Clinical trial NCT02148328: Safety, Tolerability, and Immunogenicity Study of a Cell-based Virosomal Influenza Vaccine in Healthy Adults
Official title: A Phase 1, Double-blind, Active-controlled, Randomized Study in Healthy Adults to Evaluate Safety, Tolerability, and Immunogenicity of a Trivalent and Quadrivalent Cell-based Virosomal Subunit Influenza Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza
Keywords: Healthy participants
Immunogenicity
Influenza
Prevention
Safety
Lead sponsor: Crucell Holland BV
Sponsor class: INDUSTRY
First posted: 2014-05-28
Enrollment: 240
Sex: ALL
Minimum age (years): 18
Maximum age (years): 49
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of participants with Solicited Local Adverse Events (AEs)
timeFrame: Up to Day 8
measure: Number of participants with Solicited Systemic Adverse Events (AEs)
timeFrame: Up to Day 8
measure: Number of participants with Unsolicited Adverse Events (AEs)
timeFrame: Up to Day 22
measure: Number of participants with Serious Adverse Events (SAEs)
timeFrame: Up to Day 90
Secondary outcomes:
measure: Number of Participants with Seroconversion
timeFrame: Day 22
measure: Number of Participants with Seroprotection
timeFrame: Baseline and Day 22
measure: Change From Baseline in Geometric Mean Titer (GMT) of HI antibodies
timeFrame: Baseline and Day 22
Other outcomes:
Locations:
city: Aalst
country: Belgium
city: Gent
country: Belgium
city: Merksem
country: Belgium
city: Wilrijk
country: Belgium
Study officials:
affiliation: Crucell Holland BV
name: Crucell Holland BV Clinical Trial
role: STUDY_DIRECTOR
References: