CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,503 enrolled
Drug / intervention
NBP607-QIV +2 morebiological
Likely dose
Not stated in 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/NCT02467842
NCT02467842Phase 3Completed
CompareCT.gov

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine in Adults and Elderly Subjects

SK Chemicals Co., Ltd.·interventional·Posted Jun 10, 2015·Updated May 8, 2020

In Brief

A Phase 3 clinical trial evaluating NBP607-QIV, NBP607-Y, and 1 other intervention for Influenza. Completed, enrolled 1,503 participants.

Detailed Summary

All participants received a single dose of their assigned vaccine on Day 0. They were followed up for immunogenicity and safety through Day 21 post-vaccination. Serious adverse events were collected for 6 months post-vaccination.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInfluenza
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
First PostedJun 10, 2015
Enrollment StartOct 1, 2014
Primary CompletionDec 1, 2014
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 11.1 years ago

Interventions

NBP607-QIVbiological

Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria

NBP607-Ybiological

Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata

NBP607-Vbiological

Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria