Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women
NCT ID: NCT04766086
Last Updated: 2024-05-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
306 participants
INTERVENTIONAL
2022-08-12
2023-04-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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GBS6 and Tdap
Multivalent group B streptococcus vaccine and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)
Multivalent Group B streptococcus vaccine
Multivalent Group B streptococcus vaccine
Tetanus, diphtheria, and acellular pertussis vaccine
Tetanus, diphtheria, and acellular pertussis vaccine
GBS6 and Placebo
Multivalent group B streptococcus vaccine and Placebo
Multivalent Group B streptococcus vaccine
Multivalent Group B streptococcus vaccine
Placebo
Saline control
Placebo and Tdap
Placebo and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)
Tetanus, diphtheria, and acellular pertussis vaccine
Tetanus, diphtheria, and acellular pertussis vaccine
Placebo
Saline control
Interventions
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Multivalent Group B streptococcus vaccine
Multivalent Group B streptococcus vaccine
Tetanus, diphtheria, and acellular pertussis vaccine
Tetanus, diphtheria, and acellular pertussis vaccine
Placebo
Saline control
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants who are willing and able to comply with scheduled visits, investigational plan, laboratory tests, lifestyle considerations, and other study procedures, including completion of the e-diary from Day 1 to Day 7 following administration of investigational product.
* Healthy females at enrollment who are determined by medical history, physical examination, and clinical judgment of the investigator to be eligible for inclusion in the study.
* Expected to be available for the duration of the study and who can be contacted by telephone during study participation.
* Capable of giving personal signed informed consent.
Exclusion Criteria
* History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the investigational product or any diphtheria toxoid-containing or CRM197-containing vaccine.
* History of microbiologically proven invasive disease caused by group B streptococcus.
* Immunocompromised participants with known or suspected immunodeficiency.
* Bleeding diathesis or condition associated with prolonged bleeding that would in the opinion of the investigator contraindicate intramuscular injection.
* Other acute or chronic medical or psychiatric condition, including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Previous vaccination with any licensed or investigational GBS vaccine, or planned receipt during the participant's participation in the study (through the 1-month follow-up visit \[Visit 2\]).
* Vaccination within 5 years with tetanus and diphtheria toxoids and acellular pertussis-containing vaccines (Tdap) before investigational product administration.
* Participants who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids
* Vaccination with diphtheria- or CRM197-containing vaccine(s) from 6 months before investigational product administration, or planned receipt through the 1-month follow-up visit.
* Receipt or planned receipt of blood/plasma products or immunoglobulin, from 60 days before investigational product administration through the 1-month follow-up visit
* Participation in other studies involving investigational drug(s) within 28 days prior to study entry and/or during study participation
18 Years
49 Years
FEMALE
Yes
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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Alliance for Multispecialty Research, LLC
Newton, Kansas, United States
Quality Clinical Research, Inc
Omaha, Nebraska, United States
Alliance for Multispecialty Research, LLC
Las Vegas, Nevada, United States
Accellacare - Raleigh
Raleigh, North Carolina, United States
Accellacare - Wilmington
Wilmington, North Carolina, United States
PriMED Clinical Research
Dayton, Ohio, United States
PriMed Clinical Research
Dayton, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Alliance for Multispecialty Research, LLC
Knoxville, Tennessee, United States
Benchmark Research
Fort Worth, Texas, United States
DM Clinical Research - Brookline
Houston, Texas, United States
J. Lewis Research, Inc. / Foothill Family Clinic South
Salt Lake City, Utah, United States
Countries
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References
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Smith WB, Seger W, Chawana R, Skogeby Z, Silmon de Monerri NC, Feng Y, Gaylord M, Jongihlati B, Beeslaar J, Skinner JM, Bickham K, Anderson AS. A Phase 2b Trial Evaluating the Safety, Tolerability, and Immunogenicity of a 6-Valent Group B Streptococcus Vaccine Administered Concomitantly With Tetanus, Diphtheria, and Acellular Pertussis Vaccine in Healthy Nonpregnant Female Individuals. J Infect Dis. 2025 Jul 11;231(6):e1065-e1074. doi: 10.1093/infdis/jiaf096.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C1091005
Identifier Type: -
Identifier Source: org_study_id
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