Safety and Immunogenicity of Three Influenza Vaccines in Children Aged 4 Years Old to Less Than 18 Years Old

NCT01992107 | Completed Phase 3 Results

• 1 other identifier: V130_03
• Study Type: interventional
• Target: 2,333
• Locations: 1 country
• Sites: 88

Brief Summary

Evaluate safety and immunogenicity of three influenza vaccines in children ages greater than 4 years old to less than 18 years old.

Conditions

Influenza

Keywords

Influenza; Influenza vaccine; Novartis; children

Outcome Measures

Primary Outcomes (2)

• Geometric Mean Titre (GMT) in Subjects After Receiving One or Two Doses of Either QIVc, TIV1c or TIV2c

  Immunogenicity of QIVc to comparator TIV1c (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of GMT in subjects (Previously vaccinated and Not previously vaccinated) measured by hemagglutination inhibition (HI) assay, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c. Non-inferiority was established if the upper bound of the two-sided 95% confidence interval (CI) for the ratio of GMTs (GMT TIV1c or TIV2c /GMT QIVc) for HI antibody does not exceed the non-inferiority margin of 1.5.

  Day 1,Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

• Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c

  Immunogenicity of QIVc to comparator TIVc (For A/H1N1, A/H3N2 and B1 strain, the comparison was between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison was between QIVc and TIV2c) was assessed in terms of number (%) of subjects (Previously vaccinated and Not previously vaccinated) showing seroconversion or significant increase (at least a 4-fold increase in HI titer in subjects seropositive at baseline \[i.e., HI titer ≥1:10 at Day 1\] ) in HI antibody titers, three weeks after last vaccination with one or two doses of either QIVc, TIV1c or TIV2c Seroconversion was defined in subjects seronegative at baseline (i.e., HI titer \<1:10 at Day 1) as postvaccination HI titer ≥1:40, and defined in subjects seropositive at baseline (i.e., HI titer ≥1:10 at Day 1) as a minimum of a 4-fold increase in post-vaccination HI titer.

  Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Secondary Outcomes (11)

• Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years

  Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

• Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years

  Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

• Percentages of Subjects Achieving Seroconversion After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years

  Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

• Percentages of Subjects Achieving HI Titer ≥1:40 After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years

  Day 1, Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

• Geometric Mean Ratios (GMR) in Subjects After One or Two Doses of Either QIVc, TIV1c or TIV2c in ≥4 to <18 Years Age

  Three weeks post vaccination (Day 22 for previously vaccinated and Day 50 for Not previously vaccinated subjects)

Study Arms (3)

QIVc (≥4 to <18 years)

EXPERIMENTAL

Subjects received one or two doses of QIVc-Quadrivalent Cell-based Influenza Vaccine recommended for 2013-2014 season

Biological: QIVc

TIV1c (≥4 to <18 years)

ACTIVE COMPARATOR

Subjects received one or two doses of TIV1c (Trivalent Inactivated Cell-based Influenza Vaccine containing one strain from B lineage ("B1" strain) recommended for 2013-2014 season

Biological: TIV1c

TIV2c (≥4 to <18 years)

ACTIVE COMPARATOR

Subjects received one or two doses of TIV2c (Trivalent Inactivated Cell-based Influenza Vaccine containing B strain from the alternate lineage ("B2" strain) recommended for 2013-2014

Biological: TIV2c

Interventions

QIVc BIOLOGICAL

Novartis Investigational Quadrivalent Vaccine

QIVc (≥4 to <18 years)

TIV1c BIOLOGICAL

Licensed Influenza Vaccine

TIV1c (≥4 to <18 years)

TIV2c BIOLOGICAL

Novartis Investigational Vaccine

TIV2c (≥4 to <18 years)

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Male or female aged 4 years to less than 18 years of age.
• Individual who had a parent or guardian who could give written informed consent after understanding the nature of the study and comply with study procedures and were available for follow-up.
• If the individual was of an age where, according to local regulations, informed assent is required, that individual had provided assent to participate in the study.

You may not qualify if:

• Individuals recently vaccinated against influenza
• Subjects with contraindications to receive influenza vaccine

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (88)

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Huntsville, Alabama, 35802, United States

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Mobile, Alabama, 36608, United States

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Chandler, Arizona, 85224, United States

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Mesa, Arizona, 85206, United States

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Mesa, Arizona, 85213, United States

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Harrisburg, Arkansas, 72452, United States

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Jonesboro, Arkansas, 72401, United States

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Anaheim, California, 92801, United States

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Anaheim, California, 92804, United States

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Downey, California, 90241, United States

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Garden Grove, California, 92844, United States

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Modesto, California, 95350, United States

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Paramount, California, 90723, United States

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Sacramento, California, 95816, United States

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San Diego, California, 92103-6204, United States

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San Francisco, California, 94102, United States

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Santa Rosa, California, 95405, United States

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West Covina, California, 91790, United States

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Colorado Springs, Colorado, 80907, United States

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Denver, Colorado, 80246, United States

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Denver, Colorado, 80249, United States

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Thornton, Colorado, 80233, United States

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Boca Raton, Florida, 33432, United States

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Lake Mary, Florida, 32746, United States

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Melbourne, Florida, 32935, United States

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Miami Beach, Florida, 33141, United States

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Opa-locka, Florida, 33055, United States

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Pinellas Park, Florida, 33781, United States

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Atlanta, Georgia, 30338, United States

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Marietta, Georgia, 30062, United States

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Woodstock, Georgia, 30189, United States

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Boise, Idaho, 83642, United States

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Peoria, Illinois, 61602, United States

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Mishawaka, Indiana, 46545, United States

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Council Bluffs, Iowa, 51503, United States

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Newton, Kansas, 67114, United States

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Wichita, Kansas, 67010, United States

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Wichita, Kansas, 67207, United States

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Lexington, Kentucky, 40509, United States

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Louisville, Kentucky, 40291, United States

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Metairie, Louisiana, 70006, United States

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Kansas City, Missouri, 64114, United States

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St Louis, Missouri, 63141, United States

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Bellevue, Nebraska, 68005, United States

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Fremont, Nebraska, 68025, United States

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Omaha, Nebraska, 68114, United States

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Omaha, Nebraska, 68134, United States

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Las Vegas, Nevada, 89104, United States

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Binghamton, New York, 13901, United States

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Wilmington, North Carolina, 28401, United States

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Akron, Ohio, 44311, United States

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Cincinnati, Ohio, 45249, United States

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Cleveland, Ohio, 44106, United States

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Cleveland, Ohio, 44122, United States

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Dayton, Ohio, 45406, United States

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Dayton, Ohio, 45414, United States

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Kettering, Ohio, 45429, United States

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Oklahoma City, Oklahoma, 73103, United States

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Oklahoma City, Oklahoma, 73112, United States

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Tulsa, Oklahoma, 74127, United States

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Erie, Pennsylvania, 16505, United States

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Erie, Pennsylvania, 16508, United States

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Hermitage, Pennsylvania, 16148, United States

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Sellersville, Pennsylvania, 18960, United States

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Upper Saint Clair, Pennsylvania, 15241, United States

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Anderson, South Carolina, 29621, United States

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Charleston, South Carolina, 29403, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Bristol, Tennessee, 37620, United States

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Jefferson City, Tennessee, 37760, United States

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Lebanon, Tennessee, 37087, United States

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Nashville, Tennessee, 37203, United States

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Austin, Texas, 78705, United States

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Dallas, Texas, 75231, United States

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Fort Worth, Texas, 76107, United States

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Fort Worth, Texas, 76135, United States

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Round Rock, Texas, 78681, United States

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San Angelo, Texas, 76904, United States

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San Antonio, Texas, 78229, United States

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Draper, Utah, 84020, United States

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Layton, Utah, 84041, 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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South Jordan, Utah, 84095, United States

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West Jordan, Utah, 84088, United States

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Burke, Virginia, 22015, United States

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Charlottesville, Virginia, 22902, United States

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Related Publications (1)

• Hartvickson R, Cruz M, Ervin J, Brandon D, Forleo-Neto E, Dagnew AF, Chandra R, Lindert K, Mateen AA. Non-inferiority of mammalian cell-derived quadrivalent subunit influenza virus vaccines compared to trivalent subunit influenza virus vaccines in healthy children: a phase III randomized, multicenter, double-blind clinical trial. Int J Infect Dis. 2015 Dec;41:65-72. doi: 10.1016/j.ijid.2015.11.004. Epub 2015 Nov 14.

  PMID: 26585940 DERIVED

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: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

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

Study Design

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

Study Record Dates

• First Submitted: November 7, 2013
• First Posted: November 25, 2013
• Study Start: November 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 8, 2015
• Results First Posted: December 8, 2015

Record last verified: 2015-11

Locations

US (88)