Safety and Immune Response Study of an Investigational Pneumococcal Vaccine.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 2

Conditions: Prophylactic Pneumococcal Diseases

Treatments: Biological: pneumococcal vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00327522

106962

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and immunogenicity of two doses of GSK Biologicals' 11 PCV vaccine when given to healthy subjects aged 18 to 40 years .

Full description

The study is open and subjects will receive two vaccine doses of GSK Biologicals' 11 PCV vaccine. Five blood samples will be taken: prior to and one month after each vaccine dose, and 2 weeks after dose 2.

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy male or female between 18 and 40 years of age
• 23-valent pneumococcal polysaccharide vaccine naive adults.

Exclusion criteria

• Previous vaccination against Streptococcus pneumoniae.
• History of pneumonia within 3 years prior to the first vaccination
• Any confirmed or suspected immunosuppressive or immunodeficient condition
• All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
• Subjects with documented anaemia or iron-deficiency (Hemoglobin level more than 10% below lower limit of normal)
• History of administration of an experimental/licensed vaccine containing similar adjuvants.
• History of chronic alcohol consumption and/or drug abuse.
• Pregnant or lactating female.
• Female planning to become pregnant or planning to discontinue contraceptive precautions.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)