Early Two-dose Measles Vaccination Trial

This study has been completed.
Sponsor:
Collaborators:
Danish Council for Development Research
Novo Nordisk A/S
AP Moeller Foundation
Medical Research Council Unit, The Gambia
Information provided by (Responsible Party):
Bandim Health Project
ClinicalTrials.gov Identifier:
NCT00168558
First received: September 9, 2005
Last updated: March 4, 2012
Last verified: March 2012
  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 4

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:


Further study details as provided by Bandim Health Project:

Primary Outcome Measures:
  • Vaccine efficacy [ Time Frame: Assessed by study completion ] [ Designated as safety issue: No ]
  • Measles specific mortality [ Time Frame: Assessed by study completion ] [ Designated as safety issue: No ]
  • All cause sex-specific mortality until 3 years of age [ Time Frame: Assessed by study completion ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Measles antibody level at 4½, 9, 18 and 24 months of age [ Time Frame: Assessed by study completion ] [ Designated as safety issue: No ]
  • Morbidity from 4½ to 12 months of age [ Time Frame: Assessed by study completion ] [ Designated as safety issue: No ]
  • Anthropometric measures at 4½, 9, 18 and 24 months of age [ Time Frame: Assessed by study completion ] [ Designated as safety issue: No ]

Enrollment: 5879
Study Start Date: July 2003
Study Completion Date: March 2008
Primary Completion Date: March 2008 (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
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: 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 A/S
AP Moeller Foundation
Medical Research Council Unit, The 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:
No publications provided by Bandim Health Project

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: 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: March 4, 2012
Health Authority: Guinea-Bissau: Ministry of Health
Gambia: MRC Ethics Committee

Keywords provided by Bandim Health Project:
Measles vaccine
Measles
Non-specific effects of vaccines
Infant mortality
Child mortality
Mortality
Morbidity
Diphtheria-tetanus-pertussis vaccine
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 September 22, 2014