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Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00316147
First received: February 21, 2006
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
  Purpose

In this study, infants who were previously vaccinated with hepatitis B vaccine at birth will be randomly allocated into two groups:

  • one group of subjects will receive diphtheria, tetanus, acellular pertussis- hepatitis B virus-inactivated poliovirus/Haemophilus influenzae type b (DTPa-HBV-IPV/Hib) vaccine at 6-10-14 weeks of age
  • the second group of subjects will receive DTPa-HBV-IPV/Hib vaccine at 2-4-6 months of age

Condition Intervention Phase
Healthy Subjects
Infant
 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: Open Label
Primary Purpose: Prevention
Official Title: Phase IIIb, Open, Randomized, Multicenter Study to Assess the Immunogenicity & Safety of GSK Biologicals' Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants When Given at 6-10-14 Weeks of Age or at 2-4-6 Months of Age

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers

Secondary Outcome Measures:
  • 1M post-dose 3, antibody levels against all antigens
  • After each dose, solicited (day 0-3, local and general) and unsolicited (day 0-30) events
  • Serious adverse events (SAEs) for entire study

Estimated Enrollment: 224
Study Start Date: December 2005
Intervention Details:
    Biological: DTPa-HBV-IPV/Hib vaccine
    Other Name: DTPa-HBV-IPV/Hib vaccine
Detailed Description:

DTPa-HBV-IPV/Hib vaccine will be administered at two schedules (i.e. 6-10-14 weeks of age OR 2-4-6 months of age) in infants who were previously vaccinated with hepatitis B vaccine at birth. The duration of the study will be approximately 3 months for each subject who will receive vaccination at 6-10-14 weeks of age and approximately 5 months for each subject who will receive vaccination at 2-4-6 months of age. Intervention name: Diphteria, tetanus, acellular pertussis, hepatitis B, poliovirus types 1, 2, 3 & Haemophilus influenzae type b vaccine

  Eligibility

Ages Eligible for Study:   6 Weeks to 10 Weeks
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • A healthy male or female infant between, and including, 6 to 10 weeks of age at the time of the first vaccination.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Born after a normal gestation period (between 36 and 42 weeks).
  • Should have received a birth dose of hepatitis B vaccine, as evidenced by vaccination/immunisation certificate.

Exclusion Criteria:

  • Use of any investigational or non-registered product (vaccine or drug) other than the study vaccine 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 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 30 days before the administration of the first vaccine dose and ending 30 days after the last dose (with the exception of oral polio vaccine as a birth dose or for a pulse polio program, as per local, regional, or national requirements).
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b diseases.
  • Known exposure to diphtheria, tetanus, Bordetella pertussis, hepatitis B, poliomyelitis and Haemophilus influenzae type b diseases since birth.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00316147

Locations
India
GSK Investigational Site
Bangalore, India, 560034
GSK Investigational Site
Baroda, India, 390 001
GSK Investigational Site
Goa, India, 403202
GSK Investigational Site
New Delhi, India, 110002
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT00316147     History of Changes
Other Study ID Numbers: 104005
Study First Received: February 21, 2006
Last Updated: September 29, 2011
Health Authority: India: Drugs Controller General of India (DCGI)

Keywords provided by GlaxoSmithKline:
diphtheria
tetanus
poliomyelitis
pertussis
 hepatitis B
Prophylaxis
Haemophilus influenza type b diseases

Additional relevant MeSH terms:
Pentetic Acid
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
 Antidotes
Protective Agents
Physiological Effects of Drugs
Iron Chelating Agents

ClinicalTrials.gov processed this record on May 21, 2013