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To Evaluate Immunogenicity & Safety of GSK Bio's DTPa-HBV-IPV/Hib (Mixed Vaccine) and DTPa-IPV/Hib + HBV Vaccines

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00366366
First received: August 18, 2006
Last updated: September 15, 2016
Last verified: September 2016
  Purpose
This study assessed the immunogenicity and safety of two vaccination regimens that employed either GSK Biologicals' combined DTPa-HBV-IPV/Hib vaccine or DTPa-IPV/Hib vaccine. In the two groups, infants received the DTPa-IPV/Hib vaccine at 3 and 4 months of age, as the first 2 doses of the primary vaccination course. At 5 months of age, they received either the DTPa-IPV/Hib vaccine co-administered with the HBV vaccine or a dose of the DTPa-HBV-IPV/Hib vaccine as a 3rd dose. Infants in the two groups had previously received 2 doses of HBV vaccine at birth and at 1 month of age.

Condition Intervention Phase
Hepatitis B
Biological: Infanrix-Hexa
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase III, Open, Randomised Immunogenicity and Reactogenicity Study to Assess the Interchangeability Between GSK Bios' DTPa-HBV-IPV/Hib and DTPa-IPV/Hib + HBV at 3rd Dose of Primary Vac. Course in Children Who Received HBV Vac. at Birth and One Month of Age and DTPa-IPV/Hib Vac at 3-4 Mth of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-HBs conc >=10 mIU/ml, 1 month after the last vaccine dose

Secondary Outcome Measures:
  • Ab conc/titers against all vaccine antigens
  • Safety: Solicited symptoms, unsolicited AEs and SAEs

Enrollment: 150
Study Start Date: September 2001
Study Completion Date: September 2002
Primary Completion Date: September 2002 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   11 Weeks to 17 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A male or female infant at the age of 11 - 17 weeks.
  • Written informed consent obtained from the parents or guardians of the subject.
  • Free of obvious health problems as established by clinical examination before entering into the study.
  • Hepatitis B vaccine at birth and one month of age.

Exclusion Criteria:

  • Previous vaccination against measles, mumps, rubella and/or varicella.
  • Use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • A family history of congenital or hereditary immunodeficiency.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including HIV infection.
  • Major congenital defects.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
  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: NCT00366366

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

Additional Information:
Publications:
Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 217744/075
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: 217744/075
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 217744/075
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: 217744/075
For additional information about this study please refer to the GSK Clinical Study Register
Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 217744/075
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: 217744/075
For additional information about this study please refer to the GSK Clinical Study Register

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00366366     History of Changes
Other Study ID Numbers: 217744/075 
Study First Received: August 18, 2006
Last Updated: September 15, 2016
Health Authority: Singapore: Health Sciences Authority
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
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on September 30, 2016