Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)

This was an open-label non-randomized study to assess the safety and immunogenicity of PNEUMOVAXTM 23 in healthy adults in India. The participants enrolled in this study were healthy Indian adults, 50 years of age or older, with no prior history of having received a pneumococcal vaccination (14-valent or 23-valent) and no prior history of Pneumococcal disease. All participants enrolled in the study received one 0.5 mL dose of PNEUMOVAXTM 23 by intramuscular (deltoid) injection on Day 1. Serum samples were obtained prior to vaccination on Day 1 and on Day 28 (+/-7 days) postvaccination. The duration of participation for each participant was approximately one month, with the study completion at the Day 28 postvaccination bleed and return of the Vaccination Report Card (VRC). Enrollment was completed within approximately 2 months. The last postvaccination blood sample was collected within 3 months of study initiation.

Inclusion criteria

• Healthy indian adults of 50 years of age
• In good health; any underlying chronic illness must be documented to be in stable condition
• Signed and dated informed consent prior to receipt of the study vaccine

Exclusion criteria

• Functional or anatomic asplenia
• History of auto immune disease
• Hypersensitivity to any of the components of the study vaccine,including phenol
• Known or suspected immune dysfunction, including persons with congenital immunodeficiency
• Prior vaccination with any pneumococcal vaccine