RSV infection
Conditions
Brief summary
To describe the neutralizing antibody titers against RSV A and B one month after the prime dose (day 31) of Arexvy in study participants 60 65 years old and ≥80 years old.
Detailed description
Occurrence, intensity and duration of solicited AEs in the study participants at the administration site and solicited systemic AEs with an onset during the 4-day follow-up period after each vaccination., Incidence of unsolicited AEs in the study participants with an onset during the 30 day follow-up period after each vaccination., Incidence of SAEs or pIMDs in the study participants from the day of vaccination until 6 months., Occurrence of any fatal SAEs from day 1 up to study end.
Interventions
DRUGRESPIRATORY SYNCYTIAL VIRUS VACCINES
Sponsors
Karolinska Institutet
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To describe the neutralizing antibody titers against RSV A and B one month after the prime dose (day 31) of Arexvy in study participants 60 65 years old and ≥80 years old. | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence, intensity and duration of solicited AEs in the study participants at the administration site and solicited systemic AEs with an onset during the 4-day follow-up period after each vaccination., Incidence of unsolicited AEs in the study participants with an onset during the 30 day follow-up period after each vaccination., Incidence of SAEs or pIMDs in the study participants from the day of vaccination until 6 months., Occurrence of any fatal SAEs from day 1 up to study end. | — |
Countries
Sweden
Outcome results
None listed