Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00158756
First received: September 8, 2005
Last updated: September 29, 2011
Last verified: September 2011
  Purpose

To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.


Condition Intervention Phase
Healthy Subjects
Infant
Biological: Diphtheria
Biological: Tetanus
Biological: Pertussis
Biological: Hepatitis B vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assess Immunogenicity & Reactogenicity of 2 Formulations of GSK's DTPw-HBV Vaccines vs Concomitant Admn of CSL's DTPw & GSK's HBV Vaccine, Co-admnd With GSK's Rotavirus Vaccine, to Infants at 3, 4½ & 6 Mths, After Birth Dose of HBV Vaccine

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • One month after the third dose of the primary vaccination course, anti-diphtheria antibody concentration. [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • One month after the third dose of the primary vaccination course: antibody concentrations or titres against all vaccine antigens (diphtheria, tetanus, pertussis, hepatitis B, rotavirus and poliovirus antigens) [ Designated as safety issue: No ]
  • Occurrence of solicited symptoms during the specific follow-up period after each dose. [ Designated as safety issue: No ]
  • Occurrence of unsolicited symptoms during the specific follow-up period after each dose. [ Designated as safety issue: No ]
  • Occurrence of serious adverse events over the full course of the study. [ Designated as safety issue: No ]

Enrollment: 307
Study Start Date: September 2005
Study Completion Date: November 2006
Primary Completion Date: November 2006 (Final data collection date for primary outcome measure)
Detailed Description:

Randomized study with five groups to receive one of the following vaccination regimens:

One of the two formulations of GSK Biologicals' DTPw-HBV + GSK Biologicals' HRV One of the two formulations of GSK Biologicals' DTPw-HBV + Placebo CSL's DTPw + GSK Biologicals' HBV

  Eligibility

Ages Eligible for Study:   up to 4 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
  • Administration of one dose of hepatitis B vaccine at birth.
  • A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
  • Free of obvious health problems as established by medical history and clinical examination before entering into the study.

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 since birth.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
  • Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
  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 ClinicalTrials.gov identifier: NCT00158756

Locations
Russian Federation
GSK Investigational Site
Barnaul, Russian Federation, 656049
GSK Investigational Site
Ekaterinburg, Russian Federation, 620003
GSK Investigational Site
Ivanteevka Moscow region, Russian Federation, 141280
GSK Investigational Site
Krasnoyarsk, Russian Federation, 660027
GSK Investigational Site
Moscow, Russian Federation, 119991
GSK Investigational Site
Moscow, Russian Federation, 129347
GSK Investigational Site
Samara, Russian Federation, 443021
GSK Investigational Site
St Petersburg, Russian Federation, 197022
GSK Investigational Site
Tomsk, Russian Federation, 634 050
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: NCT00158756     History of Changes
Other Study ID Numbers: 104021
Study First Received: September 8, 2005
Last Updated: September 29, 2011
Health Authority: Russia: Pharmacological Committee, Ministry of Health

Keywords provided by GlaxoSmithKline:
Diphtheria
Pertussis
Prophylaxis
Hepatitis B diseases
Tetanus

ClinicalTrials.gov processed this record on July 26, 2014