SARS-CoV-2 InfectionPhase 4NCT04588480

Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Japanese Adults

A Phase 4 study testing BNT162b2 in people with SARS-CoV-2 Infection and COVID-19, run by BioNTech SE at 2 sites in Japan.

Completed

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

Official record

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Trial summary

This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults. The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19: As 2 doses, separated by 21 days At a single dose level In adults 20 to 85 years of age Read more about this study

Who is it for?: Ages 20 to 85 yearsHealthy volunteers can take part
Conditions the study is for: SARS-CoV-2 Infection, COVID-19
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: 160 participants
Where: 2 sitesJapan
Study dates: 21 Oct 2020to 25 Nov 2021
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 to 85 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Japanese male or female participants between the ages of 20 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, and clinical judgment of the investigator to be eligible for inclusion in the study.
Capable of giving personal signed informed consent.

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.
Previous confirmed diagnosis of COVID-19.
Immunocompromised individuals with known or suspected immunodeficiency, as determined by history and/or laboratory/physical examination.

Show all 15Show fewer

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.
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.
Subset only: Any screening hematology and/or blood chemistry laboratory value that meets the definition of a ≥ Grade 1 abnormality.
Investigator site staff or Pfizer 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

2 sites in 1 country.

Japan2 sites

SOUSEIKAI PS Clinic
Fukuoka, 812-0025
SOUSEIKAI Sumida Hospital
Sumida-ku, Tokyo, 130-0004

Other trials in Japan

About this study

Official title: A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, AND OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY JAPANESE ADULTS

This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults.

The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19:

As 2 doses, separated by 21 days
At a single dose level
In adults 20 to 85 years of age

Read the detailed description

From protocol amendment 3, this study is transitioned from a clinical trial to a postmarketing study (Phase 4) according to the Japanese regulation, because BNT162b2 was approved by the Ministry of Health, Labour and Welfare on 14 February 2021.

Conditions: SARS-CoV-2 Infection, COVID-19
Being tested: BNT162b2, Placebo
Medical subject headings: COVID-19

What participants receive

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

BNT162b2Biological
BNT162b2 (intramuscular injection)
PlaceboOther
Placebo (intramuscular injection)

Study groups in NCT04588480
Study group	Role	What they receive
BNT162b2	Experimental	BNT162b2 (intramuscular injection) Receives: Biological: BNT162b2
Placebo	Placebo comparator	Placebo (intramuscular injection) Receives: Other: Placebo

