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Multivalent Group B Strep Vaccine for Group B Strep Infection
Study Summary
This trial will test the safety, tolerability and effectiveness of a new vaccine for group B strep in pregnant women.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
Media Library
- You need to have a negative pregnancy test before getting vaccinated.Women must have a negative pregnancy test before receiving the vaccine.You are a healthy woman who is not pregnant, and your medical history and physical exam show that you are eligible for a booster vaccine. You also received the first part of the study vaccine at a previous visit.I am a healthy woman, aged 18-40, with an uncomplicated single pregnancy.You don't have HIV, hepatitis B, or hepatitis C infection.You must have received the experimental drug during your first visit.A parent or guardian has agreed to sign a document giving permission for the child to participate in the study, and is prepared to attend all necessary appointments and follow the study guidelines.I am a healthy woman aged 18-40, not pregnant, and deemed eligible by a doctor.You have tested negative for HIV, Hepatitis B, Hepatitis C, and Syphilis.
- Group 1: Stage 1 - Highest dose formulation b
- Group 2: Stage 2 - Lowest dose formulation a
- Group 3: Stage 2 - Lowest dose formulation b
- Group 4: Stage 2 - Middle dose formulation b
- Group 5: Stage 2 - Highest dose formulation a
- Group 6: Stage 2 - Highest dose formulation b
- Group 7: Stage 3 - Selected dose and formulation
- Group 8: Stage 1 Placebo
- Group 9: Stage 2 Placebo
- Group 10: Stage 1 - Highest dose formulation a
- Group 11: Stage 2 - Middle dose formulation a
- Group 12: Stage 3 Placebo
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Are there any available slots for participants in this experiment?
"Data from clinicaltrials.gov tells us that this trial is no longer recruiting patients. Although the study was last updated on October 26th, 2022, it is not currently seeking any more participants. There are 8 other trials with similar goals that are still looking for candidates."
If I wanted to participate in this study, how many different locations would be available to me?
"To make participating more convenient for enrollees, this trial is running at 32 sites. Some of these locations are Albuquerque, Hastings and Phoenix. There may be a site near you, so check the list to find out."
What are the objectives of this clinical research?
"This clinical trial will last for a Delivery time frame and its primary goal is to Percentages of maternal subjects reporting AEs through 1 month after administration of investigational product.. Additionally, the study will also evaluate secondary outcomes including GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination and at delivery in maternal subjects. (defined as Describe GBS serotype-specific IgG GMCs measured at 2 weeks after vaccination in maternal subjects.), GBS serotype-specific IgG GMCs measured at delivery in maternal subjects. (defined as Describe GBS serotype-specific IgG GMCs measured at"
What is the FDA's opinion on Multivalent Group B streptococcus vaccine?
"Because a Phase 2 trial only provides data on safety and not efficacy, we have given the Multivalent Group B streptococcus vaccine a score of 2."
Is this clinical trial available to elderly patients?
"This particular clinical trial is only for patients aged 0 to 40. If you are looking for a medical study that includes children under the age of 18, then there are 4 other trials. Or, if you are 65 or older, 3 other options exist."
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