- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01214889
Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.
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
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.
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Daejeon, Korea, Republic of, 301723
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Gyeionggi do, Korea, Republic of, 411706
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Gyeonggi-do, Korea, Republic of, 420767
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Gyeonggi-do, Korea, Republic of, 420818
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Incheon, Korea, Republic of, 400700
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Incheon, Korea, Republic of, 403720
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Incheon, Korea, Republic of, 405760
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Seoul, Korea, Republic of, 110744
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Seoul, Korea, Republic of, 133792
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Seoul, Korea, Republic of, 130702
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Seoul, Korea, Republic of, 132703
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Seoul, Korea, Republic of, 135710
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Seoul, Korea, Republic of, 137701
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Seoul, Korea, Republic of, 158710
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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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0.5 mL, intramuscular
Other Names:
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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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0.5 mL of each vaccine; intramuscular
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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1 month post-dose 3 vaccination
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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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Day 0 up to Day 157
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Central Nervous System Diseases
- Nervous System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Neuromuscular Diseases
- Central Nervous System Infections
- Bordetella Infections
- Gram-Negative Bacterial Infections
- Bacterial Infections
- Bacterial Infections and Mycoses
- Gram-Positive Bacterial Infections
- Actinomycetales Infections
- Enterovirus Infections
- Picornaviridae Infections
- Spinal Cord Diseases
- Clostridium Infections
- Corynebacterium Infections
- Myelitis
- Whooping Cough
- Tetanus
- Diphtheria
- Poliomyelitis
- Physiological Effects of Drugs
- Immunologic Factors
- Vaccines
Other Study ID Numbers
- E2I49
- U1111-1115-6381 (Other Identifier: WHO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Sanofi Pasteur, a Sanofi CompanyCompletedHepatitis B | Pertussis | Diphtheria | PolioTurkey
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SanofiCompletedHepatitis B | Pertussis | Tetanus | Diphtheria | PoliomyelitisArgentina
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Sanofi Pasteur, a Sanofi CompanyCompletedPertussis | Tetanus | Diphtheria | Poliomyelitis | Haemophilus Influenzae Type bArgentina
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Sanofi Pasteur, a Sanofi CompanyCompletedHepatitis B | Pertussis | Tetanus | Diphtheria | Poliomyelitis | Haemophilus Influenzae Type b InfectionKorea, Republic of
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SanofiCompletedPertussis | Tetanus | Diphtheria | PoliomyelitisThailand
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Sanofi Pasteur, a Sanofi CompanyCompletedHepatitis B | Whooping Cough | Tetanus | Diphtheria | PoliomyelitisColombia, Costa Rica
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Sanofi Pasteur, a Sanofi CompanyCompletedHepatitis B | Whooping Cough | Tetanus | Diphtheria | Poliomyelitis | Invasive Hib InfectionsIndia
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Sanofi Pasteur, a Sanofi CompanyCompletedHepatitis B | Pertussis | Tetanus | Diphtheria | Poliomyelitis | Haemophilus Influenzae Type B InfectionMexico
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SanofiCompletedPertussis | Tetanus | Diphtheria | Poliomyelitis | Haemophilus Influenzae Type bChina