Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults

NCT04816669

Last updated date
Study Location
Anaheim Clinical Trials, LLC
Anaheim, California, 92801, United States
Contact
1-800-718-1021

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting the study website. Please see the references below:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[email protected]

Call Now

Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
SARS-CoV-2 Infection, COVID-19
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-55 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female participants 18 - 55 years of age, inclusive, at Visit 1, (Day 1).

- Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.

- Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included.

- Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Other 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.


- Known infection with HIV, HCV, or HBV.


- History of severe adverse reaction associated with a vaccine and/or severe allergic
reaction (eg, anaphylaxis) to any component of the study intervention(s).


- Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result
was not available) or microbiological (based on COVID-19 symptoms/signs and a positive
SARS-CoV-2 NAAT result) diagnosis of COVID-19.


- Immunocompromised individuals with known or suspected immunodeficiency, as determined
by history and/or laboratory/physical examination.


- Bleeding diathesis or condition associated with prolonged bleeding that would, in the
opinion of the investigator, contraindicate intramuscular injection.


- Women who are pregnant or breastfeeding.


- Previous vaccination with any coronavirus vaccine.


- Receipt of medications intended to prevent COVID-19.


- Individuals who receive treatment with radiotherapy or immunosuppressive therapy,
including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids
are administered for ≥14 days at a dose of ≥20 mg/day of prednisone or equivalent),
eg, for cancer or an autoimmune disease, or planned receipt throughout the study.
Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes)
corticosteroids are permitted.


- Receipt of blood/plasma products or immunoglobulin, from 60 days before study
intervention administration or planned receipt throughout the study.


- Participation in other studies involving study intervention within 28 days prior to
study entry and/or during study participation / Previous participation in other
studies involving study intervention containing lipid nanoparticles (LNPs).


- Previous participation in other studies involving study intervention containing lipid
nanoparticles.


- Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct
of the study, site staff otherwise supervised by the investigator, and their
respective family members.

NEED INFO?

Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

pfizer-logoClinical Trials
Interested in learning more about clinical trials?
Discover how clinical trials work and the impact your participation could have.

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Based on your search, you may also be interested in

SARS-CoV-2 Infection, COVID-19Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
NCT04816669
  1. Anaheim, California
  2. Walnut Creek, California
  3. Hialeah, Florida
  4. Hollywood, Florida
  5. Jacksonville, Florida
  6. Orlando, Florida
  7. Stockbridge, Georgia
  8. Honolulu, Hawaii
  9. Meridian, Idaho
  10. Bardstown, Kentucky
  11. Omaha, Nebraska
  12. Raritan, New Jersey
  13. Wilmington, North Carolina
  14. Columbus, Ohio
  15. Austin, Texas
  16. Galveston, Texas
  17. Houston, Texas
  18. Tomball, Texas
  19. Tomball, Texas
  20. Salt Lake City, Utah
  21. Salt Lake City, Utah
ALL GENDERS
18 Years+
years
MULTIPLE SITES
SARS-CoV-2 Infection, COVID-19Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults
NCT04634760
  1. Sumida-ku, Tokyo
  2. Fukuoka,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
SARS-CoV-2 Infection, COVID-19Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults
NCT04588480
  1. Sumida-ku, Tokyo
  2. Fukuoka,
ALL GENDERS
20 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study to Evaluate the Safety, Tolerability, and Immunogenicity of Multiple Formulations of BNT162b2 Against COVID-19 in Healthy Adults
Official Title  ICMJE A PHASE 3, RANDOMIZED, OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF MULTIPLE FORMULATIONS OF THE VACCINE CANDIDATE BNT162B2 AGAINST COVID 19 IN HEALTHY ADULTS 18 THROUGH 55 YEARS OF AGE
Brief Summary

This study will compare the safety and tolerability of lyophilized BNT162b2 presented in single dose vials to those of frozen-liquid BNT162b2 in multidose vials and determine whether the immune response is noninferior. Separately, the study will also describe the safety and immunogenicity of frozen-liquid BNT162b2 with lipid nanoparticle size at the upper end of specification and ready to use BNT162b2 (the immediate manufacturing precursor to the lyophilate).

  • 2-dose schedule (separated by 21 days)
  • At a dose of 30µg (as studied in the Phase 2/3 study C4591001)
  • In healthy adults 18 through 55 years of age
  • The duration of the study for each participant will be approximately 2 months (3 visits in total)
  • The study will be conducted in the United States
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • SARS-CoV-2 Infection
  • COVID-19
Intervention  ICMJE Biological: BNT162b2
Intramuscular injection
Study Arms  ICMJE
  • Experimental: Lyophilized SDV
    Intervention: Biological: BNT162b2
  • Experimental: Frozen liquid MDV (control for lyo SDV)
    Control for lyophilized SDV
    Intervention: Biological: BNT162b2
  • Experimental: Frozen-liquid with LNP size at the upper end of specification
    Intervention: Biological: BNT162b2
  • Experimental: RTU
    Intervention: Biological: BNT162b2
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: May 18, 2021)
610
Original Estimated Enrollment  ICMJE
 (submitted: March 24, 2021)
1100
Estimated Study Completion Date  ICMJE October 30, 2021
Estimated Primary Completion Date October 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female participants 18 - 55 years of age, inclusive, at Visit 1, (Day 1).
  • Participants who are willing and able to comply with all scheduled visits, treatment plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. Note: Healthy participants with pre-existing stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrolment, can be included.
  • Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the ICD and in the protocol.

Exclusion Criteria:

  • Other 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.
  • Known infection with HIV, HCV, or HBV.
  • History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis) to any component of the study intervention(s).
  • Previous clinical (based on COVID-19 symptoms/signs alone, if a SARS-CoV-2 NAAT result was not available) or microbiological (based on COVID-19 symptoms/signs and a positive SARS-CoV-2 NAAT result) diagnosis of COVID-19.
  • Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.
  • Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection.
  • Women who are pregnant or breastfeeding.
  • Previous vaccination with any coronavirus vaccine.
  • Receipt of medications intended to prevent COVID-19.
  • Individuals who receive treatment with radiotherapy or immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids (if systemic corticosteroids are administered for ?14 days at a dose of ?20 mg/day of prednisone or equivalent), eg, for cancer or an autoimmune disease, or planned receipt throughout the study. Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes) corticosteroids are permitted.
  • Receipt of blood/plasma products or immunoglobulin, from 60 days before study intervention administration or planned receipt throughout the study.
  • Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation / Previous participation in other studies involving study intervention containing lipid nanoparticles (LNPs).
  • Previous participation in other studies involving study intervention containing lipid nanoparticles.
  • Investigator site staff or Pfizer/BioNTech employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04816669
Other Study ID Numbers  ICMJE C4591020
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party BioNTech SE
Study Sponsor  ICMJE BioNTech SE
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account BioNTech SE
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP