13-valent Pneumococcal Conjugate Vaccine Study in Adults => 50 Years of Age in Mexico

Pfizer

Status and phase

Completed

Phase 3

Conditions

Pneumococcal Infections

Treatments

Biological: vaccine-13vPnC

Study type

Interventional

Funder types

Industry

Identifiers

NCT01432262

B1851048

6115A1-3020

Details and patient eligibility

About

The purpose of this study will be to assess the safety, tolerability, and immunogenicity of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) when given to healthy adults older than 50 years of age who haven't received 23-valent pneumococcal polysaccharide vaccine in Mexico.

Enrollment

324 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male or female older than 50 years of age
Eligibility must be determined by medical history, physical exam and clinical judgment
Able to complete an electronic diary
Available for duration of study
Negative pregnancy test for subjects in group 2 age 50 to 64 years
Practice abstinence or use reliable birth control if age is 50 to 64 years

Exclusion criteria

History of allergic reaction to any vaccine
Previous vaccination with licensed or experimental pneumococcal vaccine
S. pneumonia infection within past 5 years before investigational product administration
Known or suspected immunodeficiency or received treatment including cytotoxic agents or systemic corticosteroids, serious chronic disorder such as malignancy cancer
Receipt of plasma products or immunoglobulins within 60 days
Bleeding conditions or diathesis
Receipt of investigational product within 28 days before study entry
Other severe acute or chronic medical or psychiatric condition