NCT02583256

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,601

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2016

Shorter than P25 for phase_3

Geographic Reach
3 countries

17 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 16, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 22, 2015

Completed
3 months until next milestone

Study Start

First participant enrolled

January 29, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 9, 2017

Completed
2 years until next milestone

Results Posted

Study results publicly available

April 24, 2019

Completed
Last Updated

April 24, 2019

Status Verified

April 1, 2019

Enrollment Period

10 months

First QC Date

October 16, 2015

Results QC Date

February 25, 2019

Last Update Submit

April 23, 2019

Conditions

Influenza

Keywords

Influenza VaccineMF59 adjuvant

Outcome Measures

Primary Outcomes (2)

  • 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.

    Day 22

  • 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.

    Day 22

Secondary Outcomes (20)

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

    Day 22

  • Immunogenicity Endpoint: GMT and GMT Ratio as Determined by HI Assay on Day 181 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)

    Day 181

  • Immunogenicity Endpoint: Seroconversion Rate (SCR) on Day 22 Against Homologous Strains (aQIV-primed and QIV-primed Comparison)

    Day 1, Day 22

  • 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

    Day 22, Day 181

  • Immunogenicity Endpoint: Percentage of Subjects With HI Titer ≥1:40 on Day 22 and Day 181 Against Homologous Strains

    Day 22, Day 181

  • +15 more secondary outcomes

Study Arms (4)

aQIV/aQIV

EXPERIMENTAL

Subjects previously vaccinated with aQIV followed one year later by aQIV

Biological: Adjuvanted QIV (aQIV)

aQIV/QIV

EXPERIMENTAL

Subjects previously vaccinated with aQIV followed one year later by QIV

Biological: Non-adjuvanted QIV

QIV/aQIV

EXPERIMENTAL

Subjects previously vaccinated with QIV followed one year later by aQIV

Biological: Adjuvanted QIV (aQIV)

QIV/QIV

EXPERIMENTAL

Subjects previously vaccinated with QIV followed one year later by QIV

Biological: Non-adjuvanted QIV

Interventions

Adjuvanted QIV (aQIV)BIOLOGICAL

Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

QIV/aQIVaQIV/aQIV
Non-adjuvanted QIVBIOLOGICAL

Non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

QIV/QIVaQIV/QIV

Eligibility Criteria

Age12 Months - 7 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (17)

Investigational Site- 001

Espoo, Etelä-Suomen Lääni, 02230, Finland

Location

Investigational Site- 002

Helsinki, Etelä-Suomen Lääni, 00100, Finland

Location

Investigational Site- 003

Helsinki, Etelä-Suomen Lääni, 00100, Finland

Location

Investigational Site- 004

Jarvenpaa, Etelä-Suomen Lääni, 04400, Finland

Location

Investigational Site- 005

Kokkola, Länsi-Suomen Lääni, 67100, Finland

Location

Investigational Site- 007

Pori, Länsi-Suomen Lääni, 28100, Finland

Location

Investigational Site- 009

Tampere, Länsi-Suomen Lääni, 33100, Finland

Location

Investigational Site- 010

Turku, Länsi-Suomen Lääni, 20520, Finland

Location

Investigational Site- 006

Oulu, 90220, Finland

Location

Investigational Site- 303

Laguna, Matro Manila, 1781, Philippines

Location

Investigational Site- 304

Muntinlupa, National Capital Region, 1781, Philippines

Location

Investigational Site- 305

Muntinlupa, National Capital Region, 1781, Philippines

Location

Investigational Site- 306

Cavite, 4114, Philippines

Location

Investigational Site- 325

Pathum Thani, Bangkok, 12120, Thailand

Location

Investigational Site- 320

Bangkok, Changwat Samut Prakan, 10400, Thailand

Location

Investigational Site- 327

Bangkok, Krung Thep Maha Nakhon [Bangko, 10400, Thailand

Location

Investigational Site- 323

Bangkok, 10330, Thailand

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Seqirus Clinical Trial Disclosure Manager
Organization
Seqirus
Seqirus.ClinicalTrials@Seqirus.com
Phone: 1-855-358-8966

Study Officials

  • Clinical Program Director

    Seqirus

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 16, 2015

First Posted

October 22, 2015

Study Start

January 29, 2016

Primary Completion

November 15, 2016

Study Completion

May 9, 2017

Last Updated

April 24, 2019

Results First Posted

April 24, 2019

Record last verified: 2019-04

Locations

FI(9)PH(4)TH(4)