Phase II, Observer-blind Follow-up Study to Assess reacto-and Immunogenicity of GSK Biologicals' Pneumococcal Conjugate Vaccine (GSK1024850A), When Given as Booster in Primed Children or as 2-dose Catch-up in Unprimed Children.

GlaxoSmithKline1 site in 1 country163 target enrollmentAugust 22, 2007

ConditionsInfections, Streptococcal

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Infections, Streptococcal
Sponsor: GlaxoSmithKline
Enrollment: 163
Locations: 1
Primary Endpoint: Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a booster study in 2 groups of healthy children less than 3 years old to measure the reactogenicity, safety and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine, when given as a booster or as a two-dose catch-up vaccination.

This protocol posting deals with objectives and outcome measures of the booster phase. The objectives and outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00338351).

Detailed Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Registry

clinicaltrials.gov

Start Date

August 22, 2007

End Date

August 28, 2008

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or female between, and including, 18-21 months of age at the time of vaccination.
•Subjects who previously participated in the primary study and received 3 doses of study or control vaccines during the primary study.
•Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
•Written informed consent obtained from the parent or guardian of the subject.
•Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

•Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days preceding the booster doses of study vaccines, or planned use during the study period (active phase and extended safety follow-up).
•Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month (30 days) before the booster doses of vaccine(s) and during the active phase of the study (up to the follow-up visit (Visit 3)).
•History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
•History of seizures (subjects who have had a single, uncomplicated febrile convulsion in the past can be included) or progressive neurological disease.
•Acute disease at the time of enrolment.
•Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster doses of study vaccines.
•Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
•A family history of congenital or hereditary immunodeficiency.
•Major congenital defects or serious chronic illness.
•Administration of immunoglobulins and/or any blood products within the last 3 months prior to booster or follow-up vaccination or planned administration during the active phase of the study.

Outcomes

Primary Outcomes

Number of Subjects Reporting Grade 3 Symptoms (Solicited and Unsolicited)

Time Frame: Within 4 days after the administration of any study vaccine dose

Grade 3 symptoms are symptoms which prevent normal, everyday activities (e.g. in a young child such symptom would prevent attendance at school/ kindergarten/ a day-care center and would cause the parents/guardians to seek medical advice).

Secondary Outcomes

Number of Subjects With Anti-protein D Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the administration of Dose 2)
Number of Subjects Reporting Solicited General Symptoms(Within 4 days after the administration of any study vaccine dose)
Number of Subjects Reporting Unsolicited Adverse Events(Within 31 days after the administration of any study vaccine dose)
Number of Subjects Reporting Serious Adverse Events During the Active Phase of the Study(Throughout the active phase of the study ( from the beginning of the booster phase up to 1 month after the second booster dose))
Number of Subjects Reporting Solicited Local Symptoms(Within 4 days after the administration of any study vaccine dose)
Number of Subjects Reporting Serious Adverse Events Throughout the Entire Study Period(Throughout the entire study period (from the beginning of the booster phase up to the end of the 6-month extended safety follow-up))
Anti-hepatitis A Virus Antibodies Concentration(Before (pre) and one month after (post) the administration of Dose 2)
Number of Subjects With Anti-hepatitis A Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the administration of Dose 2)
Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value(Before (pre) and one month after (post) the administration of Dose 2)
Number of Subjects With Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes Above the Cut-off Value(Before (pre) and one month after (post) the administration of Dose 2)