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

April 25, 2024 updated by: Pfizer

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
306

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Reporting Local Reactions Within 7 Days After Vaccination
Time Frame: Day 1 (day of vaccination) to Day 7
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
Time Frame: Day 1 (day of vaccination) to Day 7
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
Time Frame: Day 1 (day of vaccination) through 1 Month post-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
Time Frame: Day 1 (day of vaccination) through 6 Months post-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
Time Frame: 1 Month after Vaccination (Day 1, day of vaccination)
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
Time Frame: 1 Month after Vaccination (Day 1, day of 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
Time Frame: 1 Month after Vaccination (Day 1, day of 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Pfizer

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 12, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 27, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 27, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 23, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 24, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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