UMIN-CTR Clinical Trial

Public title

Cohort Survey at the Beginning of SARS-CoV-2 Vaccination in Japan

Acronym

Cohort Survey on SARS-CoV-2 Advance Vaccination in Japan

Scientific Title

Cohort Survey at the Beginning of SARS-CoV-2 Vaccination in Japan

Scientific Title:Acronym

Cohort Survey on SARS-CoV-2 Advance Vaccination in Japan

Region

Japan

Condition

COVID-19

Classification by specialty

Medicine in general	Infectious disease	Adult

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Safety on SARS-CoV-2 Vaccine

Basic objectives2

Safety

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Safety of SARS-CoV-2 vaccinated persons up to 4 weeks after the final vaccination

Key secondary outcomes

Incidence of COVID-19 up to 4 weeks after the last vaccination of SARS-CoV-2 vaccinated persons
Exceed admission rate due to SARS-CoV-2 vaccination

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

Purpose of intervention

Type of intervention

Interventions/Control_1

Interventions/Control_2

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Pfizer Comirnaty
Healthcare workers and long-term care workers
COVID-19 Moderna
Ministry of Defense staff
AstraZeneca Vaxzevria
Those who received the vaccine to be surveyed
Persons over 20 years old who have obtained the written consent

Key exclusion criteria

Those who the investigator has determined to be inappropriate as the subject of the survey

Target sample size

20000

Name of lead principal investigator

1st name	Suminobu
Middle name
Last name	Ito

Organization

Juntendo University, School of Medicine

Division name

Clinical Research and Trial Center, Juntendo Hospital

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421 JAPAN

TEL

03-3813-3111

Email

sito@juntendo.ac.jp

Name of contact person

1st name	Morikuni
Middle name
Last name	Tobita

Organization

Juntendo University, School of Medicine

Division name

SARS-CoV-2 vaccine Research Secretariat

Zip code

113-8421

Address

2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421 JAPAN

TEL

03-3813-3111

Homepage URL

https://jcrtc.juntendo.ac.jp/about/results-of-activity/covid19-covidresearch/

Email

covidvac@juntendo.ac.jp

Institute

Juntendo University, School of Medicine

Institute

Department

Personal name

Organization

Ministry of Health, Labour and Welfare, Japan

Welfare and Labor Administration Promotion Survey Project
Emerging / re-emerging infectious diseases and vaccination policy promotion research project

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Tokushuukai Group Ethics Committee

Address

1-8-7 Kojimachi Chiyoda-ku Tokyo

Tel

03-3263-4801

Email

mirai-ec1@mirai-iryo.com

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

ファイザー社
NHO北海道がんセンター(北海道),NHO北海道医療センター(北海道),NHO函館病院(北海道),NHO仙台医療センター(宮城県),NHO水戸医療センター(茨城県),NHO茨城東病院(茨城県),NHO宇都宮病院(栃木県),NHO高崎総合医療センター(群馬県),NHO渋川医療センター(群馬県),NHO東埼玉病院(埼玉県),NHO千葉医療センター(千葉県),NHO千葉東病院(千葉県),NHO東京医療センター(東京都),NHO東京病院(東京都),NHO村山医療センター(東京都),NHO相模原病院(神奈川県),NHO新潟病院(新潟県),NHO信州上田医療センター(長野県),NHO長良医療センター(岐阜県),NHO名古屋医療センター(愛知県),NHO豊橋医療センター(愛知県),NHO三重病院(三重県),NHO鈴鹿病院(三重県),NHO三重中央医療センター(三重県),NHO京都医療センター(京都府),NHO南京都病院(京都府),NHO大阪医療センター(大阪府),NHO大阪刀根山医療センター(大阪府),NHO神戸医療センター(兵庫県),NHO鳥取医療センター(鳥取県),NHO米子医療センター(鳥取県),NHO松江医療センター(島根県),NHO岡山医療センター(岡山県),NHO呉医療センター(広島県),NHO広島西医療センター(広島県),NHO東広島医療センター(広島県),NHO関門医療センター(山口県),NHO岩国医療センター(山口県),NHO四国こどもとおとなの医療センター(香川県),NHO高知病院(高知県),NHO九州がんセンター(福岡県),NHO九州医療センター(福岡県),NHO福岡病院(福岡県),NHO大牟田病院(福岡県),NHO福岡東医療センター(福岡県),NHO佐賀病院(佐賀県),NHO肥前精神医療センター(佐賀県),NHO嬉野医療センター(佐賀県),NHO長崎医療センター(長崎県),NHO熊本再春医療センター(熊本県),NHO別府医療センター(大分県),NHO鹿児島医療センター(鹿児島),JCHO北海道病院(北海道),JCHO札幌北辰病院(北海道),JCHO仙台病院(宮城県),JCHO仙台南病院(宮城県),JCHO秋田病院(秋田県),JCHO千葉病院(千葉県),JCHO船橋中央病院(千葉県),JCHO東京山手メディカルセンター(東京都),JCHO東京城東病院(東京都),JCHO東京蒲田医療センター(東京都),JCHO相模野病院(神奈川県),JCHO山梨病院(山梨県),JCHO高岡ふしき病院(富山県),JCHO金沢病院(石川県),JCHO福井勝山総合病院(福井県),JCHO桜ケ丘病院(静岡県),JCHO中京病院(愛知県),JCHO四日市羽津医療センター(三重県),JCHO神戸中央病院(兵庫県),JCHO下関医療センター(山口県),JCHO高知西病院(高知県),JCHO諫早総合病院(長崎県),JCHO熊本総合病院(熊本県),JCHO人吉医療センター(熊本県),JCHO南海医療センター(大分県),JCHO湯布院病院(大分県),JCHO宮崎江南病院(宮崎県),JOHAS北海道中央労災病院(北海道),JOHAS釧路労災病院(北海道),JOHAS青森労災病院(青森県),JOHAS東北ろうさい病院(宮城県),JOHAS千葉ろうさい病院(千葉県),JOHAS東京労災病院(東京都),JOHAS関東労災病院(神奈川県),JOHAS横浜労災病院(神奈川県),JOHAS新潟労災病院(新潟県),JOHAS富山労災病院(富山県),JOHAS中部ろうさい病院(愛知県),JOHAS関西ろうさい病院(兵庫県),JOHAS神戸労災病院(兵庫県),JOHAS山陰労災病院(鳥取県),JOHAS岡山ろうさい病院(岡山県),JOHAS中国労災病院(広島県),JOHAS山口労災病院(山口県),JOHAS愛媛労災病院(愛媛県),JOHAS九州労災病院(福岡県),JOHAS長崎労災病院(長崎県),JOHAS熊本労災病院(熊本県)
モデルナ筋注
JCHO札幌北辰病院(北海道),NHO北海道医療センター(北海道),自衛隊大湊病院(青森県),自衛隊三沢病院(青森県),JCHO仙台南病院(宮城県),NHO仙台医療センター(宮城県),JCHO秋田病院(秋田県),NHO宇都宮病院(栃木県),NHO東埼玉病院(埼玉県),JCHO船橋中央病院(千葉県),NHO千葉医療センター(千葉県),JCHO東京山手メディカルセンター(東京都),NHO東京医療センター(東京都),NHO村山医療センター(東京都),防衛省共済組合本部診療所(市ヶ谷共済診療所)自衛隊横須賀病院(神奈川県),自衛隊岐阜病院(岐阜県),NHO名古屋医療センター(愛知県),NHO京都医療センター(京都府),自衛隊舞鶴病院(京都府),NHO大阪医療センター(大阪府),NHO大阪刀根山医療センター(大阪府),NHO神戸医療センター(兵庫県),NHO米子医療センター(鳥取県),NHO広島西医療センター(広島県),NHO東広島医療センター(広島県),自衛隊呉病院(広島県),NHO九州がんセンター(福岡県),NHO肥前精神医療センター(佐賀県),自衛隊佐世保病院(長崎県),JCHO宮崎江南病院(宮崎県),自衛隊那覇病院(沖縄県)
アストラゼネカ社
順天堂大学浦安病院(千葉県),JCHO東京蒲田医療センター(東京都),順天堂大学順天堂医院(東京都),順天堂大学練馬病院(東京都),JCHO桜ケ丘病院(静岡県),NHO三重中央医療センター(三重県),NHO神戸医療センター(兵庫県),JCHO熊本総合病院(熊本県)

Date of disclosure of the study information

2021

Year

02

Month

19

Day

URL releasing protocol

https://jcrtc.juntendo.ac.jp/about/results-of-activity/covid19-covidresearch/

Publication of results

Partially published

URL related to results and publications

https://jcrtc.juntendo.ac.jp/about/results-of-activity/covid19-covidresearch/

Number of participants that the trial has enrolled

33580

Results

Fever after the 1st dose of Pfizer vaccine was 3.3%, and 38.1% after the 2nd. headache(ca50%) and malaise(ca70%) were seen with 2nd . The frequency of AEs differed by age and sex, and was higher in young people and women. The AEs of Moderna were similar to Pfizer's, but 76.7% developed fever with 2nd. 49.4% of first dose of AstraZeneca had fever.
The delayed skin reaction was seen as high as ca10% in women over the age of 30 in Moderna.
GI symptoms and axillary lymphadenopathy/pain were reported.

Results date posted

2022

Year

12

Month

19

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Pfizer's vaccine (Comirnaty) was administered at a total of 100 facilities, including 52 National Hospital Organization (NHO) hospitals, 27 Japan Community Health care Organization (JCHO) hospitals, and 21 Japan Organization of Occupational Health and Safety (JOHAS) hospitals, The first vaccination in Japan started on the February 17th, and 19,806 health care workers were registered . Moderna's vaccine (currently Spikevax) was administered to 13,220 Self-Defense Forces/Ministry of Defense employees at the 17 NHO hospitals, 6 JCHO hospitals, and 9 Self-Defense Forces hospitals since May 27 . AstraZeneca's vaccine (Vaxzevria) was delayed due to concerns on the thrombosis with thrombocytopenia syndrome (TTS), but 554 general public were vaccinated at 3 Juntendo University hospitals, 3 JCHO hospitals, and 2 NHO hospitals since August 21, 2021.

Participant flow

Pfizer Vaccines: Recruitment through independent administrative agency headquarters of the National Hospital Organization, the Japan Community Health care Organization, and the Japan Organization of Occupational Health and Safety
Moderna Vaccine: Recruitment for Self-Defense Forces/Ministry of Defense personnel through the Ministry of Defense
AstraZeneca: General Recruitmen

Adverse events

We reported 22 SAE cases to PMDA, including 1 case of anaphylactic shock, 2 cases of anaphylaxis, 1 case of oral allergy syndrome, and 1 case of myocarditis for Pfizer vaccines, 1 case of urticaria for Moderna vaccines, and 1 case of cerebral infarction for AstraZeneca vaccines.

Outcome measures

Pfizer's vaccine, which is an mRNA vaccine, caused a fever (37.5centigrade or higher) after the first vaccination in 3.3%, but the second vaccination was as high as 38.1%. Most cases of fever occurred on the next day, and the fever almost subsided 3 days after vaccination (Day 4). More than 90% of the recipients felt pain at the injection site, and the pain was most frequent on the day after the injection, but almost all subsided 4 days after the injection (Day 5). Compared to the 1st dose, 50% of the 2nd doses experienced headache and 70% felt malaise on the day after the vaccination. The incidence of adverse reactions differed by age and gender, and was higher in young people and women.
Moderna's vaccine, which is the same mRNA vaccine, showed almost the same side effects after the first vaccination as the Pfizer vaccine. On the day after the second vaccination, 76.7% of the recipients had a fever of 37.5centigrade or higher (59.5% of the recipients had a fever of 38centigrade or higher). Two days after vaccination (Day 3), 21.2% of the recipients had a fever, but the fever almost subsided 3 days after vaccination (Day 4). In terms of age and gender, adverse reactions were more frequent in women. The frequency of pain tended to increase with age, but the frequency of other side effects decreased with age.
AstraZeneca's vaccine, which is a viral vector, showed fever in 49.4% and local pain in 73.5% until 1 week after the first vaccination. Local redness peaked 2 days after vaccination (Day 3) and was seen in 14.6%, but it remained in about 5.2% even 1 week after vaccination (Day 8). Fever, malaise, headache, etc. were more frequent in young people, and AE was more frequent in women. AEs were less frequent after the second dose than after the first dose. In addition, local pain continues even after 3 days compared to mRNA vaccine, and side effects may be longer.
Delayed skin reaction was observed as redness accompanied by itching from around 7 days after the first vaccination, and the frequency was high in women in their 30s or older, and occurred at about 10%. Delayed skin reactions were observed not only with the Moderna vaccine but also with the Pfizer vaccine, although the frequency is low.
Gastrointestinal symptoms, such as nausea, and axillary lymphadenopathy/pain were conspicuously reported in spontaneous reports in the free-form field.
We reported 22 SAE cases to PMDA, including 1 case of anaphylactic shock, 2 cases of anaphylaxis, 1 case of oral allergy syndrome, and 1 case of myocarditis for Pfizer vaccines, 1 case of urticaria for Moderna vaccines, and 1 case of cerebral infarction for AstraZeneca vaccines.
Regarding the Pfizer vaccine, we surveyed the number of hospitalized health care workers regardless of vaccinations during the vaccination periods for the purpose of investigating excess hospitalization rate related to SARS-CoV-2 vaccination. t medical institutions requesting surveys that occurred during this survey period and the number of medical staff hospitalized regardless of vaccinations subject to this survey, and examined whether there was excess hospitalization. As a result,the hospitalization rate of health care workers was slightly higher in March compaired to February or April 2021, but there was no statistical difference (The hospitalization rate per 1,000 person-months for helth care workers over a 3-month period was 3.73 (2.98-4.47, unit: 1,000 person-months).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Main results already published

Date of protocol fixation

2021

Year

02

Month

16

Day

Date of IRB

2021

Year

02

Month

16

Day

Anticipated trial start date

2021

Year

02

Month

17

Day

Last follow-up date

2022

Year

01

Month

31

Day

Date of closure to data entry

2022

Year

02

Month

28

Day

Date trial data considered complete

2022

Year

09

Month

30

Day

Date analysis concluded

2022

Year

10

Month

31

Day

Other related information

Safety of SARS-CoV-2 vaccinated persons up to 4 weeks after the final vaccination

Registered date

2021

Year

02

Month

19

Day

Last modified on

2024

Year

04

Month

03

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049528