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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 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

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 antipyretics

Seroprotection 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

Page last updated: August 23, 2015

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