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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

Last updated on March 15, 2019

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Study Location
Seishinkai Inoue Hospital
Itoshima, Fukuoka, Japan
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Vaccines, Pneumococcal Conjugate Vaccine
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
65 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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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
The factors, or reasons, that prevent a person from participating in a clinical study.
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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.

NCT01646398
Pfizer
Completed
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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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