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

Completed · Phase 2 · Has a placebo group

Conditions studied: Group B Streptococcal Infections

In brief

This is the Phase 1/2 first-in-human, randomized, placebo-controlled, observer-blinded study evaluating the investigational multivalent group B streptococcus vaccine. Healthy adults aged 18 to 49 years of age with no history of group B streptococcal vaccination will be randomized to receive either a single intramuscular dose of multivalent group B streptococcus vaccine (various formulations at 3 dose levels) or a placebo (saline control).

Key facts

Study ID

NCT03170609

Run by

Pfizer

People needed

365

Starts

2017-06-05

Expected to finish

2018-06-25

Last updated by the study team

2019-07-02

Who can join

Age: 18 and older, up to 49. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.
• Negative urine pregnancy test at Visit 1 for all female subjects who are of childbearing potential.

You may not qualify if…

• 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.
• 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.
• History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis) to any vaccine.
• History of microbiologically proven invasive disease caused by group B streptococcus (Streptococcus agalactiae).
• 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).

Where it is running

• Clinical Research Atlanta — Stockbridge, Georgia, United States
• Kentucky Pediatric / Adult Research — Bardstown, Kentucky, United States
• J. Lewis Research, Inc. / Foothill Family Clinic — Salt Lake City, Utah, United States
• J. Lewis Research, Inc. / Foothill Family Clinic South — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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