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Completed

NCT Number: NCT02148328

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Aalst, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trivalent virosomal influenza vaccine

Biological

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

Other names: Trivalent FluCell

Commercial vaccine 1

Biological

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

Other names: Inflexal V (trivalent)

Quadrivalent virosomal influenza vaccine

Biological

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

Other names: Quadrivalent FluCell

Commercial vaccine 2

Biological

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

Other names: Fluarix Tetra (quadrivalent)

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Crucell Holland BV

Industry

Registry information

Official study 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

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
May 28, 2014
Registry last updated
Oct 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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