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A Phase 1, Randomized, Controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Aged 18 to 49 Years

Last updated on March 14, 2019

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Study Location
New Haven Clinical Research Unit
New Haven, Connecticut, 06511 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Pneumococcal Infections
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-49 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
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1. Male or female adults 18 to 49 years of age.

2. Healthy adults determined by medical history, physical examination, laboratory
screening, and clinical judgment to be eligible for the study.

3. Negative serum pregnancy test for all female subjects who are of childbearing
potential.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
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1. Baseline laboratory test results outside of the normal reference range considered
clinically significant.

2. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis)
associated with a vaccine.

3. History of culture-proven invasive disease caused by S pneumoniae.

4. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
planned receipt through study participation.

5. Vaccination with diphtheria-, pertussis-, or tetanus-containing vaccine(s) from 12
months before investigational product administration, or planned receipt through study
participation.

6. Male subjects and female subjects of childbearing potential who are unwilling or
unable to use a highly effective method of contraception as outlined in this protocol
for the duration of the study participation and for at least 6 months after the last
dose of investigational product.

NCT02955160
Pfizer
Completed
A Phase 1, Randomized, Controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Aged 18 to 49 Years

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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