Immunogenicity and Safety of Pentaxim™ in an Indian Population
This study has been completed.
Sponsor:
Sanofi
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT00259337
First received: November 24, 2005
Last updated: April 13, 2012
Last verified: April 2012
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Purpose
The present clinical study will assess the immunogenicity as the primary objective and the reactogenicity as the secondary objective of Aventis Pasteur's DTacP-IPV// PRP~T combined vaccine (Pentavac™ or Pentaxim™) as a three-dose primary vaccination at 6, 10 and 14 weeks of age followed by a booster dose during the second year of life.
Safety:
This study will describe the safety after each dose of the primary series of the study's combined vaccine (Pentaxim™).
| Condition | Intervention | Phase |
|---|---|---|
|
Diphtheria Tetanus Polio Pertussis Haemophilus Infections |
Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Immunogenicity and Safety of the Sanofi Pasteur DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Given as a Three-Dose Primary Vaccination at 6, 10, and 14 Weeks of Age and Followed by a Booster Dose at 18-19 Months of Age in Healthy Infants in India. |
Resource links provided by NLM:
Further study details as provided by Sanofi:
Primary Outcome Measures:
- To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine [ Time Frame: 19 months ] [ Designated as safety issue: Yes ]
| Enrollment: | 226 |
| Study Start Date: | February 2006 |
| Study Completion Date: | December 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: 1 |
Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
0.5 mL, IM
Other Name: PENTAXIM™
|
Eligibility| Ages Eligible for Study: | 42 Days to 56 Days |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Aged 42 to 56 days inclusive on the day of inclusion
- Born at full term pregnancy (> 37 weeks) with a birth weight ≥ 2.5 kg
- Informed consent form signed by the parent(s) or other legal representative
- 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 (first) trial vaccination
- Planned participation in another clinical trial during the present trial period
- Congenital or acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
- Systemic hypersensitivity to any of the vaccine components or history of a life-threatening reaction to the trial vaccine or 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 past.
- Any vaccination preceding the trial vaccination (except BCG and hepatitis B)
- History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or Haemophilus influenza type b (confirmed either clinically, serologically or microbiologically).
- Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenza type b infection with the trial vaccine or another vaccine.
- Thrombocytopenia or a bleeding disorder contraindicating intramuscular vaccination
- History of/current seizures
- Febrile illness (rectal temperature ≥ 38.0°C or axillary temperature ≥ 37.4°C) or acute illness on the day of inclusion.
Contacts and Locations More Information
Additional Information:
No publications provided
| Responsible Party: | Sanofi |
| ClinicalTrials.gov Identifier: | NCT00259337 History of Changes |
| Other Study ID Numbers: | E2I41 |
| Study First Received: | November 24, 2005 |
| Last Updated: | April 13, 2012 |
| Health Authority: | India: Indian Council of Medical Research |
Keywords provided by Sanofi:
|
Diphteria Tetanus Polio |
Acellular Pertussis Hib Haemophilus influenzae type B |
Additional relevant MeSH terms:
|
Diphtheria Haemophilus Infections Whooping Cough Poliomyelitis Tetanus Tetany Corynebacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections Pasteurellaceae Infections Gram-Negative Bacterial Infections Bordetella Infections Respiratory Tract Infections Infection |
Respiratory Tract Diseases Myelitis Central Nervous System Viral Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Clostridium Infections Neuromuscular Manifestations Neurologic Manifestations |
ClinicalTrials.gov processed this record on May 23, 2013