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
Status: | Completed |
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Conditions: | Infectious Disease |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - 49 |
Updated: | 8/5/2018 |
Start Date: | June 5, 2017 |
End Date: | June 25, 2018 |
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).
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).
Inclusion Criteria:
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:
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).
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