Phase 2
N=365
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
Group B Streptococcal Infections
Bottom Line
View on ClinicalTrials.gov: NCT03170609 ↗Enrolled (actual)
365
Serious AEs
0.8%
Results posted
Jul 2019
Primary outcome: Primary: Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade — 0; 6.3; 12.5; 0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Multivalent group B streptococcus vaccine (Biological); Placebo (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Laboratory Abnormalities at 1-Week After Vaccination as Measured by Food and Drug Administration (FDA) Grade |
0; 6.3; 12.5; 0; 0; 6.3 | — |
| PRIMARY Percentage of Participants With Local Reactions by Maximum Severity Within 14 Days After Vaccination |
53.8; 32.7; 48.1; 38.5; 51.9; 25.0 | — |
| PRIMARY Percentage of Participants With Systemic Events by Maximum Severity Within 14 Days After Vaccination |
0; 0; 1.9; 0; 1.9; 1.9 | — |
| PRIMARY Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination |
19.2; 5.8; 19.2; 13.5; 26.9; 28.8 | — |
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Month After Vaccination |
1.9; 0; 1.9; 0; 1.9; 0 | — |
| PRIMARY Percentage of Participants With Medically Attended Adverse Events (MAEs) Within 6 Months After Vaccination |
21.2; 23.1; 28.8; 19.2; 34.6; 26.9 | — |
| SECONDARY GBS6 Serotype-Specific Immunoglobulin G (IgG) Geometric Mean Concentrations (GMCs) at 1 Month After Vaccination |
30.880; 20.341; 24.723; 41.826; 21.125; 17.829 | — |
Summary
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).
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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).
Data sourced from ClinicalTrials.gov (NCT03170609). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.