The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age (MVEPI)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01306006|
Recruitment Status : Unknown
Verified August 2014 by Bandim Health Project.
Recruitment status was: Recruiting
First Posted : March 1, 2011
Last Update Posted : August 7, 2014
The national Expanded Programme on Immunization (EPI) in Guinea-Bissau focuses its efforts exclusively on children below 12 months of age; children who have reached 12 months of age are no longer entitled to vaccines through the EPI program. This has affected the measles vaccination coverage, approx. 30% of the children in the rural area do not receive measles vaccine (MV).
Studies from the Bandim Health Project (BHP) have shown that MV has a profound impact on survival, reducing mortality by approximately 50% - far more than can be explained by prevention of measles deaths. Hence, MV seems to have non-specific beneficial effects on survival, and the current policy may have important consequences for overall child mortality.
To test the implications of the current policy of only vaccinating children below 12 months of age, the investigators will conduct a cluster randomized trial, in which children will receive their vaccines according to the current national EPI policy (National policy) or receive MV regardless of age and whether some doses of MV may be lost (MV-for-all policy).
The investigators hypothesise that among children enrolled after 12 months of age, mortality is 50% lower in children randomised to receive MV compared with children randomised to follow the national policy and not receive MV.
|Condition or disease||Intervention/treatment||Phase|
|Mortality Vaccines||Biological: Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||3500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Effect on Overall Mortality of a National Policy of Limiting Measles Vaccination to Children Below 12 Months of Age|
|Study Start Date :||February 2011|
|Estimated Primary Completion Date :||December 2015|
|Estimated Study Completion Date :||December 2016|
Active Comparator: MV-for-all
Measles vaccine provided to all children aged 9 months -3 years of age
Biological: Providing measles vaccine for all children 9-35 months who have not yet received a routine measles vaccine
Normal measles vaccines licensed for distribution through the national EPI program
No Intervention: National policy
Measles vaccine provided to children aged 9-11 months, if there are sufficient children to open a measles vaccine vial.
- Hospital morbidity
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): NCT01306006
|Bandim Health Project||Not yet recruiting|
|Contact: Ane B Fisker, MD email@example.com|
|Contact: Christina Rasmussen firstname.lastname@example.org|
|Principal Investigator: Ane B Fisker, MD|
|Principal Investigator: Amabelia Rodrigues, PhD|
|Principal Investigator: Christine S Benn, MD, PhD|
|Principal Investigator: Peter Aaby, DMSC|
|Bandim Health Project||Recruiting|
|Contact: Ane Fisker, MD email@example.com|