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Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

Primary Purpose

Influenza, Human, Virus Diseases

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
QIVc
Comparator QIV
Sponsored by
Seqirus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza focused on measuring Influenza, RNA Virus, WHO Strains

Eligibility Criteria

6 Months - 47 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Individuals of 6 through 47 months of age on the day of informed consent.
  • Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry.
  • Individuals who can comply with study procedures including follow-up
  • Individual is in generally good health as per the Investigator's medical judgement

Exclusion Criteria:

  • Acute (severe) febrile illness
  • History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study
  • A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis
  • Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study
  • Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.

Sites / Locations

  • 84035 CCR Research
  • 84040 Southland Clnical Research Center
  • 84044 Premier Health Research Center
  • 84028 Orange County Research Institute
  • 84029 Center for Clinical Trials
  • 84012 Benchmark Research
  • 84006 California Research Foundation
  • 84001 Acevedo Clincal Research Associates
  • 84005 Sunshine Research Center
  • 84052 Tekton Research
  • 84036 Advanced Clinical Research
  • 84027 Heartland Research Associates
  • 84020 Heartland Research Associates
  • 84014 Heartland Research Associates
  • 84026 Heartland Research Associates
  • 84041 Kentucky Pediatric/ Adult Research
  • 84009 Bluegrass Clinical Research Inc.
  • 84008 Meridian Clinical Research
  • 84046 ACC Pediatric Research
  • 84004 Benchmark Research
  • 84022 Med Pharmics
  • 84053 MedPharmics
  • 84051 Office of Craig A. Spiegel
  • 84016 Center for Pharmaceutical Research
  • 84037 Meridian Clinical Research
  • 84017 Meridian Clinical Research
  • 84033 Med Pharmics
  • 84013 Regional Clinical Research
  • 84045 Dayton Clinical
  • 84003 PriMed Clinical Research
  • 84015 Meridian Clinical Research
  • 84032 Clinical Research Associates
  • 84007 Benchmark Research
  • 84023 Ventavia Research Group
  • 84042 Universtiy of North Texas Health Science Center
  • 84043 Benchmark Research
  • 84047 Ventavia Research Group
  • 84011 West Houston Clinical Research
  • 84019 Ventavia Research Group
  • 84021 Benchmark Research
  • 84002 Tekton Research
  • 84025 Pediatric Healthcare of NW Houston
  • 84018 Tanner Clinic
  • 84050 JBR Clinical Research Group
  • 84048 J. Lewis Research/Foothill Family Clinic South
  • 84031 Advanced Clinical Research
  • 84039 Pediatric Research of Charlottesville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

QIVc

Comparator QIV

Arm Description

Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains

Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains

Outcomes

Primary Outcome Measures

Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HAI) Assay Using Cell-derived Target Viruses
The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc.
Immunogenicity Endpoint: Seroconversion Rates (SCR) and Differences in SCR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived Target Viruses
The SCR is defined as the percentage of subjects with either a prevaccination HAI titer <1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in postvaccination HAI titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses
The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) MN titer for the Comparator QIV divided by the geometric mean of the postvaccination MN titer for QIVc.
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses
The SCR is defined as the percentage of subjects with either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.

Secondary Outcome Measures

Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses
The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc.
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H1N1, B/Victoria and B/ Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses
The SCR is defined as the percentage of subjects with either a prevaccination HAI titer <1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in postvaccination HAI titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses
The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) MN titer for the Comparator QIV divided by the geometric mean of the postvaccination MN titer for QIVc.
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses
The SCR is defined as the percentage of subjects with either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived and Egg-derived Target Viruses
GMR is defined as the geometric mean of the (within-subject) fold increase in serum HAI GMT postvaccination (Day 29/57) compared to prevaccination (Day 1).
Immunogenicity Endpoint: GMR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived and Egg-derived Target Viruses
GMR is defined as the geometric mean of the (within-subject) fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1).
Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses
GMR is defined as the geometric mean of the (within-subject) fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1).
Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs)
The percentage of subjects with at least one solicited AE Day 1 through Day 7 after any study vaccination.
Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs
The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29 for previously vaccinated subjects and from Day 1 to Day 57 for not previously vaccinated subjects. Related AEs = considered at least possibly related to study vaccination by the investigator; Severity = based on the greatest severity associated with a preferred term for a reported AE.
Safety Endpoint: Percentage of Subjects With Any Serious Adverse Events (SAEs), New Onset of Chronic Disease (NOCD) or AEs Leading to Withdrawal During the Entire Study Period
The percentage of subjects with any SAE, NOCD or AE leading to withdrawal during the study period from Day 1 to Day 181 for previously vaccinated subjects or from Day 1 to Day 209 for not previously vaccinated subjects. Definitions: SAEs = AEs defined as any untoward medical occurrence that at any dose resulted in one or more of the following: 1. Death, 2. Life-threatening 3. Required/prolonged hospitalization 4. Persistent or significant disability/incapacity 5. congenital anomaly/or birth defect 6. An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based on appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above

