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Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi
ClinicalTrials.gov Identifier:
NCT01214889
First received: October 1, 2010
Last updated: April 13, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention 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
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
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

Resource links provided by NLM:


Further study details as provided by Sanofi:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Information regarding the safety (in terms of solicited injection site and systemic reactions) of PENTAXIM™ vaccine. [ Time Frame: Day 0 up to Day 157 ] [ Designated as safety issue: No ]

Enrollment: 370
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Other Names:
  • TETRAXIM™
  • ActHIB™

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.

  Eligibility

Ages Eligible for Study:   56 Days to 70 Days
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 2 months (56 to 70 days) inclusive on the day of inclusion
  • 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:

  • Participation in another clinical trial in the 4 weeks preceding the trial inclusion
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01214889

Locations
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, 405760
Incheon, Korea, Republic of, 403720
Incheon, Korea, Republic of, 400700
Seoul, Korea, Republic of, 135710
Seoul, Korea, Republic of, 158710
Seoul, Korea, Republic of, 130702
Seoul, Korea, Republic of, 133792
Seoul, Korea, Republic of, 132703
Seoul, Korea, Republic of, 137701
Seoul, Korea, Republic of, 110744
Sponsors and Collaborators
Sanofi
Investigators
Study Director: Medical Director Sanofi Pasteur SA
  More Information

Additional Information:
No publications provided

Responsible Party: Sanofi
ClinicalTrials.gov Identifier: NCT01214889     History of Changes
Other Study ID Numbers: E2I49, U1111-1115-6381
Study First Received: October 1, 2010
Last Updated: April 13, 2012
Health Authority: Korea: Food and Drug Administration

Keywords provided by Sanofi:
Diphtheria
Tetanus
Pertussis
Haemophilus influenzae type B
Poliomyelitis
PENTAXIM™
TETRAXIM™

Additional relevant MeSH terms:
Diphtheria
Poliomyelitis
Actinomycetales Infections
Bacterial Infections
Central Nervous System Diseases
Central Nervous System Infections
Central Nervous System Viral Diseases
Corynebacterium Infections
Enterovirus Infections
Gram-Positive Bacterial Infections
Myelitis
Nervous System Diseases
Neuromuscular Diseases
Picornaviridae Infections
RNA Virus Infections
Spinal Cord Diseases
Virus Diseases

ClinicalTrials.gov processed this record on November 20, 2014