Immunogenicity Study of Antibody Persistence and Booster Effect of DTaP-HB-PRP~T Combined Vaccine or Tritanrix-HepB/Hib™
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00534833
First received: September 24, 2007
Last updated: April 13, 2012
Last verified: April 2012
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Purpose
The present trial is a follow-up of AL203 study.
Primary Objectives:
To describe the antibody persistence at 15 to 18 months of age and the booster effect of a dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ (given concomitantly with OPV).
Secondary Objective:
To describe the safety profile of a booster dose of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ when administered concomitantly with OPV in each vaccine group.
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria Tetanus Pertussis Hepatitis B Haemophilus Influenzae Type b |
Biological: DTaP-HB-PRP~T vaccine Biological: Tritanrix-HepB/Hib™ |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: 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 or Tritanrix HepB/Hib™ at 15 to 18 Months of Age Following a Primary Series at 6, 10 and 14 Weeks of Age in Healthy Filipino Infants |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- To provide information concerning the immune response to DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ after vaccination [ Time Frame: 28 Days Post-vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- To provide information concerning the safety after administration of DTaP-HB-PRP~T or Tritanrix-HepB/Hib™ [ Time Frame: 6 Months post-vaccination ] [ Designated as safety issue: Yes ]
| Enrollment: | 362 |
| Study Start Date: | September 2007 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | September 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 vaccine
0.5 mL, Intramuscular
|
|
Active Comparator: Group 2
Tritanrix-HepB/Hib™ + OPV vaccine group
|
Biological: Tritanrix-HepB/Hib™
0.5 mL, Intramuscular
|
Eligibility| Ages Eligible for Study: | 15 Months to 18 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Toddler aged 15 to 18 months of age on the day of inclusion (range: 456 days to 578 days of age inclusive)
- Participated in the AL203 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
- 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 intramuscular (IM) vaccination
- Serious adverse event related to any vaccination in the AL203 study.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00534833 History of Changes |
| Other Study ID Numbers: | AL205 |
| Study First Received: | September 24, 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 22, 2013