Early Two-Dose Measles Vaccination Trial - Full Text View

Sponsors and Collaborators:	Bandim Health Project 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

MedlinePlus related topics: Measles

Drug Information available for: Diphtheria-Pertussis-Tetanus Vaccine Measles Vaccine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Measles Vaccination in Guinea-Bissau. Strategies to Reduce Disease Burden and Improve Child Survival

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
1: Active Comparator 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
2: Active Comparator 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
3: Active Comparator 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, Apartado 861
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

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

Publications indexed to this study:

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:	Bandim Health Project ( May-Lill Garly )
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
ClinicalTrials.gov Identifier:	NCT00168558
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

Study placed in the following topic categories:

Virus Diseases
Paramyxoviridae Infections
Measles
Whooping Cough

Diphtheria
Tetanus
Whooping cough

Additional relevant MeSH terms:

RNA Virus Infections
Morbillivirus Infections
Mononegavirales Infections

ClinicalTrials.gov processed this record on January 16, 2009