Phase 2
N=306
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women
Group B Streptococcus Infections
Bottom Line
View on ClinicalTrials.gov: NCT04766086 ↗Enrolled (actual)
306
Serious AEs
0.3%
Results posted
May 2024
Primary outcome: Primary: Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination — 39.2; 45.9; 33.0; 27.5 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Multivalent Group B streptococcus vaccine (Biological); Tetanus, diphtheria, and acellular pertussis vaccine (Biological); Placebo (Biological)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Pfizer
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination |
39.2; 45.9; 33.0; 27.5; 35.7; 26.2 | — |
| PRIMARY Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination |
1.0; 4.0; 2.9; 0; 2.0; 2.9 | — |
| PRIMARY Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Vaccination |
5.9; 8.1; 3.9 | — |
| PRIMARY Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 6 Months After Vaccination |
4.9; 4.0; 6.8; 0; 0; 1.0 | — |
| PRIMARY Percentage of Participants Achieving Anti-tetanus Toxoid (Anti-TTd) and Anti-diphtheria Toxoid (Anti-DTd) Antibody Concentration >=0.1 IU/mL at 1 Month After Vaccination: GBS6 + Tdap and Placebo + Tdap Groups |
100.0; 100.0; 100.0; 100.0 | — |
| PRIMARY Geometric Mean Concentration (GMC) of Anti-Pertussis Toxin (PT), Anti-Filamentous Hemagglutinin (FHA), and Anti-Pertactin (PRN) Antibodies; GMR of Anti-PT, Anti-FHA, and Anti-PRN for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination |
17.975; 32.916; 108.377; 191.140; 158.887; 270.294 | — |
| PRIMARY GMC of GBS Capsular Polysaccharide (CPS) Serotype-Specific Immunoglobulin G (IgG) Antibodies; GMR of GBS CPS Serotype-specific IgG Antibodies for GBS6 + Tdap to Placebo + Tdap at 1 Month After Vaccination |
13.015; 14.616; 2.421; 2.106; 63.656; 61.709 | — |
Summary
This phase 2B, placebo-controlled, randomized, observer-blinded trial will evaluate the safety, tolerability, and immunogenicity of the investigational multivalent group B streptococcus vaccine administered concomitantly with Tdap in healthy nonpregnant women 18 through 49 years of age.
Eligibility Criteria
Inclusion Criteria
- Healthy women ≥18 and ≤49 years of age.
- 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
- Pregnant female participants; breastfeeding female participants; positive urine pregnancy test for women of childbearing potential (WOCBP) at Visit 1 (prior to vaccination)
- 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
Data sourced from ClinicalTrials.gov (NCT04766086). 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.