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Additional Measles Vaccine at 4 Months of Age

This study is currently recruiting participants. (see Contacts and Locations)
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
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 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:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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:
Infection
Measles
Mononegavirales Infections
Morbillivirus Infections
Paramyxoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 27, 2014