CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 300 enrolled
Drug / intervention
Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 +1 morebiological
Likely dose
Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 0.5 mLfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02550197
NCT02550197Phase 3Completed
CompareCT.gov

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

Sanofi Pasteur, a Sanofi Company·interventional·Posted Sep 15, 2015·Updated Mar 28, 2022

In Brief

A Phase 3 clinical trial evaluating Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016 and Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulation for Influenza. Completed, enrolled 300 participants across 5 sites.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
CountriesSouth Korea
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedSep 15, 2015
Enrollment StartSep 1, 2015
Primary CompletionApr 1, 2016
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 10.8 years ago

Interventions

Quadrivalent influenza vaccine (QIV) (split virion, inactivated) Northern Hemisphere (NH) 2015-2016biological

0.5 mL, Intramuscular

Trivalent influenza vaccine (TIV) (split virion, inactivated) NH 2015-2016 formulationbiological

0.5 mL, Intramuscular