Vaccination With GSK 1024850A in Children Primed With GSK 1024850A & Boosted With Pneumovax 23™

GlaxoSmithKline52 enrolled

Overview

The aim of this study is to assess the immune response, safety and reactogenicity following administration of an additional dose of a pneumococcal conjugate vaccine at approximately 4 years of age in children previously vaccinated with 3 primary doses of GSK 1024850A or Prevenar™ vaccine within the first 6 months of life and a booster dose of plain polysaccharide pneumococcal (Pneumovax 23™) vaccine at 11-14 months of age. Antibody persistence will also be assessed at approximately 4 years of age in children previously vaccinated with 3 doses of either GSK 1024850A or Prevenar™ vaccine followed by a booster dose of Pneumovax 23™. This protocol posting deals with objectives \& outcome measures of the extension phase at year 4. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT 00307541). The objectives \& outcome measures of the booster phase are presented in a separate protocol posting (NCT 00333450).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Infections, Streptococcal Streptococcus Pneumoniae

Interventions

Eligibility

Sex: ALLMin age: 46 MonthsMax age: 50 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male or female between, and including, 46-50 months of age at the time of vaccination. * Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * Subjects who previously participated in study NCT00333450 in centres with more than 2 subjects and received a booster dose of Pneumovax 23™. * Written informed consent obtained from both parents/guardians 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 other than the study vaccine(s) within 30 days preceding the vaccination, or planned use during the study period. * Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the vaccination. * Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting one month before study vaccination and during the entire study period. * Administration of any pneumococcal vaccine since the end of study NCT00333450. * Administration of immunoglobulins and/or any blood products less than 3 months prior to the vaccination or planned use during the study period. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical * History of any neurologic disorders or seizures * Anaphylactic reaction following previous administration of the vaccine or history of reactions or allergic disease likely to be exacerbated by any component of the vaccine. * History of hypotonic-hyporesponsive episode after any previous vaccination. * Major congenital defects or serious chronic illness. * History of invasive pneumococcal diseases. * Acute disease at the time of vaccination * Rectal temperature \>= 38.0°C or oral/axillary/tympanic temperature \>= 37.5°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.

Locations (17)

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Nördlingen, Bavaria, Germany

GSK Investigational Site

Bad Oeynhausen, North Rhine-Westphalia, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

GSK Investigational Site

Heiligenhaus, North Rhine-Westphalia, Germany

GSK Investigational Site

Mönchengladbach, North Rhine-Westphalia, Germany

GSK Investigational Site

Mönchengladbach, North Rhine-Westphalia, Germany

GSK Investigational Site

Willich, North Rhine-Westphalia, Germany

GSK Investigational Site

Frankenthal, Rhineland-Palatinate, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

...and 7 more locations

Outcomes

Primary Outcomes

Vaccine Pneumococcal Serotype Antibody Concentrations

The anti-pneumococcal antibody concentration cut-off value assessed was greater than or equal to ≥ 0.05 microgram per milliliter (μg/mL). The vaccine pneumococcal serotypes assessed include 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, and 23F.