Back to resultsClinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)
Primary Purpose
Influenza
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adjuvanted QIV (aQIV)
Non-adjuvanted QIV
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Influenza Vaccine, MF59 adjuvant
Eligibility Criteria
Inclusion Criteria:
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
- Subject's parent/legal guardian has voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
- Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118_05.
- For naïve subjects in parent trial V118_05 to have received two doses of the same study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV).
Exclusion Criteria:
- Previous immunization with any influenza vaccine (licensed or investigational) within 6 months prior to enrollment.
- Subjects with a clinical condition representing a contraindication to intramuscular vaccination or blood draws.
- Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to participate in another clinical trial while enrolled in V118-05E3.
Additional eligibility criteria may be discussed by contacting the site.
Sites / Locations
- Investigational Site- 001
- Investigational Site- 002
- Investigational Site- 003
- Investigational Site- 004
- Investigational Site- 005
- Investigational Site- 007
- Investigational Site- 009
- Investigational Site- 010
- Investigational Site- 006
- Investigational Site- 303
- Investigational Site- 304
- Investigational Site- 305
- Investigational Site- 306
- Investigational Site- 325
- Investigational Site- 327
- Investigational Site- 320
- Investigational Site- 323
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
aQIV/aQIV
aQIV/QIV
QIV/aQIV
QIV/QIV
Arm Description
Subjects previously vaccinated with aQIV followed one year later by aQIV
Subjects previously vaccinated with aQIV followed one year later by QIV
Subjects previously vaccinated with QIV followed one year later by aQIV
Subjects previously vaccinated with QIV followed one year later by QIV
Outcomes
Primary Outcome Measures
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis
GMT and 95% confidence interval (CI) were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis
GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Secondary Outcome Measures
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)
GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
GMT and 95% CI were analyzed for Day 181 against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported against homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer <1:10 on Day 1) as postvaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination is reported against homologous strains.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains
The percentage of subjects achieving HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 at Day 22 after vaccination is reported against homologous strains.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
GMT and 95% CI were analyzed for Day 22 for the heterologous strains using ANCOVA with study specific covariates.
The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/ Victoria lineage strain, B/Malaysia/2506/2004.
Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the heterologous strains using ANCOVA with study specific covariates.
The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B Victoria lineage strain, B/Malaysia/2506/2004.
Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination and the percentage of subject who experienced seroconversion is reported for homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer <1:10 on Day 1) as post-vaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/Victoria lineage strain, B/Malaysia/2506/2004.
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
To further characterize immune response, MN GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
The GMR is the geometric mean of the fold increase in MN titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
To further characterize immune response, adjusted anti-NA GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.
Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
The GMR is the geometric mean of the fold increase in anti-NA titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.
Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Safety Endpoint: Percentage of Subjects With Solicited AEs
Safety of revaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Safety of revaccination was assessed in terms of percentage of subjects reporting unsolicited AEs during the overall study period (Day 1 to Day 366).
Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE.
Safety of revaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCD, AESI and medically attended AE. Each subject was followed for a period of 12 months after receipt of the study vaccine.
NOCDs include AEs that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment. AESIs include potentially immune-mediated disorders which were reported by the investigators.
Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature
Safety of revaccination was assessed in terms of percentage of subjects reporting diagnosis of failure to thrive or short stature up to 12 months after last vaccination.
Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness
Safety of revaccination was assessed in terms of percentage of subjects reporting otitis media, or pneumonia, or influenza-like illness up to 12 months after last vaccination.
Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains
The percentage of subjects achieving MN titer ≥1:20, ≥1:40, ≥1:80 ≥1:160, ≥1:320 and ≥1:640 at Day 22 and Day 181 after vaccination is reported against homologous strains.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains
The percentage of subjects achieving anti-NA titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 after vaccination is reported against homologous strains
Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02583256
Brief Title
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)
Official Title
A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to Either the Same or Alternate Type of Vaccine, Adjuvanted or Non-adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV or QIV), Administered to Subjects Previously Vaccinated in Trial V118_05 (NCT01964989)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 29, 2016 (Actual)
Primary Completion Date
November 15, 2016 (Actual)
Study Completion Date
May 9, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Safety, Immunogenicity of an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine Compared to Non-Adjuvanted Comparator Influenza Vaccine in Children Previously vaccinated in Trial V118_05. Subjects will receive either the Same or Alternate Type of Vaccine.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza Vaccine, MF59 adjuvant
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1601 (Actual)
8. Arms, Groups, and Interventions
Arm Title
aQIV/aQIV
Arm Type
Experimental
Arm Description
Subjects previously vaccinated with aQIV followed one year later by aQIV
Arm Title
aQIV/QIV
Arm Type
Experimental
Arm Description
Subjects previously vaccinated with aQIV followed one year later by QIV
Arm Title
QIV/aQIV
Arm Type
Experimental
Arm Description
Subjects previously vaccinated with QIV followed one year later by aQIV
Arm Title
QIV/QIV
Arm Type
Experimental
Arm Description
Subjects previously vaccinated with QIV followed one year later by QIV
Intervention Type
Biological
Intervention Name(s)
Adjuvanted QIV (aQIV)
Intervention Description
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
Intervention Type
Biological
Intervention Name(s)
Non-adjuvanted QIV
Intervention Description
Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
Primary Outcome Measure Information:
Title
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio as Determined by Hemagglutination Inhibition (HI) Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Noninferiority Analysis
Description
GMT and 95% confidence interval (CI) were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 22
Title
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis
Description
GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 22
Secondary Outcome Measure Information:
Title
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)
Description
GMT and 95% CI were analyzed for Day 22 against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 22
Title
Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
Description
GMT and 95% CI were analyzed for Day 181 against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 181
Title
Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
Description
The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported against homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer <1:10 on Day 1) as postvaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 1, Day 22
Title
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 for Against Homologous Strains
Description
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 22, Day 181
Title
Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
Description
The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination is reported against homologous strains.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 22, Day 181
Title
Immunogenicity Endpoints: Percentage of Subjects With HI Titer ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 on Day 22 Against Homologous Strains
Description
The percentage of subjects achieving HI Titers ≥1:110, ≥1:151, ≥1:215, ≥1:330 and ≥1:629 at Day 22 after vaccination is reported against homologous strains.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 22
Title
Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
Description
GMT and 95% CI were analyzed for Day 22 for the heterologous strains using ANCOVA with study specific covariates.
The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/ Victoria lineage strain, B/Malaysia/2506/2004.
Time Frame
Day 1, Day 22, Day 181
Title
Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains
Description
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the heterologous strains using ANCOVA with study specific covariates.
The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B Victoria lineage strain, B/Malaysia/2506/2004.
Time Frame
Day 22/Day 1 and Day 181/Day 1
Title
Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
Description
The percentage of subjects achieving HI titer ≥1:40 at Day 22 and Day 181 after vaccination and the percentage of subject who experienced seroconversion is reported for homologous strains. Seroconversion was defined in subjects seronegative at baseline (i.e. HI titer <1:10 on Day 1) as post-vaccination HI titer ≥1:40 and defined in subjects seropositive at baseline (i.e. HI titer ≥1:10 on Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.
The two heterologous strains selected for HI testing in this study were the H3N2 strain, A/Hong Kong/4801/2014 (X-263B), and the B/Victoria lineage strain, B/Malaysia/2506/2004.
Time Frame
Day 22, Day 181
Title
Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
Description
To further characterize immune response, MN GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 1, Day 22, Day 181
Title
Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
Description
The GMR is the geometric mean of the fold increase in MN titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed for the homologous strains using ANCOVA with study specific covariates.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 22/Day 1 and Day 181/Day 1
Title
Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
Description
To further characterize immune response, adjusted anti-NA GMT and 95% CI were analyzed for Day 1, Day 22, and Day 181 against homologous strains.
Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 1, Day 22, Day 181
Title
Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
Description
The GMR is the geometric mean of the fold increase in anti-NA titer from Day 1 to Day 22 or Day 181. GMR and 95% CI were analyzed against homologous strains using ANCOVA with study specific covariates.
Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 22/Day 1 and Day 181/Day 1
Title
Safety Endpoint: Percentage of Subjects With Solicited AEs
Description
Safety of revaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.
Time Frame
Day 1 to Day 7 after vaccination
Title
Safety Endpoint: Percentage of Subjects With Unsolicited AEs
Description
Safety of revaccination was assessed in terms of percentage of subjects reporting unsolicited AEs during the overall study period (Day 1 to Day 366).
Time Frame
Day 1 to Day 366
Title
Safety Endpoint: Percentage of Subjects With Serious Adverse Events (SAE), AEs Leading to Withdrawal, New Onset of Chronic Disease (NOCD), AE of Special Interest (AESI), and Medically Attended AE.
Description
Safety of revaccination was assessed in terms of percentage of subjects reporting SAEs, AEs leading to withdrawal, NOCD, AESI and medically attended AE. Each subject was followed for a period of 12 months after receipt of the study vaccine.
NOCDs include AEs that represents a new diagnosis of a chronic medical condition that was not present or suspected in a subject prior to study enrollment. AESIs include potentially immune-mediated disorders which were reported by the investigators.
Time Frame
Day 1 to Day 366
Title
Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature
Description
Safety of revaccination was assessed in terms of percentage of subjects reporting diagnosis of failure to thrive or short stature up to 12 months after last vaccination.
