Trials / Completed
CompletedNCT04101435
Immunogenicity and Safety Evaluation of QIS in Healthy Subjects
Immunogenicity and Safety Evaluation of AdimFlu-S Quadrivalent Inactivated Influenza Vaccine (QIS) in Healthy Subjects Aged 3 Years Old to 17 Years Old
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 174 (actual)
- Sponsor
- Adimmune Corporation · Industry
- Sex
- All
- Age
- 3 Years – 17 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study was to evaluate the antibody response to each of the four influenza vaccine strains included in the study vaccine, as measured by hemagglutination inhibition (HAI) at 4 weeks after the last dose of the study vaccine in young subjects aged between 3 years old and 17 years old.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | AdimFlu-S (QIS) | This was an open study to demonstrate the use of AdimFlu-S (QIS) (2016-2017 season) vaccine in young subjects aged between 3 years old to 17 years old. All subjects were divided into two subgroups. That were subjects aged 3 to 8 years old, who received 2 doses of 0.5 mL vaccine separated by 4 weeks, and subjects aged 9 to 17 years old, who received one dose of 0.5 mL vaccine. |
Timeline
- Start date
- 2016-12-28
- Primary completion
- 2017-07-12
- Completion
- 2017-12-27
- First posted
- 2019-09-24
- Last updated
- 2019-09-24
Source: ClinicalTrials.gov record NCT04101435. Inclusion in this directory is not an endorsement.