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
2 other identifiers
interventional
370
1 country
14
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2010
Shorter than P25 for phase_3
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2010
CompletedFirst Submitted
Initial submission to the registry
October 1, 2010
CompletedFirst Posted
Study publicly available on registry
October 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedApril 17, 2012
April 1, 2012
1.2 years
October 1, 2010
April 13, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
1 month post-dose 3 vaccination
Secondary Outcomes (1)
Information regarding the safety (in terms of solicited injection site and systemic reactions) of PENTAXIM™ vaccine.
Day 0 up to Day 157
Study Arms (2)
Study Group A
EXPERIMENTALParticipants will receive a single dose of DTacP-IPV//PRP T combined vaccine (PENTAXIM™) at age 2, 4 and 6 months.
Study Group B
ACTIVE COMPARATORParticipants will receive a dose of DTacP IPV combined vaccine (TETRAXIM™) and PRP-T vaccine (ActHIB™) at 2, 4, and 6 months of age.
Interventions
0.5 mL, intramuscular
0.5 mL of each vaccine; intramuscular
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
- Known family history of congenital or genetic immuno-deficiency.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sanofilead
Study Sites (14)
Unknown Facility
Daejeon, 301723, South Korea
Unknown Facility
Gyeionggi Do, 411706, South Korea
Unknown Facility
Gyeonggi-do, 420767, South Korea
Unknown Facility
Gyeonggi-do, 420818, South Korea
Unknown Facility
Incheon, 400700, South Korea
Unknown Facility
Incheon, 403720, South Korea
Unknown Facility
Incheon, 405760, South Korea
Unknown Facility
Seoul, 110744, South Korea
Unknown Facility
Seoul, 130702, South Korea
Unknown Facility
Seoul, 132703, South Korea
Unknown Facility
Seoul, 133792, South Korea
Unknown Facility
Seoul, 135710, South Korea
Unknown Facility
Seoul, 137701, South Korea
Unknown Facility
Seoul, 158710, South Korea
Related Publications (1)
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.
PMID: 27510380DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Sanofi Pasteur SA
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 1, 2010
First Posted
October 5, 2010
Study Start
September 1, 2010
Primary Completion
November 1, 2011
Study Completion
December 1, 2011
Last Updated
April 17, 2012
Record last verified: 2012-04