AzTrials
AzTrials

SARS-CoV-2Phase 2NCT04649021

Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population

A Phase 2 study testing BNT162b2 in people with SARS-CoV-2, run by BioNTech SE at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

This was 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 lasted for approximately 13 months. Read more about this study

Who is it for?
Ages 18 to 85 yearsHealthy volunteers can take part
Conditions the study is for
SARS-CoV-2
What is being tested?
BNT162b2
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
960 participants
Where
1 siteChina
Study dates
4 Dec 2020to 9 Jan 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Male or female participants between the ages of 18 and 85 years, inclusive, at randomization.
  • Participants who were willing and able to comply with all scheduled visits, vaccination plan, laboratory tests, lifestyle considerations, and other study procedures.
  • Healthy participants who were 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, were allowed to be included.
  • Capable of giving personal signed informed consent, which included compliance with the requirements and restrictions listed in the informed consent form and the protocol.
  • SARS-CoV-2 antibody test screening was 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).

Who cannot join

  • 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.
Show all 18Show fewer
  • Women who were pregnant or breastfeeding.
  • Previous vaccination with any coronavirus vaccine.
  • Individuals who received 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 were 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Jiangsu Provincial Center for Disease Control and Prevention

    Nanjing, 210009

Other trials in China

About this study

Official title: Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b2) in Chinese Healthy Population: A Phase II, Randomized, Placebo-controlled, Observer-blinded Study

This was 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 lasted for approximately 13 months. Screening period was 2 weeks prior to randomization (Day -14 to Day 0), and two doses of either SARS-CoV-2 vaccine (BNT162b2) or placebo were given intramuscularly (IM) separated by 21 days.

Conditions
SARS-CoV-2
Being tested
BNT162b2, Placebo
Keywords
Coronavirus Disease 2019, Coronavirus infection, Vaccine, Protection against COVID-19, Covid19, SARS (Severe Acute Respiratory Syndrome)
Medical subject headings
COVID-19, Coronavirus Infections, Severe Acute Respiratory Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BNT162b2Biological

    Intramuscular injection

  • PlaceboOther

    Intramuscular injection

Study groups in NCT04649021
Study groupRoleWhat they receive
BNT162b2 18-85 years of ageExperimentalNot described
Receives: Biological: BNT162b2
Placebo 18-85 years of agePlacebo comparatorNot described
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR)

    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.

    Measured: 1 Month after Dose 2

  2. The geometric mean titer (GMT) of SARS-CoV-2 serum neutralizing titers at 1 month after dose 2

    Measured: 1 Month after Dose 2

Secondary outcomes (14)

  1. SARS-CoV-2 serum neutralizing titers - SCR

    Compared with baseline before Vaccination 1, SCR of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.

    Measured: 1 Week, 6 and 12 Months after Dose 2

  2. SARS-CoV-2 serum neutralizing titers - GMT

    GMT of SARS-CoV-2 serum neutralizing titers at 1 week, 6 and 12 months after dose 2.

    Measured: 1 Week, 6 and 12 Months after Dose 2

  3. SARS-CoV-2 anti-S1 immunoglobulin G (IgG) antibody level - SCR

    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.

    Measured: 1 Week, 1, 6 and 12 Months after Dose 2

  4. SARS-CoV-2 anti-S1 IgG antibody level - GMT

    GMT of SARS-CoV-2 anti-S1 IgG antibody level at 1 week, 1, 6 and 12 months after dose 2.

    Measured: 1 Week, 1, 6 and 12 Months after Dose 2

  5. SARS-CoV-2 serum neutralizing antibody level - Geometric mean fold rise (GMFR)

    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.

    Measured: 1 Week, 1, 6 and 12 Months after Dose 2

  6. SARS-CoV-2 anti-S1 IgG antibody level - GMFR

    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.

    Measured: 1 Week, 1, 6 and 12 Months after Dose 2

  7. Percentage of participants reporting local reactions

    Pain at the injection site, redness, and swelling as self-reported on diary cards.

    Measured: Within 7 Days and 14 Days after each vaccination

  8. Percentage of participants reporting systemic events

    Fever, fatigue, headache, chills, vomiting, diarrhea, new or worsened muscle pain, and new or worsened joint pain as self-reported on diary cards.

    Measured: Within 7 Days and 14 Days after each vaccination

  9. Hematology laboratory assessments

    Percentage of participants with abnormal hematology laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.

    Measured: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2

  10. Chemistry laboratory assessments

    Percentage of participants with abnormal chemistry laboratory values 1 and 7 days after dose 1, before dose 2, and 7 days after dose 2.

    Measured: Day 1 and 7 Days after Dose 1, before Dose 2, and 7 Days after Dose 2

  11. Hematology laboratory assessments

    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.

    Measured: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2

  12. Chemistry laboratory assessments

    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.

    Measured: Day 1 and 7 Days after Dose 1; and before Dose 2 and 7 Days after Dose 2

  13. Adverse events (AEs)

    AEs from dose 1 to 1 month after the last dose.

    Measured: From Dose 1 through 1 Month after the last Dose

  14. Serious AEs (SAEs)

    SAEs from dose 1 to 6 months after the last dose.

    Measured: From Dose 1 through 6 Months after the last Dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2020
  2. Study start4 Dec 2020
  3. Primary completion7 Feb 2021
  4. Study completion9 Jan 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
960 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04649021
Sponsor's protocol ID
BNT162-06
Status last verified
Mar 2026
First submitted
17 Nov 2020
Last updated
20 Mar 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hui AM, Li J, Zhu L, Tang R, Ye H, Lin M, Ge L, Wang X, Peng F, Wu Z, Guo X, Shi Y, Pan H, Zhu J, Song Z, Qiu J, Wang W, Zheng J, Ozhelvaci O, Shpyro S, Bushway M, Derhovanessian E, Kuhnle MC, Luxemburger U, Muik A, Shishkova Y, Khondker Z, Hu S, Lagkadinou E, Sahin U, Tureci O, Zhu F. Immunogenicity and safety of BNT162b2 mRNA vaccine in Chinese adults: A phase 2 randomised clinical trial. Lancet Reg Health West Pac. 2022 Dec;29:100586. doi: 10.1016/j.lanwpc.2022.100586. Epub 2022 Sep 14.

    PubMed 36120090

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BNT162b2 in people with SARS-CoV-2, run by BioNTech SE at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SARS-CoV-2 serum neutralizing titers - Seroconversion rates (SCR) (time frame: 1 Month after Dose 2). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04649021, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in