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Additional Measles Vaccine at 4 Months of Age

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2013 by Bandim Health Project.
Recruitment status was:  Recruiting
Information provided by:
Bandim Health Project Identifier:
First received: August 3, 2011
Last updated: November 14, 2013
Last verified: November 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 Intervention Phase
Measles Infection Biological: Measles vaccine Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Prevention
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

Resource links provided by NLM:

Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Mortality
    Differences in mortality rates between the intervention and control groups

Secondary Outcome Measures:
  • Morbidity
    Symptoms of infection

  • Hospitalisations/consultations
    Visits to health center for consultation due to illness, hospitalisation

  • Growth
    Weight, length, arm circumference

  • Measles infection
    Measles infection assessed by medical doctor and/or verified by blood samples

Study Start Date: August 2011
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


Ages Eligible for Study:   4 Months to 7 Months   (Child)
Sexes Eligible for Study:   All

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01486355

Contact: Peter Aaby, DMSc +45 3268 3950
Contact: Christine S Benn, MD, PhD +45 3268 8354

Bandim Health Project Recruiting
Bissau, Guinea-Bissau, 1004
Principal Investigator: Cesario L Martins, MD, PhD         
Sponsors and Collaborators
Bandim Health Project
  More Information

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT01486355     History of Changes
Other Study ID Numbers: MVurban
Study First Received: August 3, 2011
Last Updated: November 14, 2013

Keywords provided by Bandim Health Project:
Measles infection

Additional relevant MeSH terms:
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017