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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00879827
First received: April 9, 2009
Last updated: September 6, 2016
Last verified: September 2016

April 9, 2009
September 6, 2016
September 2000
May 2001   (final data collection date for primary outcome measure)
  • Anti-PT, anti-FHA and anti-PRN antibody titers. [ Time Frame: One month after the 3rd dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • Anti-diphtheria toxoid and anti-tetanus toxoid antibody titers [ Time Frame: One month after the 3rd dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • Anti-HBs antibody titers [ Time Frame: One month after the 3rd dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • Anti-polio virus types 1, 2 and 3 antibody titers [ Time Frame: One month after the 3rd dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • Anti-PRP antibody titers [ Time Frame: One month after the 3rd dose of the primary vaccination course ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00879827 on ClinicalTrials.gov Archive Site
  • Occurrence of solicited adverse events [ Time Frame: During the 4-day follow-up period after each dose ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: During the 30-day follow-up period after each dose ] [ Designated as safety issue: No ]
  • Occurrence of Serious Adverse Events [ Time Frame: Over the course of the study ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
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
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.
Not Provided
Interventional
Phase 3
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diphtheria
  • Poliomyelitis
  • Hepatitis B
  • Tetanus
  • Acellular Pertussis
  • 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.
Experimental: Single Group
Interventions:
  • Biological: Pediarix TM, Infanrix penta TM
  • Biological: Hiberix TM
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.
 
Completed
60
May 2001
May 2001   (final data collection date for primary outcome measure)

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.
Both
6 Weeks to 8 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00879827
217744/049
Not Provided
Yes
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

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