NCT02148328

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2014

Shorter than P25 for phase_1

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2014

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

May 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 28, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2014

Completed
Last Updated

October 24, 2014

Status Verified

October 1, 2014

Enrollment Period

5 months

First QC Date

May 23, 2014

Last Update Submit

October 23, 2014

Conditions

Influenza

Keywords

Healthy participantsImmunogenicityInfluenzaPreventionSafety

Outcome Measures

Primary Outcomes (4)

  • Number of participants with Solicited Local Adverse Events (AEs)

    The local AEs pain, erythema, and induration at the study vaccine injection site will be noted in the participant Diary from Day 1 to Day 8. The extent (largest diameter) of any redness or induration should be measured daily and recorded, along with any functional limitation of activity. Local AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3) and potentially life threatening (Grade 4).

    Up to Day 8

  • Number of participants with Solicited Systemic Adverse Events (AEs)

    The solicited systemic AEs headache, fatigue, myalgia, malaise, and shivering/rigors will be noted in the participant Diary from Day 1 to Day 8. Fever (defined as body temperature greater than 38.0 Celsius) is another solicited systemic AE. Local AEs will be graded according to severity as mild (grade 1), moderate (grade 2), severe (grade 3) and potentially life threatening (grade 4).

    Up to Day 8

  • Number of participants with Unsolicited Adverse Events (AEs)

    Unsolicited AEs are all AEs the participants are not specifically asked about in the participant Diary.

    Up to Day 22

  • Number of participants with Serious Adverse Events (SAEs)

    The SAE is a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization or is a suspected transmission of any infectious agent via medicinal product.

    Up to Day 90

Secondary Outcomes (3)

  • Number of Participants with Seroconversion

    Day 22

  • Number of Participants with Seroprotection

    Baseline and Day 22

  • Change From Baseline in Geometric Mean Titer (GMT) of HI antibodies

    Baseline and Day 22

Study Arms (4)

Trivalent virosomal influenza vaccine

EXPERIMENTAL

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

Biological: Trivalent virosomal influenza vaccine

Commercial vaccine 1

ACTIVE COMPARATOR

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

Biological: Commercial vaccine 1

Quadrivalent virosomal influenza vaccine

EXPERIMENTAL

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

Biological: Quadrivalent virosomal influenza vaccine

Commercial vaccine 2

ACTIVE COMPARATOR

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

Biological: Commercial vaccine 2

Interventions

Trivalent virosomal influenza vaccineBIOLOGICAL

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

Also known as: Trivalent FluCell
Trivalent virosomal influenza vaccine
Commercial vaccine 1BIOLOGICAL

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

Also known as: Inflexal V (trivalent)
Commercial vaccine 1
Quadrivalent virosomal influenza vaccineBIOLOGICAL

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

Also known as: Quadrivalent FluCell
Quadrivalent virosomal influenza vaccine
Commercial vaccine 2BIOLOGICAL

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

Also known as: Fluarix Tetra (quadrivalent)
Commercial vaccine 2

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Unknown Facility

Aalst, Belgium

Location

Unknown Facility

Ghent, Belgium

Location

Unknown Facility

Merksem, Belgium

Location

Unknown Facility

Wilrijk, Belgium

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Inflexal V

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Crucell Holland BV Clinical Trial

    Crucell Holland BV

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2014

First Posted

May 28, 2014

Study Start

May 1, 2014

Primary Completion

October 1, 2014

Study Completion

October 1, 2014

Last Updated

October 24, 2014

Record last verified: 2014-10

Locations

BE(4)