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

Novartis

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: TIV2c; Biological: TIV1c; Biological: QIVc

Study type: Interventional

Funder types: Industry

Identifiers

NCT01992094

V130_01

Details and patient eligibility

About

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

Enrollment: 2,680 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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2,680 participants in 3 patient groups

QIVc

Experimental group

Description:

Influenza vaccine

Treatment:

Biological: QIVc

TIV1c

Active Comparator group

Description:

Influenza vaccine

Treatment:

Biological: TIV1c

TIV2c

Active Comparator group

Description:

Influenza vaccine

Treatment:

Biological: TIV2c