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

NCT ID: NCT02255409

Last Updated: 2023-03-15

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

607 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2016-01-31

Brief Summary

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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

Detailed Description

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Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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aQIV

Adjuvanted Quadrivalent Subunit Influenza

Group Type EXPERIMENTAL

Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

Intervention Type BIOLOGICAL

1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months

QIV

Non-Adjuvanted Quadrivalent Subunit Influenza

Group Type ACTIVE_COMPARATOR

non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Intervention Type BIOLOGICAL

1 dose 0.25 ml: ≥6 months to \<36 months, 0.5 ml: ≥36 months to \<72 months

Interventions

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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

Intervention Type 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

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

12 Months

Maximum Eligible Age

84 Months

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seqirus

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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San Diego, California, United States

Site Status

San Gabriel, California, United States

Site Status

Colorado Springs, Colorado, United States

Site Status

Melbourne, Florida, United States

Site Status

Augusta, Kansas, United States

Site Status

Newton, Kansas, United States

Site Status

Louisville, Kentucky, United States

Site Status

Metairie, Louisiana, United States

Site Status

Bellevue, Nebraska, United States

Site Status

Binghamton, New York, United States

Site Status

Dayton, Ohio, United States

Site Status

Austin, Texas, United States

Site Status

Fort Worth, Texas, United States

Site Status

San Angelo, Texas, United States

Site Status

Tomball, Texas, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Salt Lake City, Utah, United States

Site Status

Salt Lake City, Utah, United States

Site Status

West Jordan, Utah, United States

Site Status

Espoo, , Finland

Site Status

Helsinki, , Finland

Site Status

Helsinki, , Finland

Site Status

Järvenpää, , Finland

Site Status

Kokkola, , Finland

Site Status

Pori, , Finland

Site Status

Tampere, , Finland

Site Status

Turku, , Finland

Site Status

Vantaa, , Finland

Site Status

Countries

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United States Finland

Other Identifiers

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2014-002599-95

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

V118_05E1

Identifier Type: -

Identifier Source: org_study_id

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