Study to Evaluate the Safety, Tolerability, and Immunogenicity of an RNA Vaccine Candidate Against COVID-19 in Healthy Children

Summary

This is a Phase 1/2/3 study in healthy children. Dependent upon safety and/or immunogenicity data generated during the course of this study, and the resulting assessment of benefit-risk, the safety, tolerability, and immunogenicity of BNT162b2 in participants \<6 months of age may subsequently be evaluated.

Timeline

Start

2021-03-24

Primary completion

2023-10-04

Completion

2023-12-08

Publications

• Pather S, Charpentier N, van den Ouweland F, Rizzi R, Finlayson A, Salisch N, Muik A, Lindemann C, Khanim R, Abduljawad S, Smith ER, Gurwith M, Chen RT; Benefit-Risk Assessment of VAccines by TechnolOgy Working Group (BRAVATO; ex-V3SWG). A Brighton Collaboration standardized template with key considerations for a benefit-risk assessment for the Comirnaty COVID-19 mRNA vaccine. Vaccine. 2024 Sep 17;42(22):126165. doi: 10.1016/j.vaccine.2024.126165. Epub 2024 Aug 27.
• Simoes EAF, Klein NP, Sabharwal C, Gurtman A, Kitchin N, Ukkonen B, Korbal P, Zou J, Xie X, Sarwar UN, Xu X, Lockhart S, Cunliffe L, Lu C, Ma H, Swanson KA, Koury K, Shi PY, Cooper D, Tureci Ӧ, Jansen KU, Sahin U, Gruber WC. Immunogenicity and Safety of a Third COVID-19 BNT162b2 mRNA Vaccine Dose in 5- to 11-Year Olds. J Pediatric Infect Dis Soc. 2023 Apr 28;12(4):234-238. doi: 10.1093/jpids/piad015.
• Munoz FM, Sher LD, Sabharwal C, Gurtman A, Xu X, Kitchin N, Lockhart S, Riesenberg R, Sexter JM, Czajka H, Paulsen GC, Maldonado Y, Walter EB, Talaat KR, Englund JA, Sarwar UN, Hansen C, Iwamoto M, Webber C, Cunliffe L, Ukkonen B, Martinez SN, Pahud BA, Munjal I, Domachowske JB, Swanson KA, Ma H, Koury K, Mather S, Lu C, Zou J, Xie X, Shi PY, Cooper D, Tureci O, Sahin U, Jansen KU, Gruber WC; C4591007 Clinical Trial Group. Evaluation of BNT162b2 Covid-19 Vaccine in Children Younger than 5 Years of Age. N Engl J Med. 2023 Feb 16;388(7):621-634. doi: 10.1056/NEJMoa2211031.
• 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.

Drugs

Indications