Study to Evaluate the Consistency of Three Consecutive Production Lots of Influenza Vaccine in Healthy Subjects 18 to 49 Years Old

Novartis

Status and phase: Completed; Phase 3

Conditions: Influenza

Treatments: Biological: Lot B of Influenza virus vaccine; Biological: Lot A of Influenza virus vaccine; Biological: Comparator influenza virus vaccine; Biological: Lot C of Influenza virus vaccine; Biological: All 3 consecutive lots of influenza virus vaccine pooled

Study type: Interventional

Funder types: Industry

Identifiers

NCT00617851

13299

V71P6

Details and patient eligibility

About

The purpose of this research is to demonstrate immunologic equivalence of three consecutive production lots of the subunit influenza vaccine compared to egg-derived inactivated influenza vaccine in healthy subjects 18 to 49 years of ages. In addition, this study is to show how safe and well tolerated a conventional inactivated subunit influenza vaccine, licensed in many countries outside the United States, is compared to an inactivated influenza vaccine, licensed in the United States.

Enrollment: 1,507 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 18 to 49 years of age;
• In good health as determined by medical history and physical examination;
• Able and willing to provide written informed consent prior to any study procedure;
• Able to comply with all study procedures and available for all clinic visits scheduled in the study.

Exclusion criteria

• Any serious disease, such as: cancer, autoimmune disease (including rheumatoid arthritis), advanced arteriosclerotic disease or complicated diabetes mellitus
• History of any anaphylaxis, serious vaccine reactions, or hypersensitivity to eggs, egg protein, chicken feathers, influenza viral protein, neomycin, polymyxin, or any other vaccine component, chemically related substance, or component of the potential packaging materials (latex);
• Known or suspected impairment/alteration of immune function
• Receipt of an influenza vaccine within 6 months prior to Visit 1;
• Current drug or alcohol abuse or a history of drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of the study objectives;
• Laboratory-confirmed influenza disease within 6 months prior to Visit 1

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1,507 participants in 5 patient groups

Influenza virus vaccine (lot A)

Experimental group

Description:

Lot A of the investigational influenza virus vaccine

Treatment:

Biological: Lot A of Influenza virus vaccine

Influenza virus vaccine (lot B)

Experimental group

Description:

Lot B of the investigational influenza virus vaccine

Treatment:

Biological: Lot B of Influenza virus vaccine

Influenza virus vaccine (lot C)

Experimental group

Description:

Lot C of the investigational influenza virus vaccine

Treatment:

Biological: Lot C of Influenza virus vaccine

Influenza virus vaccine (pooled)

Experimental group

Description:

Pooled data of all three lots (Lot A, B and C) of the investigational influenza virus vaccine

Treatment:

Biological: All 3 consecutive lots of influenza virus vaccine pooled

Comparator influenza vaccine

Active Comparator group

Description:

A US licensed influenza virus vaccine

Treatment:

Biological: Comparator influenza virus vaccine