drugset / Trial / NCT03704740

Immunogenicity and Safety of NBP607-QIV Compared to Agrippal in Children Aged 6 to 35 Months

NCT03704740

Phase 3 Completed 676 enrolled SK Bioscience Co., Ltd.
RandomizedParallel-groupQuadruple-blindPrevention

Summary

This study assesses immunogenicity and safety of NBP607-QIV to Agrippal which are indicated for active immunization for the prevention of influenza disease. Total of 675 subjects or above (450 subjects for NBP607-QIV arm and 225 subjects for Agrippal arm) of 6 to 35 months of age are enrolled, and each subject is administered with single or two doses of vaccines depending on previous vaccination history.

Timeline

Start
2018-10-25
Primary completion
2019-07-12
Completion
2019-07-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Agrippal Vaccine 0.25 ml Intramuscular
Subject NBP607-QIV Vaccine 0.5 ml Intramuscular

Indications