Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00627458
First received: February 20, 2008
Last updated: September 29, 2009
Last verified: September 2009
  Purpose

The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).


Condition Intervention Phase
Diphtheria
Tetanus
Whooping Cough
Hepatitis B
Poliovirus
Meningitis
Biological: Infanrix Hexa
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Reactogenicity of GSK Bio's DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose.

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Seroprotection status for the selected groups: anti-diphtheria and anti-tetanus toxoid antibody concentrations [ Time Frame: Before and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • Seroprotection status for the selected groups: anti-HBs antibody concentrations [ Time Frame: Before and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • Seroprotection status for the selected groups: anti-poliovirus type 1, type 2 & type 3 antibody titres [ Time Frame: Before and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • Seroprotection status for the selected groups: anti-PRP antibody concentrations [ Time Frame: Before and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • Seropositivity status for selected groups: anti-PT, anti-FHA and anti-PRN concentrations [ Time Frame: Before and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • For selected groups: vaccine response to PT, FHA and PRN [ Time Frame: One month after the booster vaccination ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • In all groups, use of concomitant medications and antipyretics [ Time Frame: During the 4-day follow-up period and the 31-day follow-up period after booster vaccination. ]
  • Seroprotection status for the selected groups: anti-diphtheria and anti-tetanus toxoid antibody concentrations. [ Time Frame: Before and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • Seroprotection status for the selected groups: anti-HBs antibody concentrations [ Time Frame: Before and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • Seroprotection status for the selected groups: anti-poliovirus type 1, type 2 & type 3 antibody titres [ Time Frame: Before and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • Seroprotection status for the selected groups: anti-PRP antibody concentrations [ Time Frame: Before and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • In selected groups, seropositivity status: anti-PT, anti-FHA and anti-PRN concentrations [ Time Frame: Before and one month after the booster vaccination ] [ Designated as safety issue: No ]
  • In selected groups: vaccine response to PT, FHA and PRN [ Time Frame: One month after the booster vaccination ] [ Designated as safety issue: No ]
  • In all groups, occurrence of solicited local symptoms. [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after the booster vaccination ] [ Designated as safety issue: No ]
  • In all groups, occurrence of solicited general symptoms [ Time Frame: During the 4-day (Day 0-Day 3) follow-up period after the booster vaccination. ] [ Designated as safety issue: No ]
  • In all groups, occurrence of unsolicited symptoms [ Time Frame: During the 31-day (Day 0-Day 30) follow-up period after the booster vaccination. ] [ Designated as safety issue: No ]
  • In all groups, occurrence of serious adverse events (SAEs) [ Time Frame: From study vaccine administration throughout the study period. ] [ Designated as safety issue: No ]

Enrollment: 219
Study Start Date: February 2008
Study Completion Date: August 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group B
Alternative antigens, preservative-containing (The groups in this study are identified according to the vaccine received in the primary study)
Biological: Infanrix Hexa
Vaccine administered as a booster dose at 16-20 months of age
Other Name: GSK Biological's combined DTPa-HBV-IPV/Hib vaccine
Experimental: Group A
Alternative antigens, preservative-free formulation (The groups in this study are identified according to the vaccine received in the primary study)
Biological: Infanrix Hexa
Vaccine administered as a booster dose at 16-20 months of age
Other Name: GSK Biological's combined DTPa-HBV-IPV/Hib vaccine
Active Comparator: Group C
Licensed formulation (The groups in this study are identified according to the vaccine received in the primary study)
Biological: Infanrix Hexa
Vaccine administered as a booster dose at 16-20 months of age
Other Name: GSK Biological's combined DTPa-HBV-IPV/Hib vaccine

Detailed Description:

This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.

  Eligibility

Ages Eligible for Study:   16 Months to 20 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
  • Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
  • A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
  • 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 vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
  • Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
  • Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Acute disease at the time of enrolment.
  • Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose 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: NCT00627458

Locations
Finland
GSK Investigational Site
Jarvenpaa, Finland, 04400
GSK Investigational Site
Oulu, Finland, 90220
GSK Investigational Site
Pori, Finland, 28100
GSK Investigational Site
Tampere, Finland, 33100
GSK Investigational Site
Turku, Finland, 20520
GSK Investigational Site
Vantaa, Finland, 01300
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Study Director, GSK
ClinicalTrials.gov Identifier: NCT00627458     History of Changes
Other Study ID Numbers: 111344
Study First Received: February 20, 2008
Last Updated: September 29, 2009
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by GlaxoSmithKline:
Booster
Hexavalent vaccine

Additional relevant MeSH terms:
Hepatitis B
Meningitis
Whooping Cough
Bacterial Infections
Bordetella Infections
Central Nervous System Diseases
Central Nervous System Infections
DNA Virus Infections
Digestive System Diseases
Gram-Negative Bacterial Infections
Hepadnaviridae Infections
Hepatitis
Hepatitis, Viral, Human
Infection
Liver Diseases
Nervous System Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases

ClinicalTrials.gov processed this record on November 25, 2014