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

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ClinicalTrials.gov Identifier: NCT00332566
Recruitment Status : Completed
First Posted : June 1, 2006
Last Update Posted : September 28, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Tracking Information
First Submitted Date  ICMJE May 31, 2006
First Posted Date  ICMJE June 1, 2006
Last Update Posted Date September 28, 2016
Study Start Date  ICMJE June 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 11, 2008)
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 31, 2006)
Ab conc to all vaccine antigens except anti-BPT
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 11, 2008)
  • 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. ]
Original Secondary Outcome Measures  ICMJE
 (submitted: May 31, 2006)
  • Anti-BPT ab conc & vacc response
  • Pre-booster ab conc to all vacc antigens, Solicited & unsolicited symptoms, SAEs
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib
Official Title  ICMJE 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.
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • Hepatitis B
  • Whole Cell Pertussis
  • Tetanus
  • Haemophilus Influenzae Type b
  • Diphtheria
Intervention  ICMJE
  • Biological: DTPw-HBV/Hib Kft vaccine GSK323527A
    Intramuscular injection, 1 dose
  • Biological: Tritanrix™-HepB/Hiberix™
    Intramuscular injection, 1 dose
Study Arms  ICMJE
  • Experimental: Group A
    Intervention: Biological: DTPw-HBV/Hib Kft vaccine GSK323527A
  • Active Comparator: Group B
    Intervention: Biological: Tritanrix™-HepB/Hiberix™
Publications * Espinoza F, Tregnaghi M, Gentile A, Abarca K, Casellas J, Collard A, Lefevre I, Jacquet JM. Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial. BMC Infect Dis. 2010 Oct 15;10:297. doi: 10.1186/1471-2334-10-297.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 11, 2008)
148
Original Enrollment  ICMJE
 (submitted: May 31, 2006)
340
Actual Study Completion Date  ICMJE October 2006
Actual Primary Completion Date October 2006   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Months to 24 Months   (Child)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Argentina,   Nicaragua
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00332566
Other Study ID Numbers  ICMJE 106602
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
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.
Responsible Party GlaxoSmithKline
Study Sponsor  ICMJE GlaxoSmithKline
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: GSK Clinical Trials GlaxoSmithKline
PRS Account GlaxoSmithKline
Verification Date September 2016

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