Additional Measles Vaccine at 4 Months of Age
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|ClinicalTrials.gov Identifier: NCT01486355|
Recruitment Status : Unknown
Verified November 2013 by Bandim Health Project.
Recruitment status was: Recruiting
First Posted : December 6, 2011
Last Update Posted : November 15, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Measles Infection||Biological: Measles vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||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|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||July 2016|
Experimental: Early measles vaccine
Receives an early measles vaccine in addition to the standard measles vaccine at 9 months of age
Biological: Measles vaccine
Edmonston-Zagreb measles vaccine
No Intervention: No early measles vaccine
Receives only the standard measles vaccine at 9 months of age
- MortalityDifferences in mortality rates between the intervention and control groups
- MorbiditySymptoms of infection
- Hospitalisations/consultationsVisits to health center for consultation due to illness, hospitalisation
- GrowthWeight, length, arm circumference
- Measles infectionMeasles infection assessed by medical doctor and/or verified by blood samples
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01486355
|Contact: Peter Aaby, DMSc||+45 3268 firstname.lastname@example.org|
|Contact: Christine S Benn, MD, PhD||+45 3268 email@example.com|
|Bandim Health Project||Recruiting|
|Bissau, Guinea-Bissau, 1004|
|Principal Investigator: Cesario L Martins, MD, PhD|