Vaccination Course in Primed Children and Age-matched Unprimed Children With Pneumococcal Vaccine GSK1024850A

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Streptococcal

Treatments: Biological: Pneumococcal conjugate vaccine GSK1024850A

Study type: Interventional

Funder types: Industry

Identifiers

NCT00792909

111736

Details and patient eligibility

About

The purpose of this study is to assess the immune memory induced by primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life through evaluation of the immune responses following vaccination with a booster dose of pneumococcal conjugate vaccine GSK1024850A in the fourth year of life and to assess immune responses following vaccination with a single dose of pneumococcal conjugate vaccine GSK1024850A in age-matched unprimed children.

The study also aims to assess the antibody persistence in the fourth year of life following primary and booster vaccination with pneumococcal conjugate vaccine GSK1024850A in the first year of life.

The study is also designed to evaluate the immunogenicity in terms of antibody response and the safety/reactogenicity in terms of solicited and unsolicited symptoms and serious adverse events following a 2-dose vaccination with pneumococcal conjugate vaccine GSK1024850A in the fourth year of life.

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 = 00307034)

Enrollment: 172 patients

Sex: All

Ages: 36 to 46 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female between, and including, +- 36-46 months of age at the time of vaccination.
• For primed subjects: having completed the full vaccination course with GSK1024850A in the primary study (NCT00307034).
• Subjects for whom the investigator believes that their parent(s)/guardian(s) can and will comply with the requirements of the protocol.
• Written informed consent obtained from the parent(s)/guardian(s) of the subject.
• Free of obvious health problems 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 vaccines within 30 days preceding the first dose of the study vaccines, or planned use during the study period.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to vaccination.
• For primed subjects: administration of any pneumococcal vaccine since the end of the primary study (NCT00307034).
• For unprimed subjects: previous vaccination with any pneumococcal vaccine.
• Administration of immunoglobulins and/or any blood products less than 6 months prior to the vaccination or planned administration during the study period.
• 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 vaccine.
• Acute disease at the time of enrolment.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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172 participants in 3 patient groups

Synflorix™ Group 1

Experimental group

Description:

Subjects previously vaccinated with the Synflorix™ vaccine according to a 2+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.

Treatment:

Biological: Pneumococcal conjugate vaccine GSK1024850A

Biological: Pneumococcal conjugate vaccine GSK1024850A

Synflorix™ Group 2

Experimental group

Description:

Subjects previously vaccinated with the Synflorix™ vaccine according to a 3+1 schedule, receiving one dose of Synflorix™ at 36-46 months of age.

Treatment:

Biological: Pneumococcal conjugate vaccine GSK1024850A

Biological: Pneumococcal conjugate vaccine GSK1024850A

Unprimed Group

Active Comparator group

Description:

Age-matched subjects not previously vaccinated with any pneumococcal vaccine receiving two doses of Synflorix™ at 36-46 and 38-48 months of age. Age-matching was ensured by the enrolment of subjects 36-46 months of age.

Treatment:

Biological: Pneumococcal conjugate vaccine GSK1024850A

Biological: Pneumococcal conjugate vaccine GSK1024850A