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

Crucell

Status and phase: Completed; Phase 1

Conditions: Influenza

Treatments: Biological: Quadrivalent virosomal influenza vaccine; Biological: Trivalent virosomal influenza vaccine; Biological: Commercial vaccine 2; Biological: Commercial vaccine 1

Study type: Interventional

Funder types: Industry

Identifiers

NCT02148328

FLUCELLFLZ1003 (Other Identifier)

2014-000573-39 (EudraCT Number)

CR104114

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 49 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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240 participants in 4 patient groups

Trivalent virosomal influenza vaccine

Experimental group

Description:

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

Treatment:

Biological: Trivalent virosomal influenza vaccine

Commercial vaccine 1

Active Comparator group

Description:

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

Treatment:

Biological: Commercial vaccine 1

Quadrivalent virosomal influenza vaccine

Experimental group

Description:

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

Treatment:

Biological: Quadrivalent virosomal influenza vaccine

Commercial vaccine 2

Active Comparator group

Description:

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

Treatment:

Biological: Commercial vaccine 2