Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women

A PHASE 2B, PLACEBO-CONTROLLED, RANDOMIZED, OBSERVER-BLINDED TRIAL TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A MULTIVALENT GROUP B STREPTOCOCCUS VACCINE WHEN ADMINISTERED CONCOMITANTLY WITH TETANUS, DIPHTHERIA, AND ACELLULAR PERTUSSIS VACCINE (TDAP) IN HEALTHY NONPREGNANT WOMEN 18 THROUGH 49 YEARS OF AGE

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.

Study Overview

• Status: Completed
• Conditions: Group B Streptococcus Infections
• Intervention / Treatment: Biological: Placebo; Biological: Multivalent Group B streptococcus vaccine; Biological: Tetanus, diphtheria, and acellular pertussis vaccine

• Study Type: Interventional
• Enrollment (Actual): 306
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Kansas
    • Newton, Kansas, United States, 67114
      • Alliance for Multispecialty Research, LLC
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc
  • Nevada
    • Las Vegas, Nevada, United States, 89119
      • Alliance for Multispecialty Research, LLC
  • North Carolina
    • Raleigh, North Carolina, United States, 27609
      • Accellacare - Raleigh
    • Wilmington, North Carolina, United States, 28401
      • Accellacare - Wilmington
  • Ohio
    • Dayton, Ohio, United States, 45419
      • PriMed Clinical Research
    • Dayton, Ohio, United States, 45429
      • PriMed Clinical Research
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
  • Tennessee
    • Knoxville, Tennessee, United States, 37909
      • Alliance for Multispecialty Research, LLC
  • Texas
    • Fort Worth, Texas, United States, 76135
      • Benchmark Research
    • Houston, Texas, United States, 77081
      • DM Clinical Research - Brookline
  • Utah
    • Salt Lake City, Utah, United States, 84121
      • J. Lewis Research, Inc. / Foothill Family Clinic South

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 49 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GBS6 and Tdap; Multivalent group B streptococcus vaccine and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)	Biological: Multivalent Group B streptococcus vaccine; Multivalent Group B streptococcus vaccine; Biological: Tetanus, diphtheria, and acellular pertussis vaccine; Tetanus, diphtheria, and acellular pertussis vaccine; Other Names: Tdap
Experimental: GBS6 and Placebo; Multivalent group B streptococcus vaccine and Placebo	Biological: Placebo; Saline control; Biological: Multivalent Group B streptococcus vaccine; Multivalent Group B streptococcus vaccine
Experimental: Placebo and Tdap; Placebo and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)	Biological: Placebo; Saline control; Biological: Tetanus, diphtheria, and acellular pertussis vaccine; Tetanus, diphtheria, and acellular pertussis vaccine; Other Names: Tdap

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants reporting prompted local reactions within 7 days following investigational product administration	Describe prompted local reactions following investigational product administration	Day 7
Proportion of participants reporting prompted systemic events within 7 days following investigational product administration	Describe prompted systemic events following investigational product administration	Day 7
Proportion of participants reporting adverse events (AEs) through 1 month following investigational product administration	Describe AEs occurring through 1 month following administration of investigational product	1 month following administration of investigational product
Proportion of participants reporting medically attended adverse events (MAEs) and serious adverse events (SAEs) through 1 month following investigational product administration	Describe MAEs and SAEs through 1 month following administration of investigational product	1 month following administration of investigational product
Difference in proportions of participants with anti-tetanus toxoid antibody concentrations greater than or equal to 0.1 IU/mL measured 1 month after vaccination between the GBS6 and Tdap group and the placebo and Tdap group	Describe that the immune responses induced by Tdap when administered concomitantly with GBS6 compared to the immune responses induced by Tdap alone.	1 month after investigational product administration
Difference in proportions of participants with anti-diphtheria toxoid antibody concentrations greater than or equal to 0.1 IU/mL measured 1 month after vaccination between GBS6 and Tdap group and placebo and Tdap group	Describe that the immune responses induced by Tdap when administered concomitantly with GBS6 compared to the immune responses induced by Tdap alone.	1 month after investigational product administration
Geometric mean ratio (GMR), estimated by GMR of anti-pertussis toxin antibodies from the GBS6 and Tdap group to the placebo and Tdap group measured 1 month after vaccination.	Describe that the immune responses induced by Tdap when administered concomitantly with GBS6 compared to the immune responses induced by Tdap alone.	1 month after investigational product administration
GMR, estimated by the GMR of anti-filamentous hemagglutinin (anti-FHA) antibodies from the GBS6 and Tdap group to the placebo and Tdap group measured 1 month after vaccination.	Describe that the immune responses induced by Tdap when administered concomitantly with GBS6 compared to the immune responses induced by Tdap alone.	1 month after investigational product administration
GMR, estimated by the GMR of antipertactin (anti-PRN) antibodies from the GBS6 and Tdap group to the placebo and Tdap group measured 1 month after vaccination.	Describe that the immune responses induced by Tdap when administered concomitantly with GBS6 compared to the immune responses induced by Tdap alone.	1 month after investigational product administration
GBS capsular polysaccharide (CPS) serotype-specific IgG GMR, estimated by the GMR of GBS CPS serotype-specific IgG antibodies from the GBS6 and Tdap group to the GBS6 and placebo group measured 1 month after vaccination.	Describe that the immune responses induced by GBS6 when administered concomitantly with Tdap (GBS6 and Tdap) compared to the immune responses induced by GBS6 (GBS6 and placebo) alone	1 month after investigational product administration

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

Helpful Links

• To obtain contact information for a study center near you, click here.

Study record dates

Study Major Dates

• Study Start (Actual): August 12, 2022
• Primary Completion (Actual): April 27, 2023
• Study Completion (Actual): April 27, 2023

Study Registration Dates

• First Submitted: February 18, 2021
• First Submitted That Met QC Criteria: February 18, 2021
• First Posted (Actual): February 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 26, 2023
• Last Update Submitted That Met QC Criteria: June 23, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Bacterial Infections; Bacterial Infections and Mycoses; Gram-Positive Bacterial Infections; Streptococcal Infections; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: C1091005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No