Reactogenicity, Safety and Immunogenicity Study of a Alla... | NCT03028116

NCT03028116

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Name	Class
Asfendiyarov Kazakh National Medical University	OTHER
Research Institute of Influenza, Russia	OTHER

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Allantoic split inactivated seasonal influenza vaccine	Active Comparator	Allantoic split inactivated seasonal influenza vaccine	Biological: influenza vaccine
Placebo	Placebo Comparator	Water for Injection	Biological: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
influenza vaccine	Biological	A allantoic split inactivated seasonal influenza vaccine has been prepared on eggs and is made from inactivated parts of the following influenza virus strains: NIBRG-121xp (A/California/7/2009 (H1N1)v and А/PR/8/34 (H1N1)), NYMC X-217 (A/Victoria/361/2011(H3N2) and А/PR/8/34 (H1N1)), NYMC BX-49 (B/Texas/06/2011 (Yamagata lineage) - like High Yield Reassortant (1:1:6) With B/Lee/40 NP, B/Panama/45/90 NS genes).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs)	Participants recorded solicited injection site and systemic adverse events in a Subject Diary. Solicited Locals AEs were: Injection Site Pain, Injection Site Redness, Injection Site Swelling, Injection Site Induration and Injection Site Ecchymosis. Solicited Systemic AEs were: Pyrexia, Malaise, Chills, Fatigue, Headache, Sweaty, Myalgia, Arthralgia, Nausea and Vomiting.	Two hours
Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE)	Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product. TEAE is defined as an adverse event with an onset that occurs after receiving study drug.	Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose
Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs	The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.	Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days
Serious adverse events (SAEs), including abnormal laboratory findings	Serious adverse events (SAEs) are medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.	Three weeks of receipt

Secondary Outcomes

Measure	Description	Time Frame
Geometric Mean Fold Increase in HI Antibody Titer	Geometric mean fold increase in HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination, as compared with Baseline.	Change from Baseline HI Antibody Titer at 21 days
Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy volunteers of both sexes aged 18-60 years.
Persons seronegative against A/H1N1 influenza virus, A/H3N2 and type B (with antibody titers ≤1: 10, according to hemagglutination-inhibition (HI) assay to determine).
Literate and willing to provide written informed consent.
A signed informed consent.

Exclusion Criteria:

Available in anamnaze volunteer at any allergic reactions.
Allergic reactions to chicken proteins, or any preceding vaccination.
Acute illness with a fever (37.0 C).
Vaccination against influenza in the 2012/2013 season.
Seropositive volunteers against A/H1N1 influenza virus, A/H3N2 and type B (with antibody titers greater than 1:10 according HI).
Current or recent (within two weeks of enrollment) acute respiratory illness with or without fever.
Hypersensitivity after previous administration of any vaccine.
History of chronic alcohol abuse and/or illegal drug use.
Any clinically significant abnormal laboratory finding.
A positive pregnancy test for all women of childbearing potential.
Administration of immunosuppressive drugs or other immune modifying drugs within 4 weeks prior to study enrollment.
Acute or chronic clinically significant pulmonary disease, cardiovascular disease, gastrointestinal disease, liver disease, neurological illness, liver disease, blood disease, skin disorder, endocrine disorder, neurological illness and psychiatric disorder as determined by medical history, physical examination or clinical laboratory screening tests, which in the opinion of the investigator, might interfere with the study objectives.
History of leukemia or any other blood or solid organ cancer.
Seropositive for HIV, hepatitis B surface antigen and/or hepatitis C antibodies.
Receipt of antivirals, antibiotics, immunoglobulins or other blood products within 4 weeks prior to study enrollment or planned receipt of such products during the period of subject participation in the study.
Participation in another clinical trial within the previous three months or planned enrollment in such a trial during the period of this study.
Subjects who are, in the opinion of the investigator, at significantly increased risk of non-cooperation with requirements of the study protocol.

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

ID	Term
D014765	Viral Vaccines
D014612	Vaccines
D001688	Biological Products
D045424	Complex Mixtures