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Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00332566
First Posted: June 1, 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
  Purpose
This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Condition Intervention Phase
Hepatitis B Whole Cell Pertussis Tetanus Haemophilus Influenzae Type b Diphtheria Biological: DTPw-HBV/Hib Kft vaccine GSK323527A Biological: Tritanrix™-HepB/Hiberix™ Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals' DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals' DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration [ Time Frame: One month after the booster dose ]
  • Anti-hepatitis B surface antigen (HBs) antibody concentration [ Time Frame: One month after the booster dose ]
  • Anti-diphtheria antibody concentration [ Time Frame: One month after the booster dose ]
  • Anti-tetanus antibody concentration [ Time Frame: One month after the booster dose ]

Secondary Outcome Measures:
  • Anti-Bordetella pertussis (BPT) antibody concentration [ Time Frame: One month after the booster dose ]
  • Anti-PRP antibody concentration [ Time Frame: Prior to the booster dose ]
  • Anti-HBs antibody concentration [ Time Frame: Prior to the booster dose ]
  • Anti-diphtheria antibody concentration [ Time Frame: Prior to the booster dose ]
  • Anti-tetanus antibody concentration [ Time Frame: Prior to the booster dose ]
  • Anti-BPT antibody concentration [ Time Frame: Prior to the booster dose ]
  • Occurrence of solicited symptoms [ Time Frame: During the 4-day follow-up period after the booster dose ]
  • Occurrence of unsolicited symptoms [ Time Frame: During the 31-day follow-up period after the booster dose ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study period. ]

Enrollment: 148
Study Start Date: June 2006
Study Completion Date: October 2006
Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: DTPw-HBV/Hib Kft vaccine GSK323527A
Intramuscular injection, 1 dose
Active Comparator: Group B Biological: Tritanrix™-HepB/Hiberix™
Intramuscular injection, 1 dose

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Months to 24 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
  • A male or female toddler, 18 to 24 months of age at the time of booster vaccination, who completed the three-dose primary vaccination course in the 101223 study.
  • Written informed consent obtained from the parent or guardian of the subject.
  • Healthy subjects 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 vaccines within 30 days preceding the booster 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 within six months prior to the booster vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of the booster vaccine dose, with the exception of oral polio vaccine (OPV).
  • Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study.
  • History of diphtheria, tetanus, pertussis, hepatitis B and Hib disease.
  • Known exposure to diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products during the study period.
  • Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
  • One of the following adverse events that constitute absolute contraindications to further administration of DTP vaccine, having occurred after previous administration of DTPw vaccine.

    • Known hypersensitivity to any component of the vaccine, or having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or HB vaccines.
    • Encephalopathy
    • Axillary temperature of >= 40 °C/ rectal temperature >= 40.5 °C within 48 hours of vaccination.
    • Collapse or shock-like state within 48 hours of vaccination.
    • Persistent, inconsolable crying lasting >= 3 hours occurring within 48 hours of vaccination.
    • Seizures with or without fever occurring within 3 days of vaccination.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00332566


Locations
Argentina
GSK Investigational Site
Capital Federal, Buenos Aires, Argentina, 1425
Nicaragua
GSK Investigational Site
Leon, Nicaragua
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Additional Information:
Study Data/Documents: Statistical Analysis Plan  This link exits the ClinicalTrials.gov site
Identifier: 106602
For additional information about this study please refer to the GSK Clinical Study Register
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: 106602
For additional information about this study please refer to the GSK Clinical Study Register
Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: 106602
For additional information about this study please refer to the GSK Clinical Study Register
Individual Participant Data Set  This link exits the ClinicalTrials.gov site
Identifier: 106602
For additional information about this study please refer to the GSK Clinical Study Register
Clinical Study Report  This link exits the ClinicalTrials.gov site
Identifier: 106602
For additional information about this study please refer to the GSK Clinical Study Register
Dataset Specification  This link exits the ClinicalTrials.gov site
Identifier: 106602
For additional information about this study please refer to the GSK Clinical Study Register

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00332566     History of Changes
Other Study ID Numbers: 106602
First Submitted: May 31, 2006
First Posted: June 1, 2006
Last Update Posted: September 28, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
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.

Additional relevant MeSH terms:
Hepatitis B
Diphtheria
Hepadnaviridae Infections
DNA Virus Infections
Virus Diseases
Hepatitis, Viral, Human
Hepatitis
Liver Diseases
Digestive System Diseases
Corynebacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Vaccines
Immunologic Factors
Physiological Effects of Drugs


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