Immunogenicity and Safety of Sanofi Pasteur Pentaxim Combined Vaccine in Infants in Thailand
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00255021 |
Recruitment Status :
Completed
First Posted : November 17, 2005
Last Update Posted : April 16, 2012
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diphtheria Tetanus Poliomyelitis Haemophilus Infections Pertussis | Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 186 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Study Start Date : | December 2005 |
Actual Primary Completion Date : | September 2007 |
Actual Study Completion Date : | January 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1 |
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Vac
0.5 mL, IM
Other Name: PENTAXIM |
- Immunogenicity: To provide information concerning the immune response of the DTacP-IPV//PRP~T combined vaccine [ Time Frame: 1 month post-vaccination ]

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 2 Months to 2 Months (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Aged 53 to 70 days inclusive on the day of inclusion
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 corticosteroid 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.
- Mother known as seropositive to HIV or hepatitis B
- Any vaccination in the 5 weeks preceding the first trial vaccination (except Bacille Calmette-Guerin [BCG])
- History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection or hepatitis B (confirmed either clinically, serologically or microbiologically).
- Previous vaccination against the diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae 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): NCT00255021
Thailand | |
Bangkok, Thailand |
Study Director: | Clinical Trials | Sanofi Pasteur, a Sanofi Company |
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00255021 |
Other Study ID Numbers: |
E2I34 |
First Posted: | November 17, 2005 Key Record Dates |
Last Update Posted: | April 16, 2012 |
Last Verified: | April 2012 |
Diphteria Tetanus Pertussis |
Poliomyelitis Haemophilus influenzae type b acellular |
Whooping Cough Tetanus Diphtheria Poliomyelitis 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 |
Nervous System Diseases Corynebacterium Infections Actinomycetales Infections Myelitis Central Nervous System Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Virus Diseases Central Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases Pasteurellaceae Infections |