INAVAC Vaccine Phase III (Immunobridging Study) in Healthy Population Aged 12 to 17 Years Old

NCT06282692 | Recruiting Phase 3 DMC

• 1 other identifier: UNAIR-MP-INAKTIF-R-005
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval. All subjects will be followed for 12 months. INAVAC is an inactivated vaccine made of SARS-CoV-2 virus isolated from a patient in Surabaya, composed with aluminium hydroxy gel, tween 80, and L-histidine, and this study will be the first phase III in adolescents.

Conditions

COVID-19 Pandemic; COVID-19 Vaccines

Keywords

Inactivated COVID-1 9 Vaccine; Immunogenicity; Safety; COVID-19; Indonesia; Immunobridging Study

Outcome Measures

Primary Outcomes (1)

• Vaccine Neutralizing Antibody Profile

  SARS-CoV-2 neutralizing titers in serum measured by a virus neutralization assay, at 28 days after two doses vaccination of INAVAC in healthy adolescents age 12 to 17 years old, compared with previous results in adults with two doses of similar vaccine (phase 3 in adults).

  28 days after two doses vaccination of INAVAC.

Secondary Outcomes (6)

• Incidence of Adverse Events

  30 minutes, 24 hours, 7 and 28 days following the first dose and 30 minutes, 24 hours, 7 and 28 days, 3, 6 and 12 months after the second doses of INAVAC

• Humoral Immunogenicity - The Neutralizing Antibody Titers in Serum

  3, 6, and 12 months, following vaccination with two doses of INAVAC

• Humoral Immunogenicity - Levels of SARS-CoV-2 Binding Antibodies by CLIA

  28 days, 3, 6, and 12 months after the second vaccination of INAVAC

• Cellular Immunogenicity Profile

  28 days, 3, 6, and 12 months, following vaccination with two doses of INAVAC

• Persistence of Antibody Level

  12 months after the second injection

Study Arms (1)

Experimental:

EXPERIMENTAL

INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg Study product are provided in the form of liquid in vial single dose (0.5 ml). The vaccine will be given 1 dose (0.5 ml) twice.

Biological: INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg

Interventions

INAVAC (Vaksin Merah Putih - UA-SARS CoV-2 (Vero Cell Inactivated) 5 µg BIOLOGICAL

Dose : 1 dose 0.5 ml containing 5 µg inactivated SARS-CoV-2 virus, Tween 80, histidine, Polysorbate 80, Aluminium hydroxide gel, and sodium chloride.

Experimental:

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy adolescents, age 12 to 17 years old, males and females. Healthy status will be determined by the investigator based on medical history, clinical laboratory results, vital sign measurements, and physical examination at screening.
• Subjects and the parents or guardians have been informed properly regarding the study and signed the informed consent and assent forms
• Subject and the parents or guardians will commit to comply with the instructions of the investigator and the schedule of the trial
• Participants agree not to donate bone marrow, blood, and blood products from the first study vaccine administration until 3 months after receiving the last dose of study vaccine.
• Subjects and the parents or guardians must be willing to provide verifiable identification, has means to be contacted and to contact the investigator during the study.

You may not qualify if:

• Subjects concomitantly enrolled or scheduled to be enrolled in another vaccine trial
• Evolving mild, moderate, and severe illness, especially infectious diseases or fever (axillary temperature 37.5oC or more) concurrent or within 7 days prior to first study vaccination. This includes respiratory or constitutional symptms consistent with SARS-CoV-2 (cough, sore throat, difficulty in breathing, etc)
• Known history of allergy to any component of the vaccines
• History of uncontrolled coagulopathy or blood disorders contraindicating intramuscular injection
• Any autoimmune or immunodeficiency disease/condition
• Subjects who have received in the previous 4 weeks a treatment likely to alter the immune response (intravenous immunoglobulin, blood derived products, long term corticosteroid - more than 2 weeks, and so on), OR anticipation of the need for immunosuppressive treatment within 6 months after last vaccination. The use of topical or nasal steroid will be permitted.
• Unstable chronic disease, inclusive of uncontrolled hypertension, congestive heart failure, chronic obstructive pulmonary disease, asthma, chronic urticaria, diabetes requiring use of medicine. The final decision regarding this condition will be decided by the attending field clinicians or investigator.
• Any abnormality or chronic disease which according to the investigator might interfere with the assessment of the trial objectives
• Individuals who previously receive any vaccines against Covid-19
• Subjects already immunized with any vaccine within 4 weeks prior and expect to receive other vaccines within 60 days following the first dose
• Individuals who have a previously ascertained Covid-19 in the period of 1 month (for mild, moderate, or asymptomatic people) or 3 months (for severe Covid-19) before the first recruit of this study, or in a close contact in the last 14 days with confirmed case of Covid-19.
• Positive test for SARS-CoV-2 (Antigen test or, if necessary, PCR test) at screening prior to first vaccination. Testing may be repeated during the screening period if exposure to positive confirmed case of SARS-CoV-2 is suspected, at the discretion of investigator.
• Alcohol or substance abuse
• HIV patients.
• Malignancy patients within 2 years prior to first study vaccination.

Sponsors & Collaborators

• Dr. Soetomo General Hospital: lead
• Indonesia-MoH: collaborator
• Universitas Airlangga: collaborator
• PT Biotis Pharmaceuticals, Indonesia: collaborator

Study Sites (1)

Dr. Soetomo General Hospital

Surabaya, East Java, 67161, Indonesia

RECRUITING

Related Publications (55)

• Wang C, Wang Z, Wang G, Lau JY, Zhang K, Li W. COVID-19 in early 2021: current status and looking forward. Signal Transduct Target Ther. 2021 Mar 8;6(1):114. doi: 10.1038/s41392-021-00527-1.

  PMID: 33686059 BACKGROUND

• Noh JY, Song JY, Yoon JG, Seong H, Cheong HJ, Kim WJ. Safe hospital preparedness in the era of COVID-19: The Swiss cheese model. Int J Infect Dis. 2020 Sep;98:294-296. doi: 10.1016/j.ijid.2020.06.094. Epub 2020 Jun 30.

  PMID: 32619759 BACKGROUND

• New York Vaccine Tracker. Downloaded from https://www.nytimes.com/interactive/2020/science/coronavirus-vaccinetracker.html. Accessed 11 April 2022.

  BACKGROUND

• Badan POM Republik Indonesia. Dowloaded from https://www.pom.go.id/new/view/more/pers/605/Pastikan-Keamanan-danMutu-Vaksin---Badan-POM-Kawal-Uji-Klinik-Vaksin-Merah-Putih.html. Accessed 11 October 2021.

  BACKGROUND

• Irwin A. What it will take to vaccinate the world against COVID-19. Nature. 2021 Apr;592(7853):176-178. doi: 10.1038/d41586-021-00727-3. No abstract available.

  PMID: 33767468 BACKGROUND

• So AD, Woo J. Reserving coronavirus disease 2019 vaccines for global access: cross sectional analysis. BMJ. 2020 Dec 15;371:m4750. doi: 10.1136/bmj.m4750.

  PMID: 33323376 BACKGROUND

• Worldometer coronavirus cases. Downloaded from https://www.worldometers.info/coronavirus/. Accessed 11 October 2021.

  BACKGROUND

• Biswas M, Rahaman S, Biswas TK, Haque Z, Ibrahim B. Association of Sex, Age, and Comorbidities with Mortality in COVID-19 Patients: A Systematic Review and Meta-Analysis. Intervirology. 2020 Dec 9:1-12. doi: 10.1159/000512592. Online ahead of print.

  PMID: 33296901 BACKGROUND

• Satuan Tugas Penanganan Covid-19. Downloaded from https://covid19.go.id/petasebaran. Accessed 11 October 2021

  BACKGROUND

• Cirrincione L, Plescia F, Ledda C, Rapisarda V, Martorana D, Moldovan RE, Theodoridou K, Cannizzaro E. COVID-19 Pandemic: Prevention and Protection Measures to Be Adopted at the Workplace. Sustainability 2020; 12: 3603

  BACKGROUND

• Bloomberg. Downloaded from https://www.bloomberg.com/graphics/covidresilience-ranking/. Accessed 11 October 2021.

  BACKGROUND

• Polack FP, Thomas SJ, Kitchin N, Absalon J, Gurtman A, Lockhart S, Perez JL, Perez Marc G, Moreira ED, Zerbini C, Bailey R, Swanson KA, Roychoudhury S, Koury K, Li P, Kalina WV, Cooper D, Frenck RW Jr, Hammitt LL, Tureci O, Nell H, Schaefer A, Unal S, Tresnan DB, Mather S, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591001 Clinical Trial Group. Safety and Efficacy of the BNT162b2 mRNA Covid-19 Vaccine. N Engl J Med. 2020 Dec 31;383(27):2603-2615. doi: 10.1056/NEJMoa2034577. Epub 2020 Dec 10.

  PMID: 33301246 BACKGROUND

• Baden LR, El Sahly HM, Essink B, Kotloff K, Frey S, Novak R, Diemert D, Spector SA, Rouphael N, Creech CB, McGettigan J, Khetan S, Segall N, Solis J, Brosz A, Fierro C, Schwartz H, Neuzil K, Corey L, Gilbert P, Janes H, Follmann D, Marovich M, Mascola J, Polakowski L, Ledgerwood J, Graham BS, Bennett H, Pajon R, Knightly C, Leav B, Deng W, Zhou H, Han S, Ivarsson M, Miller J, Zaks T; COVE Study Group. Efficacy and Safety of the mRNA-1273 SARS-CoV-2 Vaccine. N Engl J Med. 2021 Feb 4;384(5):403-416. doi: 10.1056/NEJMoa2035389. Epub 2020 Dec 30.

  PMID: 33378609 BACKGROUND

• Voysey M, Clemens SAC, Madhi SA, Weckx LY, Folegatti PM, Aley PK, Angus B, Baillie VL, Barnabas SL, Bhorat QE, Bibi S, Briner C, Cicconi P, Collins AM, Colin-Jones R, Cutland CL, Darton TC, Dheda K, Duncan CJA, Emary KRW, Ewer KJ, Fairlie L, Faust SN, Feng S, Ferreira DM, Finn A, Goodman AL, Green CM, Green CA, Heath PT, Hill C, Hill H, Hirsch I, Hodgson SHC, Izu A, Jackson S, Jenkin D, Joe CCD, Kerridge S, Koen A, Kwatra G, Lazarus R, Lawrie AM, Lelliott A, Libri V, Lillie PJ, Mallory R, Mendes AVA, Milan EP, Minassian AM, McGregor A, Morrison H, Mujadidi YF, Nana A, O'Reilly PJ, Padayachee SD, Pittella A, Plested E, Pollock KM, Ramasamy MN, Rhead S, Schwarzbold AV, Singh N, Smith A, Song R, Snape MD, Sprinz E, Sutherland RK, Tarrant R, Thomson EC, Torok ME, Toshner M, Turner DPJ, Vekemans J, Villafana TL, Watson MEE, Williams CJ, Douglas AD, Hill AVS, Lambe T, Gilbert SC, Pollard AJ; Oxford COVID Vaccine Trial Group. Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK. Lancet. 2021 Jan 9;397(10269):99-111. doi: 10.1016/S0140-6736(20)32661-1. Epub 2020 Dec 8.

  PMID: 33306989 BACKGROUND

• Our world in Data. Downloaded from https://ourworldindata.org/covidvaccinations. Accessed 11 April 2022.

  BACKGROUND

• CNN. Downloaded from https://edition.cnn.com/2021/04/03/health/uscoronavirus-saturday/index.html. Accessed 11 October 2021.

  BACKGROUND

• World Health Organization. Downloaded from https://www.who.int/newsroom/feature-stories/detail/vaccine-efficacy-effectiveness-and-protection. Accessed 11 October 2021.

  BACKGROUND

• Palacios R, Patino EG, de Oliveira Piorelli R, Conde MTRP, Batista AP, Zeng G, Xin Q, Kallas EG, Flores J, Ockenhouse CF, Gast C. Double-Blind, Randomized, Placebo-Controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of treating Healthcare Professionals with the Adsorbed COVID-19 (Inactivated) Vaccine Manufactured by Sinovac - PROFISCOV: A structured summary of a study protocol for a randomised controlled trial. Trials. 2020 Oct 15;21(1):853. doi: 10.1186/s13063-020-04775-4.

