Immunogenicity and Safety of Pentaxim™ in an Indian Population
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ClinicalTrials.gov Identifier: NCT00259337 |
Recruitment Status :
Completed
First Posted : November 29, 2005
Last Update Posted : April 16, 2012
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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 or disease | Intervention/treatment | Phase |
---|---|---|
Diphtheria Tetanus Polio Pertussis Haemophilus Infections | Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 226 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (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. |
Study Start Date : | February 2006 |
Actual Primary Completion Date : | April 2008 |
Actual Study Completion Date : | December 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Biological: Diphteria/Tetanus/Polio/Acellular Pertussis/Hib vaccine
0.5 mL, IM
Other Name: PENTAXIM™ |
- To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine [ Time Frame: 19 months ]

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Ages Eligible for Study: | 42 Days to 56 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259337
India | |
New Delhi, India |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00259337 |
Other Study ID Numbers: |
E2I41 |
First Posted: | November 29, 2005 Key Record Dates |
Last Update Posted: | April 16, 2012 |
Last Verified: | April 2012 |
Diphteria Tetanus Polio |
Acellular Pertussis Hib Haemophilus influenzae type B |
Whooping Cough Tetanus Diphtheria Haemophilus Infections Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |
Infections Respiratory Tract Infections Respiratory Tract Diseases Clostridium Infections Gram-Positive Bacterial Infections Corynebacterium Infections Actinomycetales Infections Pasteurellaceae Infections |