Safety & Immunogenicity of Pneumococcal Vaccine 2189242A in Children Aged 12-23 Months at the Time of First Vaccination

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Infections, Streptococcal

Treatments: Biological: Pneumococcal vaccine GSK2189242A (formulation 1); Biological: Pneumococcal vaccine GSK1024850A; Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4); Biological: Pneumococcal vaccine GSK2189242A (formulation 2); Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00985751

113171

2009-012701-19 (EudraCT Number)

Details and patient eligibility

About

This study will assess the safety, reactogenicity and immunogenicity of different formulations of GSK Biologicals' pneumococcal vaccine 2189242A when administered alone or in combination with the 10-valent pneumococcal conjugate vaccine (GSK1024850A vaccine) as a 2-dose primary vaccination course followed by a booster dose in healthy children aged 12-23 months at the time of first vaccination. Considering that febrile reactions are frequently observed following pneumococcal vaccination, usually co-administered with other routine paediatric vaccines, the primary study objective will focus on evaluating the increase in grade 3 fever (i.e. rectal temperature >40.0°C).

Enrollment: 257 patients

Sex: All

Ages: 12 to 23 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) (LAR) can and will comply with the requirements of the protocol
• Male or female between, and including, 12 and 23 months of age at the time of the first vaccination.
• Written informed consent obtained from the parents/LAR(s) 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 first dose of study vaccine, or planned use during the study period.
• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Planned administration/administration of a vaccine not foreseen by the study protocol during the study period starting from 30 days before each dose and ending 30 days after each dose of vaccine(s).
• Previous vaccination against S. pneumoniae since birth.
• History of any hypersensitivity reaction following any previous vaccination.
• Eczema and any history of allergy
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required), including human immunodeficiency virus infection.
• A family history of congenital or hereditary immunodeficiency.
• Major congenital defects or any chronic illness.
• History of any neurologic disorders or seizures.
• Acute disease and/or fever at the time of enrolment.
• Fever is defined as temperature >= 37.5°C on oral or axillary setting, or >= 38.0°C on rectal setting.
• Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
• Administration of immunoglobulins and/ or any blood products within the 3 months preceding the first dose of study vaccine or planned use during the study period.
• Child in care.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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257 participants in 5 patient groups

Group 1

Experimental group

Treatment:

Biological: Pneumococcal vaccine GSK2189242A (formulation 1)

Group 2

Experimental group

Treatment:

Biological: Pneumococcal vaccine GSK2189242A (formulation 2)

Group 3

Experimental group

Treatment:

Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 3)

Group 4

Experimental group

Treatment:

Biological: Pneumococcal vaccine GSK2189242A combined with pneumococcal vaccine GSK1024850A (formulation 4)

Control Group

Experimental group

Treatment:

Biological: Pneumococcal vaccine GSK1024850A