  PMID: 33059771 BACKGROUND

• Tanriover MD, Doganay HL, Akova M, Guner HR, Azap A, Akhan S, Kose S, Erdinc FS, Akalin EH, Tabak OF, Pullukcu H, Batum O, Simsek Yavuz S, Turhan O, Yildirmak MT, Koksal I, Tasova Y, Korten V, Yilmaz G, Celen MK, Altin S, Celik I, Bayindir Y, Karaoglan I, Yilmaz A, Ozkul A, Gur H, Unal S; CoronaVac Study Group. Efficacy and safety of an inactivated whole-virion SARS-CoV-2 vaccine (CoronaVac): interim results of a double-blind, randomised, placebo-controlled, phase 3 trial in Turkey. Lancet. 2021 Jul 17;398(10296):213-222. doi: 10.1016/S0140-6736(21)01429-X. Epub 2021 Jul 8.

  PMID: 34246358 BACKGROUND

• Reuters. Downloaded from https://www.reuters.com/business/healthcarepharmaceuticals/indonesia-study-finds-chinas-sinovac-covid-19-vaccine-effectivemedical-staff-2021-05-12/. Accessed 11 October 2021

  BACKGROUND

• Al Kaabi N, Zhang Y, Xia S, Yang Y, Al Qahtani MM, Abdulrazzaq N, Al Nusair M, Hassany M, Jawad JS, Abdalla J, Hussein SE, Al Mazrouei SK, Al Karam M, Li X, Yang X, Wang W, Lai B, Chen W, Huang S, Wang Q, Yang T, Liu Y, Ma R, Hussain ZM, Khan T, Saifuddin Fasihuddin M, You W, Xie Z, Zhao Y, Jiang Z, Zhao G, Zhang Y, Mahmoud S, ElTantawy I, Xiao P, Koshy A, Zaher WA, Wang H, Duan K, Pan A, Yang X. Effect of 2 Inactivated SARS-CoV-2 Vaccines on Symptomatic COVID-19 Infection in Adults: A Randomized Clinical Trial. JAMA. 2021 Jul 6;326(1):35-45. doi: 10.1001/jama.2021.8565.

  PMID: 34037666 BACKGROUND

• Kyriakidis NC, Lopez-Cortes A, Gonzalez EV, Grimaldos AB, Prado EO. SARS-CoV-2 vaccines strategies: a comprehensive review of phase 3 candidates. NPJ Vaccines. 2021 Feb 22;6(1):28. doi: 10.1038/s41541-021-00292-w.

  PMID: 33619260 BACKGROUND

• Mendonca SA, Lorincz R, Boucher P, Curiel DT. Adenoviral vector vaccine platforms in the SARS-CoV-2 pandemic. NPJ Vaccines. 2021 Aug 5;6(1):97. doi: 10.1038/s41541-021-00356-x.

  PMID: 34354082 BACKGROUND

• Yadav T, Srivastava N, Mishra G, Dhama K, Kumar S, Puri B, Saxena SK. Recombinant vaccines for COVID-19. Hum Vaccin Immunother. 2020 Dec 1;16(12):2905-2912. doi: 10.1080/21645515.2020.1820808. Epub 2020 Nov 24.

  PMID: 33232211 BACKGROUND

• Pollard AJ, Bijker EM. A guide to vaccinology: from basic principles to new developments. Nat Rev Immunol. 2021 Feb;21(2):83-100. doi: 10.1038/s41577-020-00479-7. Epub 2020 Dec 22.

  PMID: 33353987 BACKGROUND

• Excler JL, Saville M, Berkley S, Kim JH. Vaccine development for emerging infectious diseases. Nat Med. 2021 Apr;27(4):591-600. doi: 10.1038/s41591-021-01301-0. Epub 2021 Apr 12.

  PMID: 33846611 BACKGROUND

• Bhattacharya S, Dasgupta R. Smallpox and polio eradication in India: comparative histories and lessons for contemporary policy. Cien Saude Colet. 2011 Feb;16(2):433-44. doi: 10.1590/s1413-81232011000200007.

