Influenza A Virus, H7N9 Subtype Clinical Trial
Official title:
A Phase I Study In Healthy Adults To Assess The Safety And Immunogenicity Of Priming With Live Attenuated A/H7N9 Influenza Virus Vaccine Followed By Inactivated A/H7N9 Influenza Virus Vaccine With AS03 Adjuvant
The purpose of this study is to evaluate the safety and immunogenicity of one dose of H7N9 pandemic live attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9 pandemic inactivated influenza vaccine (H7N9 pIIV).
This study will evaluate the safety and immunogenicity of one dose of H7N9 pandemic live
attenuated influenza vaccine (H7N9 pLAIV) followed by AS03-adjuvanted H7N9 pandemic
inactivated influenza vaccine (H7N9 pIIV).
This study will enroll healthy adults who will choose which study group to join. Participants
in Group 1 will receive one dose of H7N9 pLAIV in an inpatient setting at study entry (Day
0). They will remain in an isolation unit through at least Day 9. They will also receive one
dose of AS03-adjuvanted H7N9 pIIV on Day 84.
Participants in Group 2 will receive one dose of AS03-adjuvanted H7N9 pIIV at study entry
(Day 0) and a second dose of AS03-adjuvanted H7N9 pIIV at Day 84. Participants in Group 3
will receive one dose of AS03-adjuvanted H7N9 pIIV at study entry (Day 0).
All participants will attend multiple study visits through Day 264. Study visits may include
blood collection, physical examinations, and nasal wash and nasal wick procedures.
These three groups will be compared to two historical control groups who received one dose of
H7N9 pLAIV at study entry (Day 0), one dose of H7N9 pLAIV at Day 28, and one dose of
unadjuvanted H7N9 pIIV at Day 84.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
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| Completed |
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|
Phase 1 |