A Phase 3 Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 13-valent Pneumococcal Conjugate Vaccine in Japanese Elderly Adults Aged 65 Years Old and Older

Pfizer

Status and phase: Completed; Phase 3

Conditions: Pneumococcal Conjugate Vaccine; Pneumococcal Vaccines

Treatments: Biological: 13-valent pneumococcal conjugate vaccine; Biological: 23-valent pneumococcal polysaccharide vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT01646398

B1851088

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability and immunogenicity of a single dose of 13-valent pneumococcal conjugate vaccine compared to a single dose of 23-valent pneumococcal polysaccharide vaccine in Japanese adults aged 65 years old and older.

Enrollment: 764 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy Japanese male and female adults aged 65 years old and older at time of enrollment. Subjects with preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease 12 weeks before receipt of the study vaccine, are eligible.
2. Male and female subjects of childbearing potential must agree to use a highly effective method of contraception throughout the study or for at least 28 days after the last dose of the study vaccine whichever is longer.

Exclusion criteria

1. History of severe adverse reaction including hypersensitivity such as anaphylaxis associated with a vaccine or vaccine component.
2. Previous vaccination with any licensed or experimental pneumococcal vaccine.
3. Documented Streptococcus pneumoniae infection within the past 5 years.
4. Residence in a nursing home, long-term care facility, or other institution or requirement of semiskilled nursing care.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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764 participants in 2 patient groups

>= 65-year age group-13vPnC

Experimental group

Treatment:

Biological: 13-valent pneumococcal conjugate vaccine

>= 65-year age group-23vPS

Active Comparator group

Treatment:

Biological: 23-valent pneumococcal polysaccharide vaccine