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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:
ClinicalTrials.gov Identifier:
NCT00316147
First Posted: April 20, 2006
Last Update Posted: September 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
February 21, 2006
April 20, 2006
September 28, 2016
December 2005
Not Provided
1M post-dose 3, vaccine response for pertussis and anti-poliovirus types 1, 2, and 3 titers
  • Primary outcome: 1M post-dose 3, vaccine response for pertussis & anti-poliovirus types 1,2 & 3 titers.
  • Secondary outcome: 1M post-dose 3, antibody levels against all antigens. After each dose, solicited (day 0-3, local & general) & unsolicited (day 0-30) events. SAEs for entire study.
Complete list of historical versions of study NCT00316147 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
Not Provided
 
Immunogenicity & Safety of GSK's Combined DTPa-HBV-IPV/Hib Vaccine in Indian Infants at 2 Diff Vaccination Schedules
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

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
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
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Diphtheria
  • Acellular Pertussis
  • Tetanus
  • Haemophilus Influenzae Type b
  • Hepatitis B
  • Poliomyelitis
Biological: DTPa-HBV-IPV/Hib vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
224
August 2006
Not Provided

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.
Sexes Eligible for Study: All
6 Weeks to 10 Weeks   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
India
 
 
NCT00316147
104005
Not Provided
Not Provided
Plan to Share IPD: Yes
Plan Description: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP