Avian Influenza
Conditions
Brief summary
HI antibody titers expressed as group GMT ratio 1 month after the second dose the H5N8 vaccine (at Day 57)., HI seroconversion rates 1 month after the second dose of the H5N8 vaccine (From Day 1 to Day 57)
Detailed description
Occurrence of solicited administration site AEs with onset within 7 days (i.e. from Day 1 to Day 7 included) of each study intervention administration, Occurrence of solicited systemic AEs with onset within 7 days (i.e. from Day 1 to Day 7 included) of each study intervention administration, Occurrence of unsolicited AEs with onset within 28 days (i.e. from Day 1 to Day 28 included) of each study intervention administration, Occurrence of AESIs within 6 months (i.e. from Day 1 to Day 181 included) of study intervention administration, Occurrence of SAEs within 6 months (i.e. from Day 1 to Day 181 included) of study intervention administration, Occurrence of SAEs related to study participation from signing of ICF up to end of study
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HI antibody titers expressed as group GMT ratio 1 month after the second dose the H5N8 vaccine (at Day 57)., HI seroconversion rates 1 month after the second dose of the H5N8 vaccine (From Day 1 to Day 57) | — |
Secondary
| Measure | Time frame |
|---|---|
| Occurrence of solicited administration site AEs with onset within 7 days (i.e. from Day 1 to Day 7 included) of each study intervention administration, Occurrence of solicited systemic AEs with onset within 7 days (i.e. from Day 1 to Day 7 included) of each study intervention administration, Occurrence of unsolicited AEs with onset within 28 days (i.e. from Day 1 to Day 28 included) of each study intervention administration, Occurrence of AESIs within 6 months (i.e. from Day 1 to Day 181 included) of study intervention administration, Occurrence of SAEs within 6 months (i.e. from Day 1 to Day 181 included) of study intervention administration, Occurrence of SAEs related to study participation from signing of ICF up to end of study | — |