Additional Measles Vaccine at 4 Months of Age
Information source: Bandim Health Project
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Measles Infection
Intervention: Measles vaccine (Biological)
Phase: Phase 4
Status: Recruiting
Sponsored by: Bandim Health Project Overall contact: Peter Aaby, DMSc, Phone: +45 3268 3950, Email: p.aaby@bandim.org
Summary
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.
Clinical Details
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 design: Allocation: Randomized, Primary Purpose: Prevention
Primary outcome: Mortality
Secondary outcome: MorbidityHospitalisations/consultations Growth Measles infection
Eligibility
Minimum age: 4 Months.
Maximum age: 7 Months.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Children aged 4 to 7 months who received the third dose of pentavalent vaccine at
least 4 weeks earlier
Exclusion Criteria:
- Malformations
- Severely ill
- Severely malnourished
Locations and Contacts
Peter Aaby, DMSc, Phone: +45 3268 3950, Email: p.aaby@bandim.org
Bandim Health Project, Bissau 1004, Guinea-Bissau; Recruiting Cesario L Martins, MD, PhD, Principal Investigator
Additional Information
Related publications: Aaby P, Martins CL, Garly ML, Balé 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.
Starting date: August 2011
Last updated: November 14, 2013
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