Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.
NCT ID: NCT01214889
Last Updated: 2012-04-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
370 participants
INTERVENTIONAL
2010-09-30
2011-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Study Group A
Participants will receive a single dose of DTacP-IPV//PRP T combined vaccine (PENTAXIM™) at age 2, 4 and 6 months.
PENTAXIM™: DTacP IPV//PRP~T combined vaccine
0.5 mL, intramuscular
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.
TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
0.5 mL of each vaccine; intramuscular
Interventions
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PENTAXIM™: DTacP IPV//PRP~T combined vaccine
0.5 mL, intramuscular
TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
0.5 mL of each vaccine; intramuscular
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
56 Days
70 Days
ALL
Yes
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Sanofi Pasteur SA
Locations
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Daejeon, , South Korea
Gyeionggi Do, , South Korea
Gyeonggi-do, , South Korea
Gyeonggi-do, , South Korea
Incheon, , South Korea
Incheon, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Countries
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References
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Kang JH, Lee HJ, Kim KH, Oh SH, Cha SH, Lee J, Kim NH, Eun BW, Kim CH, Hong YJ, Kim HH, Lee KY, Kim YJ, Cho EY, Kim HS, Guitton F, Ortiz E. The Immunogenicity and Safety of a Combined DTaP-IPV//Hib Vaccine Compared with Individual DTaP-IPV and Hib (PRP~T) Vaccines: a Randomized Clinical Trial in South Korean Infants. J Korean Med Sci. 2016 Sep;31(9):1383-91. doi: 10.3346/jkms.2016.31.9.1383.
Related Links
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Related Info
Other Identifiers
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U1111-1115-6381
Identifier Type: OTHER
Identifier Source: secondary_id
E2I49
Identifier Type: -
Identifier Source: org_study_id
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