Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.
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ClinicalTrials.gov Identifier: NCT01214889 |
Recruitment Status :
Completed
First Posted : October 5, 2010
Last Update Posted : April 17, 2012
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This study is designed to assess the immunogenicity and safety of PENTAXIM™ combined vaccine versus TETRAXIM™ vaccine to support registration of PENTAXIM™ in South Korea.
Primary Objective:
To demonstrate the non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate [PRP]) and vaccine response rates to acellular Pertussis antigens of sanofi pasteur's PENTAXIM™ vaccine versus sanofi pasteur's TETRAXIM™ and Act (Haemophilus influenzae type b) HIB™ vaccines, one month after the three-dose primary vaccination.
Condition or disease | Intervention/treatment | Phase |
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Diphtheria Tetanus Pertussis Poliomyelitis Haemophilus Influenzae Type B | Biological: PENTAXIM™: DTacP IPV//PRP~T combined vaccine Biological: TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 370 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | Immunogenicity and Safety of the Sanofi Pasteur's DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM™) Versus Sanofi Pasteur's DTacP-IPV Combined Vaccine (TETRAXIM™) Given Simultaneously at Separate Sites With PRP~T Conjugate Vaccine (ACTHIB™) as a Three-dose Primary Vaccination at 2, 4 and 6 Months of Age in South Korean Infants |
Study Start Date : | September 2010 |
Actual Primary Completion Date : | November 2011 |
Actual Study Completion Date : | December 2011 |

Arm | Intervention/treatment |
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Experimental: Study Group A
Participants will receive a single dose of DTacP-IPV//PRP T combined vaccine (PENTAXIM™) at age 2, 4 and 6 months.
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Biological: PENTAXIM™: DTacP IPV//PRP~T combined vaccine
0.5 mL, intramuscular
Other Name: PENTAXIM™ |
Active Comparator: Study Group B
Participants will receive a dose of DTacP IPV combined vaccine (TETRAXIM™) and PRP-T vaccine (ActHIB™) at 2, 4, and 6 months of age.
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Biological: TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
0.5 mL of each vaccine; intramuscular
Other Names:
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- Non-inferiority in terms of seroprotection rates (Diphtheria, Tetanus, Polio types 1, 2 and 3, Polyribosyl Ribitol Phosphate conjugated to Tetanus protein) of PENTAXIM™ Vaccine to the Tetraxim™ and PRP~T conjugate (Act-HIB™) vaccines. [ Time Frame: 1 month post-dose 3 vaccination ]
- Information regarding the safety (in terms of solicited injection site and systemic reactions) of PENTAXIM™ vaccine. [ Time Frame: Day 0 up to Day 157 ]

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Ages Eligible for Study: | 56 Days to 70 Days (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Aged 2 months (56 to 70 days) inclusive on the day of inclusion
- Born at full term of pregnancy (≥ 37 weeks) and 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 or current or planned administration during the trial (including immunoglobulins).
- Any vaccination in the 3 weeks preceding the first trial vaccination.
- History of diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b infection (confirmed either clinically, serologically or microbiologically).
- Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or Human Immunodeficiency Virus (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 major neurological diseases or seizures.
- Febrile illness (axillary temperature ≥ 38ºC) or acute illness on the day of inclusion.
- Known family history of congenital or genetic immuno-deficiency.

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): NCT01214889
Korea, Republic of | |
Daejeon, Korea, Republic of, 301723 | |
Gyeionggi do, Korea, Republic of, 411706 | |
Gyeonggi-do, Korea, Republic of, 420767 | |
Gyeonggi-do, Korea, Republic of, 420818 | |
Incheon, Korea, Republic of, 400700 | |
Incheon, Korea, Republic of, 403720 | |
Incheon, Korea, Republic of, 405760 | |
Seoul, Korea, Republic of, 110744 | |
Seoul, Korea, Republic of, 130702 | |
Seoul, Korea, Republic of, 132703 | |
Seoul, Korea, Republic of, 133792 | |
Seoul, Korea, Republic of, 135710 | |
Seoul, Korea, Republic of, 137701 | |
Seoul, Korea, Republic of, 158710 |
Study Director: | Medical Director | Sanofi Pasteur SA |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Sanofi |
ClinicalTrials.gov Identifier: | NCT01214889 |
Other Study ID Numbers: |
E2I49 U1111-1115-6381 ( Other Identifier: WHO ) |
First Posted: | October 5, 2010 Key Record Dates |
Last Update Posted: | April 17, 2012 |
Last Verified: | April 2012 |
Diphtheria Tetanus Pertussis Haemophilus influenzae type B |
Poliomyelitis PENTAXIM™ TETRAXIM™ |
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 Vaccines Immunologic Factors Physiological Effects of Drugs |