Safety, Tolerability and Immunogenicity of Pneumovax 23 in Healthy Adults in India (V110-011)
Status and phase
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Details and patient eligibility
About
To describe the safety, tolerability and immunogenicity of pneumovax 23 (V110) in healthy adults in India.
Full description
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.
Enrollment
Sex
Ages
Volunteers
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
Trial design
Primary purpose
Allocation
Interventional model
Masking
133 participants in 1 patient group
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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