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

NCT04766086 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: C1091005
• Study Type: interventional
• Target: 306
• Locations: 1 country
• Sites: 12

Brief 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.

Conditions

Group B Streptococcus Infections

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination

  Local reactions (redness, swelling, and pain at the injection site of the left arm) were recorded by participants in e-diary. Erythema/Redness and induration/swelling were measured and recorded in measuring device units (1 measuring device unit=0.5 centimeter \[cm\]). Grading: Grade 1/mild (greater than \[\>\] 2.0 to 5.0 cm), Grade 2/moderate (\>5.0 to 10.0 cm), Grade 3/severe (\>10.0 cm) and Grade 4 (necrosis \[swelling\] or necrosis or exfoliative dermatitis \[redness\]). Pain at injection site was graded as Grade 1/mild (did not interfere with activity), Grade2/moderate (interfered with activity), Grade 3/severe (prevented daily activity) and Grade 4 (emergency room \[ER\] visit or hospitalization for severe pain at injection site). Grade 4 were classified by investigator or medically qualified person.

  Day 1 (day of vaccination) to Day 7

• Percentage of Participants Reporting Systemic Reactions Within 7 Days After Vaccination

  Systemic events were recorded in e-diary. Fever: oral temperature greater than or equal to (\>=) 38.0 degree Celsius (deg C) and categorized as \>=38.0-38.4 deg C, \>38.4-38.9 deg C, \>38.9-40.0 deg C and \>40.0 deg C. Nausea/vomiting was graded as: Grade 1/mild (1-2 times in 24 hours \[h\]), Grade 2/moderate: (\>2 times in 24h), Grade 3/severe (required intravenous hydration) and Grade 4 (ER visit/hospitalization for hypotensive shock). Diarrhea was graded as: Grade 1/mild (2-3 loose stools in 24h), Grade 2/moderate (4-5 loose stools in 24h), Grade 3/severe (6 or more loose stools in 24h) and Grade 4 (ER visit/hospitalization for severe diarrhea). Fatigue/tiredness, headache, chills, muscle pain and joint pain were graded as: Grade 1/mild (did not interfere with activity), Grade 2/moderate (some interference with activity), Grade 3/severe (prevented daily routine activity) and Grade 4 (ER visit/hospitalization). Grade 4 were classified by investigator or medically qualified person.

  Day 1 (day of vaccination) to Day 7

• Percentage of Participants Reporting Adverse Events (AEs) Through 1 Month After Vaccination

  An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. In this outcome measure results excluded data for local reactions and systemic events.

  Day 1 (day of vaccination) through 1 Month post-vaccination

• Percentage of Participants Reporting Medically Attended Adverse Events (MAEs) and Serious Adverse Events (SAEs) Through 6 Months After Vaccination

  A MAE was defined as a non-serious AE that resulted in an evaluation at a medical facility. A SAE was defined as any untoward medical occurrence at any dose that resulted in any of the following outcomes: death; life-threatening (immediate risk of death); required inpatient hospitalization or prolongation of existing hospitalization; persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); congenital anomaly/birth defect; or that was considered as an important medical event.

  Day 1 (day of vaccination) through 6 Months post-vaccination

• 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

  IU/mL stands for international units per milliliter.

  1 Month after Vaccination (Day 1, day of vaccination)

• 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

  GMCs of anti-PT, anti-FHA, and anti-PRN was reported as descriptive data for the GBS6 +Tdap and placebo + Tdap groups, along with associated 2-sided 95% confidence interval. GMR for anti-PT, anti-FHA and anti-PRN antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data.

  1 Month after Vaccination (Day 1, day of vaccination)

• 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

  GBS CPS serotype-specific IgG GMCs (Ia, Ib, II, III, IV, V) were reported as descriptive data for the GBS6+Tdap and GBS6+placebo groups, along with associated 2-sided 95% confidence interval. GMR of GBS CPS serotype-specific IgG antibodies were estimated from the GBS6 + Tdap group to the placebo + Tdap group and reported as statistical data.

  1 Month after Vaccination (Day 1, day of vaccination)

Study Arms (3)

GBS6 and Tdap

EXPERIMENTAL

Multivalent group B streptococcus vaccine and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)

Biological: Multivalent Group B streptococcus vaccine; Biological: Tetanus, diphtheria, and acellular pertussis vaccine

GBS6 and Placebo

EXPERIMENTAL

Multivalent group B streptococcus vaccine and Placebo

Biological: Multivalent Group B streptococcus vaccine; Biological: Placebo

Placebo and Tdap

EXPERIMENTAL

Placebo and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)

Biological: Tetanus, diphtheria, and acellular pertussis vaccine; Biological: Placebo

Interventions

Multivalent Group B streptococcus vaccine BIOLOGICAL

Multivalent Group B streptococcus vaccine

GBS6 and Placebo; GBS6 and Tdap

Tetanus, diphtheria, and acellular pertussis vaccine BIOLOGICAL

Tetanus, diphtheria, and acellular pertussis vaccine

Also known as: Tdap

GBS6 and Tdap; Placebo and Tdap

Placebo BIOLOGICAL

Saline control

GBS6 and Placebo; Placebo and Tdap

Eligibility Criteria

• Age: 18 Years - 49 Years
• Gender Eligibility Details: Healthy women ≥18 and ≤49 years of age.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Pfizer: lead

Study Sites (12)

Alliance for Multispecialty Research, LLC

Newton, Kansas, 67114, United States

Location

Quality Clinical Research, Inc

Omaha, Nebraska, 68114, United States

Location

Alliance for Multispecialty Research, LLC

Las Vegas, Nevada, 89119, United States

Location

Accellacare - Raleigh

Raleigh, North Carolina, 27609, United States

Location

Accellacare - Wilmington

Wilmington, North Carolina, 28401, United States

Location

PriMED Clinical Research

Dayton, Ohio, 45419, United States

Location

PriMed Clinical Research

Dayton, Ohio, 45429, United States

Location

Lynn Health Science Institute

Oklahoma City, Oklahoma, 73112, United States

Location

Alliance for Multispecialty Research, LLC

Knoxville, Tennessee, 37909, United States

Location

Benchmark Research

Fort Worth, Texas, 76135, United States

Location

DM Clinical Research - Brookline

Houston, Texas, 77081, United States

Location

J. Lewis Research, Inc. / Foothill Family Clinic South

Salt Lake City, Utah, 84121, United States

Location

Related Publications (1)

• 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.

  PMID: 40036340 DERIVED

Related Links

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

MeSH Terms

Interventions

Diphtheria-Tetanus-acellular Pertussis Vaccines

Intervention Hierarchy (Ancestors)

Pertussis Vaccine; Bacterial Vaccines; Vaccines; Biological Products; Complex Mixtures; Diphtheria Toxoid; Toxoids; Tetanus Toxoid; Vaccines, Combined; Vaccines, Acellular; Vaccines, Subunit

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer Inc.

ClinicalTrials.gov_Inquires@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This is an observer-blinded study. Study staff dispensing and administering the vaccine will be unblinded, but all other study personnel, including the principal investigator, and the subject, will be blinded.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2021
• First Posted: February 23, 2021
• Study Start: August 12, 2022
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: May 24, 2024
• Results First Posted: May 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share

Locations

US (12)