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

October 23, 2014 updated by: Crucell Holland BV

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

240

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
      • Gent, Belgium
      • Merksem, Belgium
      • Wilrijk, Belgium

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 49 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: Trivalent virosomal influenza vaccine
Trivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Other Names:
  • Trivalent FluCell
Active Comparator: Commercial vaccine 1
Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Biological: Commercial vaccine 1
Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Other Names:
  • Inflexal V (trivalent)
Experimental: Quadrivalent virosomal influenza vaccine
Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Biological: Quadrivalent virosomal influenza vaccine
Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Other Names:
  • Quadrivalent FluCell
Active Comparator: Commercial vaccine 2
Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Biological: Commercial vaccine 2
Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Other Names:
  • Fluarix Tetra (quadrivalent)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with Solicited Local Adverse Events (AEs)
Time Frame: Up to Day 8
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)
Time Frame: Up to Day 8
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)
Time Frame: Up to Day 22
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)
Time Frame: Up to Day 90
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants with Seroconversion
Time Frame: Day 22
Number of participants with seroconversion will be the participants with a greater than or equal to (>=) 4-fold increase in hemagglutination inhibition (HI) antibody titer and a titer of >=1:40 at Day 22. HI against homologous strains will be measured with the HI test in serum.
Day 22
Number of Participants with Seroprotection
Time Frame: Baseline and Day 22
Number of participants with seroprotection is defined as number of participants with HI antibody >=1:40 at Day 22. HI against homologous strains will be measured with the HI test in serum.
Baseline and Day 22
Change From Baseline in Geometric Mean Titer (GMT) of HI antibodies
Time Frame: Baseline and Day 22
GMT and increase in GMT of HI antibodies from Baseline to Day 22 will be assessed.
Baseline and Day 22

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Crucell Holland BV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2014

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

May 23, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (Estimate)

May 28, 2014

Study Record Updates

Last Update Posted (Estimate)

October 24, 2014

Last Update Submitted That Met QC Criteria

October 23, 2014

Last Verified

October 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR104114
  • FLUCELLFLZ1003 (Other Identifier: Crucell Holland BV)
  • 2014-000573-39 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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