Study Evaluating Safety of 13-Valent Pneumococcal Conjugate Vaccine in Healthy Elderly Subjects

Pfizer

Status and phase

Completed

Phase 3

Conditions

Pneumococcal Infections

Treatments

Biological: 13-valent Pneumococcal Conjugate Vaccine (13vPnC)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00500266

6115A1-3000

Details and patient eligibility

About

To evaluate the safety of 13-valent pneumococcal conjugate vaccine (13vPnC) in elderly subjects who were vaccinated with one or more doses of 23-valent pneumococcal polysaccharide vaccine (23vPS) at least 3 years before study enrollment.

Enrollment

1,053 patients

Sex

All

Ages

68+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

MAIN INCLUSION CRITERIA:

Male or female aged 68 years or older
Determined by medical history, physical examination, and clinical judgment to be eligible for the study
Documented vaccination with 1 or more doses of pneumococcal vaccine at least 3 years before study enrollment

MAIN EXCLUSION CRITERIA:

Known history of severe reaction to a vaccine
Documented S pneumoniae infection within the past 5 years.
Known or suspected immunodeficiency or receiving treatment with immunosuppressive therapy including cytotoxic agents or systemic corticosteroids
Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that in the investigator's opinion precludes the subject from participating in the study.