Full Information

First Posted
August 27, 2019
Last Updated
December 13, 2021
Sponsor
Seqirus
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1. Study Identification

Unique Protocol Identification Number
NCT04074928
Brief Title
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
Official Title
A Phase 3, Randomized, Observer-Blind, Multicenter, Noninferiority Study to Evaluate Safety and Immunogenicity of a Cell-Based Quadrivalent Subunit Influenza Virus Vaccine (QIVc) and a United States Licensed Quadrivalent Influenza Virus Vaccine (QIV) in Healthy Subjects 6 Months Through 47 Months
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
September 6, 2019 (Actual)
Primary Completion Date
September 3, 2020 (Actual)
Study Completion Date
September 3, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seqirus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This phase 3 clinical study is a randomized, observer-blind, comparator-controlled, multicenter study of QIVc versus a US-licensed comparator QIV in children 6 months through 47 months of age. The purpose of this study is to demonstrate that vaccination with QIVc elicits an immune response that is noninferior to that of a US-licensed comparator QIV containing the same virus strains, in children 6 months through 47 months of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Virus Diseases
Keywords
Influenza, RNA Virus, WHO Strains

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
The trial is designed as an observer-blind study. During the treatment period of the study designated unblinded nurse(s), physician(s), or other qualified health care professional will be responsible for administering the study vaccine to the subjects.
Allocation
Randomized
Enrollment
2414 (Actual)

