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

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Streptococcal

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00911144

112933

Details and patient eligibility

About

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.

Enrollment: 450 patients

Sex: All

Ages: 12 to 18 months old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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450 participants in 2 patient groups

Synflorix Group

Experimental group

Description:

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.

Treatment:

Biological: GSK Biologicals' Synflorix™ (Pneumococcal vaccine GSK1024850A)

Biological: GSK Biologicals' Hiberix™

Prevenar Group

Active Comparator group

Description:

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.

Treatment:

Biological: Wyeth-Lederle's Prevenar™

Biological: GSK Biologicals' Hiberix™