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The study the safety, reactogenicity and obtain preliminary data on the immunogenicity of Flu-M Quadro, 4-valent inactivated split influenza vaccine, in healthy volunteers
The maximum period of the volunteers' participation in the trial will be 35 ± 2 days. Screening period - up to 7 days. The vaccine administration period is 1 day. Follow-up period - 28±2 days.
All volunteers are followed by a clinical investigator for 6 months after vaccination outside of this trial with the aim of detecting possible late adverse reactions. If a volunteer has any delayed-type reactions, the volunteer will be invited to the clinic for correction of his/her condition.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flu-M Quadro with preservative | Experimental | 25 volunteers were vaccinated with the Flu-M Quadro inactivated split influenza vaccine with a preservative |
|
| Flu-M Quadro without preservative | Experimental | 25 volunteers were vaccinated with the Flu-M Quadro inactivated split influenza vaccine without a preservative |
|
| Placebo | Placebo Comparator | 25 volunteers were vaccinated with a Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flu-M Quadro [inactivated split influenza vaccine] with preservative | Biological | solution for intramuscular injection, 0.5 ml |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (local and systemic post-vaccination reactions) | days 1-7 | |
| Incidence of adverse events (systemic post-vaccination reactions) | days 1-7 | |
| Incidence of any serious adverse events during the trial | days 1-28 |
| Measure | Description | Time Frame |
|---|---|---|
| The content of specific anti-influenza antibodies in serum | days 0, 28 after the vaccination | |
| The geometric mean titer (GMT) of antibodies to hemagglutinins of the influenza virus | days 0, 28 after the vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Federally Funded Healthcare Institution Primary Healthcare Unit No. 163 | Novosibirsk | Russia |
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| Flu-M Quadro [inactivated split influenza vaccine] without preservative | Biological | solution for intramuscular injection, 0.5 ml |
|
| Placebo | Biological | solution for intramuscular injection, 0.5 ml |
|
| Seroconversion factor | It shout be more than 2.5 after the vaccination | days 0, 28 |
| Seroconversion level | days 0, 28 after the vaccination |
| Seroprotection level | days 0, 28 after the vaccination |
| 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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