Trials / Completed
CompletedNCT03765437
Safety of a Quadrivalent Influenza Vaccine (VaxigripTetra™) in Subjects Aged 6 Months and Older in Vietnam
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 230 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 6 Months
- Healthy volunteers
- Accepted
Summary
The primary objective of this study is to describe the safety of the Quadrivalent Influenza Vaccine (QIV). Safety is assessed throughout the study period, and includes solicited injection site and systemic reactions (Day 0 to Day 7 post-vaccination); unsolicited adverse events up to Day 28, and serious adverse events occurring throughout the study.
Detailed description
Study duration for previously unvaccinated participants aged 6 months to 8 years is approximately 56 days. Study duration for previously vaccinated participants aged 6 months to 8 years and any participant aged 9 years and older is approximately 28 days.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Quadrivalent Influenza Vaccine | Pharmaceutical form: Suspension for injection Route of administration: Intramuscular |
Timeline
- Start date
- 2019-01-15
- Primary completion
- 2019-03-17
- Completion
- 2019-03-17
- First posted
- 2018-12-05
- Last updated
- 2022-04-25
Locations
1 site across 1 country: Vietnam
Source: ClinicalTrials.gov record NCT03765437. Inclusion in this directory is not an endorsement.