Trial record 8 of 105 for:    "Measles"

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
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 April 15, 2014