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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:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00366366
First received: August 18, 2006
Last updated: October 18, 2006
Last verified: September 2006
History of Changes
  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
Diphtheria
Tetanus
Pertussis
Hepatitis B
Polio
Haemophilus Influenzae Type 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: To Assess Interchangeability b/w GSK Bio’s DTPa-HBV-IPV/Hib (Mixed Vaccine) & DTPa-IPV/Hib + HBV at 3rd Dose of Primary Vaccination Course in Children Who Received HBV Vaccine at Birth & 1 Mth & DTPa-IPV/Hib Vaccine at 3 & 4 Mths of Age

Resource links provided by NLM:

U.S. FDA Resources

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

Estimated Enrollment: 150
  Eligibility

Ages Eligible for Study:   11 Weeks to 17 Weeks
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00366366

Locations
Singapore
GSK Clinical Trials Call Center
Choa Chu Kang, Singapore
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: Clinical Trials GlaxoSmithKline
  More Information

No publications provided by GlaxoSmithKline

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00366366     History of Changes
Other Study ID Numbers: 217744/075
Study First Received: August 18, 2006
Last Updated: October 18, 2006
Health Authority: Singapore: Health Sciences Authority

Additional relevant MeSH terms:
Diphtheria
Hepatitis
Hepatitis A
Hepatitis B
Influenza, Human
Whooping Cough
Poliomyelitis
Tetanus
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
 Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Orthomyxoviridae Infections
Respiratory Tract Infections
Respiratory Tract Diseases
Bordetella Infections
Gram-Negative Bacterial Infections
Infection
Myelitis
Central Nervous System Viral Diseases
Central Nervous System Infections

ClinicalTrials.gov processed this record on May 23, 2013