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

This study has been completed.
Information provided by:
GlaxoSmithKline Identifier:
First received: February 21, 2006
Last updated: September 29, 2011
Last verified: September 2011

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
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:

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
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

Ages Eligible for Study:   6 Weeks to 10 Weeks   (Child)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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
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: NCT00316147

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
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure 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:
hepatitis B
Haemophilus influenza type b diseases

Additional relevant MeSH terms:
Immunologic Factors
Physiological Effects of Drugs processed this record on July 28, 2016