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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02255409
Recruitment Status : Completed
First Posted : October 2, 2014
Last Update Posted : October 27, 2016
Sponsor:
Information provided by (Responsible Party):
Seqirus

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

Condition or disease Intervention/treatment Phase
Influenza Biological: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) Biological: non-adjuvanted Quadrivalent Influenza Vaccine (QIV) Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 607 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: 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_0
Study Start Date : October 2014
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Evaluate antibody responses to homologous vaccine strains according to CBER criteria after one dose of either aQIV or QIV [ Time Frame: 21 days Post-vaccination ]

Secondary Outcome Measures :
  1. Evaluate antibody responses to heterologous vaccine strains according to CBER criteria after one dose of either aQIV or QIV [ Time Frame: 180 days Post-vaccination ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   12 Months to 84 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02255409


Locations
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United States, California
San Diego, California, United States, 92103
San Gabriel, California, United States, 91706
United States, Colorado
Colorado Springs, Colorado, United States, 80920
United States, Florida
Melbourne, Florida, United States, 32935
United States, Kansas
Augusta, Kansas, United States, 67010
Newton, Kansas, United States, 67114
United States, Kentucky
Louisville, Kentucky, United States, 40291
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Nebraska
Bellevue, Nebraska, United States, 68005
United States, New York
Binghamton, New York, United States, 13901
United States, Ohio
Dayton, Ohio, United States, 45406
United States, Texas
Austin, Texas, United States, 78705
Fort Worth, Texas, United States, 76135
San Angelo, Texas, United States, 76904
Tomball, Texas, United States, 77375
United States, Utah
Salt Lake City, Utah, United States, 84109
Salt Lake City, Utah, United States, 84121
Salt Lake City, Utah, United States, 84124
West Jordan, Utah, United States, 84088
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
Sponsors and Collaborators
Seqirus
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Responsible Party: Seqirus
ClinicalTrials.gov Identifier: NCT02255409    
Other Study ID Numbers: V118_05E1
2014-002599-95 ( EudraCT Number )
First Posted: October 2, 2014    Key Record Dates
Last Update Posted: October 27, 2016
Last Verified: October 2016
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs