Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children and Adolescents

NCT02621164 | Completed Phase 3 DMC

• 1 other identifier: NBP607-QIV_FluC_III_2014
• Study Type: interventional
• Target: 454
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study is a multi-center, randomized, double-blind Phase III clinical trial. The aim of the study is to describe the immunogenicity and safety of the quadrivalent cell culture-derived influenza vaccine compared to the trivalent egg-derived influenza vaccine among subjects.

Conditions

Influenza, Human

Outcome Measures

Primary Outcomes (1)

• CHMP criteria

  Seroprotection rate \> 70%, Seroconversion rate \> 40%, GMR \> 2.5

  At Day 28 post-vaccination

Secondary Outcomes (6)

• Immunogenicity in subjects with a pre-vaccination HI antibody titer < 1:80

  At Day 28 post-vaccination

• Immunogenicity compared to control group

  At Day 28 post-vaccination

• Incidence rate of Advers Event (AE)

  During 7 days post-vaccination for Solicited AE and during 28 days post-vaccination for Unsolicited AE

• Incidence rate of Severe Adverse Event (SAE)

  During 6 months post-vaccination

• Vital Sign

  At Day 0 and at Day 28 post-vaccination

Study Arms (2)

NBP607-QIV

EXPERIMENTAL

Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine

Biological: NBP607-QIV

Agrippal S1

ACTIVE COMPARATOR

Trivalent Inactivated Egg-derived Influenza Vaccine

Biological: Agrippal S1

Interventions

NBP607-QIV BIOLOGICAL

For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)

NBP607-QIV

Agrippal S1 BIOLOGICAL

For subjects 6 months to 8 years of age, single intramuscular dose for primed subjects, two doses for unprimed subjects. For subjects 9 to 18 years of age, single intramuscular dose (0.25mL/0.5 mL)

Agrippal S1

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children and adolescents aged 6 months to 18 years.
• Those who was born after normal pregnancy period(37 weeks) for aged 6 months to \< 1 year
• Those whose legally acceptable representative have given written consent to participate in the study and comply with all study requirements.

You may not qualify if:

• Subjects who are hypersensitive to any component of vaccine, i.e., eggs, chicken or chicken products.
• Subjects with immune deficiency disorder or malignant cancer.
• History of Guillain-Barre syndrome.
• Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
• Subjects who experienced fever within 72 hours before vaccination or with the febrile disease(exceeding 38.0℃) on screening day.
• Subjects who had received immunosuppressant or immune-modifying drug within 3 months before screening.
• Subjects who had received blood products or immunoglobulin within 3 months before screening.
• Subjects who had received influenza vaccination within 6 months prior to the screening.
• Subjects who had received other vaccination within a month before. screening, or those who had another vaccination scheduled within a month after study vaccination.
• Subjects who had participated in other clinical trial within 4 weeks prior to study vaccination.
• Subjects with clinically significant chronic disease.
• Pregnant women, breast-feeding women.
• Any other condition which, in the opinion of the Investigator, prevents the subject from participating in the study.

Sponsors & Collaborators

• SK Chemicals Co., Ltd.: lead

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Yun Kyung Kim

  Korea University Ansan Hospital

  STUDY CHAIR

• Byung Wook Eun

  Eulji General Hospital

  PRINCIPAL INVESTIGATOR

• Taek Jin Lee

  CHA University

  PRINCIPAL INVESTIGATOR

• Jina Lee

  Asan Medical Center

  PRINCIPAL INVESTIGATOR

• Ki Hwan Kim

  Severance Children's Hospital

  PRINCIPAL INVESTIGATOR

• Dong Ho Kim

  Korea Institute of Radiological and Medical Science

  PRINCIPAL INVESTIGATOR

• Dae Sun Jo

  Chonbuk National University Hospital

  PRINCIPAL INVESTIGATOR

• Seon Hee Shin

  Hallym University Dongtan Sacred Heart Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 30, 2015
• First Posted: December 3, 2015
• Study Start: September 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: June 1, 2015
• Last Updated: December 3, 2015

Record last verified: 2015-12