Non-inferiority of GSK Biologicals' DTPw-HBV/Hib Compared to Two Formulations of GSK Biologicals' DTPw-HBV/Hib

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00473668
First received: May 14, 2007
Last updated: June 14, 2012
Last verified: June 2012
  Purpose

The purpose of this observer-blind study is to generate immunogenicity data with one formulation of GSK Biologicals' DTPw-HBV/Hib vaccine after the primary vaccination course and to demonstrate non-inferiority of this vaccine as compared to two formulations of GSK Biologicals' DTPw-HBV/Hib vaccine with respect to the anti-PRP antibody response. Additionally to assess the reactogenicity and safety of GSK Biologicals' DTPw-HBV/Hib vaccine. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.


Condition Intervention Phase
Haemophilus Influenzae Type b Disease
Hepatitis B
Diphtheria
Pertussis
Tetanus
Biological: DTPw-HBV/Hib Kft GSK32327A
Biological: DTPw HBV/Hib2.5 GSK357939A
Biological: Tritanrix™-HepB/ Hiberix™
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Non-inferiority of One Formulation of GSK Biologicals' DTPw-HBV/Hib to 2 Formulations of GSK Biologicals' DTPw-HBV/Hib With Respect to the Immune Response to the PRP Antigen, When Administered to Healthy Infants at 6, 10, 14 Weeks of Age

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration. [ Time Frame: One month after the third dose of the primary vaccination course ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anti-hepatitis B surface antigen (HBs) antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • Anti-diphtheria antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • Anti-tetanus antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • Anti- Bordetella pertussis (BPT) antibody concentration [ Time Frame: One month after the third dose of the primary vaccination course ] [ Designated as safety issue: No ]
  • Occurrence of solicited symptoms [ Time Frame: During the 4-day follow-up period after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after each vaccine dose. ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: June 2007
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: DTPw-HBV/Hib Kft GSK32327A
Intramuscular injection, 1 dose
Active Comparator: Group B Biological: DTPw HBV/Hib2.5 GSK357939A
Intramuscular injection, 1 dose
Active Comparator: Group C Biological: Tritanrix™-HepB/ Hiberix™
Intramuscular injection, 1 dose

  Eligibility

Ages Eligible for Study:   6 Weeks to 8 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female between, and including, 6 and 8 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Born after a gestation period of 36 to 42 weeks inclusive.
  • Administration of one dose of hepatitis B vaccine at birth

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period with the exception of OPV.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs since birth.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first vaccine dose, (with the exception of OPV).
  • Bacille Calmette-Guérin (BCG) vaccine received after the first 2 weeks of life.
  • Hepatitis B vaccine received after the first week of life.
  • Previous vaccination against diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B (except hepatitis B at birth).
  • History of diphtheria, tetanus, pertussis, Haemophilus influenzae or hepatitis B diseases.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  • Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  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: NCT00473668

Locations
India
GSK Investigational Site
Bangalore, India, 560034
GSK Investigational Site
Kolkotta, India, 700072
GSK Investigational Site
Varanasi, India, 221005
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00473668     History of Changes
Other Study ID Numbers: 104977
Study First Received: May 14, 2007
Last Updated: June 14, 2012
Health Authority: India: Drugs Controller General of India

Keywords provided by GlaxoSmithKline:
Hepatitis B
Tetanus
Diphtheria
Pertussis
Haemophilus influenzae type b Vaccines

Additional relevant MeSH terms:
Hepatitis
Diphtheria
Hepatitis B
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human

ClinicalTrials.gov processed this record on September 16, 2014