Booster Vaccination Study With a Pneumococcal Vaccine in Children Primed With the Same Vaccine

Phase 3

Completed

Conditions: Infections, Streptococcal

Interventions: Biological: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)
Biological: Wyeth-Lederle's Prevenar™
Biological: GSK Biologicals' Hiberix™

Registration Number: NCT00911144

Lead Sponsor: GlaxoSmithKline

Brief Summary: The purpose of this study is to evaluate the reactogenicity, safety and immunogenicity of a booster (fourth) dose of pneumococcal vaccine GSK1024850A when co-administered with Hiberix at 12-18 months of age, in children primed with the same vaccines in primary study NCT00680914.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 450

Inclusion Criteria

A male or female between, and including, 12-18 months of age at the time of booster vaccination.
Subjects for whom the investigator believes that their parent(s)/ guardian(s) can and will comply with the requirements of the protocol.
Subjects who received three doses of pneumococcal conjugate vaccine in study NCT00680914.
Written informed consent obtained from the parent(s)/guardian(s) of the child/ward.
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) within 30 days preceding the vaccination, or planned use during the study period.
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).
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to vaccination.
Administration of immunoglobulins and/or any blood products within three months preceding the vaccination or planned administration during the study period.
Administration of any pneumococcal and/or Hib vaccine since the end of study NCT00680914.
Planned administration/administration of a vaccine not allowed by the study protocol during the period starting 1 month (30 days) before the administration of the booster dose of the study vaccines (Visit 1) and up to the follow-up visit (Visit 2) with the exception of vaccines included in the Korean routine immunization which can be given at least one week before the administration of the study vaccines or after study end.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
History of reactions or allergic disease likely to be exacerbated by any component of the study vaccines.
Known hypersensitivity to any component of the study vaccines including anaphylactic reactions following the administration of the study vaccines.
Major congenital defects or serious chronic illness.
History of any neurologic disorders or seizures.
Tympanic or axillary/ oral temperature >= 37.5°C or rectal temperature >= 38.0°C. A temperature greater than or equal to these cut-offs warrants deferral of the vaccination pending recovery of the subject.
Acute disease at the time of enrolment.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Synflorix Group	GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Prevenar Group	GSK Biologicals' Hiberix™	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Synflorix Group	GSK Biologicals' Hiberix™	Subjects previously primed (NCT00680914) with 3 doses of Synflorix and Hiberix in the first year of life receiving a booster dose of the same vaccines in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.
Prevenar Group	Wyeth-Lederle's Prevenar™	Subjects previously primed (NCT00680914) with 3 doses of Prevenar and Hiberix in the first year of life receiving a booster dose of Prevenar and Hiberix in the second year of life by intramuscular injection into the right and the left thigh or deltoid, respectively.

Primary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Grade 3 Adverse Events	Within 31 days (Day 0 - Day 30) after booster vaccination.	Grade 3 adverse events are severe symptoms that prevent normal, everyday activities.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects Reporting Serious Adverse Events	After booster vaccination up to study end (Month 0 to Month 1)	Serious adverse events are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.
Concentration of Antibodies Against Vaccine Pneumococcal Serotypes	One month after booster vaccination (Month 1)	Concentrations of antibodies are measured by 22F-inhibition enzyme-linked immunosorbent assay (ELISA) and are presented as geometric mean concentrations expressed as microgram per milliliter (ug/mL). Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Concentration of Antibodies Against Polyribosyl-ribitol-phosphate (PRP)	One month after booster vaccination (Month 1)	Concentrations of antibodies are presented as geometric mean concentrations expressed as microgram per milliliter.
Opsonophagocytic Activity Against Vaccine Pneumococcal Serotypes	One month after booster vaccination (Month 1)	Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions. Vaccine pneumococcal serotypes included serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F and 23F.
Opsonophagocytic Activity Against Cross-reactive Pneumococcal Serotypes 6A and 19A	One month after booster vaccination (Month 1)	Streptococcus pneumoniae opsonophagocytic activity was measured by a killing-assay using a HL 60 cell line. The results are presented as the dilution of serum (opsonic titer) able to sustain 50% killing of live pneumococci under the assay conditions.
Number of Subjects Reporting Solicited Symptoms	Within 4 days (Days 0 to 3) after booster vaccination	Solicited local symptoms assessed include pain, redness and swelling at the injection site. Solicited general symptoms assessed include drowsiness, fever (equal to or above 37.5 degrees Celsius), irritability and loss of appetite.
Number of Subjects Reporting Unsolicited Adverse Events	Within 31 days (Days 0 to 30) after booster vaccination	An unsolicited adverse event is any adverse event (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product) reported in addition to those solicited during the clinical study. Also any "solicited" symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited adverse event.
Concentration of Antibodies Against Cross-reactive Pneumococcal Serotypes 6A and 19A	One month after booster vaccination (Month 1)	Concentrations of antibodies are measured by 22F-inhibition ELISA and are presented as geometric mean concentrations expressed as microgram per milliliter.
Concentration of Antibodies Against Protein D (PD)	One month after booster vaccination (Month 1)	Concentrations of antibodies are presented as geometric mean concentrations expressed as Enzyme-Linked Immuno-Sorbent Assay (ELISA) units per milliliter (EU/mL).