Safety, Tolerability, and Immunogenicity Study of a Cell-based Virosomal Influenza Vaccine in Healthy Adults

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-05-31

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to examine the safety and tolerability after administration of trivalent and quadrivalent cell-based virosomal influenza vaccine in healthy adults.

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Detailed Description

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This is a double-blind and randomized study in healthy adults. The duration of study will be approximately 90 days per participant. The study will include 4 visits: Day 1 (for vaccination), Day 4, Day 22 and day 90 (Follow-up visits). Safety and tolerability will be assessed by the rate of solicited, unsolicited, and serious adverse events.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Trivalent virosomal influenza vaccine

Trivalent virosomal influenza vaccine will be administered intramuscularly (injection of a substance into a muscle) on Day 1 in healthy participants.

Group Type EXPERIMENTAL

Trivalent virosomal influenza vaccine

Intervention Type BIOLOGICAL

Trivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Commercial vaccine 1

Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Group Type ACTIVE_COMPARATOR

Commercial vaccine 1

Intervention Type BIOLOGICAL

Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Quadrivalent virosomal influenza vaccine

Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Group Type EXPERIMENTAL

Quadrivalent virosomal influenza vaccine

Intervention Type BIOLOGICAL

Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Commercial vaccine 2

Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Group Type ACTIVE_COMPARATOR

Commercial vaccine 2

Intervention Type BIOLOGICAL

Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Interventions

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Trivalent virosomal influenza vaccine

Trivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Intervention Type BIOLOGICAL

Commercial vaccine 1

Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Intervention Type BIOLOGICAL

Quadrivalent virosomal influenza vaccine

Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Intervention Type BIOLOGICAL

Commercial vaccine 2

Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Intervention Type BIOLOGICAL

Other Intervention Names

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Trivalent FluCell Inflexal V (trivalent) Quadrivalent FluCell Fluarix Tetra (quadrivalent)

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female adults
* Body Mass Index \<= 30 kilogram per square meter (kg/m\^2)
* Written informed consent

Exclusion Criteria

* Vaccination with 2013/2014-seasonal influenza vaccine and/or receipt of any vaccine in the 4 weeks preceding receipt of study vaccine and/or any vaccination planned within 3 weeks from the study vaccine
* Diagnosis (by rapid test, performed at clinic/hospital laboratory) of laboratory-confirmed influenza in the 2013/2014 season
* Acute exacerbation of bronchopulmonary infection (cough, sputum, lung findings) or other acute disease
* Acute febrile illness (greater than or equal to 38.0 celcius)
* Pregnancy as assessed by urine pregnancy test before vaccination, or lactation. Women of childbearing potential (that is, not surgically sterilized/hysterectomized or post-menopausal for more than 2 years) will be excluded if one of the following criteria is met: 1). Intention to become pregnant during the course of the study or to donate eggs (ova, oocytes) for the purposes of assisted reproduction 2). If heterosexually active, not using or not willing to continue using a medically reliable method of contraception for the entire study duration (up to 90 days). A medically reliable method of contraception includes oral contraceptive preparation (for example pills), hormonal implant, progestative injection, patch contraceptive formulation, an intrauterine device, concomitant use of barrier method and spermicide, or another method considered sufficiently reliable by the investigator in individual cases

Minimum Eligible Age

18 Years

Maximum Eligible Age

49 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes