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| ID | Type | Description | Link |
|---|---|---|---|
| FLUCELLFLZ1003 | Other Identifier | Crucell Holland BV | |
| 2014-000573-39 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Commercial vaccine 1 | Active Comparator | Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. |
|
| Quadrivalent virosomal influenza vaccine | Experimental | Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. |
|
| Commercial vaccine 2 | Active Comparator | Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Trivalent virosomal influenza vaccine | Biological | Trivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Crucell Holland BV Clinical Trial | Crucell Holland BV | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalst | Belgium | |||||
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| Commercial vaccine 1 | Biological | Trivalent commercial virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. |
|
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| Quadrivalent virosomal influenza vaccine | Biological | Quadrivalent virosomal influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. |
|
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| Commercial vaccine 2 | Biological | Quadrivalent commercial influenza vaccine will be administered intramuscularly on Day 1 in healthy participants. |
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| 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 |
| 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 |
| Ghent |
| Belgium |
| Merksem | Belgium |
| Wilrijk | Belgium |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C475022 | Inflexal V |
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