  PMID: 21340319 BACKGROUND

• CNN Indonesia. Downloaded from https://www.cnnindonesia.com/ekonomi/20210615172504-92-654688/bio-farmayakin-ri-bisa-dapat-400-juta-dosis-vaksin-tahun-ini. Accessed 111 October 2021.

  BACKGROUND

• Suara.com. Downloaded from https://www.suara.com/bisnis/2020/11/06/151502/ini-6-lembaga-yangkembangkan-vaksin-merah-putih. Accessed 11 October 2021.

  BACKGROUND

• World Health Organization. Considerations of evaluation of Covid-19 vaccines. Revised. Version of 30 March 2022. Geneva: WHO, 2021.

  BACKGROUND

• Wang K, Jia Z, Bao L, et al. A subset of Memory B-derived antibody repertoire from 3-dose vaccinees is ultrapotent against diverse and highly transmissible SARS-CoV-2 variants, including Omicron. BioRXiv 2021; doi: https://doi.org/10.1101/2021.12.24.474084;

  BACKGROUND

• Jara A, Undurraga EA, Gonzalez C, Paredes F, Fontecilla T, Jara G, Pizarro A, Acevedo J, Leo K, Leon F, Sans C, Leighton P, Suarez P, Garcia-Escorza H, Araos R. Effectiveness of an Inactivated SARS-CoV-2 Vaccine in Chile. N Engl J Med. 2021 Sep 2;385(10):875-884. doi: 10.1056/NEJMoa2107715. Epub 2021 Jul 7.

  PMID: 34233097 BACKGROUND

• Fonseca MHG, de Souza TFG, de Carvalho Araujo FM, de Andrade LOM. Dynamics of antibody response to CoronaVac vaccine. J Med Virol. 2022 May;94(5):2139-2148. doi: 10.1002/jmv.27604. Epub 2022 Jan 28.

  PMID: 35060174 BACKGROUND

• Mascellino MT, Di Timoteo F, De Angelis M, Oliva A. Overview of the Main Anti-SARS-CoV-2 Vaccines: Mechanism of Action, Efficacy and Safety. Infect Drug Resist. 2021 Aug 31;14:3459-3476. doi: 10.2147/IDR.S315727. eCollection 2021.

  PMID: 34511939 BACKGROUND

• Prubeta BM. Current State of the First COVID-19 Vaccines. Vaccines (Basel). 2021 Jan 8;9(1):30. doi: 10.3390/vaccines9010030.

  PMID: 33429880 BACKGROUND

• Mallapaty S. China's COVID vaccines have been crucial - now immunity is waning. Nature. 2021 Oct;598(7881):398-399. doi: 10.1038/d41586-021-02796-w. No abstract available.

  PMID: 34650240 BACKGROUND

• Fadlyana E, Rusmil K, Tarigan R, Rahmadi AR, Prodjosoewojo S, Sofiatin Y, Khrisna CV, Sari RM, Setyaningsih L, Surachman F, Bachtiar NS, Sukandar H, Megantara I, Murad C, Pangesti KNA, Setiawaty V, Sudigdoadi S, Hu Y, Gao Q, Kartasasmita CB. A phase III, observer-blind, randomized, placebo-controlled study of the efficacy, safety, and immunogenicity of SARS-CoV-2 inactivated vaccine in healthy adults aged 18-59 years: An interim analysis in Indonesia. Vaccine. 2021 Oct 22;39(44):6520-6528. doi: 10.1016/j.vaccine.2021.09.052. Epub 2021 Sep 24.

  PMID: 34620531 BACKGROUND

• Dinc HO, Saltoglu N, Can G, Balkan II, Budak B, Ozbey D, Caglar B, Karaali R, Mete B, Tuyji Tok Y, Ersoy Y, Ahmet Kuskucu M, Midilli K, Ergin S, Kocazeybek BS. Inactive SARS-CoV-2 vaccine generates high antibody responses in healthcare workers with and without prior infection. Vaccine. 2022 Jan 3;40(1):52-58. doi: 10.1016/j.vaccine.2021.11.051. Epub 2021 Nov 22.

  PMID: 34839992 BACKGROUND

• Guzel EC, Celikkol A, Erdal B, Sedef N. Immunogenicity after CoronaVac vaccination. Rev Assoc Med Bras (1992). 2021 Oct;67(10):1403-1408. doi: 10.1590/1806-9282.20210389.

  PMID: 35018966 BACKGROUND

• Palacios R, Batista AP, Albuquerque, et al. Efficacy and Safety of a COVID-19 Inactivated Vaccine in Healthcare Professionals in Brazil: The PROFISCOV Study. SSRN 2021; Accessed 3 June 2022. Downoaded at: https://deliverypdf.ssrn.com/delivery.php?ID=840017005024119064102107098125 11906903501500902000007511010309309600701707412300401002803210012605 40480091071111150880671220840550440900110641010140001211230940790260 90054017013015119014069102013003005084113002106123108105096064121107 008029000084020104&EXT=pdf&INDEX=TRUE.

  BACKGROUND

• Escobar A, Reyes-Lopez FE, Acevedo ML, Alonso-Palomares L, Valiente-Echeverria F, Soto-Rifo R, Portillo H, Gatica J, Flores I, Nova-Lamperti E, Barrera-Avalos C, Bono MR, Vargas L, Simon V, Leiva-Salcedo E, Vial C, Hormazabal J, Cortes LJ, Valdes D, Sandino AM, Imarai M, Acuna-Castillo C. Evaluation of the Immune Response Induced by CoronaVac 28-Day Schedule Vaccination in a Healthy Population Group. Front Immunol. 2022 Jan 31;12:766278. doi: 10.3389/fimmu.2021.766278. eCollection 2021.

  PMID: 35173705 BACKGROUND

• Hitchings MDT, Ranzani OT, Torres MSS, de Oliveira SB, Almiron M, Said R, Borg R, Schulz WL, de Oliveira RD, da Silva PV, de Castro DB, Sampaio VS, de Albuquerque BC, Ramos TCA, Fraxe SHH, da Costa CF, Naveca FG, Siqueira AM, de Araujo WN, Andrews JR, Cummings DAT, Ko AI, Croda J. Effectiveness of CoronaVac among healthcare workers in the setting of high SARS-CoV-2 Gamma variant transmission in Manaus, Brazil: A test-negative case-control study. Lancet Reg Health Am. 2021 Sep;1:100025. doi: 10.1016/j.lana.2021.100025. Epub 2021 Jul 25.

  PMID: 34386791 BACKGROUND

• De Faria E, Guedes AR, Oliveira MS, et al. Performance of vaccination with CoronaVac in a cohort of healthcare workers (HCW) - preliminary report. MedRXiv 2021; https://doi.org/10.1101/2021.04.12.21255308

  BACKGROUND

• Ranzani OT, Hitchings MDT, Dorion M, D'Agostini TL, de Paula RC, de Paula OFP, Villela EFM, Torres MSS, de Oliveira SB, Schulz W, Almiron M, Said R, de Oliveira RD, Vieira da Silva P, de Araujo WN, Gorinchteyn JC, Andrews JR, Cummings DAT, Ko AI, Croda J. Effectiveness of the CoronaVac vaccine in older adults during a gamma variant associated epidemic of covid-19 in Brazil: test negative case-control study. BMJ. 2021 Aug 20;374:n2015. doi: 10.1136/bmj.n2015.

  PMID: 34417194 BACKGROUND

• Soto JA, Melo-Gozales F, Gutierrez-Vera C, et al. An inactivated SARS-CoV-2 vaccine is safe and induces humoral and cellular immunity against virus variants in healthy children and adolescents in Chile. MedRXiv 2021; https://doi.org/10.1101/2022.02.15.22270973;

  BACKGROUND

• Schultz BM, Melo-Gonzales, Duarte LF, et al. A booster dose of an inactivated SARS-1 CoV-2 vaccine increases neutralizing antibodies and T cells that recognize Delta and Omicron variants of concern. MedRXiv 2021; https://doi.org/10.1101/2021.11.16.21266350

  BACKGROUND

• Joko Widodo gets first Sinovac vaccine shot as Indonesia starts mass Covid-19 inoculations. South China Morning Post. Accessed 3 June 2022. Downloaded at: https://www.scmp.com/video/coronavirus/3117548/joko-widodo-gets-first-sinovacvaccine-shot-indonesia-starts-mass-covid

  BACKGROUND

• Peng Q, Zhou R, Wang Y, Zhao M, Liu N, Li S, Huang H, Yang D, Au KK, Wang H, Man K, Yuen KY, Chen Z. Waning immune responses against SARS-CoV-2 variants of concern among vaccinees in Hong Kong. EBioMedicine. 2022 Mar;77:103904. doi: 10.1016/j.ebiom.2022.103904. Epub 2022 Mar 3.

  PMID: 35248996 BACKGROUND

• Chen F, He Y, Shi Y. Parents' and Guardians' Willingness to Vaccinate Their Children against COVID-19: A Systematic Review and Meta-Analysis. Vaccines (Basel). 2022 Jan 24;10(2):179. doi: 10.3390/vaccines10020179.

  PMID: 35214638 BACKGROUND

• Walter EB, Talaat KR, Sabharwal C, Gurtman A, Lockhart S, Paulsen GC, Barnett ED, Munoz FM, Maldonado Y, Pahud BA, Domachowske JB, Simoes EAF, Sarwar UN, Kitchin N, Cunliffe L, Rojo P, Kuchar E, Ramet M, Munjal I, Perez JL, Frenck RW Jr, Lagkadinou E, Swanson KA, Ma H, Xu X, Koury K, Mather S, Belanger TJ, Cooper D, Tureci O, Dormitzer PR, Sahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Evaluation of the BNT162b2 Covid-19 Vaccine in Children 5 to 11 Years of Age. N Engl J Med. 2022 Jan 6;386(1):35-46. doi: 10.1056/NEJMoa2116298. Epub 2021 Nov 9.

  PMID: 34752019 BACKGROUND

• Ali K, Berman G, Zhou H, Deng W, Faughnan V, Coronado-Voges M, Ding B, Dooley J, Girard B, Hillebrand W, Pajon R, Miller JM, Leav B, McPhee R. Evaluation of mRNA-1273 SARS-CoV-2 Vaccine in Adolescents. N Engl J Med. 2021 Dec 9;385(24):2241-2251. doi: 10.1056/NEJMoa2109522. Epub 2021 Aug 11.

  PMID: 34379915 BACKGROUND

• Han B, Song Y, Li C, Yang W, Ma Q, Jiang Z, Li M, Lian X, Jiao W, Wang L, Shu Q, Wu Z, Zhao Y, Li Q, Gao Q. Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine (CoronaVac) in healthy children and adolescents: a double-blind, randomised, controlled, phase 1/2 clinical trial. Lancet Infect Dis. 2021 Dec;21(12):1645-1653. doi: 10.1016/S1473-3099(21)00319-4. Epub 2021 Jun 28.

  PMID: 34197764 BACKGROUND

• Chinadaily. Downloaded from: https://www.chinadaily.com.cn/a/202107/20/WS60f60b13a310efa1bd662ea4.html. Accessed at 30 April 2022

  BACKGROUND

• Pfizer. Dowloaded from: https://www.pfizer.com/news/press-release/press-releasedetail/pfizer-and-biontech-provide-update-rolling-submission. Accessed at 30 April 2022.

  BACKGROUND

• NBC. Downloaded from: https://www.nbcnews.com/health/health-news/modernaasks-fda-authorize-covid-vaccine-children-6-rcna25816. Accessed at 30 April 2022.

  BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

vaksin merah putih - UA SARS-CoV-2 COVID-19 vaccine

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Dominicus Husada, MD

  Dr. Soetomo General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dominicus Husada, MD

CONTACT

+6281 232266377; dominicushusada@yahoo.com

Damayanti Tinduh, MD

CONTACT

+6281 703293335; damayanti.tinduh@fk.unair.ac.id

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Masking Details: This is an open label, phase III trial - immunobridging study. There will be only 1 group in the study. All subjects (12 to 17 years old) will receive INAVAC 5 µg dose. The vaccine will be administered with 2-dose schedule, intramuscularly, with 28 day interval.
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 21, 2023
• First Posted: February 28, 2024
• Study Start: June 19, 2023
• Primary Completion: May 19, 2024
• Study Completion: July 19, 2024
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)