Time Frame
Day 1 to Day 366
Title
Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness
Description
Safety of revaccination was assessed in terms of percentage of subjects reporting otitis media, or pneumonia, or influenza-like illness up to 12 months after last vaccination.
Time Frame
Day 1 to Day 366
Title
Immunogenicity Endpoint: Percentage of Subjects With MN Titer ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Day 22 and Day 181 Against Homologous Strains
Description
The percentage of subjects achieving MN titer ≥1:20, ≥1:40, ≥1:80 ≥1:160, ≥1:320 and ≥1:640 at Day 22 and Day 181 after vaccination is reported against homologous strains.
Strains tested: A/H1N1 California/07/2009; A/H3N2 Switzerland/9715293/2013; B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 22, Day 181
Title
Immunogenicity Endpoint: Percentage of Subjects Achieving Anti-NA Titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 Against Homologous Strains
Description
The percentage of subjects achieving anti-NA titers ≥1:20, ≥1:40, ≥1:80, ≥1:160, ≥1:320 and ≥1:640 on Days 22 and 181 after vaccination is reported against homologous strains
Strains tested: N1 (PR8 H6N1 California/07/2009), N2 (PR8 H6N2 Switzerl/9715293/2013); B/Victoria Brisbane/60/2008; B/Yamagata Phuket/3073/2013.
Time Frame
Day 22, Day 181
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.
Subject's parent/legal guardian has voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
Male or female subject who has completed their Visit 13 (Study Day 366 for non-naïve subjects) or clinic Visit 15 (Day 390 for naïve subjects) in parent trial V118_05.
For naïve subjects in parent trial V118_05 to have received two doses of the same study vaccine (i.e. 2 doses of aQIV or 2 doses of QIV).
Exclusion Criteria:
Previous immunization with any influenza vaccine (licensed or investigational) within 6 months prior to enrollment.
Subjects with a clinical condition representing a contraindication to intramuscular vaccination or blood draws.
Unwillingness of the parent(s)/ legal guardian(s) of the subject to refuse to participate in another clinical trial while enrolled in V118-05E3.
Additional eligibility criteria may be discussed by contacting the site.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Program Director
Organizational Affiliation
Seqirus
Official's Role
Study Director
Facility Information:
Facility Name
Investigational Site- 001
City
Espoo
State/Province
Etelä-Suomen Lääni
ZIP/Postal Code
02230
Country
Finland
Facility Name
Investigational Site- 002
City
Helsinki
State/Province
Etelä-Suomen Lääni
ZIP/Postal Code
00100
Country
Finland
Facility Name
Investigational Site- 003
City
Helsinki
State/Province
Etelä-Suomen Lääni
ZIP/Postal Code
00100
Country
Finland
Facility Name
Investigational Site- 004
City
Järvenpää
State/Province
Etelä-Suomen Lääni
ZIP/Postal Code
04400
Country
Finland
Facility Name
Investigational Site- 005
City
Kokkola
State/Province
Länsi-Suomen Lääni
ZIP/Postal Code
67100
Country
Finland
Facility Name
Investigational Site- 007
City
Pori
State/Province
Länsi-Suomen Lääni
ZIP/Postal Code
28100
Country
Finland
Facility Name
Investigational Site- 009
City
Tampere
State/Province
Länsi-Suomen Lääni
ZIP/Postal Code
33100
Country
Finland
Facility Name
Investigational Site- 010
City
Turku
State/Province
Länsi-Suomen Lääni
ZIP/Postal Code
20520
Country
Finland
Facility Name
Investigational Site- 006
City
Oulu
ZIP/Postal Code
90220
Country
Finland
Facility Name
Investigational Site- 303
City
Laguna
State/Province
Matro Manila
ZIP/Postal Code
1781
Country
Philippines
Facility Name
Investigational Site- 304
City
Muntinlupa
State/Province
National Capital Region
ZIP/Postal Code
1781
Country
Philippines
Facility Name
Investigational Site- 305
City
Muntinlupa
State/Province
National Capital Region
ZIP/Postal Code
1781
Country
Philippines
Facility Name
Investigational Site- 306
City
Cavite
ZIP/Postal Code
4114
Country
Philippines
Facility Name
Investigational Site- 325
City
Pathum Thani
State/Province
Bangkok
ZIP/Postal Code
12120
Country
Thailand
Facility Name
Investigational Site- 327
City
Bangkok
State/Province
Krung Thep Maha Nakhon [Bangko
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Investigational Site- 320
City
Bangkok
State/Province
Samut Prakan
ZIP/Postal Code
10400
Country
Thailand
Facility Name
Investigational Site- 323
City
Bangkok
ZIP/Postal Code
10330
Country
Thailand
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine in Children Previously Vaccinated in Trial V118_05 (NCT01964989)
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