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

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

Tracking Information

• First Submitted Date: April 9, 2009
• First Posted Date: April 13, 2009
• Last Update Posted Date: September 7, 2016
• Study Start Date: September 2000
• Actual Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Immunogenicity and Reactogenicity of GSK Bio DTPa-HBV-IPV and Hib Vaccines When Coadministered to Healthy Infants
• Official Title: 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: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Prevention

Condition

• Diphtheria
• Poliomyelitis
• Hepatitis B
• Tetanus
• Acellular Pertussis

Intervention

• 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

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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 9, 2009): 60
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: May 2001
• Actual Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 6 Weeks to 8 Weeks (Child)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00879827
• Other Study ID Numbers: 217744/049
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• 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: GlaxoSmithKline
• Collaborators: Not Provided

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

• PRS Account: GlaxoSmithKline
• Verification Date: September 2016