Immunogenicity and Safety of Quadrivalent Influenza Vaccine (NBP607-QIV) in Adults and Elderly Subjects

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1503 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-05-31

Brief Summary

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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.

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Detailed Description

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In a randomized controlled phase III trial undertaken in 10 university hospitals of South Korea, adults and elderly subjects were randomly assigned in a 2:1:1 ratio to NBP607-QIV versus cell culture-based trivalent inactivated influenza vaccine (TIV), NBP607-Y and NBP607-V. Immunogenicity was assessed 3 weeks after vaccination by hemagglutination inhibition (HI) assay. Safety was assessed for 6 months post-vaccination: solicited adverse events for 7 days, unsolicited adverse events (AEs) for 21 days and serious adverse events (SAE) for 6 months.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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NBP607-QIV

Participants aged 19 years and older received a 0.5mL single intramuscular dose of Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine containing 4 virus strains; A/H1N1, A/H3N2, B/Yamagata, B/Victoria on Day 0

Group Type EXPERIMENTAL

NBP607-QIV

Intervention Type BIOLOGICAL

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

NBP607-Y

Participants aged 19 years and older received a 0.5mL single intramuscular dose of Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Yamagata on Day 0

Group Type ACTIVE_COMPARATOR

NBP607-Y

Intervention Type BIOLOGICAL

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

NBP607-V

Participants aged 19 years and older received a 0.5mL single intramuscular dose of Trivalent Inactivated Cell Culture-derived Influenza Vaccine containing 3 virus strains; A/H1N1, A/H3N2, B/Victoria on Day 0

Group Type ACTIVE_COMPARATOR

NBP607-V

Intervention Type BIOLOGICAL

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

Interventions

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NBP607-QIV

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

Intervention Type BIOLOGICAL

NBP607-Y

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

Intervention Type BIOLOGICAL

NBP607-V

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Adults aged 19 years and older
* Those who are able to comply with the requirements for the study
* If women, a negative pregnancy test and willingness to use birth control measures for the entire study duration

Exclusion Criteria

* Disorders in immune function
* Any malignancy or lymphoproliferative disorder
* History of Guillain-Barré syndrome
* Individuals with a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
* Experience of fever (\>38.0 ℃) within 24 hours following vaccination
* Body temperature \>38.0 ℃ at the vaccination day
* Concomitant medications/therapy such as immunosuppressants or immune modifying drugs, systemic corticosteroids, immunoglobulins, blood or blood- derived products within 3 months
* Influenza vaccination within 6 months
* Subjects who have participated in other interventional study within 4 weeks
* Any vaccination within 1 month
* Those who are planning to receive any vaccine within 1 month from the study vaccine
* Individuals with any serious chronic or progressive disease
* Pregnant or breast-feeding women
* Any other reason that in the opinion of the investigator might interfere with the study

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes