- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04649021
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population
May 9, 2022 updated by: BioNTech SE
Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population: A Phase II, Randomized, Placebo-controlled, Observer-blinded Study
This is a phase II, randomized, placebo-controlled, observer-blinded study of the safety and immunogenicity of SARS-CoV-2 messenger RNA (mRNA) vaccine (BNT162b2) in Chinese healthy population.
After randomization, the trial for each participant will last for approximately 13 months.
Screening period is 2 weeks prior to randomization (Day -14 to Day 0), and two doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo will be given intramuscularly (IM) separated by 21 days.
Study Overview
Study Type
Interventional
Enrollment (Actual)
950
Phase
- 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
-
-
-
Jiangsu, China, 210009
- Jiangsu Provincial Center for Disease Control and Prevention
-
-
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
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female participants between the ages of 18 and 85 years, inclusive, at randomization.
- Participants who are willing and able to comply with all scheduled visits, vaccination 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 preexisting stable disease, defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 6 weeks before enrollment, can be included.
- Capable of giving personal signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form and this protocol.
- SARS-CoV-2 antibody test screening is negative.
- Negative SARS-CoV-2 test in throat swabs by reverse transcription-polymerase chain reaction (RT-PCR) (only for the first approximately 150 subjects).
- Normal in chest computed tomography (CT) scans (no imaging features of coronavirus disease 2019 (COVID-19), only for the first approximately 150 subjects).
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 human immunodeficiency virus (HIV), hepatitis C virus (HCV), or hepatitis B virus (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).
- Receipt of medications intended to prevent COVID-19.
- Immunocompromised individuals with known or suspected immunodeficiency, 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.
- Individuals who receive treatment with immunosuppressive therapy, including cytotoxic agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or planned receipt throughout the study. If systemic corticosteroids have been administered short term (<14 days) for treatment of an acute illness, participants should not be enrolled into the study until corticosteroid therapy has been discontinued for at least 28 days before study intervention administration. 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.
- Have had contact with confirmed COVID-19 patients or persons tested positive for SARS-CoV-2 within the 30 days prior to Screening Visit.
- Travel or live in any country or region with a high SARS-CoV-2 infection risk (as defined at Screening Visit) within the 14 days prior to Screening Visit.
- Symptoms of COVID-19, e.g., respiratory symptoms, fever, cough, shortness of breath and breathing difficulties.
- Fever, defined as axillary temperature ≥37.3ºC or oral temperature ≥38ºC.
- History of SARS, SARS-CoV-2 or middle east respiratory syndrome (MERS) infection. Suspected SARS patients should be screened for SARS antibodies.
- Investigator site staff or Fosun employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.
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: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: BNT162b2 18-85 years of age
|
Intramuscular injection
|
Placebo Comparator: Placebo 18-85 years of age
|
Intramuscular injection
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR)
Time Frame: 1 Month after Dose 2
|
SCR of SARS-CoV-2 serum neutralizing titers at 1-month after dose 2. Seroconversion is defined as ≥4-fold rise from before vaccination to 1-month post dose 2.
|
1 Month after Dose 2
|
The geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing titers at 1 month after dose 2
Time Frame: 1 Month after Dose 2
|
1 Month after Dose 2
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
SARS-CoV-2 serum neutralizing titers - SCR
Time Frame: 1 Week, 6 and 12 Months after Dose 2
|
Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.
|
1 Week, 6 and 12 Months after Dose 2
|
SARS-CoV-2 serum neutralizing titers - GMT
Time Frame: 1 Week, 6 and 12 Months after Dose 2
|
GMT of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.
|
1 Week, 6 and 12 Months after Dose 2
|
SARS-CoV-2 anti-S1 immunoglobulin G (IgG) antibody level - SCR
Time Frame: 1 Week, 1, 6 and 12 Months after Dose 2
|
Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.
|
1 Week, 1, 6 and 12 Months after Dose 2
|
SARS-CoV-2 anti-S1 IgG antibody level - GMT
Time Frame: 1 Week, 1, 6 and 12 Months after Dose 2
|
GMT of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.
|
1 Week, 1, 6 and 12 Months after Dose 2
|
SARS-CoV-2 serum neutralizing antibody level - Geometric mean fold rise (GMFR)
Time Frame: 1 Week, 1, 6 and 12 Months after Dose 2
|
Compared with baseline before Vaccination 1, the GMFR of SARS-CoV-2 serum neutralizing antibody titers at 1 week, 1, 6 and 12 months after dose 2.
