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

NCT02255409 | Completed Phase 3 Results

• 2 other identifiers: V118_05E12014-002599-95
• Study Type: interventional
• Target: 607
• Locations: 2 countries
• Sites: 28

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

Conditions

Influenza

Outcome Measures

Primary Outcomes (3)

• Safety Endpoint: Number of Subjects With SAEs, AEs Leading to Withdrawal From the Study, NOCDs, AESIs and Medically Attended AEs.

  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)

  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).

  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 Outcomes (11)

• Safety Endpoint: Number of Subjects With a Diagnosis of Failure to Thrive or Short Stature

  Day 1 through Day 366 (Day 1, Day 22, Day 181, Day 366)

• Safety Endpoint: Number of Subjects With Any Unsolicited AEs

  Day 1 through Day 22

• Safety Endpoint: Number of Subjects With Solicited Local and Systemic Adverse Events (AEs)

  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)

  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)

  Day 1, Day 181

Study Arms (2)

aQIV

EXPERIMENTAL

Adjuvanted Quadrivalent Subunit Influenza

Biological: Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV)

QIV

ACTIVE COMPARATOR

Non-Adjuvanted Quadrivalent Subunit Influenza

Biological: non-adjuvanted Quadrivalent Influenza Vaccine (QIV)

Interventions

Adjuvanted Quadrivalent Subunit Influenza Virus Vaccine (aQIV) BIOLOGICAL

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

aQIV

non-adjuvanted Quadrivalent Influenza Vaccine (QIV) BIOLOGICAL

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

QIV

Eligibility Criteria

• Age: 12 Months - 84 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• Individuals who give written informed consent, who can comply with study procedures, and who are available for follow-up

You may not qualify if:

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

Sponsors & Collaborators

• Seqirus: lead

Study Sites (28)

Unknown Facility

San Diego, California, 92103, United States

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Unknown Facility

San Gabriel, California, 91706, United States

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Colorado Springs, Colorado, 80920, United States

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Melbourne, Florida, 32935, United States

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Augusta, Kansas, 67010, United States

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Newton, Kansas, 67114, United States

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Louisville, Kentucky, 40291, United States

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Metairie, Louisiana, 70006, United States

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Bellevue, Nebraska, 68005, United States

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Binghamton, New York, 13901, United States

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Dayton, Ohio, 45406, United States

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Austin, Texas, 78705, United States

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Fort Worth, Texas, 76135, United States

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San Angelo, Texas, 76904, United States

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Tomball, Texas, 77375, United States

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Salt Lake City, Utah, 84109, United States

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Salt Lake City, Utah, 84121, United States

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Salt Lake City, Utah, 84124, United States

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West Jordan, Utah, 84088, United States

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Unknown Facility

Espoo, 02230, Finland

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Helsinki, 00100, Finland

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Unknown Facility

Helsinki, 00930, Finland

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Jarvenpaa, 04400, Finland

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Kokkola, 67100, Finland

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Pori, 28100, Finland

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Tampere, 33100, Finland

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Turku, 20520, Finland

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Vantaa, 01300, Finland

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MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Clinical Study Disclosure Manager
• Organization: Seqirus

Seqirus.ClinicalTrials@Seqirus.com

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2014
• First Posted: October 2, 2014
• Study Start: October 1, 2014
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: March 15, 2023
• Results First Posted: March 15, 2023

Record last verified: 2023-03

Locations

US (19); FI (9)