Trials / Completed
CompletedNCT02550197
Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Given by Intramuscular Route in Subjects Aged 18 to 60 Years
Immunogenicity and Safety of a Quadrivalent Influenza Vaccine Administered Via the Intramuscular Route in Subjects Aged 18 to 60 Years in the Republic of Korea
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 300 (actual)
- Sponsor
- Sanofi Pasteur, a Sanofi Company · Industry
- Sex
- All
- Age
- 18 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The aim of the trial is to evaluate immunogenicity and safety of the quadrivalent influenza vaccine (QIV) and the trivalent influenza vaccine (TIV) (split-virion inactivated) Northern Hemisphere (NH) 2015 2016 seasonal formulations, in subjects aged 18 to 60 years in the Republic of Korea for the registration of the QIV by the Ministry of Food and Drug Safety. Objectives: * To evaluate the immunogenicity of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations. The compliance, in terms of immunogenicity, of the QIV NH 2015-2016 formulation, with the requirements of the Committee for Medicinal Products for Human Use (CHMP) Note for Guidance (NfG) CPMP/BWP/214/96 will be assessed. * To evaluate the safety profile of QIV and TIV (split-virion, inactivated) NH 2015-2016 seasonal formulations
Detailed description
All subjects will receive one dose of either QIV or TIV on Day 0. They will be monitored for safety and immunogenicity for up to Day 21 post-vaccination.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 | 0.5 mL, Intramuscular |
| BIOLOGICAL | Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation | 0.5 mL, Intramuscular |
Timeline
- Start date
- 2015-09-01
- Primary completion
- 2016-04-01
- Completion
- 2016-07-01
- First posted
- 2015-09-15
- Last updated
- 2022-03-28
- Results posted
- 2016-11-04
Locations
5 sites across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02550197. Inclusion in this directory is not an endorsement.