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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


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:




Measles infection


Minimum age: 4 Months. Maximum age: 7 Months. Gender(s): Both.


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

Page last updated: August 20, 2015

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