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Trial record 97 of 112 for:    mf59

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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02583256
Recruitment Status : Completed
First Posted : October 22, 2015
Results First Posted : April 24, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Seqirus

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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Adjuvanted QIV (aQIV) Biological: Non-adjuvanted QIV Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1601 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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)
Actual Study Start Date : January 29, 2016
Actual Primary Completion Date : November 15, 2016
Actual Study Completion Date : May 9, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: aQIV/aQIV
Subjects previously vaccinated with aQIV followed one year later by aQIV
Biological: Adjuvanted QIV (aQIV)
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Experimental: aQIV/QIV
Subjects previously vaccinated with aQIV followed one year later by QIV
Biological: Non-adjuvanted QIV
Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Experimental: QIV/aQIV
Subjects previously vaccinated with QIV followed one year later by aQIV
Biological: Adjuvanted QIV (aQIV)
Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Experimental: QIV/QIV
Subjects previously vaccinated with QIV followed one year later by QIV
Biological: Non-adjuvanted QIV
Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)




Primary Outcome Measures :
  1. 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 [ Time Frame: Day 22 ]

    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.


  2. Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis [ Time Frame: Day 22 ]

    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 :
  1. Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison) [ Time Frame: Day 22 ]

    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.


  2. Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) [ Time Frame: Day 181 ]

    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.


  3. Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison) [ Time Frame: Day 1, Day 22 ]

    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.


  4. 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 [ Time Frame: Day 22, Day 181 ]

    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.


  5. Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains [ Time Frame: Day 22, Day 181 ]

    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.


  6. 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 [ Time Frame: Day 22 ]

    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.


  7. Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains [ Time Frame: Day 1, Day 22, Day 181 ]

    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.


  8. Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains [ Time Frame: Day 22/Day 1 and Day 181/Day 1 ]

    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.


  9. Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains [ Time Frame: Day 22, Day 181 ]

    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.


  10. Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains [ Time Frame: Day 1, Day 22, Day 181 ]

    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.


  11. Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains [ Time Frame: Day 22/Day 1 and Day 181/Day 1 ]

    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.


  12. Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains [ Time Frame: Day 1, Day 22, Day 181 ]

    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.


  13. Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains [ Time Frame: Day 22/Day 1 and Day 181/Day 1 ]

    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.


  14. Safety Endpoint: Percentage of Subjects With Solicited AEs [ Time Frame: Day 1 to Day 7 after vaccination ]
    Safety of revaccination was assessed in terms of percentage of subjects reporting solicited AEs up to 7 days after vaccination.

  15. Safety Endpoint: Percentage of Subjects With Unsolicited AEs [ Time Frame: Day 1 to Day 366 ]
    Safety of revaccination was assessed in terms of percentage of subjects reporting unsolicited AEs during the overall study period (Day 1 to Day 366).

  16. 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. [ Time Frame: Day 1 to Day 366 ]

    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.


  17. Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature [ Time Frame: Day 1 to Day 366 ]
    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.

  18. Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness [ Time Frame: Day 1 to Day 366 ]
    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.

  19. 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 [ Time Frame: Day 22, Day 181 ]

    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.


  20. 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 [ Time Frame: Day 22, Day 181 ]

    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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Months to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02583256


Locations
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Finland
Investigational Site- 001
Espoo, Etelä-Suomen Lääni, Finland, 02230
Investigational Site- 002
Helsinki, Etelä-Suomen Lääni, Finland, 00100
Investigational Site- 003
Helsinki, Etelä-Suomen Lääni, Finland, 00100
Investigational Site- 004
Järvenpää, Etelä-Suomen Lääni, Finland, 04400
Investigational Site- 005
Kokkola, Länsi-Suomen Lääni, Finland, 67100
Investigational Site- 007
Pori, Länsi-Suomen Lääni, Finland, 28100
Investigational Site- 009
Tampere, Länsi-Suomen Lääni, Finland, 33100
Investigational Site- 010
Turku, Länsi-Suomen Lääni, Finland, 20520
Investigational Site- 006
Oulu, Finland, 90220
Philippines
Investigational Site- 303
Laguna, Matro Manila, Philippines, 1781
Investigational Site- 304
Muntinlupa, National Capital Region, Philippines, 1781
Investigational Site- 305
Muntinlupa, National Capital Region, Philippines, 1781
Investigational Site- 306
Cavite, Philippines, 4114
Thailand
Investigational Site- 325
Pathum Thani, Bangkok, Thailand, 12120
Investigational Site- 327
Bangkok, Krung Thep Maha Nakhon [Bangko, Thailand, 10400
Investigational Site- 320
Bangkok, Samut Prakan, Thailand, 10400
Investigational Site- 323
Bangkok, Thailand, 10330
Sponsors and Collaborators
Seqirus
Investigators
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Study Director: Clinical Program Director Seqirus

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Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT02583256     History of Changes
Other Study ID Numbers: V118_05E3
2015-002973-39 ( EudraCT Number )
First Posted: October 22, 2015    Key Record Dates
Results First Posted: April 24, 2019
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Seqirus:
Influenza Vaccine
MF59 adjuvant

Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs