Inlive (enterovirus type 71 vaccine（Vero Cell), inactivated) / Sinovac - LARVOL DELTA

Long-term protection of an inactivated enterovirus type 71 vaccine against hand, foot, and mouth diseases in children: a modelling study. (PubMed, Vaccine) - "Under the current EV71 epidemic conditions in China, the two-dose regimen of the inactivated EV71 vaccine provides durable protection exceeding 72% for at least 20 years."

Journal

Evaluation of immunity persistences of different enterovirus A71 vaccine in healthy infants and young children aged 6-35 months (PubMed, Zhonghua Liu Xing Bing Xue Za Zhi) - "There was no significant difference in neutralizing antibody GMT among the four groups 3 years later, but there was significant difference in neutralizing antibody GMT 5 years later (P<0.001). The immunity induced by different EV-A71 vaccines has good persistence within 5 years after full vaccination."

Journal

Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial (clinicaltrials.gov) - P1/2 | N=744 | Active, not recruiting | Sponsor: Sinovac Biotech Co., Ltd | Recruiting ➔ Active, not recruiting | Trial completion date: Apr 2025 ➔ Mar 2026 | Trial primary completion date: Dec 2024 ➔ Dec 2025

Enrollment closed • Trial completion date • Trial primary completion date

Impact-CML: Indian multicentric data supporting safe pregnancy and molecular control in women with chronic myeloid leukemia (ASH 2025) - "Most women (N=45, 90%) were on Imatinib, and the rest on Dasatinib...Rates of spontaneous abortions were not higher than published data in the generalpopulation, highlighting the potential to reduce physician-advised MTPs in this setting. Our data indicatespotentially safe outcomes in pregnant women with CML with pre-conception planning and subsequentmonitoring."

Clinical • Chronic Myeloid Leukemia • Hematological Malignancies • Hypertension • Leukemia • Long-acting Reversible Contraceptives • Obstetrics • Postpartum Hemorrhage

Pregnancy outcomes in women conceiving after HSCT for childhood or adolescent leukemia (ASH 2025) - "High-dose alkylating-agent conditioning yielded maternal and perinatal outcomes similar toconventional chemotherapy, countering prevailing concerns derived from reduced uterine volume seenon imaging. In contrast, TBI markedly compromises later reproductive success and amplifies obstetricand perinatal risks, so pregnancies in these survivors should be managed in tertiary-level high-risk units.Routine reproductive guidance remains essential, because nearly one in six HSCT pregnancies wasunintended, demonstrating that residual fertility—although unpredictable—persists even in women withprior ovarian failure. These data may inform reproductive counseling and obstetric surveillance in femaleleukemia survivors treated with HSCT during childhood and adolescence."

Clinical • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Leukemia • Obstetrics • Postpartum Hemorrhage • Women's Health

Clinical Trial for Batch Consistency of EV71 Vaccine (clinicaltrials.gov) - P4 | N=720 | Completed | Sponsor: Sinovac Biotech Co., Ltd

New P4 trial

Development of In Vitro Potency Methods to Replace In Vivo Tests for Enterovirus 71 Inactivated Vaccine (Human Diploid Cell-Based/Vero Cell-Based). (PubMed, Vaccines (Basel)) - "Based on conformational epitope-targeting neutralizing MAbs, manufacturer-specific IVRP methods, which were sensitive to process variations and correlated with in vivo results, have been established. IVRP methods provide a reliable, animal-free alternative for EV71 vaccine batch release."

Journal • Preclinical

Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell) (clinicaltrials.gov) - P3 | N=8000 | Recruiting | Sponsor: Sinovac Biotech Co., Ltd | Not yet recruiting ➔ Recruiting

Enrollment open

Efficacy, Safety, and Immunogenicity of the Bivalent Inactivated Enterovirus Vaccine (Vero Cell) (clinicaltrials.gov) - P3 | N=8000 | Not yet recruiting | Sponsor: Sinovac Biotech Co., Ltd

New P3 trial

Immunogenicity and safety of an inactivated COVID-19 vaccine (CoronaVac®) co-administered with an inactivated enterovirus type 71 vaccine (Inlive®): A phase 4, randomized, controlled trial. (PubMed, Hum Vaccin Immunother) - P4 | "NCT04993365 (ClinicalTrials.gov)."

Journal • P4 data • Infectious Disease • Novel Coronavirus Disease

PRO-nCOV-4002: Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell) (clinicaltrials.gov) - P4 | N=520 | Completed | Sponsor: Sinovac Research and Development Co., Ltd. | Suspended ➔ Completed

Trial completion • Infectious Disease • Novel Coronavirus Disease

Inactivated Bivalent Enterovirus Vaccine (Vero Cell) Phase I/II Clinical Trial (clinicaltrials.gov) - P1/2 | N=744 | Recruiting | Sponsor: Sinovac Biotech Co., Ltd

New P1/2 trial