Seasonal Trivalent Inactivated Split Virion Influenza Vaccine Clinical Trial (IVACFLU-S) - PHASE 2/3 (IVACFLUS-0203)
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|ClinicalTrials.gov Identifier: NCT03095599|
Recruitment Status : Recruiting
First Posted : March 29, 2017
Last Update Posted : March 29, 2017
|Condition or disease||Intervention/treatment||Phase|
|Influenza, Human||Biological: IVACFLU-S Other: Placebo||Phase 2 Phase 3|
This is a phase 2/3, double-blind, placebo-controlled trial of 888 adults, ages 18 to 60 years old randomized to receive vaccine or placebo in a 5:1 vaccine:placebo randomization. Phase 2 will be conducted at 1 site of Long An (252 subjects). Following a determination of safety of vaccine in phase 2 study by Protocol Safety Review Team (PSRT) review and with approval from Vietnam Ministry of Health (MOH), Phase 3 enrollment will commence at 2 sites, Long An (252 subjects) and Dong Nai (384 subjects).
Safety will be assessed in all Phase 2 and 3 participants through Day 91. Safety data till Day 8 post-vaccination from the phase 2 study will be presented to Protocol Safety Review Team (PSRT) for evaluation and an interim report will be filed with local institutional review board (IRB) and MOH. Immunogenicity will be assessed only in Phase 3 participants. Blood samples will be collected in a subset of 252 individuals randomized at one of the study sites to get evaluable samples from at least 200 vaccine recipients (100 each from both age groups) and 40 placebo recipients (20 each from both age groups) 21 days after vaccination.
Approximate participant distribution based on age, study arm and study will be as follows:
Age group: Phase 2 will have 2 age groups (18-45; 46-60). In each age group, 105 subjects will receive IVACFLU-S and 21 subjects will receive Placebo, resulting in 126 subjects total per age group. Phase 3 will have 2 age groups (18-45; 46-60). In each age group, 265 subjects will receive IVACFLU-S and 53 subjects will receive Placebo, resulting in 318 subjects total per age group.
A single dose of seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) will be safe and well tolerated in adults 18 to 60 years of age.
A single dose of seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) will induce immune responses to each of the three vaccine antigens to meet one or both age group specific Vietnam Ministry of Health (MOH) licensure requirements.
The criteria for 18-45 year olds for HAI seroprotection (HAI ≥1:40) is ≥70%; for 46-60 year olds is ≥60%.
The criteria for seroconversion for 18-45 year olds is ≥40%; for 46-60 year olds is ≥30%.
The criteria for HAI GMT increase for 18-45 year olds is ≥2.5 times; for 46-60 year olds is
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||888 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Phase 2/3 Double Blinded, Randomized, Placebo-Controlled Study in Healthy Adult Volunteers in Vietnam to Examine the Safety and Immunogenicity of a Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVACFLU-S) Produced by IVAC|
|Actual Study Start Date :||March 20, 2017|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||December 2017|
IVACFLU-S is seasonal inactivated, split virion, trivalent influenza vaccine (A/H3N2, A/H1N1, and B), produced in GCP facility by IVAC uses embryonated chicken eggs. This vaccine is purified by sucrose gradient ultracentrifugation (Alfa Wassermann, West Caldwell, NJ), and inactivated with formaldehyde. It contains
Trivalent inactivated split virion influenza vaccine
Placebo Comparator: Placebo
PBS with pH 7.2; 0.5 ml/per dose
- Number of AEs [ Time Frame: 90 days ]Number of AEs per arm
- Immunogenicity [ Time Frame: 21 days post immunization ]HAI
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03095599
|Contact: Phan Cong Hung, MD||+084 firstname.lastname@example.org|
|Pasteur Institute, Ho Chi Minh City||Recruiting|
|Ho Chi Minh City, Vietnam|
|Contact: Phan Cong Hung, MD 0935288287|
|Contact: Hoang Anh Thang, MD 0903224407|
|Principal Investigator:||Phan Cong Hung, MD||Pasteur Institute, Ho Chi Minh City|