8. Arms, Groups, and Interventions

Arm Title
QIVc
Arm Type
Experimental
Arm Description
Cell-derived Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Arm Title
Comparator QIV
Arm Type
Active Comparator
Arm Description
Comparator Quadrivalent Influenza Vaccine containing 2 influenza type A strains and 2 influenza type B strains
Intervention Type
Biological
Intervention Name(s)
QIVc
Other Intervention Name(s)
Flucelvax Quadrivalent
Intervention Description
Previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1; not previously vaccinated subjects received a 0.5 mL intramuscular dose of QIVc on Day 1 and Day 29.
Intervention Type
Biological
Intervention Name(s)
Comparator QIV
Other Intervention Name(s)
Afluria Quadrivalent
Intervention Description
Previously vaccinated subjects received a dose of Comparator QIV on Day 1; not previously vaccinated subjects received a dose of Comparator QIV on Day 1 and Day 29. Subjects 6 months through 35 months of age received a 0.25 mL intramuscular dose of Comparator QIV; subjects 36 months through 47 months of age received a 0.5 mL intramuscular dose of Comparator QIV.
Primary Outcome Measure Information:
Title
Immunogenicity Endpoint: Geometric Mean Titer (GMT) and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by Hemagglutination Inhibition (HAI) Assay Using Cell-derived Target Viruses
Description
The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc.
Time Frame
Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects
Title
Immunogenicity Endpoint: Seroconversion Rates (SCR) and Differences in SCR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived Target Viruses
Description
The SCR is defined as the percentage of subjects with either a prevaccination HAI titer <1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in postvaccination HAI titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.
Time Frame
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Title
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by Microneutralization (MN) Assay Using Cell-derived Target Viruses
Description
The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) MN titer for the Comparator QIV divided by the geometric mean of the postvaccination MN titer for QIVc.
Time Frame
Day 29 for previously vaccinated subjects; Day 57 for not previously vaccinated subjects
Title
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived Target Viruses
Description
The SCR is defined as the percentage of subjects with either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.
Time Frame
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Secondary Outcome Measure Information:
Title
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses
Description
The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) HAI titer for the Comparator QIV divided by the geometric mean of the postvaccination HAI titer for QIVc.
Time Frame
Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Title
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H1N1, B/Victoria and B/ Yamagata Vaccine Strains by HAI Assay Using Egg-derived Target Viruses
Description
The SCR is defined as the percentage of subjects with either a prevaccination HAI titer <1:10 and a postvaccination HAI titer ≥1:40, or a prevaccination HAI titer ≥1:10 and a ≥4-fold increase in postvaccination HAI titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.
Time Frame
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Title
Immunogenicity Endpoint: GMT and GMT Ratio Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses
Description
The GMT ratio is defined as the geometric mean of the postvaccination (28 days after last vaccination) MN titer for the Comparator QIV divided by the geometric mean of the postvaccination MN titer for QIVc.
Time Frame
Day 1 and Day 29 for previously vaccinated subjects; Day 1 and Day 57 for not previously vaccinated subjects
Title
Immunogenicity Endpoint: SCR and Difference in SCR Against the A/H3N2 Vaccine Strain by MN Assay Using Egg-derived Target Viruses
Description
The SCR is defined as the percentage of subjects with either a prevaccination MN titer <1:10 and a postvaccination MN titer ≥1:40, or a prevaccination MN titer ≥1:10 and a ≥4-fold increase in postvaccination MN titer. The SCR difference is defined as the Comparator QIV SCR minus the QIVc SCR.
Time Frame
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Title
Immunogenicity Endpoint: Geometric Mean Ratio (GMR) Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by HAI Assay Using Cell-derived and Egg-derived Target Viruses
Description
GMR is defined as the geometric mean of the (within-subject) fold increase in serum HAI GMT postvaccination (Day 29/57) compared to prevaccination (Day 1).
Time Frame
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Title
Immunogenicity Endpoint: GMR Against the A/H1N1, B/Victoria and B/Yamagata Vaccine Strains by MN Assay Using Cell-derived and Egg-derived Target Viruses
Description
GMR is defined as the geometric mean of the (within-subject) fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1).
Time Frame
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Title
Immunogenicity Endpoint: GMR Against the A/H3N2 Vaccine Strain by MN Assay Using Cell-derived and Egg-derived Target Viruses
Description
GMR is defined as the geometric mean of the (within-subject) fold increase in serum MN GMT postvaccination (Day 29/57) compared to prevaccination (Day 1).
Time Frame
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Title
Safety Endpoint: Percentage of Subjects With Solicited Adverse Events (AEs)
Description
The percentage of subjects with at least one solicited AE Day 1 through Day 7 after any study vaccination.
Time Frame
Day 1 to Day 7 after each vaccination (Day 1 to Day 7 for previously vaccinated subjects; Day 1 to Day 7 and Day 29 to Day 35 for not previously vaccinated subjects)
Title
Safety Endpoint: Percentage of Subjects With Any Unsolicited AEs
Description
The percentage of subjects with at least one unsolicited AE from Day 1 to Day 29 for previously vaccinated subjects and from Day 1 to Day 57 for not previously vaccinated subjects. Related AEs = considered at least possibly related to study vaccination by the investigator; Severity = based on the greatest severity associated with a preferred term for a reported AE.
Time Frame
Day 1 to Day 29 for previously vaccinated subjects; Day 1 to Day 57 for not previously vaccinated subjects
Title
Safety Endpoint: Percentage of Subjects With Any Serious Adverse Events (SAEs), New Onset of Chronic Disease (NOCD) or AEs Leading to Withdrawal During the Entire Study Period
Description
The percentage of subjects with any SAE, NOCD or AE leading to withdrawal during the study period from Day 1 to Day 181 for previously vaccinated subjects or from Day 1 to Day 209 for not previously vaccinated subjects. Definitions: SAEs = AEs defined as any untoward medical occurrence that at any dose resulted in one or more of the following: 1. Death, 2. Life-threatening 3. Required/prolonged hospitalization 4. Persistent or significant disability/incapacity 5. congenital anomaly/or birth defect 6. An important and significant medical event that may not be immediately life threatening or resulting in death or hospitalization but, based on appropriate medical judgment, may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above
Time Frame
Day 1 to Day 181 for previously vaccinated subjects; Day 1 to Day 209 for not previously vaccinated subjects

