Additional Measles Vaccine at 4 Months of Age
|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
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|