Safety and Immunogenicity of Two Trivalent Subunit Influenza Vaccines in Healthy Adult Subjects

Novartis

Status and phase: Completed; Phase 3

Conditions: Prophylaxis: Influenza

Treatments: Biological: TIVc_LOT A; Biological: TIVc_LOT C; Biological: TIVf; Biological: TIVc_LOT B

Study type: Interventional

Funder types: Industry

Identifiers

NCT02256488

V58_23

Details and patient eligibility

About

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.

Enrollment: 1,561 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,561 participants in 4 patient groups

TIVc-Lot A

Experimental group

Description:

Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot A

Treatment:

Biological: TIVc_LOT A

TIVc-Lot B

Experimental group

Description:

Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot B

Treatment:

Biological: TIVc_LOT B

TIVc-Lot C

Experimental group

Description:

Subjects 18 to ≤ 49 years of age who received one vaccination with an investigational vaccine TIVc from Lot C

Treatment:

Biological: TIVc_LOT C

TIVf

Active Comparator group

Description:

Subjects 18 to ≤ 49 years of age who received one vaccination of Control vaccine TIVf

Treatment:

Biological: TIVf