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Vaccine

Multivalent Group B streptococcus vaccine for Group B Strep Infection

Phase 2
Waitlist Available
Research Sponsored by Pfizer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 month after investigational product administration
Awards & highlights

Study Summary

This trial will study if a new vaccine for group B strep is safe and effective when given with another vaccine.

Eligible Conditions
  • Group B Strep Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 month after investigational product administration
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 month after investigational product administration for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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
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
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.
+7 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Placebo and TdapExperimental Treatment2 Interventions
Placebo and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)
Group II: GBS6 and TdapExperimental Treatment2 Interventions
Multivalent group B streptococcus vaccine and Tetanus, diphtheria, and acellular pertussis vaccine (Tdap)
Group III: GBS6 and PlaceboExperimental Treatment2 Interventions
Multivalent group B streptococcus vaccine and Placebo
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Multivalent Group B streptococcus vaccine
2022
Completed Phase 2
~1520
Tetanus, diphtheria, and acellular pertussis vaccine
2022
Completed Phase 3
~370
Placebo
1995
Completed Phase 3
~2670

Find a Location

Who is running the clinical trial?

PfizerLead Sponsor
4,567 Previous Clinical Trials
10,911,567 Total Patients Enrolled
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,735 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the participant criteria of this clinical trial limited to those over 50 years of age?

"The age criteria for this research project requires participants to be above 18 but below 49 years old."

Answered by AI

Are any hospitals in North America conducting experiments with this treatment protocol?

"Accellacare - Wilmington in Wilmington, Accellcare - Raleigh in Raleigh and Lynn Health Science Institute in Oklahoma City are among the 11 distinct sites currently operating for this trial."

Answered by AI

Am I eligible to participate in this investigation?

"The purpose of this trial is to evaluate the efficacy and safety of a medication for 53 female participants between 18-49 years old who have contracted group b streptococcal infection. In order to be eligible, women must meet all the following criteria: Be in good health at enrollment; agree to adhere to specific visit times, tests, lifestyle guidelines and other study procedures; demonstrate their understanding by giving personal signed informed consent; remain available throughout the duration of the trial as contactable via telephone."

Answered by AI

How reliable is the protection offered by administration of a Multivalent Group B streptococcus vaccine?

"Our internal safety assessment of the multivalent Group B streptococcus vaccine yielded a rating of 2, given that this is only in its second phase; there are limited results suggesting success regarding efficacy and some data indicating it may be safe."

Answered by AI

Has there been any prior research conducted regarding the Multivalent Group B streptococcus vaccine?

"The initial research for the multivalent Group B streptococcus vaccine was conducted in 2016 at Ohio State University Comprehensive Cancer Center. As of now, 18362 trials have been completed and 7 remain active with many taking place from Wilmington, North carolina."

Answered by AI

To what extent is this medical experiment taking on participants?

"This clinical trial has now closed, with the initial posting on August 12th 2022 and the latest edit occurring November 21st 2022. For those exploring other trials, 8 studies currently recruiting participants suffering from group b streptococcal infection while 7 medical centres are admitting patients for a Multivalent Group B streptococcus vaccine."

Answered by AI

Have these procedures been implemented before in similar investigations?

"Since its research inception in 2016, Multivalent Group B streptococcus vaccine has been granted Phase 2 drug approval after a study conducted by Pharmacyclics LLC. Now, there are seven ongoing trials for the medication across 42 cities and 6 countries."

Answered by AI

Are there any vacancies in the experiment for new participants?

"According to clinicaltrials.gov, this medical trial is no longer active and has stopped recruiting patients as of November 21st 2022. Nevertheless, 15 other trials are enrolling participants at present."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women
2022. "Trial to Evaluate the Safety, Tolerability, and Immunogenicity of A Multivalent Group B Streptococcus Vaccine When Administered Concomitantly With Tdap in Healthy Nonpregnant Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04766086.
~115 spots leftby Apr 2025
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