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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
Sponsor:
Information provided by (Responsible Party):
Sanofi

Tracking Information
First Submitted Date  ICMJE October 1, 2010
First Posted Date  ICMJE October 5, 2010
Last Update Posted Date April 17, 2012
Study Start Date  ICMJE September 2010
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 4, 2010)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01214889 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 4, 2010)
Information regarding the safety (in terms of solicited injection site and systemic reactions) of PENTAXIM™ vaccine. [ Time Frame: Day 0 up to Day 157 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of PENTAXIM™ Vaccine Versus TETRAXIM™ Vaccine Given With ACTHIB™ Vaccine in South Korean Infants.
Official Title  ICMJE 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
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.

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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Tetanus
  • Pertussis
  • Poliomyelitis
  • Haemophilus Influenzae Type B
Intervention  ICMJE
  • Biological: PENTAXIM™: DTacP IPV//PRP~T combined vaccine
    0.5 mL, intramuscular
    Other Name: PENTAXIM™
  • Biological: TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
    0.5 mL of each vaccine; intramuscular
    Other Names:
    • TETRAXIM™
    • ActHIB™
Study Arms  ICMJE
  • 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.
    Intervention: Biological: PENTAXIM™: DTacP IPV//PRP~T combined vaccine
  • 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.
    Intervention: Biological: TETRAXIM™: DTacP IPV combined vaccine and ActHIB™: PRP tetanus conjugate vaccine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 13, 2012)
370
Original Estimated Enrollment  ICMJE
 (submitted: October 4, 2010)
418
Actual Study Completion Date  ICMJE December 2011
Actual Primary Completion Date November 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 56 Days to 70 Days   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01214889
Other Study ID Numbers  ICMJE E2I49
U1111-1115-6381 ( Other Identifier: WHO )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sanofi
Study Sponsor  ICMJE Sanofi
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Medical Director Sanofi Pasteur SA
PRS Account Sanofi
Verification Date April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP