UMIN-ICDS Clinical Trial

Unique ID issued by UMIN	UMIN000062124
Receipt number	R000070180
Scientific Title	Effectiveness of maternal RSVpreF vaccination during Pregnancy against REspiratory syncytial Virus illnEss requiring hospitalizatioN of infanTs in Japan: a multicentre, prospective, test-negative design study
Date of disclosure of the study information	2026/07/02
Last modified on	2026/07/02 18:12:12

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Basic information

Public title

Effectiveness of maternal RSVpreF vaccination during Pregnancy against REspiratory syncytial Virus illnEss requiring hospitalizatioN of infanTs in Japan: a multicentre, prospective, test-negative design study

Acronym

RSV PREVENT-J Study

Scientific Title

Scientific Title:Acronym

RSV PREVENT-J Study

Region

Japan

Condition

Lower Respiratory Tract Disease

Classification by specialty

Pneumology Infectious disease Pediatrics

Classification by malignancy

Others

Genomic information

Objectives

Narrative objectives1

To estimate the effectiveness of the RSVpreF vaccine for pregnant women in Japan against lower respiratory tract disease (LRTD) requiring hospitalization in infants under real-world clinical conditions

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Assessment

Primary outcomes

Efficacy of the maternal-fetal vaccine RSVpreF for hospitalization of infants due to RSV-positive lower respiratory tract disease occurring within 180 days after birth

Key secondary outcomes

1) Efficacy of vaccine for hospitalization of infants due to RSV-positive severe lower respiratory tract disease occurring within 180 days after birth
2) Efficacy of vaccine for hospitalization of infants due to RSV-positive lower respiratory tract disease occurring within 180 days after birth stratified by age (c.f. 0-90 days / 91-180 days) and cumulative age (c.f. 0-90 days / 0-180 days)
3) Efficacy of vaccine for hospitalization of infants due to RSV-positive severe lower respiratory tract disease occurring within 180 days after birth stratified by age and cumulative age
4) Efficacy of vaccine for hospitalization of infants due to RSV-positive lower respiratory tract disease occurring within 180 days after birth stratified by gestational age at the time of RSVpreF vaccination and the interval between vaccination and delivery
5) Efficacy of vaccine for hospitalization of infants due to RSV-positive severe lower respiratory tract disease occurring within 180 days after birth stratified by gestational age at the time of RSVpreF vaccination and the interval between vaccination and delivery

Base

Study type

Observational

Study design

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

Intervention

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

Eligibility

Age-lower limit

Not applicable

Age-upper limit

360 days-old >=

Gender

Male and Female

Key inclusion criteria

1) Patients with clinical symptoms and findings consistent with LRTD who are hospitalized at participating medical institutions
2) Infants aged 360 days or younger at the index date (date of admission)
3) Infants born at 37 weeks of gestation or later
4) Patients born on or after April 1, 2026
5) Patients whose mothers were 19 years of age or older at the time of birth
6) Patients for whom written consent has been obtained from the infant's legal representatives and the mother to participate in this study

Key exclusion criteria

1) Patients who have received any RSV prophylactic agent (e.g., palivizumab, nilsebumab, or other RSV vaccines) that has been approved or is currently in clinical trials after birth
2) Patients who have received one or more transfusions or other blood products containing antibodies (e.g., fresh frozen plasma) after birth
3) Patients who had been enrolled in this study within the past 30 days. Patients who had been lastly enrolled in this study before 30 days but tested positive for RSV at the last enrollment will be excluded.
4) Patients whose mother received another approved or investigational RSV vaccine during pregnancy
5) Cases where the responsible investigator determines that participation in this study is inappropriate for medical, social, or psychiatric reasons (including the infants or legal representatives, etc.)

Target sample size

939

Research contact person

Name of lead principal investigator

1st name Tetsuya

Middle name

Last name Kunikata

Organization

Saitama Medical University Hospital

Division name

Department of Pediatrics

Zip code

350-0495

Address

38 Moro-Hongo, Moroyama-machi, Iruma-gun, Saitama Prefecture, Japan

TEL

049-276-1218

Email

tekunika@saitama-med.ac.jp

Public contact

Name of contact person

1st name Makoto

Middle name

Last name Kato

Organization

Saitama Medical University

Division name

Research Management Center

Zip code

350-0495

Address

38 Moro-Hongo, Moroyama-machi, Iruma-gun, Saitama Prefecture, Japan

TEL

049-276-1226

Homepage URL

Email

m_katou@saitama-med.ac.jp

Sponsor or person

Institute

Saitama Medical University

Institute

Department

Personal name

Funding Source

Organization

Pfizer Japan Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Other related organizations

Co-sponsor

Name of secondary funder(s)

IRB Contact (For public release)

Organization

Saitama Medical University Central Ethics Review Committee

Address

38 Moro-Hongo, Moroyama-machi, Iruma-gun, Saitama Prefecture, Japan

Tel

049-276-1662

Email

chuoirb@saitama-med.ac.jp

Secondary IDs

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Other administrative information

Date of disclosure of the study information

2026 Year 07 Month 02 Day

Related information

URL releasing protocol

Publication of results

Unpublished

Result

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Progress

Recruitment status

Preinitiation

Date of protocol fixation

2026 Year 06 Month 10 Day

Date of IRB

2026 Year 07 Month 02 Day

Anticipated trial start date

2026 Year 08 Month 01 Day

Last follow-up date

2028 Year 09 Month 30 Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other

Other related information

Using residual specimens from nasal or other swabs collected from study patients (or new specimens if none are available), RSV detection will be performed using the PCR method. The mother's vaccination status will be determined by reviewing the Maternal and Child Health Handbook. Registered infants will be followed until discharge from the hospital. RSV-positive cases will be designated as the case group, and RSV-negative cases as the control group. Using a test-negative design (TND) case-control study, we will evaluate the efficacy of RSVpreF vaccination during pregnancy in preventing RSV-related hospitalizations in full-term infants.

Management information

Registered date

2026 Year 07 Month 02 Day

Last modified on

2026 Year 07 Month 02 Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070180