What is being measured

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

Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (>) 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Events were classified as Grade 4 based on study investigator's judgement. Maximum severity was the highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.
Measured: Within 7 days after Dose 1
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: > 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Events were classified as Grade 4 based on study investigator's judgement. Maximum severity was the highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.
Measured: Within 7 days after Dose 2
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1
Systemic events were recorded by participants in e-diary. Fever was categorized as greater than or equal to (>=)37.5 to 38.4 degrees(deg) Celsius(C), >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Events were classified as Grade 4 potentially life threatening (emergency room visit or hospitalization) based on study investigator's judgement. Maximum severity=highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.
Measured: Within 7 days after Dose 1
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2
Systemic events were recorded by participants in an e-diary. Fever was categorized as >= 37.5 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Events were classified as Grade 4 potentially life threatening (emergency room visit or hospitalization) based on study investigator's judgement. Maximum severity=highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.
Measured: Within 7 days after Dose 2
Percentage of Participants With Adverse Events (AEs) From Dose 1 up to 1 Month After Dose 2
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with AEs and the associated 95% confidence interval (CI) based on the Clopper and Pearson method was presented. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Measured: Dose 1 up to 1 month after Dose 2
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 up to 12 Months After Dose 2
SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or considered an important medical event. Percentage of participants with SAEs and the associated 95% CI based on the Clopper and Pearson method was presented.
Measured: Dose 1 up to 12 months after Dose 2
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 1 Day After Dose 1 by Age Category
The pre-defined criteria for laboratory parameters included: hemoglobin (HGB), hematocrit, erythrocytes(ery.) less than (<)0.8* lower limit of normal (LLN); ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration <0.9*LLN and >1.1*upper limit of normal (ULN); platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes, neutrophils <0.8*LLN and >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN; urea nitrogen, creatinine >1.3*ULN. Percentage of participants with abnormal hematology and chemistry laboratory values by age categories 20 to 64 years and 65 to 85 years were reported in this outcome measure. Categories with at least 1 non-zero data values were reported.
Measured: Within 1 day after Dose 1
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 7 Days After Dose 1 by Age Category
The pre-defined criteria for laboratory parameters included: HGB, hematocrit, ery. <0.8* LLN; ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration <0.9*LLN and >1.1*ULN; platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes, neutrophils <0.8*LLN and >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN; urea nitrogen, creatinine >1.3*ULN. Percentage of participants with abnormal hematology and chemistry laboratory values by age categories 20 to 64 years and 65 to 85 years were reported in this outcome measure. Categories with at least 1 non-zero data values were reported.
Measured: Within 7 days after Dose 1
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 7 Days After Dose 2 by Age Category
The pre-defined criteria for laboratory parameters included: HGB, hematocrit, ery. <0.8* LLN; ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration <0.9*LLN and >1.1*ULN; platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes, neutrophils <0.8*LLN and >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN; urea nitrogen, creatinine >1.3*ULN. Categories with at least 1 non-zero data value were reported (only 65-85 years: Lymphocytes category was reported).
Measured: Within 7 days after Dose 2
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category
Hematology parameters: hemoglobin, eosinophils, lymphocytes decrease, neutrophil decrease, platelets decrease, white blood cell (WBC) decrease, WBC increase. Chemistry parameters: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased, creatinine increased, blood urea nitrogen. Laboratory abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology and chemistry laboratory values by age categories (20 to 64 years and 65 to 85 years) were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 day after dose 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
Measured: From baseline (observation prior to Dose 1) up to 1 day after Dose 1
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 7 Days After Dose 1 by Age Category
Hematology parameters included: hemoglobin, eosinophils, lymphocytes decrease, neutrophil decrease, platelets decrease, WBC decrease, WBC increase. Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased, creatinine increased, urea nitrogen. Laboratory abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology and chemistry laboratory values by age categories (20 to 64 years and 65 to 85 years) were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in grade from baseline to 7 days after dose 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
Measured: From baseline (observation prior to Dose 1) up to 7 days after Dose 1
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category
Hematology parameters included: hemoglobin, eosinophils, lymphocytes decrease, neutrophil decrease, platelets decrease, WBC decrease, WBC increase. Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased, creatinine increased, urea nitrogen. Laboratory abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3= severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology and chemistry laboratory values by age categories (20 to 64 years and 65 to 85 years) were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in grade from before dose 2 to 7 days after dose 2 were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
Measured: Before Dose 2 up to 7 days after Dose 2
Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 2
GMT of SARS-CoV-2 neutralizing titer was calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student's t distribution. GMT of SARS-CoV-2 neutralization titer 50% (NT50) was reported in this outcome measure.
Measured: 1 month after Dose 2
Geometric Mean Fold Rises (GMFRs) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After Dose 2
GMFR was defined as the result after vaccination divided by the result before vaccination. GMFR and the corresponding 2-sided 95% CIs was calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t distribution). GMFR of SARS-CoV-2 NT50 was reported in this outcome measure.
Measured: Before vaccination up to 1 month after Dose 2

Secondary outcomes (4)

GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2
GMTs of SARS-CoV-2 neutralizing titers were calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student's t distribution. GMTs of SARS-CoV-2 NT50 and neutralization titer 90% (NT90) were reported in this outcome measure.
Measured: NT50: Baseline (observation prior to Dose 1), 21 days after Dose 1; 7 and 14 days and 6 and 12 months after Dose 2; NT90: Baseline (observation prior to Dose 1), 21 days after Dose 1; 7 and 14 days after Dose 2
GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2
GMFR was defined as the result after vaccination divided by the result before vaccination. GMFRs and the corresponding 2-sided 95% CIs were calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t distribution). GMFRs of SARS-CoV-2 NT50 and NT90 were reported in this outcome measure.
Measured: NT50: Before vaccination up to 21 days after Dose 1; 7 and 14 days and 6 and 12 months after Dose 2; NT90: Before vaccination up to 21 days after Dose 1; 7 and 14 days after Dose 2
GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 1, 6 and 12 Months After Dose 2 in Participants With or Without Confirmed COVID-19 Before Dose 2
GMTs of SARS-CoV-2 neutralizing titers was planned to be calculated by exponentiating the mean logarithm of the titers and the corresponding 95% CI was based on the Student's t distribution.
Measured: Baseline (observation prior to Dose 1), 21 days after Dose 1; 7 and 14 days and 1, 6 and 12 months after Dose 2
GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 1, 6 and 12 Months After Dose 2 in Participants With or Without Confirmed COVID-19 Before Dose 2
GMFR was defined as the result after vaccination divided by the result before vaccination. GMFRs and the corresponding 2-sided 95% CIs were planned to be calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t distribution).
Measured: Before vaccination up to 21 days after Dose 1; 7 and 14 days after Dose 2 and 1, 6 and 12 months after Dose 2

Timeline

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

21 Oct 202025 Nov 2021

First posted19 Oct 2020
Study start21 Oct 2020
Primary completion25 Nov 2021
Study completion25 Nov 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for SARS-CoV-2 InfectionStudies of the same condition, open and under way.
More trials run by BioNTech SEThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 160 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04588480
Sponsor's protocol ID: C4591005
Status last verified: Jan 2023
First submitted: 14 Oct 2020
Last updated: 1 Feb 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Haranaka M, Baber J, Ogama Y, Yamaji M, Aizawa M, Kogawara O, Scully I, Lagkadinou E, Tureci Ӧ, Sahin U, Dormitzer PR, Gruber WC, Lockhart S. A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults. Nat Commun. 2021 Dec 14;12(1):7105. doi: 10.1038/s41467-021-27316-2.
PubMed 34907170

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A PHASE 1/2, PLACEBO-CONTROLLED, RANDOMIZED, AND OBSERVER-BLIND STUDY TO EVALUATE THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A SARS-COV-2 RNA VACCINE CANDIDATE AGAINST COVID-19 IN HEALTHY JAPANESE ADULTS
ClinicalTrials.gov ID: NCT04588480
Acronym / sponsor ID: C4591005
Conditions: SARS-CoV-2 Infection, COVID-19
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 160 participants (actual)
Lead sponsor: BioNTech SEIndustry (pharma, biotech, devices)
Collaborators: Pfizer
Study start: 21 Oct 2020 (actual)
Primary completion: 25 Nov 2021 (actual)
Study completion: 25 Nov 2021 (actual)
First posted: 19 Oct 2020 (actual)
Results: Posted 1 Feb 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This is a Phase 1/2, randomized, placebo-controlled, and observer-blind study in healthy Japanese adults.

The study will evaluate the safety, tolerability, and immunogenicity of the SARS-CoV-2 RNA vaccine candidate against COVID-19:

As 2 doses, separated by 21 days
At a single dose level
In adults 20 to 85 years of age

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
BNT162b2	Experimental	Biological: BNT162b2BNT162b2 (intramuscular injection)
Placebo	Placebo comparator	Other: PlaceboPlacebo (intramuscular injection)

Who may qualify

Ages: 20 to 85 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Japanese male or female participants between the ages of 20 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, and clinical judgment of the investigator to be eligible for inclusion in the study.
Capable of giving personal signed informed consent.

Key exclusion criteria (15 listed)

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.
Previous confirmed diagnosis of COVID-19.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BNT162b2BNT162b2 (intramuscular injection)	Biological	BNT162b2
PlaceboPlacebo (intramuscular injection)	Other	Placebo

Primary outcome

Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1
Time frame: Within 7 days after Dose 1
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm) and graded as mild: greater than (>) 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Events were classified as Grade 4 based on study investigator's judgement. Maximum severity was the highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.
Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2
Time frame: Within 7 days after Dose 2
Local reactions included pain at injection site, redness and swelling and were recorded by participants in an e-diary. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 cm and graded as mild: > 2.0 to 5.0 cm, moderate: >5.0 to 10.0 cm, severe: >10.0 cm, grade 4 (potentially life threatening): necrosis or exfoliative dermatitis for redness and necrosis for swelling. Pain at injection site was graded as mild: did not interfere with daily activity, moderate: interfered with daily activity, severe: prevented daily activity and grade 4 (potentially life threatening): emergency room visit or hospitalization for severe pain. Events were classified as Grade 4 based on study investigator's judgement. Maximum severity was the highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1
Time frame: Within 7 days after Dose 1
Systemic events were recorded by participants in e-diary. Fever was categorized as greater than or equal to (>=)37.5 to 38.4 degrees(deg) Celsius(C), >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24 hours(h), moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Events were classified as Grade 4 potentially life threatening (emergency room visit or hospitalization) based on study investigator's judgement. Maximum severity=highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.
Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2
Time frame: Within 7 days after Dose 2
Systemic events were recorded by participants in an e-diary. Fever was categorized as >= 37.5 to 38.4 deg C, >38.4 to 38.9 deg C, >38.9 to 40.0 deg C and >40.0 deg C. Fatigue, headache, chills, new or worsened muscle pain and new or worsened joint pain were graded as mild: did not interfere with activity, moderate: some interference with activity and severe: prevented daily routine activity. Vomiting was graded as mild: 1 to 2 times in 24h, moderate: >2 times in 24h and severe: required intravenous hydration. Diarrhea was graded as mild: 2 to 3 loose stools in 24h, moderate: 4 to 5 loose stools in 24h and severe: 6 or more loose stools in 24h. Events were classified as Grade 4 potentially life threatening (emergency room visit or hospitalization) based on study investigator's judgement. Maximum severity=highest grade within 7 days after vaccination among severity grades where the answers were neither "no" nor missing for at least 1 day.
Percentage of Participants With Adverse Events (AEs) From Dose 1 up to 1 Month After Dose 2
Time frame: Dose 1 up to 1 month after Dose 2
An AE was any untoward medical occurrence in a participant temporally associated with the use of study intervention, whether or not considered related to the study intervention. Percentage of participants with AEs and the associated 95% confidence interval (CI) based on the Clopper and Pearson method was presented. Only AEs collected by non-systematic assessment (i.e. excluding local reactions and systemic events) were reported in this outcome measure.
Percentage of Participants With Serious Adverse Events (SAEs) From Dose 1 up to 12 Months After Dose 2
Time frame: Dose 1 up to 12 months after Dose 2
SAE was defined as any untoward medical occurrence that, at any dose, resulted in death; was life-threatening; required inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or considered an important medical event. Percentage of participants with SAEs and the associated 95% CI based on the Clopper and Pearson method was presented.
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 1 Day After Dose 1 by Age Category
Time frame: Within 1 day after Dose 1
The pre-defined criteria for laboratory parameters included: hemoglobin (HGB), hematocrit, erythrocytes(ery.) less than (<)0.8* lower limit of normal (LLN); ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration <0.9*LLN and >1.1*upper limit of normal (ULN); platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes, neutrophils <0.8*LLN and >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN; urea nitrogen, creatinine >1.3*ULN. Percentage of participants with abnormal hematology and chemistry laboratory values by age categories 20 to 64 years and 65 to 85 years were reported in this outcome measure. Categories with at least 1 non-zero data values were reported.
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 7 Days After Dose 1 by Age Category
Time frame: Within 7 days after Dose 1
The pre-defined criteria for laboratory parameters included: HGB, hematocrit, ery. <0.8* LLN; ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration <0.9*LLN and >1.1*ULN; platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes, neutrophils <0.8*LLN and >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN; urea nitrogen, creatinine >1.3*ULN. Percentage of participants with abnormal hematology and chemistry laboratory values by age categories 20 to 64 years and 65 to 85 years were reported in this outcome measure. Categories with at least 1 non-zero data values were reported.
Percentage of Participants With Abnormal Hematology and Chemistry Laboratory Values 7 Days After Dose 2 by Age Category
Time frame: Within 7 days after Dose 2
The pre-defined criteria for laboratory parameters included: HGB, hematocrit, ery. <0.8* LLN; ery. mean corpuscular volume, ery. mean corpuscular hemoglobin, ery. mean corpuscular HGB concentration <0.9*LLN and >1.1*ULN; platelets <0.5*LLN and >1.75*ULN; leukocytes <0.6*LLN and >1.5*ULN; lymphocytes, neutrophils <0.8*LLN and >1.2*ULN; basophils, eosinophils, monocytes >1.2*ULN; bilirubin >1.5*ULN; aspartate aminotransferase, alanine aminotransferase, alkaline phosphatase >3.0*ULN; urea nitrogen, creatinine >1.3*ULN. Categories with at least 1 non-zero data value were reported (only 65-85 years: Lymphocytes category was reported).
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 1 Day After Dose 1 by Age Category
Time frame: From baseline (observation prior to Dose 1) up to 1 day after Dose 1
Hematology parameters: hemoglobin, eosinophils, lymphocytes decrease, neutrophil decrease, platelets decrease, white blood cell (WBC) decrease, WBC increase. Chemistry parameters: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased, creatinine increased, blood urea nitrogen. Laboratory abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology and chemistry laboratory values by age categories (20 to 64 years and 65 to 85 years) were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in Grade from baseline to 1 day after dose 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Baseline to 7 Days After Dose 1 by Age Category
Time frame: From baseline (observation prior to Dose 1) up to 7 days after Dose 1
Hematology parameters included: hemoglobin, eosinophils, lymphocytes decrease, neutrophil decrease, platelets decrease, WBC decrease, WBC increase. Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased, creatinine increased, urea nitrogen. Laboratory abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3=severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology and chemistry laboratory values by age categories (20 to 64 years and 65 to 85 years) were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in grade from baseline to 7 days after dose 1 (post-baseline) were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
Percentage of Participants With Shift in Hematology and Chemistry Laboratory Values From Before Dose 2 to 7 Days After Dose 2 by Age Category
Time frame: Before Dose 2 up to 7 days after Dose 2
Hematology parameters included: hemoglobin, eosinophils, lymphocytes decrease, neutrophil decrease, platelets decrease, WBC decrease, WBC increase. Chemistry parameters included: alanine aminotransferase increased, alkaline phosphatase increased, aspartate aminotransferase increased, bilirubin increased, creatinine increased, urea nitrogen. Laboratory abnormalities were graded by toxicity grading scale for healthy adult volunteers enrolled in preventive vaccine clinical trials as grade 1=mild; grade 2=moderate; grade 3= severe and grade 4=potentially life-threatening. Percentage of participants with shift in hematology and chemistry laboratory values by age categories (20 to 64 years and 65 to 85 years) were reported in this outcome measure. Categories with at least 1 non-zero data values showing any shift in grade from before dose 2 to 7 days after dose 2 were reported. Participants whose grade category was unchanged (e.g. normal to normal) were not reported.
Geometric Mean Titers (GMTs) of SARS-CoV-2 Neutralizing Titers at 1 Month After Dose 2
Time frame: 1 month after Dose 2
GMT of SARS-CoV-2 neutralizing titer was calculated by exponentiating the mean logarithm of the titers and the corresponding 95% confidence interval (CI) was based on the Student's t distribution. GMT of SARS-CoV-2 neutralization titer 50% (NT50) was reported in this outcome measure.
Geometric Mean Fold Rises (GMFRs) of SARS-CoV-2 Neutralizing Titers From Before Vaccination to 1 Month After Dose 2
Time frame: Before vaccination up to 1 month after Dose 2
GMFR was defined as the result after vaccination divided by the result before vaccination. GMFR and the corresponding 2-sided 95% CIs was calculated by exponentiating the mean logarithm of fold rises and the corresponding CIs (based on the Student's t distribution). GMFR of SARS-CoV-2 NT50 was reported in this outcome measure.

4 secondary outcomes

GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2
Time frame: NT50: Baseline (observation prior to Dose 1), 21 days after Dose 1; 7 and 14 days and 6 and 12 months after Dose 2; NT90: Baseline (observation prior to Dose 1), 21 days after Dose 1; 7 and 14 days after Dose 2
GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 6 and 12 Months After Dose 2
Time frame: NT50: Before vaccination up to 21 days after Dose 1; 7 and 14 days and 6 and 12 months after Dose 2; NT90: Before vaccination up to 21 days after Dose 1; 7 and 14 days after Dose 2
GMTs of SARS-CoV-2 Neutralizing Titers at Baseline, 21 Days After Dose 1; 7 and 14 Days and 1, 6 and 12 Months After Dose 2 in Participants With or Without Confirmed COVID-19 Before Dose 2
Time frame: Baseline (observation prior to Dose 1), 21 days after Dose 1; 7 and 14 days and 1, 6 and 12 months after Dose 2
GMFRs of SARS-CoV-2 Neutralizing Titers Before Vaccination to 21 Days After Dose 1; 7 and 14 Days and 1, 6 and 12 Months After Dose 2 in Participants With or Without Confirmed COVID-19 Before Dose 2
Time frame: Before vaccination up to 21 days after Dose 1; 7 and 14 days after Dose 2 and 1, 6 and 12 months after Dose 2

Results and safety

Results posted to the registry on 1 Feb 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
BNT162b2	119	119
Placebo	41	41
Placebo Then BNT162b2	0	0

Primary outcome: Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1

Time frame: Within 7 days after Dose 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	BNT162b2 n = 119	Placebo n = 41
Redness: Mild	7.6 (3.5 to 13.9)	0.0 (0.0 to 8.6)
Redness: Moderate	5.9 (2.4 to 11.7)	0.0 (0.0 to 8.6)
Redness: Severe	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)
Redness: Grade 4	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)
Swelling: Mild	9.2 (4.7 to 15.9)	0.0 (0.0 to 8.6)
Swelling: Moderate	3.4 (0.9 to 8.4)	0.0 (0.0 to 8.6)
Swelling: Severe	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)
Swelling: Grade 4	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)

Population analysed: Safety population included all randomized participants who received at least 1 dose of the study intervention.

Primary outcome: Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 2

Time frame: Within 7 days after Dose 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	BNT162b2 n = 116	Placebo n = 41
Redness: Mild	6.0 (2.5 to 12.0)	0.0 (0.0 to 8.6)
Redness: Moderate	4.3 (1.4 to 9.8)	0.0 (0.0 to 8.6)
Redness: Severe	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)
Redness: Grade 4	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)
Swelling: Mild	4.3 (1.4 to 9.8)	0.0 (0.0 to 8.6)
Swelling: Moderate	4.3 (1.4 to 9.8)	0.0 (0.0 to 8.6)
Swelling: Severe	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)
Swelling: Grade 4	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)

Population analysed: Safety population included all randomized participants who received at least 1 dose of the study intervention. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.

Primary outcome: Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 1

Time frame: Within 7 days after Dose 1. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	BNT162b2 n = 119	Placebo n = 41
Fever: >= 37.5 to 38.4 deg C	11.8 (6.6 to 19.0)	0.0 (0.0 to 8.6)
Fever: >38.4 to 38.9 deg C	2.5 (0.5 to 7.2)	0.0 (0.0 to 8.6)
Fever: >38.9 to 40.0 deg C	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)
Fever: >40.0 deg C	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)
Fatigue: Mild	22.7 (15.5 to 31.3)	7.3 (1.5 to 19.9)
Fatigue: Moderate	16.8 (10.6 to 24.8)	2.4 (0.1 to 12.9)
Fatigue: Severe	0.8 (0.0 to 4.6)	0.0 (0.0 to 8.6)
Fatigue: Grade 4	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)

Population analysed: Safety population included all randomized participants who received at least 1 dose of the study intervention.

Primary outcome: Percentage of Participants With Systemic Events by Maximum Severity Within 7 Days After Dose 2

Time frame: Within 7 days after Dose 2. Number (95% Confidence Interval). Unit: Percentage of participants

Measure	BNT162b2 n = 116	Placebo n = 41
Fever: >= 37.5 to 38.4 deg C	25.0 (17.4 to 33.9)	0.0 (0.0 to 8.6)
Fever: >38.4 to 38.9 deg C	6.9 (3.0 to 13.1)	0.0 (0.0 to 8.6)
Fever: >38.9 to 40.0 deg C	0.9 (0.0 to 4.7)	0.0 (0.0 to 8.6)
Fever: >40.0 deg C	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)
Fatigue: Mild	25.9 (18.2 to 34.8)	2.4 (0.1 to 12.9)
Fatigue: Moderate	31.0 (22.8 to 40.3)	0.0 (0.0 to 8.6)
Fatigue: Severe	3.4 (0.9 to 8.6)	0.0 (0.0 to 8.6)
Fatigue: Grade 4	0.0 (0.0 to 3.1)	0.0 (0.0 to 8.6)

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Local reactions/systemic events: within 7 days after each dose; SAEs: from Dose 1 up to 12 months after Dose 2 except for Placebo Then BNT162b2 reporting arm; SAEs for Placebo Then BNT162b2 reporting arm: from Dose 3 up to 6 months after Dose 4: other AEs: from Dose 1 up to 1 month after Dose 2 for BNT162b2 and Placebo arms; from Dose 3 up to 1 month after Dose 4 for Placebo Then BNT162b2 reporting arm.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
BNT162b2	2 of 119 (1.7%)	111 of 119 (93.3%)	0 of 119
Placebo	0 of 41 (0%)	12 of 41 (29.3%)	0 of 41
Placebo Then BNT162b2	0 of 35 (0%)	31 of 35 (88.6%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 34907170Haranaka M, Baber J, Ogama Y, Yamaji M, Aizawa M, Kogawara O, Scully I, Lagkadinou E, Tureci Ӧ, Sahin U, Dormitzer PR, Gruber WC, Lockhart S. A randomized study to evaluate safety and immunogenicity of the BNT162b2 COVID-19 vaccine in healthy Japanese adults. Nat Commun. 2021 Dec 14;12(1):7105. doi: 10.1038/s41467-021-27316-2.
To obtain contact information for a study center near you, click here.Link provided by the sponsor.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pfizer CT.gov Call Center study director

Pfizer

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing BNT162b2 in people with SARS-CoV-2 Infection and COVID-19, run by BioNTech SE at 2 sites in Japan.

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 4 inclusion and 15 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 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Japan. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants With Local Reactions by Maximum Severity Within 7 Days After Dose 1 (time frame: Within 7 days after Dose 1). The study lists 14 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 NCT04588480, 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 1 Feb 2023.