Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines

Novartis

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: Adjuvanted Influenza Vaccine; Biological: Influenza Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00735020

V104P1

Details and patient eligibility

About

This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.

Enrollment: 72 patients

Sex: All

Ages: 18 to 39 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment

Exclusion criteria

• serious medical conditions
• allergies to vaccine components, including but not limited to egg/chicken products
• reduced immune function
• recent use of immunosuppressive therapy
• recent use of influenza vaccine

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

1

Experimental group

Treatment:

Biological: Adjuvanted Influenza Vaccine

2

Active Comparator group

Treatment:

Biological: Influenza Vaccine