Back to resultsSafety, Tolerability, and Immunogenicity Study of a Cell-based Virosomal Influenza Vaccine in Healthy Adults
Primary Purpose
Influenza
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
Trivalent virosomal influenza vaccine
Commercial vaccine 1
Quadrivalent virosomal influenza vaccine
Commercial vaccine 2
Sponsored by
About this trial
This is an interventional prevention trial for Influenza focused on measuring Healthy participants, Immunogenicity, Influenza, Prevention, Safety
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Experimental
Active Comparator
Arm Label
Trivalent virosomal influenza vaccine
Commercial vaccine 1
Quadrivalent virosomal influenza vaccine
Commercial vaccine 2
Arm Description
Trivalent virosomal influenza vaccine will be administered intramuscularly (injection of a substance into a muscle) on Day 1 in healthy participants.
Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Outcomes
Primary Outcome Measures
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).
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).
Number of participants with Unsolicited Adverse Events (AEs)
Unsolicited AEs are all AEs the participants are not specifically asked about in the participant Diary.
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.
Secondary Outcome Measures
Number of Participants with Seroconversion
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.
Number of Participants with Seroprotection
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.
Change From Baseline in Geometric Mean Titer (GMT) of HI antibodies
GMT and increase in GMT of HI antibodies from Baseline to Day 22 will be assessed.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02148328
Brief Title
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
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Crucell Holland BV
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Healthy participants, Immunogenicity, Influenza, Prevention, Safety
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
240 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Trivalent virosomal influenza vaccine
Arm Type
Experimental
Arm Description
Trivalent virosomal influenza vaccine will be administered intramuscularly (injection of a substance into a muscle) on Day 1 in healthy participants.
Arm Title
Commercial vaccine 1
Arm Type
Active Comparator
Arm Description
Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Arm Title
Quadrivalent virosomal influenza vaccine
Arm Type
Experimental
Arm Description
Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Arm Title
Commercial vaccine 2
Arm Type
Active Comparator
Arm Description
Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Intervention Type
Biological
Intervention Name(s)
Trivalent virosomal influenza vaccine
Other Intervention Name(s)
Trivalent FluCell
Intervention Description
Trivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Intervention Type
Biological
Intervention Name(s)
Commercial vaccine 1
Other Intervention Name(s)
Inflexal V (trivalent)
Intervention Description
Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Intervention Type
Biological
Intervention Name(s)
Quadrivalent virosomal influenza vaccine
Other Intervention Name(s)
Quadrivalent FluCell
Intervention Description
Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Intervention Type
Biological
Intervention Name(s)
Commercial vaccine 2
Other Intervention Name(s)
Fluarix Tetra (quadrivalent)
Intervention Description
Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
Primary Outcome Measure Information:
Title
Number of participants with Solicited Local Adverse Events (AEs)
Description
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).
Time Frame
Up to Day 8
Title
Number of participants with Solicited Systemic Adverse Events (AEs)
Description
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).
Time Frame
Up to Day 8
Title
Number of participants with Unsolicited Adverse Events (AEs)
Description
Unsolicited AEs are all AEs the participants are not specifically asked about in the participant Diary.
Time Frame
Up to Day 22
Title
Number of participants with Serious Adverse Events (SAEs)
Description
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.
Time Frame
Up to Day 90
Secondary Outcome Measure Information:
Title
Number of Participants with Seroconversion
Description
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.
Time Frame
Day 22
Title
Number of Participants with Seroprotection
Description
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.
Time Frame
Baseline and Day 22
Title
Change From Baseline in Geometric Mean Titer (GMT) of HI antibodies
Description
GMT and increase in GMT of HI antibodies from Baseline to Day 22 will be assessed.
Time Frame
Baseline and Day 22
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
49 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Crucell Holland BV Clinical Trial
Organizational Affiliation
Crucell Holland BV
Official's Role
Study Director
Facility Information:
City
Aalst
Country
Belgium
City
Gent
Country
Belgium
City
Merksem
Country
Belgium
City
Wilrijk
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
Safety, Tolerability, and Immunogenicity Study of a Cell-based Virosomal Influenza Vaccine in Healthy Adults
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