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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
  Purpose
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.

Condition Intervention Phase
Diphtheria
Poliomyelitis
Hepatitis B
Tetanus
Acellular Pertussis
Biological: Pediarix TM, Infanrix penta TM
Biological: Hiberix TM
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 60
Study Start Date: September 2000
Study Completion Date: May 2001
Primary Completion Date: May 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Group 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.

  Eligibility

Ages Eligible for Study:   6 Weeks to 8 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  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: NCT00879827

Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Publications:
Study Data/Documents: Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 217744/049
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 217744/049
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 217744/049
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 217744/049
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 217744/049
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00879827     History of Changes
Other Study ID Numbers: 217744/049 
Study First Received: April 9, 2009
Last Updated: September 6, 2016
Health Authority: Taiwan: Department of Health
Individual Participant Data  
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.

Additional relevant MeSH terms:
Hepatitis B
Diphtheria
Poliomyelitis
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Myelitis
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on December 09, 2016