NCT03704740

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

A Multinational, Comparative Phase III Clinical Trial to Assess the Efficacy (Immunogenicity) and Safety of NBP607-QIV (0.5 mL) (Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine) in Children Aged 6 to 35 Months

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 676 (actual)
• Sponsor: SK Bioscience Co., Ltd. · Industry
• Sex: All
• Age: 6 Months – 35 Months
• Healthy volunteers: Accepted

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.

Detailed description

This is a multi-national, multi-center, randomized, double blinded, parallel-group study to assess the immunogenicity and safety of NBP607-QIV compared to Agrippal which are indicated for active immunization for the 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. Each subject is administered with single or two doses of vaccines depending on previous vaccination history, and randomly assigned in 2:1 ratio. Stratified randomization for trial site and age strata is used to achieve the balance of treatment assignment. Total of three or five visits are scheduled depeding on dosing schedule. For subjects assigned to single-dose vaccination schedule, blood sampling is conducted for immunogenicity assessment before and 4 weeks after single vaccination at Visit 1 and 3 respectively. Safety is monitored 3 days, 4 weeks after vaccination through Visit 2\* and 3 (\* telephone contact). For subjects assigned to two-dose vaccination schedule, blood sampling is conducted before first vaccination and 4 weeks after second vaccination at Visit 1 and Visit 5 respectively. Safety is monitored 3 days, 4 weeks after each vaccination through Visit 2\*, 3, 4\*, and 5 (\* telephone contact)

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	NBP607-QIV	Purified inactivated influenza virus surface antigens of four strains (quadrivalent)
BIOLOGICAL	Agrippal	Influenza virus surface antigens of three strains (trivalent)

Timeline

• Start date: 2018-10-25
• Primary completion: 2019-07-12
• Completion: 2019-07-12
• First posted: 2018-10-15
• Last updated: 2022-05-11

Locations

1 site across 1 country: South Korea