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

Influenza Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02148328
• Other study ID #: CR104114
• Secondary ID: FLUCELLFLZ100320
• Status: Completed
• Phase: Phase 1
• First received: May 23, 2014
• Last updated: October 23, 2014
• Start date: May 2014
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Crucell Holland BV
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Federal Agency for Medicinal Products and Health ProductsBelgium: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 49 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

Biological:
• Trivalent virosomal influenza vaccine
Trivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
• Commercial vaccine 1
Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
• Quadrivalent virosomal influenza vaccine
Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.
• Commercial vaccine 2
Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Crucell Holland BV

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Primary	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	Yes
Secondary	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.	Day 22	No
Secondary	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.	Baseline and Day 22	No
Secondary	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.	Baseline and Day 22	No