Additional Measles Vaccine at 4 Months of Age

This study is currently recruiting participants.
Verified November 2013 by Bandim Health Project
Sponsor:
Information provided by:
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT01486355
First received: August 3, 2011
Last updated: November 14, 2013
Last verified: November 2013
  Purpose

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

  Eligibility

Ages Eligible for Study:   4 Months to 7 Months
Genders Eligible for Study:   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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01486355

Contacts
Contact: Peter Aaby, DMSc +45 3268 3950 p.aaby@bandim.org
Contact: Christine S Benn, MD, PhD +45 3268 8354 cb@ssi.dk

Locations
Guinea-Bissau
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:
ClinicalTrials.gov Identifier: NCT01486355     History of Changes
Other Study ID Numbers: MVurban
Study First Received: August 3, 2011
Last Updated: November 14, 2013
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics
Guinea-Bissau: Ministry of Health

Keywords provided by Bandim Health Project:
Mortality
Morbidity
Hospitalisations/consultations
Growth
Measles infection

Additional relevant MeSH terms:
Measles
Morbillivirus Infections
Paramyxoviridae Infections
Mononegavirales Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on April 17, 2014