Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP HB PRP~T Combined Vaccine in Filipino Infants
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00514709
First received: August 9, 2007
Last updated: April 13, 2012
Last verified: April 2012
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Purpose
DTaP-HB-PRP~T combined vaccine is being developed in order to comply with expanding programs for immunization in infancy, while offering the benefit of a reduced number of injections, and potentially of an increased acceptance.
Primary Objectives:
- To describe the antibody persistence following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™
- To describe the effect of a booster dose of DTaP-HB-PRP~T following a three-dose primary series vaccination of either DTaP-HB-PRP~T or Tritanrix HepB/Hib™
Secondary Objective:
To describe the safety profile of the booster dose of the DTaP-HB-PRP~T vaccine when administered concomitantly with OPV.
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria Tetanus Pertussis Hepatitis B Influenza |
Biological: DTaP HB PRP~T Combined Vaccine Biological: DTaP-HB-PRP~T vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Immunogenicity Study of the Antibody Persistence and Booster Effect of DTaP Hep B PRP-T Combined Vaccine at 12 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants Having Received Hepatitis B Vaccine at Birth |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- Antibody persistence before the booster dose with DTaP-HB-PRP~T in a subset of subjects in the study [ Time Frame: Before and after booster dose ] [ Designated as safety issue: No ]
| Enrollment: | 1843 |
| Study Start Date: | September 2007 |
| Study Completion Date: | April 2009 |
| Primary Completion Date: | December 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
DTaP-Hep B-PRP-T + OPV vaccine group
|
Biological: DTaP HB PRP~T Combined Vaccine
0.5 mL dose, IM
|
|
Experimental: Group 2
Tritanrix-HepB/Hib™ + OPV vaccine group
|
Biological: DTaP-HB-PRP~T vaccine
0.5 mL dose, IM
|
Detailed Description:
This study will assess the immunogenicity and reactogenicity of the investigational DTaP-HB-PRP~T combined vaccine when given as a booster dose, concomitantly with OPV, in Filipino children previously primed at 6, 10, and 14 weeks with the investigational DTaP-HB-PRP~T combined vaccine or Tritanrix-HepB/Hib™ vaccine and having received a first dose of HB vaccine (Recomvax B™) at birth in a previous study.
Eligibility| Ages Eligible for Study: | 12 Months to 18 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Toddler aged 12 to 18 months of age on the day of inclusion (range: 365 days to 578 days of age inclusive)
- Participated in the AL201 study and completed the three-dose primary series with either DTaP-HB-PRP~T or Tritanrix-HepB/Hib™, and OPV, at 6, 10 and 14 weeks of age, and received hepatitis B vaccine at birth
- Informed consent form signed by one parent or legal representative if appropriate (independent witness mandatory if parent is illiterate)
- Able to attend all scheduled visits and to comply with all trial procedures
Exclusion Criteria:
- Participation in another clinical trial in the 4 weeks preceding the trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term (for more than 2 weeks) systemic corticosteroid therapy within the preceding 3 months
- Known systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to a vaccine containing the same substances
- Chronic illness at a stage that could interfere with trial conduct or completion
- Blood or blood-derived products received in the last 3 months
- Any vaccination in the 4 weeks preceding the trial vaccination
- Vaccination planned in the 4 weeks following the trial vaccination
- Febrile (temperature ≥ 38.0°C) or acute illness on the day of inclusion
- History of documented diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliomyelitis infection(s) (confirmed either clinically, serologically, or microbiologically)
- Vaccination with a vaccine containing diphtheria, tetanus, pertussis, Haemophilus influenzae type b, hepatitis B or poliovirus 3 types antigen, since the end of the primary series
- Thrombocytopenia or a bleeding disorder contraindicating IM vaccination
- Serious adverse event related to any vaccination in the AL201 study.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00514709
Locations
| Philippines | |
| Muntinlupa City, Alabang Junction Alabang, Philippines | |
| Muntinlupa City, Alabang, Philippines | |
| Muntinlupa City, Bayanan Annex, Philippines | |
| Muntinlupa City, Cupang, Philippines | |
| Muntinlupa City, Filinvest, Philippines | |
| Muntinlupa City, Putatan, Philippines | |
| Muntinlupa City, Tunasan, Philippines | |
Sponsors and Collaborators
Sanofi
Investigators
| Study Director: | Medical Director | Sanofi Pasteur Inc. |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00514709 History of Changes |
| Other Study ID Numbers: | AL204 |
| Study First Received: | August 9, 2007 |
| Last Updated: | April 13, 2012 |
| Health Authority: | Philippines: Department of Health |
Keywords provided by Sanofi:
|
Diphtheria Tetanus Pertussis Hepatitis B Hansenula (HB) Haemophilus influenzae type b |
Additional relevant MeSH terms:
|
Diphtheria Hepatitis Hepatitis A Hepatitis B Influenza, Human Whooping Cough Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections DNA Virus Infections Orthomyxoviridae Infections Respiratory Tract Infections Respiratory Tract Diseases Bordetella Infections Gram-Negative Bacterial Infections Infection Clostridium Infections Neuromuscular Manifestations Neurologic Manifestations |
ClinicalTrials.gov processed this record on May 16, 2013