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Clinical Trials/JPRN-jRCT2031230191
JPRN-jRCT2031230191
Recruiting
Phase 2

A Phase 2b, randomized, controlled, open-label study to evaluate the immune response and safety of the RSVPreF3 OA investigational vaccine in adults (>-18 years of age) when administered to lung and renal transplant recipients comparing 1 versus 2 doses and compared to healthy controls (>-50 years of age) receiving 1 dose

Ogawa Masayuki0 sites375 target enrollmentJune 29, 2023
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Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Not specified
Sponsor
Ogawa Masayuki
Enrollment
375
Status
Recruiting
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 29, 2023
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Ogawa Masayuki

Eligibility Criteria

Inclusion Criteria

  • •Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol
  • •\-Participants living in the general community or in an assisted\-living facility that provides minimal assistance can be enrolled, such that the participant is primarily responsible for self\-care and activities of daily living.
  • •\-Written or witnessed informed consent obtained from the participant prior to performance of any study\-specific procedure.
  • •\-Female participants of nonchildbearing potential may be enrolled in the study. Non\-childbearing potential is defined as hysterectomy, bilateral oophorectomy, bilateral salpingectomy, and post\-menopause.
  • •\-Female participants of childbearing potential may be enrolled in the study if the participant has practiced adequate contraception from 1 month prior to study intervention administration and agreed to continue adequate contraception until study end for this study, and has a negative pregnancy test on the day of and prior to study intervention administration.
  • •Specific inclusion criteria for renal/lung transplant patients:
  • •\-A male or female, \>\-18 YoA at the time of signing the Informed consent form (ICF).
  • •\-Participant who has received an ABO compatible allogeneic renal or lung transplant (allograft) more than 12 months (365 days) prior to the first study intervention administration.
  • •\-Participant receiving maintenance immunosuppressive therapy for the prevention of allograft rejection.
  • •Specific inclusion criteria for healthy participants:

Exclusion Criteria

  • •Medical conditions:
  • •\- History of any reaction/ hypersensitivity likely to be exacerbated by any component of the study intervention.
  • •\- Acute or chronic clinically significant cardiovascular or hepatic functional abnormality as determined by physical examination or laboratory screening tests.
  • •\- Recurrent/uncontrolled neurological disorders or seizures. Participants with medically controlled chronic neurological diseases can be enrolled in the study if their condition will allow them to comply with the requirements of the protocol, with the help of a caregiver if needed.
  • •\- Any history of dementia or any medical condition that moderately or severely impairs cognition.
  • •\- Significant underlying illness that would prevent completion of the study.
  • •\- Acute disease and/or fever at the time of study intervention administration (\>\- 38 Celsius). However, participants with a minor illness without fever may be enrolled at the discretion of the investigator.
  • •\- Bedridden participants.
  • •Prior/Concomitant therapy:
  • •\- Use of any other investigational or non\-registered product up to 30 days before the first dose administration, or their planned use during the study period.

Outcomes

Primary Outcomes

Not specified

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