Clinical trial NCT02583256: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Influenza
Keywords: Influenza Vaccine
MF59 adjuvant
Lead sponsor: Seqirus
Sponsor class: INDUSTRY
First posted: 2015-10-22
Enrollment: 1601
Sex: ALL
Minimum age (years): 12
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: 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
timeFrame: Day 22
measure: Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (aQIV-primed Comparison), Superiority Analysis
timeFrame: Day 22
Secondary outcomes:
measure: Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 22 Against Homologous Strains (QIV-primed Comparison)
timeFrame: Day 22
measure: Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
timeFrame: Day 181
measure: Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)
timeFrame: Day 1, Day 22
measure: 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
timeFrame: Day 22, Day 181
measure: Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains
timeFrame: Day 22, Day 181
measure: 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
timeFrame: Day 22
measure: Immunogenicity Endpoint: GMT as Determined by HI Assay on Day 1, Day 22, and Day 181 Against Heterologous Strains
timeFrame: Day 1, Day 22, Day 181
measure: Immunogenicity Endpoint: GMR as Determined by HI Assay for Day 22/Day 1 and Day 181/Day 1 Against Heterologous Strains
timeFrame: Day 22/Day 1 and Day 181/Day 1
measure: Immunogenicity Endpoint: Percentage of Subjects Achieving SCR and HI Titer ≥1:40 on Day 22 and Day 181 Against Heterologous Strains
timeFrame: Day 22, Day 181
measure: Immunogenicity Endpoint: GMT as Determined by Microneutralization (MN) Assay on Day 1, Day 22, and Day 181 Against Homologous Strains
timeFrame: Day 1, Day 22, Day 181
measure: Immunogenicity Endpoint: GMR as Determined by MN Assay for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
timeFrame: Day 22/Day 1 and Day 181/Day 1
measure: Immunogenicity Endpoint: Anti-neuraminidase (NA) GMTs on Day 1, Day 22, and Day 181 Against Homologous Strains
timeFrame: Day 1, Day 22, Day 181
measure: Immunogenicity Endpoint: Anti-NA GMR for Day 22/Day 1 and Day 181/Day 1 Against Homologous Strains
timeFrame: Day 22/Day 1 and Day 181/Day 1
measure: Safety Endpoint: Percentage of Subjects With Solicited AEs
timeFrame: Day 1 to Day 7 after vaccination
measure: Safety Endpoint: Percentage of Subjects With Unsolicited AEs
timeFrame: Day 1 to Day 366
measure: 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.
timeFrame: Day 1 to Day 366
measure: Safety Endpoint: Percentage of Subjects With Diagnosis of Failure to Thrive or Short Stature
timeFrame: Day 1 to Day 366
measure: Safety Endpoint: Percentage of Subjects With Otitis Media, or Pneumonia, or Influenza-like Illness
timeFrame: Day 1 to Day 366
measure: 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
timeFrame: Day 22, Day 181
measure: 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
timeFrame: Day 22, Day 181
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Investigational Site- 001
state: Etelä-Suomen Lääni
city: Helsinki
country: Finland
facility: Investigational Site- 002
state: Etelä-Suomen Lääni
city: Helsinki
country: Finland
facility: Investigational Site- 003
state: Etelä-Suomen Lääni
city: Järvenpää
country: Finland
facility: Investigational Site- 004
state: Etelä-Suomen Lääni
city: Kokkola
country: Finland
facility: Investigational Site- 005
state: Länsi-Suomen Lääni
city: Pori
country: Finland
facility: Investigational Site- 007
state: Länsi-Suomen Lääni
city: Tampere
country: Finland
facility: Investigational Site- 009
state: Länsi-Suomen Lääni
city: Turku
country: Finland
facility: Investigational Site- 010
state: Länsi-Suomen Lääni
city: Oulu
country: Finland
facility: Investigational Site- 006
city: Laguna
country: Philippines
facility: Investigational Site- 303
state: Matro Manila
city: Muntinlupa
country: Philippines
facility: Investigational Site- 304
state: National Capital Region
city: Muntinlupa
country: Philippines
facility: Investigational Site- 305
state: National Capital Region
city: Cavite
country: Philippines
facility: Investigational Site- 306
city: Pathum Thani
country: Thailand
facility: Investigational Site- 325
state: Bangkok
city: Bangkok
country: Thailand
facility: Investigational Site- 327
state: Krung Thep Maha Nakhon [Bangko
city: Bangkok
country: Thailand
facility: Investigational Site- 320
state: Samut Prakan
city: Bangkok
country: Thailand
facility: Investigational Site- 323
Study officials:
affiliation: Seqirus
name: Clinical Program Director
role: STUDY_DIRECTOR
References: