Reactogenicity, Safety and Immunogenicity Study of a Allantoic Split Inactivated Seasonal Influenza Vaccine (VSI)
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|ClinicalTrials.gov Identifier: NCT03028116|
Recruitment Status : Completed
First Posted : January 23, 2017
Last Update Posted : January 23, 2017
|Condition or disease||Intervention/treatment||Phase|
|Influenza, Human||Biological: influenza vaccine Biological: Placebo||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Randomized, Blinded, Placebo-controlled Study of Phase I Allantoic Split Inactivated Seasonal Influenza Vaccine in Healthy Adults|
|Study Start Date :||May 2016|
|Primary Completion Date :||June 2016|
|Study Completion Date :||July 2016|
Active Comparator: Allantoic split inactivated seasonal influenza vaccine
Allantoic split inactivated seasonal influenza vaccine
Biological: influenza vaccine
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).
Placebo Comparator: Placebo
Water for Injection
water for injection
- Percentage of Participants With Solicited Local and Systemic Adverse Events (AEs) [ Time Frame: Two hours ]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.
- Percentage of Participants Reporting One or More Treatment-emergent Adverse Events (TEAE) [ Time Frame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days following any dose ]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.
- Percentage of Participants With Abnormal Safety Laboratory Tests at Least Once Post Dose Reported as AEs [ Time Frame: Greater than 2 hours after administration of any dose of vaccine or placebo through 7 days ]The percentage of participants with any abnormal standard safety laboratory values (Chemistry, Hematology and Urinalysis) collected throughout the study reported as AEs.
- Serious adverse events (SAEs), including abnormal laboratory findings [ Time Frame: Three weeks of receipt ]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.
- Geometric Mean Fold Increase in HI Antibody Titer [ Time Frame: Change from Baseline HI Antibody Titer at 21 days ]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.
- Seroconversion Rate of Hemagglutination Inhibition (HI) Antibody Titer [ Time Frame: Change from Baseline HI Antibody Titer at 21 days ]Seroconversion rate was measured by hemagglutination inhibition (HI) antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Seroconversion rate was defined as the percentage of participants achieving a minimal 4-fold increase from the Baseline HI antibody titer in participants with a Baseline titer ≥10, or achieving an HI antibody titer of ≥40 in participants with a Baseline titer <10.
- Seroprotection Rate of HI Antibody Titer [ Time Frame: Change from Baseline HI Antibody Titer at 21 days ]Seroprotection rate, defined as the percentage of participants with HI antibody titer of ≥40, was measured by HI antibody titer for each of the three strains (A/H1N1 strain, A/H3N2 strain, B strain), 21 days after vaccination. Day 1 data is reported for reference.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028116
|Kazakh National Medical University|
|Almaty, Kazakhstan, 050000|