Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diphtheria; Tetanus; Whooping Cough; Hepatitis B; Poliovirus; Meningitis
Intervention: Infanrix Hexa (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
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).
Clinical Details
Official title: Immunogenicity and Reactogenicity of GSK Bio's DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose.
Study design: Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Seroprotection status for the selected groups: anti-diphtheria and anti-tetanus toxoid antibody concentrationsSeroprotection status for the selected groups: anti-HBs antibody concentrations Seroprotection status for the selected groups: anti-poliovirus type 1, type 2 & type 3 antibody titres Seroprotection status for the selected groups: anti-PRP antibody concentrations Seropositivity status for selected groups: anti-PT, anti-FHA and anti-PRN concentrations For selected groups: vaccine response to PT, FHA and PRN
Secondary outcome: In all groups, use of concomitant medications and antipyreticsSeroprotection status for the selected groups: anti-diphtheria and anti-tetanus toxoid antibody concentrations. Seroprotection status for the selected groups: anti-HBs antibody concentrations Seroprotection status for the selected groups: anti-poliovirus type 1, type 2 & type 3 antibody titres Seroprotection status for the selected groups: anti-PRP antibody concentrations In selected groups, seropositivity status: anti-PT, anti-FHA and anti-PRN concentrations In selected groups: vaccine response to PT, FHA and PRN In all groups, occurrence of solicited local symptoms. In all groups, occurrence of solicited general symptoms In all groups, occurrence of unsolicited symptoms In all groups, occurrence of serious adverse events (SAEs)
Detailed description:
This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.
Eligibility
Minimum age: 16 Months.
Maximum age: 20 Months.
Gender(s): Both.
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.
Locations and Contacts
GSK Investigational Site, Jarvenpaa 04400, Finland
GSK Investigational Site, Oulu 90220, Finland
GSK Investigational Site, Pori 28100, Finland
GSK Investigational Site, Tampere 33100, Finland
GSK Investigational Site, Turku 20520, Finland
GSK Investigational Site, Vantaa 01300, Finland
Additional Information
Starting date: February 2008
Last updated: September 29, 2009
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