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

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


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

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
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Please refer to this study by its identifier: NCT00473668

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

Responsible Party: GlaxoSmithKline 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
Haemophilus influenzae type b Vaccines

Additional relevant MeSH terms:
Hepatitis B
Whooping Cough
Liver Diseases
Digestive System Diseases
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Bordetella Infections
Gram-Negative Bacterial Infections
Bacterial Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Clostridium Infections
Gram-Positive Bacterial Infections
Corynebacterium Infections
Actinomycetales Infections processed this record on October 21, 2016