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A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged >= 6 Months to < 18 Years
A Phase IV, Open Label, Multi-Centre Study to Evaluate the Safety and Tolerability Profile of CSL Limited's Influenza Virus Vaccine in a Paediatric Population Aged \>= 6 Months to \< 18 Years
Details
| Lead sponsor | Seqirus |
|---|---|
| Phase | Phase 4 |
| Status | COMPLETED |
| Enrolment | 1992 |
| Start date | 2009-03 |
| Completion | 2010-02 |
Conditions
- Influenza
Interventions
- CSL Limited Influenza Virus Vaccine
- CSL Limited Influenza Virus Vaccine
- CSL Limited Influenza Virus Vaccine
Primary outcomes
- Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) — 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability. - Duration of Local and Systemic Solicited Adverse Events, Cohort A (6 Months to Less Than 3 Years) — 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, loss of appetite, and irritability. - Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) — 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise. - Duration of Local and Systemic Solicited Adverse Events, Cohort B (3 Years to Less Than 9 Years) — 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise. - Frequency and Intensity of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) — 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise. - Duration of Local and Systemic Solicited Adverse Events, Cohort C (9 Years to Less Than 18 Years) — 7 days post-vaccination
Solicited Local Adverse Events: pain, redness, and swelling/induration. Solicited Systemic Adverse Events: fever, headache, myalgia, nausea/vomiting, diarrhea, and malaise.
Countries
Australia