Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Immunogenicity and Safety of a DTPa-HBV-IPV/Hib Vaccine Given at 2, 3 and 4 Months of Age

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: September 14, 2006
Last updated: September 29, 2011
Last verified: September 2011
The purpose of this study is to show that the immunogenicity of newly formulated DTPa-HBV-IPV/Hib vaccine is as good as the immunogenicity of the currently licensed formulation of the vaccine. The vaccine will be administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age and its safety and reactogenicity will also be assessed.

Condition Intervention Phase
Hepatitis B
Haemophilus Infection
Biological: Infanrix hexa Vaccine
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: A Study to Evaluate the Immunogenicity and Safety of a New Formulation of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine as Compared to the Currently Licensed Infanrix Hexa in Healthy Infants (2,3,4 M)

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Antibody concentration/response to all vaccine antigens after vaccination

Secondary Outcome Measures:
  • Solicited (D0-3); unsolicited events (D0-30); serious adverse events (SAEs) (full study)

Estimated Enrollment: 450
Study Start Date: October 2006

Ages Eligible for Study:   8 Weeks to 12 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • A healthy male or female between, and including, 8 and 12 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parents/guardians of the subject.
  • Born after a normal gestation period of 36 to 42 weeks.

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.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs from birth until first primary vaccination dose.
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  • Administration/planned administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the first dose and ending 30 days after the last dose, with the exception of the human rotavirus (HRV) vaccine.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
  • Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B and/or Haemophilus influenza type b (Hib) vaccination or disease.
  • Hepatitis B virus (HBV) vaccination at birth.
  • History of seizures or progressive neurological disease.
  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 identifier: NCT00376779

GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Oulu, Finland, 90100
GSK Investigational Site
Pori, Finland, 28120
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Turku, Finland, 20520
GSK Investigational Site
Vantaa, Finland, 01300
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure Identifier: NCT00376779     History of Changes
Other Study ID Numbers: 106786 
Study First Received: September 14, 2006
Last Updated: September 29, 2011
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by GlaxoSmithKline:
Haemophilus influenzae type b
phase 2
GSK Biologicals

Additional relevant MeSH terms:
Hepatitis B
Haemophilus Infections
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Spinal Cord Diseases
Neuromuscular Diseases
Pasteurellaceae Infections
Gram-Negative Bacterial Infections
Immunologic Factors
Physiological Effects of Drugs processed this record on October 21, 2016