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Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects | Clinical Trials | Clareo Health

COMPLETEDPHASE1

Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects

Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects: A Phase I, Randomized, Placebo-controlled, Observer-blind Study

NCT04523571•BioNTech SE

View on ClinicalTrials.gov

Summary

This was a phase I, randomized, placebo-controlled, observer-blind study, for evaluation of safety and immunogenicity of SARS-CoV-2 mRNA vaccine (BNT162b1) in Chinese healthy population.

Detailed Description

The participants were screened for 2 weeks (Day -14 to Day 0) before randomization, and received 1 dose of SARS-CoV-2 vaccine (BNT162b1) or placebo intramuscularly (IM) on Day 1 and Day 22, respectively. After randomization, the study for each participant lasted for approximately 12 months.

Eligibility

Age

18 - 85 years

Sex

ALL

Healthy Volunteers

Yes

Inclusion Criteria

•For adult group (age ≥18 and ≤55)
•Male or female subjects of ≥18 years old and ≤55 years old with body mass index (BMI) ≥18 and ≤30 at the Screening Visit.
•Individuals who are in good health condition at the time of entry into the trial as determined by medical history, physical examination (including vital signs, electrocardiogram \[ECG\]) and eligibility screening test (hematology, blood chemistry and urine analysis) and clinical judgment of the investigator at Screening Visit.
•The subject can provide with informed consent and signs and dates a written informed consent form (ICF) prior to the initiation of any trial procedures.
•They must be able to understand and follow trial-related instructions.
•They must be willing and able to comply with planned visits, treatment schedule, laboratory tests and other requirements of the trial.
•Negative in antibodies screening of SARS-CoV-2 (fingerstick).
•Normal in chest computed tomography (CT) scans (no imaging features of COVID-19).
•Axillary temperature ≤ 37.0ºC.
•Negative SARS-CoV-2 test in throat swabs by reverse transcription-polymerase chain reaction (RT-PCR).
+20 more criteria

Exclusion Criteria

•For adult group (age ≥18 and ≤55)
•Have had any acute illness, as determined by the investigator, with or without fever, within 72 hours prior to the prime vaccination. An acute illness which is nearly resolved with only minor residual symptoms remaining is allowable if, in the opinion of the investigator, the residual symptoms will not compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
•Are breastfeeding on the day of Screening Visit or who plan to breastfeed during the trial, starting from Screening Visit and continuously until at least 90 days after the last immunization. Women or partners who plan to become pregnant within 1 year post the Screening Visit.
•Have a known allergy, hypersensitivity, or intolerance to the planned vaccine for trial including any excipients.
•Used to have a history of hypersensitivity or serious reactions to vaccination.
•Received any vaccination within 4 weeks prior to Visit 1.
•Don't agree to not be vaccinated during the trial, starting from Screening Visit and continuously until 28 days after receiving the last immunization, except emergency vaccination (e.g. rabies vaccine, tetanus vaccine).
•Had any medical condition (e.g., autoimmune disease) or any major surgery (e.g., requiring general anesthesia) within the past 5 years, which in the opinion of the investigator, could compromise their well-being if they participate as trial subjects in the trial, or that could prevent, limit, or confound the protocol-specified assessments.
•Have any surgery planned during the trial, starting from Screening Visit and continuously until at least 90 days after the last immunization.
•Had any chronic use (more than 14 continuous days) of any systemic medications that affects immune function, including immunosuppressant or other immune-modifying drugs, within 6 months prior to Screening Visit unless in the opinion of the investigator, the medication would not prevent, limit, or confound the protocol-specified assessments or could compromise safety of subjects.
+48 more criteria

Locations (1)

Jiangsu Provincial Center for Disease Control and Prevention

Taizhou, Jiangsu, China

Key Dates

Start Date

July 28, 2020

Primary Completion Date

September 30, 2020

Completion Date

August 10, 2021

Last Updated

September 18, 2023

Enrollment

144

ACTUAL participants

Conditions

SARS-CoV-2

Interventions

BNT162b1

BIOLOGICAL

Placebo

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 18, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety and Immunogenicity of SARS-CoV-2 mRNA Vaccine (BNT162b1) in Chinese Healthy Subjects

Inclusion Criteria

Exclusion Criteria

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