVENTION: Control
Follows the normal vaccination schedule
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mortality
Time Frame: 4 months - 3 years
|
Overall mortality from 4 months to 3 years by sex and age at enrolment
|
4 months - 3 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Growth
|
||
Mortality
Time Frame: 4 to 9 months of age and from 9 months to 3 years of age
|
Mortality from 4 to 9 months of age and from 9 months to 3 years of age
|
4 to 9 months of age and from 9 months to 3 years of age
|
Morbidity
Time Frame: 4 months - 3 years of age
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Hospital admissions, consultations, specific morbidity and measles infection
|
4 months - 3 years of age
|
Antibody titres
|
Other Outcome Measures
Outcome Measure |
Measure Description |
---|---|
Immunological markers
|
Provided funding becomes available
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Cesario Martins, MD,PhD, Bandim Health Project
- Principal Investigator: Amabelia Rodrigues, DMSc, Bandim Health Project
Publications and helpful links
General Publications
- Aaby P, Martins CL, Garly ML, Bale C, Andersen A, Rodrigues A, Ravn H, Lisse IM, Benn CS, Whittle HC. Non-specific effects of standard measles vaccine at 4.5 and 9 months of age on childhood mortality: randomised controlled trial. BMJ. 2010 Nov 30;341:c6495. doi: 10.1136/bmj.c6495.
- Steiniche MM, Thysen SM, Jensen AKG, Rodrigues A, Martins C, Meyrowitsch DW, Aaby P, Fisker AB. The effect of early measles vaccination on morbidity and growth: A randomised trial from Guinea-Bissau. Vaccine. 2020 Mar 4;38(11):2487-2494. doi: 10.1016/j.vaccine.2020.01.096. Epub 2020 Feb 13.
- Schoeps A, Nebie E, Fisker AB, Sie A, Zakane A, Muller O, Aaby P, Becher H. No effect of an additional early dose of measles vaccine on hospitalization or mortality in children: A randomized controlled trial. Vaccine. 2018 Apr 5;36(15):1965-1971. doi: 10.1016/j.vaccine.2018.02.104. Epub 2018 Mar 6.
- Fisker AB, Nebie E, Schoeps A, Martins C, Rodrigues A, Zakane A, Kagone M, Byberg S, Thysen SM, Tiendrebeogo J, Coulibaly B, Sankoh O, Becher H, Whittle HC, van der Klis FRM, Benn CS, Sie A, Muller O, Aaby P. A Two-Center Randomized Trial of an Additional Early Dose of Measles Vaccine: Effects on Mortality and Measles Antibody Levels. Clin Infect Dis. 2018 May 2;66(10):1573-1580. doi: 10.1093/cid/cix1033.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- OPTIMUNISE_BHP_early MV
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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