Clinical Study to Evaluate Safety, Immunogenicity of Investigational Flu Vaccine Compared to an Approved Flu Vaccine (QIV) in Children Previously Vaccinated in Trial V118_05

March 6, 2023 updated by: Seqirus

A Phase III, Randomized, Observer Blind, Multicenter Study to Evaluate the Safety and Immunogenicity of Repeated Exposure to an Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV), Administered to Subjects Previously Vaccinated in Trial V118_05

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
607

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Espoo, Finland, 02230
      • Helsinki, Finland, 00100
      • Helsinki, Finland, 00930
      • Järvenpää, Finland, 04400
      • Kokkola, Finland, 67100
      • Pori, Finland, 28100
      • Tampere, Finland, 33100
      • Turku, Finland, 20520
      • Vantaa, Finland, 01300
  • United States
    • California
      • San Diego, California, United States, 92103
      • San Gabriel, California, United States, 91706
    • Colorado
      • Colorado Springs, Colorado, United States, 80920
    • Florida
      • Melbourne, Florida, United States, 32935
    • Kansas
      • Augusta, Kansas, United States, 67010
      • Newton, Kansas, United States, 67114
    • Kentucky
      • Louisville, Kentucky, United States, 40291
    • Louisiana
      • Metairie, Louisiana, United States, 70006
    • Nebraska
      • Bellevue, Nebraska, United States, 68005
    • New York
      • Binghamton, New York, United States, 13901
    • Ohio
      • Dayton, Ohio, United States, 45406
    • Texas
      • Austin, Texas, United States, 78705
      • Fort Worth, Texas, United States, 76135
      • San Angelo, Texas, United States, 76904
      • Tomball, Texas, United States, 77375
    • Utah
      • Salt Lake City, Utah, United States, 84121
      • Salt Lake City, Utah, United States, 84109
      • Salt Lake City, Utah, United States, 84124
      • West Jordan, Utah, United States, 84088

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

1 year to 7 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Male or female subject who has completed their Day 181 clinic visit for non-naïve subjects or their Day 209 clinic visit for naïve subjects in parent study.
  2. Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up

Exclusion Criteria:

  1. Individuals recently vaccinated against influenza.
  2. Subjects with contraindications to receive influenza vaccine.
  3. Please contact the site for additional eligibility criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: aQIV
Adjuvanted Quadrivalent Subunit Influenza
Biological: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)
1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months
Active Comparator: QIV
Non-Adjuvanted Quadrivalent Subunit Influenza
Biological: non-adjuvanted Quadrivalent Influenza Vaccine (QIV)
1 dose 0.25 ml: ≥6 months to <36 months, 0.5 ml: ≥36 months to <72 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.
Time Frame: Day 1 through Day 356
Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator): serious adverse events (SAEs), AEs leading to study withdrawal, new onset chronic disease (NOCDs), adverse events of special interest (AESIs) and medically attended AEs after vaccination.
Day 1 through Day 356
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 22)
Time Frame: Day 1, Day 22
The percentage of subjects achieving seroconversion at Day 22 after vaccination is reported for homologous strains; Seroconversion is defined as hemagglutination inhibition (HI) ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Day 1, Day 22
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and and Differences in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 22).
Time Frame: Day 1, Day 22
The percentage of subjects achieving HI titer ≥1:40 at Day 22 after vaccination is reported for homologous strains. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Day 1, Day 22

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature
Time Frame: Day 1 through Day 366 (Day 1, Day 22, Day 181, Day 366)
Short stature was defined as a height/length that was 2 or more standard deviations below the mean for age and gender within a population and was assessed as being below the 2nd z-score (worse outcome) on the length/height-for-age scale. Failure-to-thrive was defined by inadequate weight gain and physical growth and assessed through 2 or more of the following criteria: height/length-for-age, weight-for-age or weight-for-height/length below the 2nd z-score, a child's growth line crossing a z-score line, a sharp change in growth curve or a curve that remains flat. The observations were made for 2 or more time points each divided by at least 2 months.
Day 1 through Day 366 (Day 1, Day 22, Day 181, Day 366)
Safety Endpoint: Number of Subjects With Any Unsolicited AEs
Time Frame: Day 1 through Day 22
Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting unsolicited events up to 12 months after last vaccination with either aQIV or QIV (comparator).
Day 1 through Day 22
Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)
Time Frame: Up to 7 days following vaccination
Safety was assessed in terms of number of subjects between 12 months and 7 years of age reporting solicited local and systemic AEs, day 1 to day 7 after vaccination with either aQIV or QIV (comparator).
Up to 7 days following vaccination
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Differences in Percentage of Subjects Achieving Seroconversion for Homologous Influenza Strains (Day 181)
Time Frame: Day 1, Day 181
The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab.
Day 1, Day 181
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Homologous Influenza Strains (Day 181)
Time Frame: Day 1, Day 181
The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Day 1, Day 181
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) and GMT Ratios for Homologous Influenza Strains (Day 1, Day 22, Day 181)
Time Frame: Day 1, Day 22, Day 181
Adjusted GMT, GMR and 95% confidence interval (CI) were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Day 1, Day 22, Day 181
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Homologous Influenza Strains
Time Frame: Day 1, Day 22, and Day 181
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H1N1 is Influenza A H1N1 California/7/2009 Egg Ab; A/H3N2 is Influenza A H3N2 Texas/50/2012 Ab; B/Yamagata is Influenza B Massachusetts/2/2012 Ab; B/Victoria is Influenza B Brisbane/60/2008 Egg Ab
Day 1, Day 22, and Day 181
Immunogenicity Endpoint: Percentage of Subjects Achieving Seroconversion and Difference in Percentage of Subjects Achieving Seroconversion for Heterologous Influenza Strains (Day 181)
Time Frame: Day 1, Day 181
The percentage of subjects achieving seroconversion at Day 181 after vaccination is reported for homologous strains. Seroconversion is defined as HI ≥1:40 for subjects negative at baseline [<1:10]; or a minimum 4-fold increase in HI titer for subjects positive at baseline [HI ≥1:10]; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Day 1, Day 181
Immunogenicity Endpoint: Percentage of Subjects Achieving HI Titer ≥ 1:40 and Difference in Percentage of Subjects Achieving HI Titer ≥ 1:40 for Heterologous Influenza Strains (Day 181)
Time Frame: Day 1, Day 181
The percentage of subjects achieving HI titer ≥1:40 at Day 181 after vaccination is reported for homologous strains; Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Day 1, Day 181
Immunogenicity Endpoint: Geometric Mean HI Titers (GMTs) for Heterologous Influenza Strains (Day 1, Day 22, Day 181)
Time Frame: Day 1, Day 22, Day 181
Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Day 1, Day 22, Day 181
Immunogenicity Endpoint: Geometric Mean Ratios (GMR) for Heterologous Influenza Strains
Time Frame: Day 1, Day 22, and Day 181
The GMR is the geometric mean of the fold increase in HI titer from Day 1 to Day 22 or Day 181. Adjusted GMT, GMR and 95% CI were analyzed using ANCOVA with study specific covariates. Strains tested: A/H3N2 is Influenza A H3N2 Hong Kong/2014 Ab; B/Yamagata is Influenza B Phuket/2013 Ab
Day 1, Day 22, and Day 181

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Seqirus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 29, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 2, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 15, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 6, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • V118_05E1
  • 2014-002599-95 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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