Trials / Completed
CompletedNCT01214889
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 370 (actual)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 56 Days – 70 Days
- Healthy volunteers
- Accepted
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.
Detailed description
All participants will receive three primary doses of their assigned study the vaccine, on Days 0, 60, and 120. They will be assessed for immunogenicity on Day 0 before vaccination and Day 150 post-vaccination. Safety will be assessed for all participants throughout the study, up to Day 157.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | PENTAXIM™: DTacP IPV//PRP~T combined vaccine | 0.5 mL, intramuscular |
| BIOLOGICAL | TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine | 0.5 mL of each vaccine; intramuscular |
Timeline
- Start date
- 2010-09-01
- Primary completion
- 2011-11-01
- Completion
- 2011-12-01
- First posted
- 2010-10-05
- Last updated
- 2012-04-17
Locations
14 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT01214889. Inclusion in this directory is not an endorsement.