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A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age

Last updated on March 15, 2019

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Study Location
Clinical Research Atlanta
Stockbridge, Georgia, 30281 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Group B Streptococcal 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. Healthy adults (male and female) 18 to 49 years of age at enrollment who are
determined by medical history, physical examination, and clinical judgment of the
investigator to be eligible for inclusion in the study.

2. Negative urine pregnancy test at Visit 1 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. 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 at least 3 months after the last dose of investigational product.

2. Acute or chronic medical or psychiatric condition or laboratory abnormality that may
increase the risk associated with study participation or investigational product
administration or may interfere with the interpretation of study results and, in the
judgment of the investigator, would make the subject inappropriate for entry into this
study. Chronic medical conditions include human immunodeficiency virus, chronic
hepatitis B virus (HBV) infection (HBV surface antigen positive), and/or hepatitis C
virus infection.

3. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis)
to any vaccine.

4. History of microbiologically proven invasive disease caused by group B streptococcus
(Streptococcus agalactiae).

5. Previous vaccination with any licensed or investigational group B streptococcus
vaccine, or planned receipt during the subject's participation in the study (through
the last blood draw).

NCT03170609
Pfizer
Completed
A Phase 1/2, Randomized, Placebo-controlled, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Group B Streptococcus Vaccine In Healthy Adults 18 To 49 Years Of Age

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