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Trial record 2 of 2 for:    pediarix | Polio | Phase 3

Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants

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ClinicalTrials.gov Identifier: NCT00879827
Recruitment Status : Completed
First Posted : April 13, 2009
Last Update Posted : September 7, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE April 9, 2009
First Posted Date  ICMJE April 13, 2009
Last Update Posted Date September 7, 2016
Study Start Date  ICMJE September 2000
Actual Primary Completion Date May 2001   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2009)
  • Anti-PT, anti-FHA and anti-PRN antibody titers. [ Time Frame: One month after the 3rd dose of the primary vaccination course ]
  • Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers [ Time Frame: One month after the 3rd dose of the primary vaccination course ]
  • Anti-HBs antibody titers [ Time Frame: One month after the 3rd dose of the primary vaccination course ]
  • Anti-polio virus types 1, 2 and 3 antibody titers [ Time Frame: One month after the 3rd dose of the primary vaccination course ]
  • Anti-PRP antibody titers [ Time Frame: One month after the 3rd dose of the primary vaccination course ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2009)
  • Occurrence of solicited adverse events [ Time Frame: During the 4-day follow-up period after each dose ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the 30-day follow-up period after each dose ]
  • Occurrence of Serious Adverse Events [ Time Frame: Over the course of the study ]
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 Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
Official Title  ICMJE Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV and Hib Vaccines When Administered Concomitantly to Healthy Infants Administered as a Three-dose Primary Vaccination Course at the Age of 1.5, 3.5 and 6 Months
Brief Summary The purpose of this study is to evaluate the immune response and reactogenicity of GSK Biologicals' DTPa-HBV-IPV combined pentavalent vaccine and Hib tetanus conjugate vaccine, administered concomitantly as a three-dose primary vaccination course.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Diphtheria
  • Poliomyelitis
  • Hepatitis B
  • Tetanus
  • Acellular Pertussis
Intervention  ICMJE
  • Biological: Pediarix TM, Infanrix penta TM
    The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
  • Biological: Hiberix TM
    The vaccines were administered according to a 3-dose schedule at 1.5, 3.5 and 6 months of age.
Study Arms  ICMJE Experimental: Single Group
Interventions:
  • Biological: Pediarix TM, Infanrix penta TM
  • Biological: Hiberix TM
Publications * Shao PL, Lu CY, Hsieh YC; Taiwan Infanrix-049 Study Group, Bock HL, Huang LM. Immunogenicity and reactogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus and Haemophilus influenzae type B. J Formos Med Assoc. 2011 May;110(5):336-41. doi: 10.1016/S0929-6646(11)60050-8.

*   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 9, 2009)
60
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2001
Actual Primary Completion Date May 2001   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • A male or female infant between 6 and 8 weeks of age at the time of the first vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.
  • Written informed consent obtained from the parents or guardians of the subject.
  • Born after a normal gestation period (between 36 and 42 weeks).

Exclusion Criteria:

  • Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) during the study period or within 30 days preceding the first dose of study vaccine.
  • Administration of chronic immunosuppressants or other immune-modifying drugs since birth or planned administration during the study.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of vaccine(s) and ending 30 days after.
  • Previous vaccination against diphtheria, tetanus, pertussis, polio or Haemophilus influenzae type b.
  • History of, or intercurrent, diphtheria, tetanus, pertussis, hepatitis B, polio and/or Haemophilus influenzae type b.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus infection.
  • Major congenital defects
  • Serious chronic illness
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Acute disease at the time of enrollment.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Weeks to 8 Weeks   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00879827
Other Study ID Numbers  ICMJE 217744/049
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2016

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