Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older

NCT01992094 | Completed Phase 3 Results

• 1 other identifier: V130_01
• Study Type: interventional
• Target: 2,680
• Locations: 1 country
• Sites: 40

Brief Summary

Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.

Conditions

Influenza

Keywords

Influenza; Influenza vaccine; Novartis; Adults

Outcome Measures

Primary Outcomes (2)

• 1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c

  Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of GMT in subjects measured by hemagglutination inhibition (HI) assay, three weeks after vaccination with one dose of either QIVc or TIV1c and 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.

  Three weeks post vaccination (Day 22)

• 2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c

  Immunogenicity of QIVc to comparator TIVc (For H1N1, H3N2 and B1 strain, the comparison is between QIVc and TIV1c and for B2 i.e. alternate B strain, the comparison is between QIVc and TIV2c) was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with one dose of either QIVc,TIV1c or TIV2c Seroconversion is defined in subjects seronegative at baseline (i.e., HI titer \<1:10 at Day 1) as post-vaccination HI titer ≥1:40, and defined in subjects sero-positive 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)

Secondary Outcomes (11)

• 3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts

  Three weeks post vaccination (Day 22)

• 4. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age-cohorts

  Three weeks post vaccination (Day 22)

• 5.Geometric Mean Ratios (GMR) in Subjects After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts

  Three weeks post vaccination (Day 22)

• 6. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts

  Three weeks post vaccination (Day 22)

• 7. Percentages of Subjects Achieving HI Titer ≥1:40 After One Dose of Either QIVc, TIV1c or TIV2c in 18 to ≤60 Years and ≥ 61 Years Age Cohorts

  Three weeks post vaccination (Day 22)

Study Arms (3)

QIVc

EXPERIMENTAL

Influenza vaccine

Biological: QIVc

TIV1c

ACTIVE COMPARATOR

Influenza vaccine

Biological: TIV1c

TIV2c

ACTIVE COMPARATOR

Influenza vaccine

Biological: TIV2c

Interventions

QIVc BIOLOGICAL

Novartis Investigational Quadrivalent Vaccine

QIVc

TIV1c BIOLOGICAL

Licensed Influenza Vaccine

TIV1c

TIV2c BIOLOGICAL

Novartis Investigational Vaccine

TIV2c

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ages 18 years and older.
• 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

• Novartis Vaccines: lead

Study Sites (40)

Unknown Facility

Huntsville, Alabama, 35802, United States

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Phoenix, Arizona, 85050, United States

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Anaheim, California, 92801, United States

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San Diego, California, 92108, United States

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Coral Gables, Florida, 33134, United States

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Hollywood, Florida, 33024, United States

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Melbourne, Florida, 32935, United States

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South Miami, Florida, 33143, United States

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West Palm Beach, Florida, 33409, 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, 67205, United States

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Wichita, Kansas, 67207, United States

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Metairie, Louisiana, 70006, United States

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Rockville, Maryland, 20850, United States

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Edina, Minnesota, 55435, United States

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Bellevue, Nebraska, 68005, United States

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Omaha, Nebraska, 68134, United States

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Endwell, New York, 13760, United States

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Rochester, New York, 14609, United States

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Cary, North Carolina, 27518, United States

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Charlotte, North Carolina, 28209, United States

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Raleigh, North Carolina, 27609, United States

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Wilmington, North Carolina, 28401, United States

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Oklahoma City, Oklahoma, 73112, United States

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Warwick, Rhode Island, 02886, United States

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Anderson, South Carolina, 29621, United States

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Mt. Pleasant, South Carolina, 29464, United States

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Dakota Dunes, South Dakota, 57049, United States

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Austin, Texas, 78705, United States

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Austin, Texas, 78745, United States

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Dallas, Texas, 75231, 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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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

Location

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: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: December 10, 2015
• Results First Posted: December 10, 2015

Record last verified: 2015-11

Locations

US (40)