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
47 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Individuals of 6 through 47 months of age on the day of informed consent. Individuals whose parent(s)/Legally Acceptable Representative (LAR) have voluntarily given written informed consent after the nature of the study has been explained according to local regulatory requirements, prior to study entry. Individuals who can comply with study procedures including follow-up Individual is in generally good health as per the Investigator's medical judgement Exclusion Criteria: Acute (severe) febrile illness History of any anaphylaxis, serious vaccine reactions or hypersensitivity, including allergic reactions, to any component of vaccine or medical equipment whose use is foreseen in this study A known history of Guillain-Barre Syndrome or other demyelinating diseases such as encephalomyelitis and transverse myelitis Any other clinical condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subject due to participation in the study Received influenza vaccination or has had documented influenza disease in the last 6 months prior to informed consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Program Director
Organizational Affiliation
Seqirus
Official's Role
Study Director
Facility Information:
Facility Name
84035 CCR Research
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
84040 Southland Clnical Research Center
City
Anaheim
State/Province
California
ZIP/Postal Code
92804
Country
United States
Facility Name
84044 Premier Health Research Center
City
Downey
State/Province
California
ZIP/Postal Code
90240
Country
United States
Facility Name
84028 Orange County Research Institute
City
Ontario
State/Province
California
ZIP/Postal Code
91763
Country
United States
Facility Name
84029 Center for Clinical Trials
City
Paramount
State/Province
California
ZIP/Postal Code
90723
Country
United States
Facility Name
84012 Benchmark Research
City
Sacramento
State/Province
California
ZIP/Postal Code
95864
Country
United States
Facility Name
84006 California Research Foundation
City
San Diego
State/Province
California
ZIP/Postal Code
92123-1881
Country
United States
Facility Name
84001 Acevedo Clincal Research Associates
City
Miami
State/Province
Florida
ZIP/Postal Code
33142
Country
United States
Facility Name
84005 Sunshine Research Center
City
Opa-locka
State/Province
Florida
ZIP/Postal Code
33054
Country
United States
Facility Name
84052 Tekton Research
City
Chamblee
State/Province
Georgia
ZIP/Postal Code
30341
Country
United States
Facility Name
84036 Advanced Clinical Research
City
Meridian
State/Province
Idaho
ZIP/Postal Code
83642
Country
United States
Facility Name
84027 Heartland Research Associates
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
84020 Heartland Research Associates
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
84014 Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
84026 Heartland Research Associates
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
84041 Kentucky Pediatric/ Adult Research
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
84009 Bluegrass Clinical Research Inc.
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Facility Name
84008 Meridian Clinical Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
84046 ACC Pediatric Research
City
Haughton
State/Province
Louisiana
ZIP/Postal Code
71037
Country
United States
Facility Name
84004 Benchmark Research
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
84022 Med Pharmics
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
84053 MedPharmics
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39503
Country
United States
Facility Name
84051 Office of Craig A. Spiegel
City
Bridgeton
State/Province
Missouri
ZIP/Postal Code
63044
Country
United States
Facility Name
84016 Center for Pharmaceutical Research
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
84037 Meridian Clinical Research
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
84017 Meridian Clinical Research
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68116
Country
United States
Facility Name
84033 Med Pharmics
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
84013 Regional Clinical Research
City
Binghamton
State/Province
New York
ZIP/Postal Code
13901
Country
United States
Facility Name
84045 Dayton Clinical
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
84003 PriMed Clinical Research
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45419
Country
United States
Facility Name
84015 Meridian Clinical Research
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
Country
United States
Facility Name
84032 Clinical Research Associates
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
84007 Benchmark Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
84023 Ventavia Research Group
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
84042 Universtiy of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
84043 Benchmark Research
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76135
Country
United States
Facility Name
84047 Ventavia Research Group
City
Houston
State/Province
Texas
ZIP/Postal Code
77008
Country
United States
Facility Name
84011 West Houston Clinical Research
City
Houston
State/Province
Texas
ZIP/Postal Code
77055
Country
United States
Facility Name
84019 Ventavia Research Group
City
Keller
State/Province
Texas
ZIP/Postal Code
76248
Country
United States
Facility Name
84021 Benchmark Research
City
San Angelo
State/Province
Texas
ZIP/Postal Code
76904
Country
United States
Facility Name
84002 Tekton Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78240
Country
United States
Facility Name
84025 Pediatric Healthcare of NW Houston
City
Tomball
State/Province
Texas
ZIP/Postal Code
77375
Country
United States
Facility Name
84018 Tanner Clinic
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Facility Name
84050 JBR Clinical Research Group
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
84048 J. Lewis Research/Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
84031 Advanced Clinical Research
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
84039 Pediatric Research of Charlottesville
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22902
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36214072
Citation
Essink BJ, Heeringa M, Jeanfreau RJ, Finn D, Matassa V, Edelman J, Hohenboken M, Molrine D. Safety and Immunogenicity of Cell-Based Quadrivalent Influenza Vaccine: A Randomized Trial. Pediatrics. 2022 Nov 1;150(5):e2022057509. doi: 10.1542/peds.2022-057509.
Results Reference
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Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects

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