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

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: NCT01992094
Recruitment Status : Completed
First Posted : November 25, 2013
Results First Posted : December 10, 2015
Last Update Posted : December 10, 2015
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

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

Condition or disease Intervention/treatment Phase
Influenza Biological: QIVc Biological: TIV1c Biological: TIV2c Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2680 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase III, Stratified, Randomized, Double-Blind, Multicenter, NonInferiority Study to Evaluate the Safety and Immunogenicity of a Cell-based Quadrivalent Subunit Influenza Virus Vaccine and Cell-based Trivalent Subunit Influenza Virus Vaccines in Adults Ages ≥18 Years of Age
Study Start Date : November 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: QIVc
Influenza vaccine
Biological: QIVc
Novartis Investigational Quadrivalent Vaccine

Active Comparator: TIV1c
Influenza vaccine
Biological: TIV1c
Licensed Influenza Vaccine

Active Comparator: TIV2c
Influenza vaccine
Biological: TIV2c
Novartis Investigational Vaccine




Primary Outcome Measures :
  1. 1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c [ Time Frame: Three weeks post vaccination (Day 22) ]

    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.


  2. 2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c [ Time Frame: Three weeks post vaccination (Day 22) ]
    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


Secondary Outcome Measures :
  1. 3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts [ Time Frame: Three weeks post vaccination (Day 22) ]
    Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against each vaccine strains, three weeks (day 22) after vaccination with ether 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.The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving seroconversion for HI antibody should meet or exceed 40% and that for the ≥ 65 years age group should meet or exceed 30%

  2. 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 [ Time Frame: Three weeks post vaccination (Day 22) ]
    Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c The CBER criterion for 18 to <65 years age group is that the lower bound of the two-sided 95% CI for the percentage of subjects achieving an HI antibody titer ≥ 1:40 should meet or exceed 70% and that for the ≥ 65 years age group should meet or exceed 60%

  3. 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 [ Time Frame: Three weeks post vaccination (Day 22) ]
    Immunogenicity was measured as the geometric mean ratio (GMR). The ratio of post-vaccination to pre-vaccination HI GMTs, three weeks (day 22) after vaccination with either QIVc, TIV1c or TIV2c Committee for Medicinal Products for Human Use (CHMP) criterion for 18 to ≤60 years age group is >2.5 and that for ≥ 61 years age group is >2.0

  4. 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 [ Time Frame: Three weeks post vaccination (Day 22) ]
    Immunogenicity was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, three weeks (day 22) after vaccination with 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 The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving seroconversion or significant increase in HI titer is >40% and that for ≥ 61 years age group is >30%

  5. 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 [ Time Frame: Three weeks post vaccination (Day 22) ]
    Immunogenicity was assessed in terms of percentages of subjects showing HI titer ≥1:40, three weeks (day 22) after vaccination with either QIVc, TIV1c and TIV2c The CHMP criterion for 18 to ≤60 years age group is that the percentage of subjects achieving an HI titer ≥1:40 is >70% and that for ≥ 61 years age group is >60%

  6. 8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain [ Time Frame: Three weeks post vaccination (Day 22) ]

    Immunogenicity of QIVc to TIV1c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV1c.

    Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV1c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1.


  7. 9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain [ Time Frame: Three weeks post vaccination (Day 22) ]
    Immunogenicity of QIVc to TIV1c was assessed in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B2, three weeks (day 22) after vaccination with QIVc or TIV1c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV1c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points

  8. 10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain [ Time Frame: Three weeks post vaccination (Day 22) ]

    Immunogenicity of QIVc to TIV2c was assessed by GMT in subjects measured by HI assay, three weeks after vaccination with one dose of either QIVc or TIV2c.

    Superiority was established if the upper bound of the two-sided 95% CI for the ratio of GMTs (GMT TIV2c /GMT QIVc) for HI antibody does not exceed the superiority margin of 1


  9. 11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain [ Time Frame: Three weeks post vaccination (Day 22) ]
    Immunogenicity of QIVc to TIV2c in terms of percentages of subjects showing seroconversion or significant increase in HI antibody titers, against influenza strain B1, three weeks (day 22) after vaccination with QIVc or TIV2c Superiority was established if the upper bound of the two-sided 95% CI for the difference between seroconversion rates (% seroconversion TIV2c - % seroconversion QIVc) for HI antibody in ≥ 18 years age group does not exceed the margin of 0 points

  10. 12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group [ Time Frame: Day 1 to 7 post vaccination ]
    Safety was assessed in terms of number (%) of subjects reporting solicited local and systemic reactions, day 1 to 7 after vaccination with one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)

  11. 13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group [ Time Frame: Day 1 to 181 post vaccination ]
    Safety was assessed in terms of number (%) of subjects reporting unsolicited AEs (day 1 to 22 after vaccination), serious adverse events (SAEs), medically attended AEs, AEs leading to withdrawal from the study, new onset of chronic diseases (NOCDs), and concomitant medications (day 1 to day 181 post vaccination) after receiving one dose of either four (4) strain inactivated quadrivalent cell based influenza vaccine (QIVc) or trivalent inactivated influenza vaccine (TIV1c or TIV2c)



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:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ages 18 years and older.
  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): NCT01992094


Locations
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United States, Alabama
Huntsville, Alabama, United States, 35802
United States, Arizona
Phoenix, Arizona, United States, 85050
United States, California
Anaheim, California, United States, 92801
San Diego, California, United States, 92108
United States, Florida
Coral Gables, Florida, United States, 33134
Hollywood, Florida, United States, 33024
Melbourne, Florida, United States, 32935
South Miami, Florida, United States, 33143
West Palm Beach, Florida, United States, 33409
United States, Illinois
Peoria, Illinois, United States, 61602
United States, Indiana
Mishawaka, Indiana, United States, 46545
United States, Iowa
Council Bluffs, Iowa, United States, 51503
United States, Kansas
Newton, Kansas, United States, 67114
Wichita, Kansas, United States, 67205
Wichita, Kansas, United States, 67207
United States, Louisiana
Metairie, Louisiana, United States, 70006
United States, Maryland
Rockville, Maryland, United States, 20850
United States, Minnesota
Edina, Minnesota, United States, 55435
United States, Nebraska
Bellevue, Nebraska, United States, 68005
Omaha, Nebraska, United States, 68134
United States, New York
Endwell, New York, United States, 13760
Rochester, New York, United States, 14609
United States, North Carolina
Cary, North Carolina, United States, 27518
Charlotte, North Carolina, United States, 28209
Raleigh, North Carolina, United States, 27609
Wilmington, North Carolina, United States, 28401
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Rhode Island
Warwick, Rhode Island, United States, 02886
United States, South Carolina
Anderson, South Carolina, United States, 29621
Mt. Pleasant, South Carolina, United States, 29464
United States, South Dakota
Dakota Dunes, South Dakota, United States, 57049
United States, Texas
Austin, Texas, United States, 78705
Austin, Texas, United States, 78745
Dallas, Texas, United States, 75231
Fort Worth, Texas, United States, 76135
San Angelo, Texas, United States, 76904
United States, Utah
Salt Lake City, Utah, United States, 84109
Salt Lake City, Utah, United States, 84121
Salt Lake City, Utah, United States, 84124
South Jordan, Utah, United States, 84095
Sponsors and Collaborators
Novartis Vaccines
Investigators
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Study Chair: Novartis Vaccines Novartis Vaccines
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Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01992094    
Other Study ID Numbers: V130_01
First Posted: November 25, 2013    Key Record Dates
Results First Posted: December 10, 2015
Last Update Posted: December 10, 2015
Last Verified: November 2015
Keywords provided by Novartis ( Novartis Vaccines ):
Influenza
Influenza vaccine
Novartis
Adults
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases