Phase 3
N=1,561
Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects
Prophylaxis: Influenza
Bottom Line
View on ClinicalTrials.gov: NCT02256488 ↗Enrolled (actual)
1,561
Serious AEs
0.1%
Results posted
Aug 2015
Primary outcome: Primary: Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots. — 667; 738; 655; 466 Titers
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TIVc_LOT A (Biological); TIVc_LOT B (Biological); TIVc_LOT C (Biological); TIVf (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Immunologic Equivalence of 3 Consecutive Influenza Vaccine (TIVc) Production Lots. |
667; 738; 655; 466; 472; 437 | — |
| SECONDARY Percentages of Subjects Who Achieved HI Seroconversion and HI Titer ≥1:40 Against Each of Three Strains After One Vaccination of TIVc and TIVf Vaccine. |
60; 69; 49; 63; 39; 45 | — |
| SECONDARY Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After One Vaccination of TIVc and TIVf |
168; 62; 208; 77; 76; 30 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events |
139; 38; 50; 14; 0; 2 | — |
Summary
The purpose of this study is to evaluate the immunologic equivalence of three consecutive lots of a cell based trivalent subunit influenza vaccine (TIVc), and to assess immunogenicity, safety and tolerability of the vaccine and an egg based trivalent subunit influenza vaccine (TIVf).
The study comprised 1 vaccination, 2 clinic visits, 3 reminder calls and 2 blood draws. Female subjects of childbearing potential were tested for pregnancy before the administration of the vaccine and included only if using and agreeing to continue to use contraception during the course of the study.
The total study participation time per subject is about 3 weeks.
Eligibility Criteria
Inclusion Criteria
- Males or females 18 through 49 years of age.
- Subjects having provided informed consent.
- Individuals in good health
Exclusion Criteria
- Chronic or acute illness that would interfere with the subject's safety and/or could interfere with the evaluation of study vaccine, including known history of anaphylaxis, serious vaccine reactions or hypersensitivity, known immunodeficiency or receiving immunosuppressive therapy.
- Female of childbearing potential not using acceptable contraceptive methods, pregnant or breastfeeding.
Data sourced from ClinicalTrials.gov (NCT02256488). 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.