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Early Two-Dose Measles Vaccination Trial
The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2008 by Bandim Health Project.   Recruitment status was  Active, not recruiting

First Received on September 9, 2005.   Last Updated on February 27, 2008   History of Changes
Sponsor: Bandim Health Project
Collaborators: Danish Council for Development Research
Novo Nordisk
Fonden til Lægevidenskabens Fremme
Medical Research Council Laboratories, Gambia
Information provided by: Bandim Health Project
ClinicalTrials.gov Identifier: NCT00168558
  Purpose

The specific aims are to examine in Guinea-Bissau:

  • whether the standard titre Schwarz (SW) or standard-titre Edmonston-Zagreb (EZ) measles vaccine will be the best vaccine strain for use in a routine one-dose measles vaccination schedule and a two-dose measles vaccination schedule in terms of antibody response, protection against measles and child survival, and
  • whether the standard-titre Edmonston-Zagreb (EZ) vaccine will be suitable for use in a very early two-dose schedule vaccinating at 4½ and 9 months of age

Condition Intervention Phase
Measles
 Biological: Measles vaccine
 Phase IV

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Measles Vaccination in Guinea-Bissau. Strategies to Reduce Disease Burden and Improve Child Survival

Resource links provided by NLM:

MedlinePlus related topics: Measles
Drug Information available for: Measles Vaccine
U.S. FDA Resources

Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Vaccination coverage
  • Vaccine efficacy
  • Measles specific mortality
  • All cause sex-specific mortality until 3 years of age

Secondary Outcome Measures:
  • Measles antibody level at 4½, 9, 18 and 24 months of age
  • Morbidity from 4½ to 12 months of age
  • Anthropometric measures at 4½, 9, 18 and 24 months of age

Estimated Enrollment: 5755
Study Start Date: July 2003
Estimated Study Completion Date: September 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Standard titre Edmonston-Zagreb measles vaccine at 4½ and 9 months of age
 Biological: Measles vaccine

The children will be randomised to the following three arms:

Arm 1 - Very early two-dose: V (EZ) 4½ mo of age + V (EZ) 9 mo of age.

Arm 2 - 9 months one- or two-dose: V (SW) 9 mo of age + V (SW)/or nothing 18 mo of age.

Arm 3 - 9 months one- or two-dose: V (EZ) 9 mo of age + V (EZ)/or nothing 18 mo of age.

V = measles vaccination, EZ = standard titre Edmonston-Zagreb measles vaccine, SW = standard titre Schwarz measles vaccine
Active Comparator: 2
Standard titre Schwarz measles vaccine at 9 months of age
 Biological: Measles vaccine

The children will be randomised to the following three arms:

Arm 1 - Very early two-dose: V (EZ) 4½ mo of age + V (EZ) 9 mo of age.

Arm 2 - 9 months one- or two-dose: V (SW) 9 mo of age + V (SW)/or nothing 18 mo of age.

Arm 3 - 9 months one- or two-dose: V (EZ) 9 mo of age + V (EZ)/or nothing 18 mo of age.

V = measles vaccination, EZ = standard titre Edmonston-Zagreb measles vaccine, SW = standard titre Schwarz measles vaccine
Active Comparator: 3
Standard titre Edmonston-Zagreb measles vaccine at 9 months of age
 Biological: Measles vaccine

The children will be randomised to the following three arms:

Arm 1 - Very early two-dose: V (EZ) 4½ mo of age + V (EZ) 9 mo of age.

Arm 2 - 9 months one- or two-dose: V (SW) 9 mo of age + V (SW)/or nothing 18 mo of age.

Arm 3 - 9 months one- or two-dose: V (EZ) 9 mo of age + V (EZ)/or nothing 18 mo of age.

V = measles vaccination, EZ = standard titre Edmonston-Zagreb measles vaccine, SW = standard titre Schwarz measles vaccine

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   4 Months to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants of 4½ months of age registered in the Bandim Health Project registration system and currently living in the Bandim Health Project areas: Bandim I, Bandim II, Belem, Mindará and Cuntum; and who received all three diphtheria-tetanus-pertussis vaccinations at least 4 weeks before enrollment

Exclusion Criteria:

  • Severe illness requiring immediate hospitalisation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00168558

Locations
Guinea-Bissau
Bandim Health Project
Bissau, Apartado 861, Guinea-Bissau, 1004 Bissau Codex
Sponsors and Collaborators
Bandim Health Project
Danish Council for Development Research
Novo Nordisk
Fonden til Lægevidenskabens Fremme
Medical Research Council Laboratories, Gambia
Investigators
Study Director: Peter Aaby, MSc, Dr. Med Bandim Health Project
Principal Investigator: May-Lill Garly, PHD, DTM&H Bandim Health Project
  More Information

Additional Information:
Statens Serum Institut, Denmark  This link exits the ClinicalTrials.gov site

No publications provided by Bandim Health Project

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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.
Martins CL, Garly ML, Balé C, Rodrigues A, Ravn H, Whittle HC, Lisse IM, Aaby P. Protective efficacy of standard Edmonston-Zagreb measles vaccination in infants aged 4.5 months: interim analysis of a randomised clinical trial. BMJ. 2008 Jul 24;337:a661.

Responsible Party: May-Lill Garly, Bandim Health Project
ClinicalTrials.gov Identifier: NCT00168558     History of Changes
Other Study ID Numbers: RUF-91134-2601-Twodose2, RUF-91134-2601, NOVO-2624, LÆGEVIDENSKABENS FREMME-2613, LÆGEVIDENSKABENS FREMME-2623
Study First Received: September 9, 2005
Last Updated: February 27, 2008
Health Authority: Guinea-Bissau: Ministry of Health;   Gambia: MRC Ethics Committee

Keywords provided by Bandim Health Project:
Non-specific effects of vaccines
Infant mortality
Child mortality
Mortality
Morbidity
Diphtheria-tetanus-pertussis vaccine
Measles vaccine
 Measles
Immunisation
Low income country
Guinea-Bissau
Bandim Health Project
Immunology

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

ClinicalTrials.gov processed this record on February 09, 2012



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