Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.

Pfizer

Status and phase

Completed

Phase 4

Conditions

PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE

Treatments

Other: Placebo

Biological: Seasonal Inactivated Influenza Vaccine

Biological: 13-valent pneumococcal conjugate vaccine

Study type

Interventional

Funder types

Industry

Identifiers

NCT02124161

B1851138

Details and patient eligibility

About

The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine.

Enrollment

882 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study.
Male or female adults 50 years of age or older.
Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment.
Negative urine pregnancy test for all female subjects who are of child bearing potential.

Exclusion criteria

Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational pneumococcal conjugate vaccine.
History of severe adverse reactions associated with any vaccine or vaccine-related component.
Allergic to egg proteins (egg or egg products) and chicken proteins.
History of Guillain-Barré syndrome.
Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration.
Documented S pneumoniae infection within the past 5 years before investigational product administration.