|
1 Week, 1, 6 and 12 Months after Dose 2
|
SARS-CoV-2 anti-S1 IgG antibody level - GMFR
Time Frame: 1 Week, 1, 6 and 12 Months after Dose 2
|
Compared with baseline before Vaccination 1, GMFR of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.
|
1 Week, 1, 6 and 12 Months after Dose 2
|
Percentage of participants reporting local reactions
Time Frame: Within 7 Days and 14 Days after each vaccination
|
Pain at the injection site, redness, and swelling as self-reported on diary cards.
|
Within 7 Days and 14 Days after each vaccination
|
Percentage of participants reporting systemic events
Time Frame: Within 7 Days and 14 Days after each vaccination
|
Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on diary cards.
|
Within 7 Days and 14 Days after each vaccination
|
Hematology laboratory assessments
Time Frame: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2
|
Percentage of participants with abnormal hematology laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.
|
Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2
|
Chemistry laboratory assessments
Time Frame: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2
|
Percentage of participants with abnormal chemistry laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.
|
Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2
|
Hematology laboratory assessments
Time Frame: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2
|
Percentage of participants with grading shifts in hematology laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2.
|
Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2
|
Chemistry laboratory assessments
Time Frame: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2
|
Percentage of participants with grading shifts in chemistry laboratory assessments between baseline and 1 and 7 days after dose 1; and before dose 2 and 7 days after dose 2.
|
Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2
|
Adverse events (AEs)
Time Frame: From Dose 1 through 1 Month after the last Dose
|
AEs from dose 1 to 1 month after the last dose.
|
From Dose 1 through 1 Month after the last Dose
|
Serious AEs (SAEs)
Time Frame: From Dose 1 through 6 Months after the last Dose
|
SAEs from dose 1 to 6 months after the last dose.
|
From Dose 1 through 6 Months after the last Dose
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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)
December 4, 2020
Primary Completion (Actual)
February 7, 2021
Study Completion (Actual)
January 9, 2022
Study Registration Dates
First Submitted
November 17, 2020
First Submitted That Met QC Criteria
November 30, 2020
First Posted (Actual)
December 2, 2020
Study Record Updates
Last Update Posted (Actual)
May 10, 2022
Last Update Submitted That Met QC Criteria
May 9, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- BNT162-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on SARS-CoV-2
-
Argorna Pharmaceuticals Co., LTDCompleted
-
Argorna Pharmaceuticals Co., LTDCompleted
-
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.Active, not recruiting
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College; Ningbo Rongan Biological...Active, not recruiting
-
Arcturus Therapeutics, Inc.Terminated
-
University Hospital Inselspital, BerneUniversity of Bern; Lucerne University of Applied Sciences and ArtsCompleted
-
Centre Hospitalier Universitaire DijonUnknown
-
AIM Vaccine Co., Ltd.Zhejiang Provincial Center for Disease Control and PreventionNot yet recruiting
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical College; Ningbo Rongan Biological...Not yet recruiting
-
AIM Vaccine Co., Ltd.First Affiliated Hospital Bengbu Medical CollegeActive, not recruiting
Clinical Trials on Placebo
-
SamA Pharmaceutical Co., LtdUnknownAcute Bronchitis | Acute Upper Respiratory Tract InfectionKorea, Republic of
-
National Institute on Drug Abuse (NIDA)CompletedCannabis UseUnited States
-
AstraZenecaParexel; Spandauer Damm 130; 14050; Berlin, GermanyCompletedMale Subjects With Type II Diabetes (T2DM)Germany
-
Heptares Therapeutics LimitedCompletedPharmacokinetics | Safety IssuesUnited Kingdom
-
GlaxoSmithKlineCompletedPulmonary Disease, Chronic ObstructiveUnited Kingdom, Netherlands
-
Shijiazhuang Yiling Pharmaceutical Co. LtdXuanwu Hospital, BeijingCompleted
-
ItalfarmacoCompletedBecker Muscular DystrophyNetherlands, Italy
-
GlaxoSmithKlineCompletedInfections, BacterialUnited States
-
West Penn Allegheny Health SystemCompletedAsthma | Allergic RhinitisUnited States