The Extensive, Double-blind, Randomized, Placebo-controlled Phase 3 Study to Evaluate the Safety and Immunogenicity of the Seasonal Inactivated, Split Virion, Trivalent Influenza Vaccine (IVACFLU-S) Produced in Children and the Elderly in Vietnam

This was an extensive, double-blind, randomized, placebo-controlled phase 3 study that aimed to evaluate the safety and immunogenicity of the seasonal inactivated, split virion, trivalent influenza vaccine (IVACFLU-S) in children from 6 months to under 18 years old and the elderly over 60 years old in Vietnam.
The main target:
Evaluating the safety of the single or double dose of seasonal influenza vaccine (IVACFLU-S) in Vietnamese children aged 6 months to 17 years and adults over 60 years old.
Evaluating the immunogenicity of the seasonal inactivated, split virion, trivalent influenza vaccine (IVACFLU-S) after 1st injection on day 22 (+7) for groups ≥ 9 years old or day 49 (+7) for groups of 6 months to 8 years for each antigenic component of the vaccine.

Start Date05 Sep 2020

Sponsor / Collaborator

Institute Of Vaccines And Medical Biologicals, Vietnam

[+1]

NCT03095599

/ CompletedPhase 2/3

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

This Phase 2/3 study assessed whether a single dose of seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) is safe and well-tolerated in adults 18 to 60 years of age; and whether it will induce immune responses to each of the 3 vaccine antigens to meet 1 or both age group-specific Vietnam Ministry of Health (MOH) licensure requirements.

Start Date20 Mar 2017

Sponsor / Collaborator

Institute Of Vaccines And Medical Biologicals, Vietnam

[+4]

NCT02598089

/ CompletedPhase 1

A Phase 1 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

This is a phase I, double-blind, randomized, placebo-controlled trial with two groups of subjects to receive seasonal trivalent inactivated split virion influenza vaccine (A/H1N1; A/H3N2 and B strains) or placebo (phosphate buffered saline). A total of 60 healthy male and female adults 18 through 45 years of age will be randomized to receive vaccine (30) or placebo (30).

Start Date01 Nov 2015

Sponsor / Collaborator

Institute Of Vaccines And Medical Biologicals, Vietnam

[+5]

100 Clinical Results associated with Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVAC)

100 Translational Medicine associated with Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVAC)

100 Patents (Medical) associated with Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVAC)

Literatures (Medical) associated with Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVAC)

02 Dec 2019·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

A phase 2/3 double-blind, randomized, placebo-controlled study to evaluate the safety and immunogenicity of a seasonal trivalent inactivated split-virion influenza vaccine (IVACFLU-S) in healthy adults in Vietnam

Q3 · MEDICINE

Article

Author: Toan, Nguyen Trong ; Tewari, Tushar ; Nga, Nguyen Tuyet ; Thai, Duong Huu ; Francesco, Berlanda Scorza ; Tang, Yuxiao ; Huong, Vu Minh ; Thang, Tran Cong ; Holt, Renee ; Thang, Hoang Anh ; Lan, Phan Trong ; Flores, Jorge ; Be, Le Van

Background: Under the WHO's Global Action Plan for influenza vaccines, we conducted a phase 2-3 study of IVACFLU-S, a trivalent, seasonal inactivated influenza vaccine candidate.Methods: In the phase 2 portion of the study, 252 participants received one dose of 15 mcg hemagglutinin (HA) vaccine per strain or placebo. Following determination of safety, 636 additional participants were randomized in phase 3 to receive vaccine or placebo. Immunogenicity was assessed in a subset of the participants in the phase 3 study.Results: Higher proportion (70%) of participants in the IVACFLU-S arm reported solicited local adverse events (AEs) (p < .0001) as compared to placebo (25%). Mild injection site pain and tenderness were most common AEs seen in 55% and 60% of participants in the vaccine group. The solicited systemic AEs were comparable (p = .4149). The majority of solicited and unsolicited AEs were mild to moderate in severity. In the vaccine arm for the combined age group of 18-60 years of age, seroconversion against antigens A/H1N1, A/H3N2, and B was achieved in 70.3%, 76.1%, and 54.1% of participants respectively; seroprotection against antigens A/H1N1, A/H3N2, and B was achieved in 83.3%, 86.6%, and 60.3% of participants respectively; and the geometric mean fold rise for the hemagglutinin-inhibition (HI) antibody titers against antigen A/H1N1, A/H3N2, and B were 13.15, 11.85, and 5.87, respectively.Conclusion: This study demonstrates the local reactogenicity, other safety, and immunogenicity of IVACFLU-S, first domestically produced influenza vaccine in Vietnam.ClinicalTrials.gov number NCT03095599 (March 29, 2017).

01 Oct 2016·VaccineQ3 · MEDICINE

Randomized safety and immunogenicity trial of a seasonal trivalent inactivated split virion influenza vaccine (IVACFLU-S) in healthy young Vietnamese adults

Q3 · MEDICINE

Article

Author: Nga, Nguyen Tuyet ; Thiem, Vu Dinh ; Thang, Tran Cong ; Huong, Vu Minh ; Anh, Nguyen Thi Hien ; Holt, Renee ; Berlanda Scorza, Francesco ; Anh, Dang Duc ; Thai, Duong Huu ; Wahid, Rahnuma ; Chien, Vien Chinh ; Taylor, David N ; Flores, Jorge

BACKGROUNDUnder the auspices of the World Health Organization (WHO) Global Action Plan, PATH supported evaluation of a trivalent, seasonal inactivated influenza vaccine candidate produced by the Institute of Vaccines and Medical Biologicals (IVAC), a Vietnamese manufacturer.METHODSIn 2015, 60 healthy adult subjects 18-45years of age were enrolled in a Phase 1, single center, double blind, randomized, placebo-controlled study conducted at a district health center in Thai Binh Province, Vietnam. The study evaluated the overall safety and immunogenicity of a seasonal, trivalent inactivated split virion influenza vaccine. Volunteers were given either vaccine or placebo in a randomized 1:1 ratio. After undergoing screening, eligible volunteers provided their signed consent and were enrolled in the study. On the first day of immunization, randomly chosen volunteers received IVACFLU-S 15μg (mcg) hemagglutinin of each of the three strains in 0.5mL or placebo by intramuscular injection. All volunteers were monitored for adverse events and underwent blood testing at screening and Day 8 to assess the vaccine candidate's safety. Sera obtained before and 21days after immunization were tested for influenza antibody titers using the hemagglutination-inhibition (HAI) and microneutralization tests (MNT).RESULTSVaccine was well tolerated, and there were no serious adverse events reported. HAI and MNT identified serum antibody responses against the three influenza strains in nearly all volunteers who received the vaccine. Overall, serum HAI responses of fourfold or greater were observed in 93 percent, 83 percent, and 77 percent of H1, H3, and B strains, respectively. Seroprotection rates were also very high.CONCLUSIONSIVAC's seasonal, trivalent influenza vaccine was safe and well tolerated and induced high levels of seroconversion and seroprotection rates. These clinical data are a first step towards demonstrating the feasibility of producing the vaccine locally and that seasonal vaccine production in Vietnam may be an effective strategy for enhancing the global influenza vaccine supply. ClinicalTrials.gov number NCT02598089, October 15, 2015.

01 Mar 2014·Iranian journal of medical sciences

Safety of a Trivalent Inactivated Influenza Vaccine in Health Care Workers in Kurdistan Province, Western Iran; A Longitudinal Follow-up Study.

Article

Author: Soltani, Jafar ; Jamil Amjadi, Mohamad

We studied the safety of a trivalent inactivated surface antigen (split virion, inactivated) influenza vaccine, Begrivac® (Novartis Company), widely used in health care workers in Kurdistan. A longitudinal follow-up study was performed in Sanandaj city, west of Iran, recruiting 936 people. A questionnaire was completed for each participant, and all symptoms or abnormal physical findings were recorded. In part 1 of the study, the post-vaccination complaints were headache (5.3%), fever (7.9%), weakness (9.6%), chills (10.1%), sweating (10.5%), arthralgia (20.2%), and malaise (21.5%). Swelling of the injection site was seen in 267 (30.3%) participants, and pruritus of the injection site was seen in 290 (32.9%) participants. Redness and induration were also reported in 42.5% of the participants. Local reactions were mainly mild and lasted for 1-2 days. No systemic reactions were reported in the second part of the study. None of the participants experienced any inconvenience. We concluded that local adverse reactions after the trivalent inactivated split influenza vaccine, Begrivac®, in health care workers were far more common than expected. Continuous surveillance is needed to assess the potential risks and benefits of newly produced influenza vaccines.

100 Deals associated with Seasonal Trivalent Inactivated Split Virion Influenza Vaccine (IVAC)

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Indication	Highest Phase	Country/Location	Organization	Date
Influenza, Human	Phase 3	Vietnam	Institute Of Vaccines And Medical Biologicals, Vietnam	20 Mar 2017

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03095599 (IVACFLUS-0203, CTgov)	Phase 2/3	Influenza, Human	889	IVACFLU-S (Vaccine)	szzznoxepm(bspcbxyobv) = gokpokhyvd hjyrptqjbm (djzpcdqzha, gqygqakokj - zanqfliofd) View more	-	22 Jul 2019
				Placebo (Placebo)	szzznoxepm(bspcbxyobv) = vwpsqrabvg hjyrptqjbm (djzpcdqzha, jpzstegwue - fzlskcmvil) View more
NCT02598089 (IVACFLU-S, CTgov)	Phase 1	Influenza, Human	60	Trivalent Seasonal Influenza Vaccine (Trivalent Seasonal Influenza Vaccine)	osemuiirfx(rpxwjuyyeq) = miidxopihq jgrsupcgzd (kojzyojvgy, rpiryhbfbr - tbkadzgvmh) View more	-	28 Jan 2019
				Placebo (Placebo)	osemuiirfx(rpxwjuyyeq) = asocumylli jgrsupcgzd (kojzyojvgy, dtjribbjig - emnockptti) View more

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