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

Compare Immunogenicity & Safety of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine Given in Healthy Infants

This study has been completed.
Information provided by (Responsible Party):
GlaxoSmithKline Identifier:
First received: February 21, 2006
Last updated: November 21, 2012
Last verified: November 2012

In this study, infants will be randomly allocated into three groups:

  • one group of subjects will receive DTPa-HBV-IPV/Hib vaccine (new formulation)
  • the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine (current formulation)
  • the third group of subjects will receive DTPa-HBV-IPV vaccine The study will be double-blind for the two groups receiving the DTPa-HBV-IPV/Hib vaccine (new or current formulation). The study will be single-blind for the group receiving DTPa-HBV-IPV vaccine.

Condition Intervention Phase
Haemophilus Influenzae Type b Disease
Hepatitis B
Biological: DTPa-HBV-IPV/Hib vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Compare Immunogenicity & Reactogenicity of 2 Formulations of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine (New vs Current) Given in Healthy Infants. The DTPa-HBV-IPV Vaccine (New Formulation) Will Also be Assessed in a 3rd Group of Subjects

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • One month after vaccination, measurement of antibodies against all vaccine antigens.

Secondary Outcome Measures:
  • "Immunogenicity: One month after vaccination, vaccine response for the pertussis antigens.
  • Reactogenicity & safety: After each dose, solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs)."

Estimated Enrollment: 415
Study Start Date: April 2006
Study Completion Date: January 2007
Detailed Description:
A study to compare the immunogenicity & safety of 2 formulations of GlaxoSmithKline (GSK) Biologicals' DTPa-HBV-IPV/Hib vaccine given in healthy infants at 3,4 & 5 months age. The immunogenicity & safety of DTPa-HBV-IPV vaccine will also be evaluated in a 3rd group of subjects Subjects in the group that will receive DTPa-HBV-IPV/Hib vaccine (current formulation) will be the control group for the group that will receive DTPa-HBV-IPV/Hib vaccine (new formulation)

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

"Inclusion criteria:

  • A healthy male or female infant between, and including, 11 and 17 weeks of age at the time of the first vaccination.
  • Infant born to known hepatitis B surface antigen (HBsAg) seronegative mother (documented laboratory result of HBsAg assay from the maternal blood sample is available).
  • Born after a normal gestation period (between 36 and 42 weeks).
  • Written informed consent obtained from the parent or guardian of the subject.

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 of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Any chronic drug therapy to be continued during the study period.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after the last vaccine dose.
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases.
  • Known history of or exposure to diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B and/or Haemophilus influenzae diseases since birth.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  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: NCT00320463

Russian Federation
GSK Investigational Site
Murmansk, Russian Federation, 183046
GSK Investigational Site
Perm, Russian Federation, 614022
GSK Investigational Site
Syktyvkar, Russian Federation, 167011
Sponsors and Collaborators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: GlaxoSmithKline Identifier: NCT00320463     History of Changes
Other Study ID Numbers: 105910 
Study First Received: February 21, 2006
Last Updated: November 21, 2012
Health Authority: Russia: Ministry of Health of the Russian Federation

Additional relevant MeSH terms:
Hepatitis B
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
Immunologic Factors
Physiological Effects of Drugs processed this record on September 23, 2016