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Early Two-dose Measles Vaccination Trial

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ClinicalTrials.gov Identifier: NCT00168558
Recruitment Status : Completed
First Posted : September 15, 2005
Last Update Posted : March 6, 2012
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment Phase
Measles Biological: Measles vaccine Phase 4

  Show Detailed Description

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5879 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Measles Vaccination in Guinea-Bissau. Strategies to Reduce Disease Burden and Improve Child Survival
Study Start Date : July 2003
Primary Completion Date : March 2008
Study Completion Date : March 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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



Outcome Measures

Primary Outcome Measures :
  1. Vaccine efficacy [ Time Frame: Assessed by study completion ]
  2. Measles specific mortality [ Time Frame: Assessed by study completion ]
  3. All cause sex-specific mortality until 3 years of age [ Time Frame: Assessed by study completion ]

Secondary Outcome Measures :
  1. Measles antibody level at 4½, 9, 18 and 24 months of age [ Time Frame: Assessed by study completion ]
  2. Morbidity from 4½ to 12 months of age [ Time Frame: Assessed by study completion ]
  3. Anthropometric measures at 4½, 9, 18 and 24 months of age [ Time Frame: Assessed by study completion ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   4 Months to 6 Months   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: March 6, 2012
Last Verified: March 2012

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
Vaccines
Immunologic Factors
Physiological Effects of Drugs