Clinical Trials associated with Seasonal influenza virus vaccine intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences)

CTR20232853 / Active, not recruitingPhase 4

多中心、随机、双盲、安慰剂对照评价冻干鼻喷流感减毒活疫苗在3-17周岁人群保护效果的Ⅳ期临床试验

[Translation] A multicenter, randomized, double-blind, placebo-controlled phase IV clinical trial to evaluate the protective efficacy of freeze-dried nasal spray influenza live attenuated vaccine in people aged 3-17 years

主要目的：评价接种冻干鼻喷流感减毒活疫苗14天后的保护效果；次要目的： 1）评价接种冻干鼻喷流感减毒活疫苗的保护效果； 2）评价冻干鼻喷流感减毒活疫苗的安全性； 3）评价冻干鼻喷流感减毒活疫苗的排毒情况、分析遗传稳定性。探索性目的：评价接种冻干鼻喷流感减毒活疫苗14天后预防新型冠状病毒的保护效果。

[Translation]

Primary purpose: To evaluate the protective effect of freeze-dried nasal spray influenza live attenuated vaccine 14 days after vaccination; Secondary purpose: 1) To evaluate the protective effect of freeze-dried nasal spray influenza live attenuated vaccine; 2) To evaluate the safety of freeze-dried nasal spray influenza live attenuated vaccine; 3) To evaluate the detoxification of freeze-dried nasal spray influenza live attenuated vaccine and analyze the genetic stability. Exploratory purpose: To evaluate the protective effect of freeze-dried nasal spray influenza live attenuated vaccine against new coronavirus 14 days after vaccination.

Start Date22 Sep 2023

Sponsor / Collaborator

Changchun BCHT Biotechnology Co.

NCT06280144 / RecruitingPhase 4

Multi-center, Randomized, Double-blind, Placebo-controlled Trial of a Live Attenuated Influenza Vaccine in People Aged 3-17

To evaluate the protective effect 14 days after the live attenuated influenza vaccine; To evaluate the protective effect of vaccination with live attenuated influenza vaccine; To evaluate the safety of freeze-dried nasal spray live attenuated influenza vaccine; To evaluate the detoxification and genetic stability of lyophilized nasal spray vaccine.
To evaluate the protective effect of novel coronavirus after 14 days of inoculation with the live attenuated influenza vaccine.

Start Date22 Sep 2023

Sponsor / Collaborator

Changchun BCHT Biotechnology Co.

CTR20220581 / Active, not recruitingPhase 2

多中心、随机、双盲、阳性对照和安慰剂对照的三臂设计，评价鼻喷流感减毒活疫苗在3~59周岁健康人群中的免疫原性和安全性的Ⅱ期临床试验

[Translation] A phase II clinical trial with a multicenter, randomized, double-blind, positive-controlled and placebo-controlled three-arm design to evaluate the immunogenicity and safety of nasal spray live attenuated influenza vaccine in healthy people aged 3 to 59 years

主要目的：评价鼻喷流感减毒活疫苗在3~59周岁健康人群中接种的免疫原性；次要目的：评价鼻喷流感减毒活疫苗在3~59周岁健康人群中接种的安全性。

[Translation]

Primary objective: To evaluate the immunogenicity of nasal spray live attenuated influenza vaccine in healthy people aged 3-59 years; Secondary objective: To evaluate the safety of nasal spray live attenuated influenza vaccine in healthy people aged 3-59 years.

Start Date18 Mar 2022

Sponsor / Collaborator

Changchun BCHT Biotechnology Co.

100 Clinical Results associated with Seasonal influenza virus vaccine intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences)

100 Translational Medicine associated with Seasonal influenza virus vaccine intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences)

100 Patents (Medical) associated with Seasonal influenza virus vaccine intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences)

Literatures (Medical) associated with Seasonal influenza virus vaccine intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences)

01 Feb 2018·Drug SafetyQ2 · MEDICINE

Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study

Q2 · MEDICINE

Article

Author: Choudhury, Amlan ; Nigwekar, Prashant V ; Kumar, Anuj ; Kulkarni, Prasad S ; Padbidri, Vikram V ; Chaudhari, Amol B

INTRODUCTION AND AIMA trivalent live attenuated influenza vaccine (Nasovac-S^®) was developed and licensed in India. A phase 4 study was conducted to assess safety.METHODOLOGYThis non-randomized, open-label, single-arm study among individuals ≥ 2 years of age involved administration of 0.5 mL of Nasovac-S intranasally, with a 1-month follow-up after vaccination. Adverse events (AEs) were collected via structured diaries.RESULTSAmong 500 vaccinated subjects, 160 were between 2 and 17 years of age, 240 were 18-49 years old and 100 were 50 years and older. A total of 533 solicited reactions were reported. The majority of these reactions were mild, and almost all of them resolved without any sequelae. A total of 20% of subjects reported at least one local solicited reaction, and 23% reported at least one systemic solicited reaction. None of the 45 unsolicited AEs reported by 37 subjects (7.4%) were causally related to the study vaccine.CONCLUSIONSThe data from the study adds to the existing safety database of Nasovac-S.REGISTRYClinical Trials Registry of India (CTRI/2015/08/006074).

100 Deals associated with Seasonal influenza virus vaccine intranasal(Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences)

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R&D Status

Approved

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Indication	Country/Location	Organization	Date
Influenza, Human	RU	Institute Of Experimental Medicine Of The Russian Academy Of Medical Sciences	21 Dec 1993

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
influenza A subtype H3N2 infection	Phase 2	CN	Changchun BCHT Biotechnology Co.	18 Mar 2022
Influenza, Human	Discovery	EU	BioDiem Ltd.	-

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