Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine 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.
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.
|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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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|
- 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 ]
|Study Start Date:||September 2010|
|Study Completion Date:||December 2011|
|Primary Completion Date:||November 2011 (Final data collection date for primary outcome measure)|
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
Please refer to this study by its ClinicalTrials.gov identifier: 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|