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

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Primary Purpose

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

NBP607-QIV

NBP607-Y

NBP607-V

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza vaccine, Quadrivalent, Inactivated cell culture-derived

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

NBP607-QIV

NBP607-Y

NBP607-V

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects

GMTs of anti-influenza antibodies were measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. For each A strain, the titers were made with the pooled TIV group (NBP60-Y and NBP607-V). For each A strain, the comparion was made with the pooled TIV groups (Y+V/QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is Y/QIV).

Seroconversion Rate (SCR) After Vaccination in All Subjects

SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10 For each A strain, the comparion was made with the pooled TIV groups (Y+V minus QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Difference of SCR (Diff.SCR) is Y minus QIV).

Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40.

Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10

Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination.

Secondary Outcome Measures

Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects

GMTs of anti-influenza antibodies were measured for B strains: B/Victoria, and B/Yamagata. For each B strain, the comparison was made with the TIV group which did not contain the correponding B strain (i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is V/QIV).

Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects

SCR was measured for each B strain: B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10

Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years

SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40.

Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years

SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10

Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years

GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination

Full Information

NCT ID

NCT02467842

First Posted

June 3, 2015

Last Updated

April 27, 2020

Sponsor

SK Chemicals Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02467842

Brief Title

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

Official Title

A Multi-center, Randomized, Double-blind Phase III Clinical Trial to Assess the Immunogenicity and Safety of Quadrivalent Inactivated Cell Culture-derived Influenza Vaccine in Adults and Elderly Subjects

Study Type

Interventional

2. Study Status

Record Verification Date

June 2015

Overall Recruitment Status

Completed

Study Start Date

October 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

SK Chemicals Co., Ltd.

4. Oversight

Data Monitoring Committee

No

5. Study Description

Brief Summary

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Influenza

Keywords

Influenza vaccine, Quadrivalent, Inactivated cell culture-derived

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

1503 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NBP607-QIV

Arm Type

Experimental

Arm Description

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

Arm Title

NBP607-Y

Arm Type

Active Comparator

Arm Description

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

Arm Title

NBP607-V

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

NBP607-QIV

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

NBP607-Y

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

NBP607-V

Intervention Description

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

Primary Outcome Measure Information:

Title

Geometric Mean HI Titers (GMTs) After Vaccination in All Subjects

Description

GMTs of anti-influenza antibodies were measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. For each A strain, the titers were made with the pooled TIV group (NBP60-Y and NBP607-V). For each A strain, the comparion was made with the pooled TIV groups (Y+V/QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is Y/QIV).

Time Frame

At Day 21 post vaccination.

Title

Seroconversion Rate (SCR) After Vaccination in All Subjects

Description

SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10 For each A strain, the comparion was made with the pooled TIV groups (Y+V minus QIV). For each B strain, the comparison was made with the corresponding TIV group(i.e. for B/Yamagata, Difference of SCR (Diff.SCR) is Y minus QIV).

Time Frame

At Day 21 post vaccination.

Title

Seroprotection Rate (SPR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

Description

SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40.

Time Frame

At Day 21 post vaccination.

Title

Seroconversion Rate (SCR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

Description

SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10

Time Frame

At Day 21 post vaccination.

Title

Geometric Mean Ratio (GMR) of NBP607-QIV in the Elderly Subject Aged ≥60 Years

Description

GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination.

Time Frame

At Day 21 post vaccination.

Secondary Outcome Measure Information:

Title

Geometric Mean HI Titers (GMTs) of Each B Strain After Vaccination in All Subjects

Description

GMTs of anti-influenza antibodies were measured for B strains: B/Victoria, and B/Yamagata. For each B strain, the comparison was made with the TIV group which did not contain the correponding B strain (i.e. for B/Yamagata, Geometric Mean Titer Ratio (GMR) is V/QIV).

Time Frame

At Day 21 post vaccination.

Title

Seroconversion Rate (SCR) of B Strain After Vaccination in All Subjects

Description

SCR was measured for each B strain: B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10

Time Frame

At Day 21 post vaccination.

Title

Seroprotection Rate (SPR) of NBP607-QIV in the Adults Aged 19 to 59 Years

Description

SPR of NBP607-QIV was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroprotection was defined as the proportion of subjects whose post-vaccination HI titer increased to ≥1:40.

Time Frame

At Day 21 post vaccination.

Title

Seroconversion Rate (SCR) of NBP607-QIV in the Adults Aged 19 to 59 Years

Description

SCR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. Seroconversion was defined as the proportion of subjects who met either (1) post-vaccination HI titer of ≥ 1:40 for subjects with pre-vaccination HI titer of <1:10 or (2) Four-fold increase in post-vaccination HI titer for subjects with pre-vaccination HI titer of ≥ 1:10

Time Frame

At Day 21 post vaccination.

Title

Geometric Mean Ratio (GMR) of NBP607-QIV in the Subjects Aged 19 to 59 Years

Description

GMR was measured for 4 strains: A/H1N1, A/H3N2, B/Victoria, and B/Yamagata. GMR was defined as the fold-rise of the geometric mean HI titer from pre- to post-vaccination

Time Frame

At Day 21 post vaccination.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials: