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)

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02583256
• Date of registration: 16/10/2015
• Prospective Registration: Yes
• Primary sponsor: Seqirus
• Public 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)
• Scientific 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)
• Date of first enrolment: January 29, 2016
• Target sample size: 1601
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02583256
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Finland, Philippines, Thailand, United States

Contacts

• Name: Clinical Program Director
• Affiliation: Seqirus

Key inclusion & exclusion 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.



Age minimum: 12 Months
Age maximum: 7 Years
Gender: All

Health Condition(s) or Problem(s) studied

Influenza

Intervention(s)

Biological: Non-adjuvanted QIV

Biological: Adjuvanted QIV (aQIV)

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

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]

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]

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

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]

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]

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

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]

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

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]

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]

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]

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]

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]

Safety Endpoint: Percentage of Subjects With Solicited AEs [Time Frame: Day 1 to Day 7 after vaccination]

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]

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]

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]

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]

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

Safety Endpoint: Percentage of Subjects With Unsolicited AEs [Time Frame: Day 1 to Day 366]

Secondary ID(s)

2015-002973-39

V118_05E3

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/04/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02583256