Phase 3
N=2,680
Safety and Immunogenicity of Three Influenza Vaccines Adults Ages 18 and Older
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01992094 ↗Enrolled (actual)
2,680
Serious AEs
3.6%
Results posted
Dec 2015
Primary outcome: Primary: 1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c — 60.7; 59.6; NA; 302.8 Titer
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- QIVc (Biological); TIV1c (Biological); TIV2c (Biological)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Jul 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 1.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c or TIV2c |
60.7; 59.6; NA; 302.8; 298.9; NA | — |
| PRIMARY 2. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c |
49.2; 48.7; NA; 38.3; 35.6; NA | — |
| SECONDARY 3. Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c or TIV2c in 18 to <65 and ≥ 65 Years Age Cohorts |
63.1; 34.5; 60.4; 36.9; NA; NA | — |
| SECONDARY 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 |
63.8; 79.2; 64.6; 76.5; NA; NA | — |
| SECONDARY 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 |
9.2; 3.0; 9.1; 3.0; NA; NA | — |
| SECONDARY 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 |
63.5; 36.3; 62.1; 36.9; NA; NA | — |
| SECONDARY 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 |
64.4; 77.6; 65.0; 75.4; NA; NA | — |
| SECONDARY 8.Geometric Mean Titres (GMT) in Subjects After Receiving One Dose of Either QIVc, TIV1c Against B2 Strain |
45.9; 55.7; 135.4; 91.7 | — |
| SECONDARY 9.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV1c Against B2 Strain |
36.6; 17.2 | — |
| SECONDARY 10.GMT in Subjects After Receiving One Dose of Either QIVc, TIV2c Against B1 Strain |
59.7; 43.8; 177.1; 76.3 | — |
| SECONDARY 11.Percentages of Subjects Achieving Seroconversion After One Dose of Either QIVc, TIV2c Against B1 Strain |
39.7; 18.0 | — |
| SECONDARY 12.Number of Subjects Reporting Solicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group |
551; 240; 242; 134; 55; 60 | — |
| SECONDARY 13.Number of Subjects Reporting Unsolicited Adverse Events (AEs) After One Dose of Either QIVc, TIV1c or TIV2c by Overall Age Group |
213; 99; 110; 57; 22; 30 | — |
Summary
Evaluate safety and immunogenicity of three influenza vaccines in adults 18 years of age and above.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Individuals recently vaccinated against influenza
- Subjects with contraindications to receive influenza vaccine
- Please contact the site for additional eligibility criteria
Data sourced from ClinicalTrials.gov (NCT01992094). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.