Pneumococcal Vaccine Booster Study in Healthy Children 11-18 Months Old Previously Primed With the Same Vaccines

GlaxoSmithKline1,437 enrolled

Overview

The purpose of this study is to assess the safety in terms of fever (rectal temperature) higher than 39 degree Celcius (°C) and the immunogenicity in terms of antibody response following a booster vaccination with pneumococcal vaccine GSK1024850A at 11 to 18 months of age in children previously primed with the same vaccines including a pneumococcal conjugate vaccine co-administered with a diphtheria, tetanus, acellular pertussis (DTPa)-combined and meningococcal serogroup C (MenC) or combined meningococcal serogroup C and Haemophilus influenzae type b (Hib-MenC) vaccine. 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 = NCT00334334).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

1,437

Conditions

Hepatitis B Acellular Pertussis Tetanus

Interventions

Pneumococcal conjugate vaccine GSK1024850ABIOLOGICAL

Intramuscular injection, 1 dose.

PrevenarBIOLOGICAL

Intramuscular injection, 1 dose.

Infanrix hexaBIOLOGICAL

Intramuscular injection, 1 dose. In Germany and Poland.

Infanrix IPV HibBIOLOGICAL

Intramuscular injection, 1 dose. In Spain.

Infanrix pentaBIOLOGICAL

Intramuscular injection, 1 dose. In Germany and Poland.

Infanrix IPVBIOLOGICAL

Intramuscular injection, 1 dose. In Spain.

MeningitecBIOLOGICAL

Intramuscular injection, 1 dose.

NeisVac-CBIOLOGICAL

Intramuscular injection, 1 dose.

MenitorixBIOLOGICAL

Intramuscular injection, 1 dose.

Eligibility

Sex: ALLMin age: 11 MonthsMax age: 18 MonthsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol. * A male or female between, and including, 11-18 months of age at the time of the booster vaccination. * A male or female who previously participated in study 107005 and received three doses of pneumococcal conjugate vaccine. * 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: * Concurrently participating in another clinical study, at any time during the study period (active phase and extended safety follow-up), in which the subject has been or will be exposed to an investigational or a non-investigational product. * Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within one month preceding the booster dose of study vaccines, or planned use during the entire study period * Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the booster dose of study vaccines. * Planned administration/administration of a vaccine not foreseen by the study protocol, during the period starting one month before the booster dose of study vaccines and up to the follow-up visit (one month after the booster dose of study vaccines). * Administration of any pneumococcal, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, MenC and/or Hib-MenC vaccines other than the study vaccines from study 107005. * History of, or intercurrent, diphtheria, tetanus, pertussis, polio, hepatitis B, Haemophilus influenzae type b, meningococcal serogroup C disease. * History of allergic disease or reactions likely to be exacerbated by any component of the vaccines. * History of seizures (this criterion does not apply to subjects who have had a single, uncomplicated febrile convulsion in the past) or progressive neurological disease. * Acute disease at the time of enrolment. * 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 three months preceding the booster dose of study vaccines or planned administration during the active phase of the study (starting with the administration of the booster dose of study vaccines up to the follow-up visit one month after).

Locations (63)

GSK Investigational Site

Bad Saulgau, Baden-Wurttemberg, Germany

GSK Investigational Site

Bönnigheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Bretten, Baden-Wurttemberg, Germany

GSK Investigational Site

Ettenheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Karlsruhe, Baden-Wurttemberg, Germany

Outcomes

Primary Outcomes

Number of Subjects Reporting Fever Above 39.0 Degree Celsius (°C)

Fever was measured as rectal temperature.

Time frame: During the 4-day (Day 0-3) period after the booster vaccination

Secondary Outcomes

Number of Subjects Reporting Solicited Local Symptoms

Solicited local symptoms assessed include pain, redness and swelling.

Time frame: During the 4-day (Day 0-3) period after the booster vaccination

Number of Subjects Reporting Solicited General Symptoms

Solicited general symptoms assessed include drowsiness, fever, irritability, and loss of appetite.

Time frame: During the 4-day (Day 0-3) period after the booster vaccination

Number of Subjects Reporting Unsolicited Adverse Events (AE)

An AE is any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.

Time frame: During the 31-day (Day 0-30) period after the booster vaccination

Number of Subjects Reporting Serious Adverse Events (SAE)

An SAE is any untoward medical occurrence that: results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study subject, or may evolve into one of the outcomes listed above.

Time frame: During the 31-day (Day 0-30) period after the booster vaccination

Number of Subjects Reporting Serious Adverse Events (SAE)

Time frame: From the beginning of the study up to the end of the extended 6-month safety follow-up period

Number of Subjects With Vaccine Pneumococcal Serotype Antibody Concentrations Above the Cut-off Value

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