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Cancer Vaccine
BNT162b2 Vaccine for COVID-19
Phase 2 & 3
Waitlist Available
Research Sponsored by BioNTech SE
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
SSA
Received at least 3 prior doses of a US-authorized mRNA COVID-19 vaccine, with the most recent dose being a US-authorized Omicron BA.4/BA.5-adapted bivalent vaccine received at least 150 days before Visit 1 (Day 1).
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 month after vaccination.
Awards & highlights
Study Summary
This trial evaluates safety, tolerability, and immunogenicity of a new COVID-19 vaccine in people 12+ who have had 3 doses of a US-approved mRNA vaccine at least 150 days before. Blood & nasal swab samples taken in 5+ visits.
Who is the study for?
This trial is for healthy individuals aged 12 and older. Substudy A includes those who've had at least 3 doses of a US-authorized mRNA COVID-19 vaccine, with the last being an Omicron BA.4/BA.5-adapted bivalent vaccine over 150 days ago. Substudy B is for COVID-19 vaccine-naïve people who tested positive for SARS-CoV-2 more than 28 days before.Check my eligibility
What is being tested?
The study tests a new RNA-based COVID-19 vaccine candidate, BNT162b2 (Omi XBB.1.5), targeting recent variants as a single dose to evaluate safety and immune response over about six months with at least five clinic visits involving blood samples and nasal swabs.See study design
What are the potential side effects?
Potential side effects are not detailed in the provided information but may include typical reactions to vaccines such as soreness at injection site, fatigue, headache, muscle pain, chills, fever, nausea.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 1 month after the study vaccination
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 month after the study vaccination
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Difference in percentages of subjects with seroresponse to XBB.1.5 strain after BNT162b2 (Omi XBB.1.5) 30 μg given as single dose to COVID-19 vaccine-naïve subjects compared to BNT162b2 (Omi XBB.1.5) 30 μg given to vaccine experienced subjects in SSA
SSA: Geometric Mean Fold Rise (GMFR; change between 2 timepoints) of SARS-CoV-2 Omicron XBB.1.5-and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg
SSA: Geometric Mean Titers (GMT) of SARS-CoV-2 Omicron XBB.1.5- and Omicron BA.4/BA.5-neutralizing antibody levels for BNT162b2 (Omi XBB.1.5) 30 µg
+10 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: SSB: Group 2Experimental Treatment1 Intervention
Participants 12 years of age and older who were previously exposed to SARS-CoV-2 and are COVID-19 vaccine-naïve will receive 30 μg of BNT162b2 (Omi XBB.1.5) at Visit 1
Group II: SSA: Group 1Experimental Treatment1 Intervention
Participants 12 years of age and older, COVID-19 vaccine-experienced will receive 30 µg of BNT162b2 (Omi XBB.1.5) at Visit 1.
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Who is running the clinical trial?
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,143 Total Patients Enrolled
67 Trials studying COVID-19
1,437,953 Patients Enrolled for COVID-19
BioNTech SELead Sponsor
64 Previous Clinical Trials
108,451 Total Patients Enrolled
20 Trials studying COVID-19
97,839 Patients Enrolled for COVID-19
Pfizer CT.gov Call CenterStudy DirectorPfizer
3,474 Previous Clinical Trials
8,092,311 Total Patients Enrolled
49 Trials studying COVID-19
1,426,730 Patients Enrolled for COVID-19
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am generally healthy, even if I have a stable, pre-existing condition.
Research Study Groups:
This trial has the following groups:- Group 1: SSA: Group 1
- Group 2: SSB: Group 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any open slots for participants in this experiment?
"According to the information shared on clinicaltrials.gov, this study is not presently welcoming participants. The trial was first posted and last updated on August 10th of 2023. Although there are no openings for this particular study at present, 791 other trials have begun enrolling patients as of now."
Answered by AI
How widely spread is the implementation of this research in North America?
"Fifteen different clinical research organisations are recruiting patients for this trial, such as Bayview Research Group, LLC in Valley Village, Diablo Clinical Research Inc. in Walnut Creek and Clinical Research Consulting in Milford. Additionally, there are 12 more locations currently involved with the project."
Answered by AI
Who else is applying?
What site did they apply to?
Clinical Research Consulting
North Alabama Research Center
Clinical Neuroscience Solutions, Inc.
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
Why did patients apply to this trial?
I would like to learn about myself and the
negatives of life and its elements, please.
PatientReceived 1 prior treatment
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