Respiratory Syncytial Virus Infection
Conditions
Keywords
Respiratory syncytial virus infection, RSV Vaccine, Individuals aged 60 years or older, Post Marketing Study
Brief summary
This post-marketing study is a multicenter cohort study in individuals aged 60 years or older vaccinated with Abrysvo (RSV vaccine）designed to confirm the safety in individuals aged 60 years or older under actual clinical practice in Japan.
Interventions
BIOLOGICALRSVpreF vaccine
Injection in the muscle, 1 dose 0.5mL
Sponsors
Pfizer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Individuals aged 60 years or older who have been vaccinated with Abrysvo for the first time after Abrysvo is launched. Those who have previously participated in the clinical trials of this product will be excluded. 2. Vaccinated participants (or his/her legally acceptable representative) who understand the information on this study and have provided written consent regarding their participation in the study.
Exclusion criteria
-There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of individuals aged 60 years or older reporting Adverse Reactions for 28 days after vaccination. | From the day of vaccination up to 28 days after vaccination. | Adverse reaction (including serious) in individuals aged 60 years or older will be assessed. |
| Percentage of individuals aged 60 years or older reporting Serious Adverse Reactions from the day of vaccination up to 28 days after vaccination. | From the day of vaccination up to 28 days after vaccination. | Serious adverse reaction in individuals aged 60 years or older will be assessed. |
Countries
Japan
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed