[Translation] A randomized, blinded, positive-controlled phase III clinical trial to evaluate the safety and immunogenicity of quadrivalent influenza virus subunit vaccine in healthy people aged 6-35 months

主要目的：评价0.5ml/支四价流感病毒亚单位疫苗在6-35月龄健康人群中接种后的安全性和免疫原性。次要目的：评价0.25ml/支四价流感病毒亚单位疫苗在6-35月龄健康人群中接种后的安全性和免疫原性。探索性目的：1.比较 0.5ml/支与 0.25ml/支四价流感病毒亚单位疫苗在 6-35 月龄健康人群中接种后的安全性和免疫原性的差异；2.探索 0.5ml/支与 0.25ml/支四价流感病毒亚单位疫苗在 6-35 月龄健康人群中全程接种后的 3 个月和 6 个月免疫持久性。

[Translation]

Primary objective: To evaluate the safety and immunogenicity of 0.5ml/dose quadrivalent influenza virus subunit vaccine in healthy people aged 6-35 months. Secondary objective: To evaluate the safety and immunogenicity of 0.25ml/dose quadrivalent influenza virus subunit vaccine in healthy people aged 6-35 months. Exploratory objectives: 1. To compare the differences in safety and immunogenicity between 0.5ml/dose and 0.25ml/dose quadrivalent influenza virus subunit vaccine in healthy people aged 6-35 months; 2. To explore the immune persistence of 0.5ml/dose and 0.25ml/dose quadrivalent influenza virus subunit vaccine in healthy people aged 6-35 months at 3 months and 6 months after full vaccination.

Start Date06 Feb 2023

Sponsor / Collaborator

Jiangsu Zhonghui Yuantong Biological Technology Co., Ltd.Startup

NCT05645900 / CompletedPhase 3

Immunogenicity and Safety of a Quadrivalent Influenza Virus Subunit Vaccine in Subjects Aged 6-35 Months : a Randomized, Double-blind, Active-controlled Phase III Trial

A random, blind and positive control design was adopted.the investigators will assess the safety and immunogenicity of 2 doses of an quadrivalent influenza vaccine virus subunit in children aged 6 to 35 months.
A total of 2,772 subjects in the 6-35 month age group were randomly divided into experimental vaccine 1, experimental vaccine 2 and control vaccine groups at a ratio of 1:1:1, and received the corresponding vaccine respectively. 2 doses in the whole course, 28 days apart.
Safety observation: All subjects received 30 minutes of immediate response observation after each dose of vaccine and 0-7 days of systematic active safety observation; After 7 days of vaccination, the incidence of adverse events was observed by combining regular weekly follow-up with subject's voluntary report. Safety observation was conducted for 0-28/30 days after each dose of vaccine. Serious adverse events (SAE) were collected within 6 months after the first dose was administered.
Immunogenicity observation: Blood samples were collected before the first dose and 28 days after the full dose for influenza virus HI antibody detection.
Observation of immune persistence: Blood samples of 3 and 6 months after immunity were collected for influenza virus HI antibody detection.

Start Date06 Feb 2023

Sponsor / Collaborator

Jiangsu Zhonghui Yuantong Biological Technology Co., Ltd.Startup

[+1]

CTR20200971 / CompletedPhase 3

评价四价流感病毒亚单位疫苗在3岁及以上健康人群中接种后的安全性和免疫原性

[Translation] To evaluate the safety and immunogenicity of quadrivalent influenza virus subunit vaccine in healthy people aged 3 years and above

评价四价流感病毒亚单位疫苗以全程一剂免疫程序在3岁及以上健康人群中接种后的安全性和免疫原性；评价四价流感病毒亚单位疫苗以全程两剂（间隔28天）免疫程序在3-8岁健康人群中接种的安全性，与1针次相比，探索其免疫原性

[Translation]

To evaluate the safety and immunogenicity of quadrivalent influenza virus subunit vaccine in healthy people aged 3 years and above after a full one-dose immunization schedule; to evaluate the safety of quadrivalent influenza virus subunit vaccine in healthy people aged 3-8 years after a full two-dose immunization schedule (28 days apart), and to explore its immunogenicity compared with a single injection.

Start Date17 May 2020

Sponsor / Collaborator

Jiangsu Zhonghui Yuantong Biological Technology Co., Ltd.Startup

100 Clinical Results associated with Quadrivalent Subunit Influenza Vaccine(Ab&b Bio-Tech)

100 Translational Medicine associated with Quadrivalent Subunit Influenza Vaccine(Ab&b Bio-Tech)

100 Patents (Medical) associated with Quadrivalent Subunit Influenza Vaccine(Ab&b Bio-Tech)

Literatures (Medical) associated with Quadrivalent Subunit Influenza Vaccine(Ab&b Bio-Tech)

01 Feb 2022·The Lancet Respiratory MedicineQ1 · MEDICINE

Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial

Q1 · MEDICINE

Article

Author: Estcourt, Stephanie ; Hemat, Nargis ; Woodyatt, Wiesia ; Sarmiento, Rex ; Kent, Alissa ; Pearce, Jennifer ; Fok, Henry ; Wilson, Brad ; Turner, Jeremy ; Luck, Peter ; Norris, Karen ; Newport, Rachel ; Biagioni, Paul ; MacDonald, Jonathan ; Immanuel, Anita ; Evans, John ; Doyle, Katie ; Chilvers, Alison ; Townsend-Rose, Anna ; Haughney, John ; Mistry, Hema ; Muir, Scott ; Colling, Kerry ; Tuma, Eyad ; Torok-Pollok, Eva ; Brittain-Long, Robin ; Elnaggar, Mohamed ; Serrano, Sonia ; Goldsmith, Jaimie Wilson ; Boffito, Marta ; Calderwood, James ; Kalra, Philip A. ; Morselli, Franca ; Grundy, Lynne ; English, Beverley ; White, Beth ; Pandaan, Alice ; Mescall, Aoife ; Sanghera, Balraj ; Shaw, Steven ; Raguvanshi, Subhra ; Henshall, Catherine ; Rajeswaran, Thurkka ; Vilimiene, Neringa ; Galiza, Eva ; Gill, Harjeevan ; Peers, Anne-Marie ; Camilleri, Brian ; Cipriani, Andrea ; Jeanes, Christopher ; Sutton, Natalina ; Ewing, Jane ; Fofie, Hazel ; Cifuentes, Liliana ; McAuley, Daniel F. ; Housman, Rosalie ; Dent, Alexandra ; Mackay, Lynn ; Hombersley, Claire ; Longshaw, Laura ; Buazon, April ; Cooper, Alison ; Thomson, Emma C. ; Johnson, Alshia ; Chukwu, Chukwuma ; Pearce, Jasmine Marie ; Chudyk, Adrian ; Goddard, Suzanne ; Visick, Michael ; Champion, Adam ; Dewhurst, Matthew ; Rajaram, Sankarasubramanian ; McFarland, Margaret ; Helliwell, Toby ; Sparrow, Geoff ; Cicconi, Paola ; Pereira, Josyanne ; Beacon, Lynsey ; Lambley Burke, Ruth ; Byrne, Ruth ; Mathew, Moncy ; Todd, Shirley ; Robertson, Andreana ; Snashall, Emma ; Heinen, Anna ; Reid, Laura ; Jamal, Arham ; Wong, Zhi ; Bisnauthsing, Karen ; Pretswell, Carol H. ; Stewart, Jonathan ; Webb, Stewart ; Kara, Naveed ; Mohan, Mahalakshmi ; Davies, Francis ; Brown, Ellen ; Nicol, Amy ; Twigg, George ; Hughes, Kerry ; Cinardo, Paola ; Maclean, Kirsty ; Youle, Mike ; McKenna, Sonia ; Pacurar, Mihaela ; Marks, Georgina ; Ritchie, Neil ; Chowdhury, Marie ; Kyriakidou, Christina ; Clark, Rebecca ; Nago, Nyasha ; Hope, Suzy V. ; Sheridan, Ray P. ; Wilkins, Suzanne ; Mazzella, Andrea ; Broadhead, Samantha ; Regan, Karen ; Perkins, Jon ; Nandani, Aarti ; Movahedi, Roya ; Galloway, James ; O'Leary, Colin ; Cosgrove, Catherine ; Shaw, Sarah ; Brear, Lucy ; Harrison, Louise ; Katechia, Kashyap ; Osagie, Rawlings ; MacDonald, Orla ; Chenoweth, Helen ; Oliver, Robert ; Rowbotham, Bridie ; Kumar, Lakshmi ; Ikram, Sabina ; North, Janet M. ; Glenn, Greg ; Cooper, Chris ; Plested, Joyce S ; D'Allesandro, Mariella ; Hamblin, Mike ; Branch, Marie ; Murira, Jennifer ; Nathoo, Adil ; Bevan, Aisling ; Mullin, Melanie ; Osanlou, Rostam ; Edelman, Jonathan ; Browne, Duncan ; Bird, Georgie ; Dubovsky, Filip ; Jayatilleke, Thilina ; Valentine, Ruth ; Heath, Paul T ; Elliot-Garwood, Alison ; Glaves, Liz ; Ryan-Wakeling, Declan ; O'Kane, Maurice ; Stockport, Jane ; Ark, Rajiv ; Hoggarth, Thandiwe ; Hultin, Cecilia ; Munisamy, Malathy ; Lovatt, Martin ; Mutgi, Sanjay ; Cho, Iksung ; Cooney, Enya ; Hurducas, Claudia ; Cooper, Adele ; Saman, Razan ; Hayre, Rachel ; Iyengar, Shalini ; Graves-Jones, Alison ; Danos, Zsofia ; Swift, Pauline A ; Goodman, Anna L ; Williams, Claire ; Meyrick, Agnieszka ; Suggitt, Debbie ; Russell, Alice ; Stone, Mark ; Bukhari, Marwan ; Merrick, Blair ; Smith, Katharine A. ; Burden, Tom ; Mitchelmore, Philip J. ; Hill, Natalie ; Purandare, Laura ; Morley, Nick ; Coke, Lou ; Bremner, Laura ; Solomon, Danielle ; Rodolico, Lisa ; Parker, Angela ; Rivers, E Joy ; Smith, Karen ; Corrigan, Julie ; Davis, Jessica ; Shenoy, Anil ; Wright, John ; Edwards, Carole ; Storton, Kim ; Cutts, Rebecca ; Lillicrap, Caroline ; Han, Jennie ; Dhatariya, Ketan ; Scicluna, Chiara ; Bird, Olivia ; Carter, Justin ; Love-Rouse, Cathryn ; Freedman, Andrew ; Cheng, Zelda ; Collins, Katrina Lennon ; Minassian, Angela M ; Lee, Nathaniel ; Everden, Angharad ; Burns, Fiona ; Clinton, Alison ; Jackson, Matthew ; Lakeman, Nicki ; Beales, Emily ; Floyd, Hilary ; Cambell-Kelly, Melissa ; Baker, Helena ; O'Loughlin, Vikki ; Martin, Roisin ; Holliday, Kyra ; Weddell, Jake ; Heer, Amardeep ; Seenan, John Paul ; Richardson, Fiona ; Miller, Karen ; Cordle, Jessica ; Viljoen, Marianne Elizabeth ; Khan, Zara ; Burton, Katherine ; Giemza, Rafaela ; Dulawan, Pearl ; Osanlou, Orod ; Attenburrow, Mary-Jane ; Fielding, Kirsty ; Sudbury, James ; Faust, Saul N. ; Iqbal, Kinzah ; Thompson, Kim ; Hall, Alistair ; Wickens, Olivia ; Zadik, Jess ; Berry, Lisa ; Hopewell, Nancy ; Bird, Danielle ; Lunt, Craig Francis ; Mann, Sandra ; Jackson, Beth ; Essex, Sarah ; Mabesa, Fran ; Madge, Sara ; Littler, Olga ; Salkeld, Jo ; Gerdes, Leigh ; Hansel, Jan ; Bennett, Sara ; Nicholls, Helen ; Toback, Seth ; Price, Helen ; West, Raha ; Saralaya, Dinesh ; McKeon, Sean ; Barrett, Michael ; D'Alessandro, Mariella ; Wetherill, Bill ; Nagra, Deepak ; Moore, Patrick ; Villajin, John Lord ; Chadwick, David R. ; Soiza, Roy L. ; Chalk, Amanda ; Blacow, Rachel ; Trottier, Lauren ; Palmer, Natalie ; Heining, Dominic ; Mirza, Shahzeb ; Chicano, Rosavic ; Fox, Polly ; Yogo, Noah ; Keshet-Price, Jocelyn ; Saja, Khalid ; Smith, Richard ; San Francisco Ramos, Alberto ; Packham, Jonathan ; Gibson, Andy ; Trembath, Lisa ; Makanju, Esther ; Baxter, David Neil ; Munsoor, Imrozia ; Tunstall, Simon ; Lawrence, Heather ; Gan, Galvin ; Richards, Nick ; Houseman, Katy ; Sowole, Lucy ; Minton, Jane ; Wroe, Caroline ; Broad, Katharine Lucy ; Glover, Michelle ; Rudic, Milan ; Bradley, Judy ; Carr, Sharon ; Edwards, Paul ; Higham, Andrew ; Tucker, David ; Milinkovic, Ana ; Madden, Angelina ; Rosier, Josephine M.

BACKGROUNDThe safety and immunogenicity profile of COVID-19 vaccines when administered concomitantly with seasonal influenza vaccines have not yet been reported. We therefore aimed to report the results of a substudy within a phase 3 UK trial, by evaluating the safety, immunogenicity, and efficacy of NVX-CoV2373 when co-administered with licensed seasonal influenza vaccines.METHODSWe did a planned exploratory substudy as part of the randomised, observer-blinded, placebo-controlled, phase 3 trial of the safety and efficacy of the COVID-19 vaccine (NVX-CoV2373) by co-administrating the influenza vaccine at four study hospitals in the UK. Approximately, the first 400 participants meeting the main study entry criteria-with no contraindications to influenza vaccination-were invited to join the substudy. Participants of the main study were randomly assigned (1:1) to receive two intramuscular injections of either NVX-CoV2373 (5 μg) or placebo (normal saline) 21 days apart; participants enrolled into the substudy were co-vaccinated with a single (0·5 mL) intramuscular, age-appropriate (quadrivalent influenza cell-based vaccine [Flucelvax Quadrivalent; Seqirus UK, Maidenhead] for those aged 18-64 years and adjuvanted trivalent influenza vaccine [Fluad; Seqirus UK, Maidenhead] for those ≥65 years), licensed, influenza vaccine on the opposite deltoid to that of the first study vaccine dose or placebo. The influenza vaccine was administered in an open-label manner and at the same time as the first study injection. Reactogenicity was evaluated via an electronic diary for 7 days after vaccination in addition to monitoring for unsolicited adverse events, medically attended adverse events, and serious adverse events. Immunogenicity was assessed with influenza haemagglutination inhibition and SARS-CoV-2 anti-spike protein IgG assays. Vaccine efficacy against PCR-confirmed, symptomatic COVID-19 was assessed in participants who were seronegative at baseline, received both doses of study vaccine or placebo, had no major protocol deviations affecting the primary endpoint, and had no confirmed cases of symptomatic COVID-19 from the first dose until 6 days after the second dose (per-protocol efficacy population). Immunogenicity was assessed in participants who received scheduled two doses of study vaccine, had a baseline sample and at least one post-vaccination sample, and had no major protocol violations before unmasking (per-protocol immunogenicity population). Reactogenicity was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo and had data collected for reactogenicity events. Safety was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo. Comparisons were made between participants of the substudy and the main study (who were not co-vaccinated for influenza). This study is registered with ClinicalTrials.gov, number NCT04583995.FINDINGSBetween Sept 28, 2020, and Nov 28, 2020, a total of 15 187 participants were randomised into the main phase 3 trial, of whom 15 139 received treatment (7569 received dose one of NVX-CoV2373 and 7570 received dose one of placebo). 431 participants were co-vaccinated with a seasonal influenza vaccine in the substudy (217 received NVX-CoV2373 plus the influenza vaccine and 214 received placebo plus the influenza vaccine). In general, the substudy participants were younger, more racially diverse, and had fewer comorbid conditions than those in the main study. Reactogenicity events were more common in the co-administration group than in the NVX-CoV2373 alone group: tenderness (113 [64·9%] of 174 vs 592 [53·3%] of 1111) or pain (69 [39·7%] vs 325 [29·3%]) at injection site, fatigue (48 [27·7%] vs 215 [19·4%]), and muscle pain (49 [28·3%] vs 237 [21·4%]). Incidences of unsolicited adverse events, treatment-related medically attended adverse events, and serious adverse events were low and balanced between the co-administration group and the NVX-CoV2373 alone group. No episodes of anaphylaxis or deaths were reported within the substudy. Co-administration resulted in no change to influenza vaccine immune response although a reduction in antibody responses to the NVX-CoV2373 vaccine was noted. NVX-CoV2373 vaccine efficacy in the substudy (ie, participants aged 18 to <65 years) was 87·5% (95% CI -0·2 to 98·4) and in the main study was 89·8% (95% CI 79·7-95·5).INTERPRETATIONTo our knowledge, this substudy is the first to show the safety, immunogenicity, and efficacy profile of a COVID-19 vaccine when co-administered with seasonal influenza vaccines. Our results suggest concomitant vaccination might be a viable immunisation strategy.FUNDINGNovavax.

01 Nov 2020·Human Vaccines & ImmunotherapeuticsQ3 · MEDICINE

Safety and immunogenicity of a novel quadrivalent subunit influenza vaccine in animal models

Q3 · MEDICINE

Article

Author: Li, Jingxin ; Zhang, Yuhui ; Zhu, Fengcai ; Jia, Siyue ; Ye, Huayue

Background: Compared with trivalent influenza vaccines, quadrivalent influenza vaccines are expected to provide wider protection against influenza B virus infections. We developed a novel quadrivalent subunit influenza vaccine which was distinct from the influenza vaccines available on the market in production process. In this research, we evaluated the safety and immunogenicity of the quadrivalent subunit influenza vaccine in animal models. Methods: In toxicity assessment, 40 SD rats were randomly assigned to be intramuscularly injected with 1.0 ml of the tested vaccine (33 μg/ml) or 0.9% sodium chloride solution. In irritation assessment, eight rabbits were randomly assigned to receive 0.5 ml of tested vaccine or phosphate buffer solution intramuscularly. Thirty-two guinea pigs were randomly assigned to be intramuscularly injected with high-dose tested vaccine (0.5 ml), low-dose tested vaccine (0.05 ml), ovalbumin, or 0.9% sodium chloride solution, respectively, for sensitization assessment. In immunogenicity assessment, 50 BALB/c mice were equally randomized to receive one dose of tested vaccine, two doses of tested vaccine with an interval of 14 days, 0.5 ml of trivalent subunit influenza vaccine, 0.5 ml of monovalent subunit influenza vaccine, or 0.5 ml of phosphate buffer solution. Orbital blood was collected before and 28 and 42 days after administration of the injections for detecting influenza antibody titers. Results: No abnormal toxicity and irritation in rats and rabbits showed in the gross autopsy and histopathological examinations. The results of sensitization in guinea pigs indicated that no obvious allergic symptoms observed in the high-dose and low-dose vaccine groups within 30 min after twice provocations, and the result of sensitization evaluation was negative. Vaccine induced significant immune responses in mice with 100% seroconversion rates at 28 and 42 days after the first dose. The geometric mean titers (GMTs) of hemagglutination inhibition (HI) antibodies at day 28 in one-dose quadri-vaccine and two-dose quadri-vaccine groups were comparable to those in the tri-vaccine or mono-vaccine groups for shared influenza strains. However, the GMTs of HI antibodies against H1N1 (P = 0.025) and BV (P = 0.049) at day 42 in one-dose quadri-vaccine group were significantly lower than those in the tri-vaccine or mono-vaccine groups. The GMTs of HI antibodies against H1N1, H3N1, BY, and BV at day 28 and day 42 were comparable between one-dose quadri-vaccine and two-dose quadri-vaccine groups. Conclusions: The quadrivalent subunit influenza vaccine was safe and immunogenic in animal models. One dose of the vaccine could elicit a satisfactory antibody response in mice.

100 Deals associated with Quadrivalent Subunit Influenza Vaccine(Ab&b Bio-Tech)

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Influenza, Human	CN	Jiangsu Zhonghui Yuantong Biological Technology Co., Ltd.Startup	12 May 2023

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