Early Two-dose Measles Vaccination Trial
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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 |
- 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 ]
- 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 |
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| Guinea-Bissau | |
| Bandim Health Project | |
| Bissau, Apartado 861, Guinea-Bissau, 1004 Bissau Codex | |
| 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:
|
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 May 19, 2013