Safety, Reactogenicity and Immunogenicity Study of GSK Biologicals' Pneumococcal Vaccine GSK1024850A, Given Either as a Booster Dose or as a 2-dose Catch-up Immunization in Healthy Malian Children

GlaxoSmithKline1 site in 1 country218 target enrollmentNovember 12, 2009

ConditionsInfections, Streptococcal

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Infections, Streptococcal
Sponsor: GlaxoSmithKline
Enrollment: 218
Locations: 1
Primary Endpoint: Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited)
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this trial is to assess the safety, reactogenicity and immunogenicity of GSK Biologicals' pneumococcal conjugate vaccine GSK1024850A when administered either as a booster dose or as a two dose catch-up vaccination in the second year of life to the Malian subjects previously enrolled in the primary vaccination study NCT00678301.

This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00678301).

Registry

clinicaltrials.gov

Start Date

November 12, 2009

End Date

July 26, 2010

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

GlaxoSmithKline

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR(s)) can and will comply with the requirements of the protocol.
•A male or female, between and including 15-21 months of age at the time of visit
•For the Pn-Pn group, subjects who completed the full vaccination course in study NCT
•For the Zil-Pn group, subjects who were previously enrolled in the control group of study NCT
•Written informed consent, signed or thumb printed, obtained from the parent(s)/LAR(s) of the subject. Where parent(s)/LAR(s) are illiterate, the consent form will be countersigned by a witness.
•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(s)/product(s) within 30 days preceding the first dose of vaccine, or planned use during the study period.
•Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
•Planned administration/administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before each dose of study vaccine and ending 30 days after. Locally recommended vaccines for example Oral Polio Vaccine or influenza vaccine are always allowed, even if concomitantly administered with the study vaccines, but should be documented in the CRF.
•Concurrently participating in another clinical study at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product (pharmaceutical product or device).
•Administration of any pneumococcal vaccine since the end of study NCT
•Any confirmed or suspected immunosuppressive or immunodeficient condition, since the end of study NCT00678301, based on medical history and physical examination.
•Major congenital defects or serious chronic illness.
•History of any progressive neurological disorders or seizures.
•Acute disease and/or fever at the time of enrolment.
•History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.

Outcomes

Primary Outcomes

Number of Subjects With Grade 3 Adverse Events (Solicited and Unsolicited)

Time Frame: Within 31 days (Day 0-Day 30) after booster vaccination

The incidence and nature of Grade 3 symptoms (solicited and unsolicited), reported during the 31-day (Days 0-30) post-vaccination are presented.

Secondary Outcomes

Number of Subjects With Serious Adverse Events (SAEs)(From the first vaccination up to one month (31 days) after the last vaccination for each subject)
Opsonophagocytic Activity Against Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F(Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group)
Concentrations of Antibodies Against Protein D (PD)(Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group)
Number of Subjects With Any and Grade 3 Solicited Local Symptoms(Within 4 days (Day 0-Day 3) after each vaccine dose)
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms(Within 4 days (Day 0-Day 3) after each vaccine dose)
Concentrations of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A(Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group)
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A(Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group)
Number of Subjects With Any Unsolicited Adverse Events (AEs)(Within 31 days (Day 0-Day 30) after each vaccine dose)
Concentrations of Antibodies Against Vaccine Pneumococcal Serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F(Prior to (PRE) and one month after (POST) the booster immunization in the Synflorix Primed Group and prior to (PRE) the first dose and one month after (POST) the second dose of the catch-up vaccination in the Synflorix Unprimed Group)