Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Japanese Adults Aged >= 50 Years

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Pfizer

Status and phase

Completed
Phase 3

Conditions

Healthy

Treatments

Biological: 13vPnC

Study type

Interventional

Funder types

Industry

Identifiers

NCT00562354
6115A1-3004

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate (13vPnC) vaccine in healthy Japanese adults aged >= 50 years.

Enrollment

271 patients

Sex

All

Ages

50+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Japanese descent male and female adults who do not have the potential to bear children >= 50 years of age.
  • Determined to be eligible for the study based on medical history, physical examination, and clinical judgment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of study vaccine, are eligible.
  • Sexually active men must agree and commit to use a medically accepted form of contraception during the study and for at least 3 months after vaccination.

Exclusion criteria

  • History of severe adverse reaction associated with a vaccine.
  • Receipt of any vaccine within 30 days before study vaccination, except influenza vaccine.
  • Documented S pneumoniae infection within the past 5 years before study vaccination.

Trial design

271 participants in 2 patient groups

1
Experimental group
Description:
Stratum 1: >= 65 years of age
Treatment:
Biological: 13vPnC
2
Experimental group
Description:
Stratum 2: 50 to 64 years of age
Treatment:
Biological: 13vPnC

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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