Study on the Safety and Immunogenicity of a Live-Attenuated Respiratory Syncytial Virus Vaccine in Children 6 to < 24 Months of Age in Japan

JRCT ID: jRCT2051230020

Registered date:29/04/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Healthy children
• Date of first enrollment: 30/05/2023
• Target sample size: 18
• Study type: Interventional

Intervention(s)

Drug: RSV toddler (RSVt) Vaccine
Pharmaceutical form: Nasal spray suspension, Route of administration: Intranasal
Drug: Placebo
Pharmaceutical form: Nasal spray suspension, Route of administration: Intranasal

Outcome(s)

Primary Outcome

Safety:
- Unsolicited systemic adverse events (AEs) reported in the 30 minutes after each and any study intervention administration
- Solicited administration site and systemic reactions within 21 days after each study intervention administration
- Unsolicited AEs within 28 days after each study intervention administration
- AEs of special interest (AESIs) within 28 days after each study intervention administration
- Medically-attended AEs (MAAEs) within 28 days after each study intervention administration
- Serious AEs (SAEs) throughout the study (ie, from Day 01 to Day 85)

Secondary Outcome

Immunogenicity:
- RSV A serum neutralizing Ab titers up to 28 days after the second study intervention administration (Day 01 and Day 85)
- RSV serum anti-F IgG enzyme-linked immunosorbent assay (ELISA) Ab titers up to 28 days after the second study intervention administration (Day 01 and Day 85)

Key inclusion & exclusion criteria

• Age minimum: >= 6month old
• Age maximum: < 24month old
• Gender: Both

Include criteria

- Aged 6 months to < 24 months on the day of inclusion.
- Participants who are healthy as determined by medical evaluation including medical history.
- Born at full term of pregnancy (>= 37 weeks) or born after a gestation period of 27 through 36 weeks and medically stable as assessed by the investigator.
- Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative (LAR) (and by an independent witness if required by local regulations).
- Participant and parent/LAR are able to attend all scheduled visits and comply with all study procedures.

Exclude criteria

Participants are not eligible for the study if any of the following criteria are met:
- Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months).
- Known systemic hypersensitivity to any of the study intevention components, or history of a life-threatening reaction to the study intervention used in the study or to a product containing any of the same substances.
- Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion.
- Participant's mother previous receipt of an investigational RSV vaccine during pregnancy or planned administration of an investigational RSV vaccine during breastfeeding.
- Receipt or planned receipt of any of the following vaccines prior to enrollment or after the first study intervention administration:
- - Any other intranasal live attenuated vaccine within the 28 days prior to and after administration of 1st study vaccine
- - Unless given on the day of Dose 1 study administration, any other injectable live attenuated vaccines within the 28 days prior to and after. Concomitant receipt on the day of Dose 1 study administration is allowed
- Previous receipt of an investigational RSV vaccine or receiving any anti-RSV product (such as ribavirin or RSV immune globulin IG or RSV monoclonal antibody) at the time of enrollment.
- Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure.

Related Information

• Primary Sponsor: Tanaka Tomoyuki