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

NCT03704740 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 676

Last updated 2022-05-11

No results posted yet for this study

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.

Conditions

Interventions

BIOLOGICAL

NBP607-QIV

Purified inactivated influenza virus surface antigens of four strains (quadrivalent)

BIOLOGICAL

Agrippal

Influenza virus surface antigens of three strains (trivalent)

Sponsors & Collaborators

  • SK Bioscience Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Yun Kyung Kim, MD · Korea University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
35 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03704740 on ClinicalTrials.gov