Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 Months
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ClinicalTrials.gov Identifier: NCT00453570 |
Recruitment Status :
Completed
First Posted : March 29, 2007
Last Update Posted : April 17, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Diphtheria Tetanus Haemophilus Influenzae Type b Pertussis Poliomyelitis | Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 792 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Study Start Date : | March 2007 |
Actual Primary Completion Date : | December 2008 |
Actual Study Completion Date : | January 2009 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
DTacP IPV// PRP~T combined vaccine at 2, 3 and 4 months of age, and a booster dose at 18-20 months of age.
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Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, IM
Other Name: PENTAXIM™ |
Experimental: 2
DTacP-IPV// PRP~T combined vaccine at 3, 4 and 5 months of age and a booster dose at 18-20 months of age.
|
Biological: Diphtheria, Tetanus, Polio, Acellular Pertussis and Hib
0.5 mL, IM
Other Name: PENTAXIM™ |
Active Comparator: 3
Control vaccines at 3, 4 and 5 months of age and a booster dose at 18-20 months of age
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Biological: Diphtheria, Tetanus, & Acellular Pertussis Combined, Absorbed
0.5 mL, IM
Other Name: DTacP, Act-HIB™ and IMOVAX Polio™ |
- To provide information concerning the immunogenicity of DTacP-IPV//PRP~T combined vaccine [ Time Frame: 1 Month post-dose 3 ]
- To provide information concerning the safety of DTacP-IPV//PRP~T combined vaccine [ Time Frame: 19 months post-dose 1 ]

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Ages Eligible for Study: | 60 Days to 74 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria :
- Aged 2 months (60 to 74 days) inclusive on the day of inclusion
- Born at full term pregnancy (³36 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 trial inclusion
- 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 performed or planned in the 4 weeks preceding the first trial visit (except BCG and Hepatitis B, which can not be given within 8 days before the first study visit)
- Vaccination planned in the 4 weeks following any trial vaccination (except BCG and Hepatitis B, which can not be given within 8 days before or after the study vaccine(s) administration)
- History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically)
- Clinical or serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
- 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 (axillary temperature ≥ 37.1°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): NCT00453570
China, Guangxi | |
Nanning, Guangxi, China, 530022 |
Study Director: | Medical Director | Sanofi Pasteur Inc. |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT00453570 |
Other Study ID Numbers: |
E2I42 |
First Posted: | March 29, 2007 Key Record Dates |
Last Update Posted: | April 17, 2012 |
Last Verified: | April 2012 |
Diphteria Tetanus Haemophilus influenzae type b Poliomyelitis Pertussis |
Whooping Cough Tetanus Diphtheria Poliomyelitis Respiratory Tract Infections Infections RNA Virus Infections Virus Diseases Respiratory Tract Diseases Bordetella Infections Gram-Negative Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses |
Clostridium Infections Gram-Positive Bacterial Infections Nervous System Diseases Corynebacterium Infections Actinomycetales Infections Myelitis Central Nervous System Infections Enterovirus Infections Picornaviridae Infections Central Nervous System Diseases Spinal Cord Diseases Neuromuscular Diseases |