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
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.
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|
|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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
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.
Biological: TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
0.5 mL of each vaccine; intramuscular
- 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 ]
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|