Yuemei Hu1, Jianfeng Wang2, Gang Zeng3, Kai Chu1, Deyu Jiang4, Fengdong Zhu5, Zhifang Ying2, Lei Chen6, Changgui Li2, Fengcai Zhu7, Weidong Yin8. 1. Department of Vaccine Evaluation, Nanjing. 2. Division of Respiratory Virus Vaccines, National Institute for Food and Drug Control, Sinovac Biotech, Beijing. 3. Department of Clinical Research, Sinovac Biotech, Beijing. 4. Center of Research and Development, Sinovac Biotech, Beijing. 5. Guanyun County Center for Disease Control and Prevention, Guanyun. 6. Pizhou County Center for Disease Control and Prevention, Pizhou, China. 7. Office of the Deputy Director, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing. 8. Office of the General Manager, Sinovac Biotech, Beijing.
Abstract
BACKGROUND: The Sabin strain-based inactivated polio vaccine (sIPV) plays a vital role in eradicating poliomyelitis in developing countries. METHODS: The study was designed as a randomized, controlled, double-blinded, noninferiority trial. A total of 1200 healthy infants aged 60-90 days were enrolled and randomly assigned to receive 3 doses of either sIPV (the experimental arm) or IPV (the control arm) at days 0, 30, and 60. Immunogenicity and safety outcomes were assessed using the per-protocol and safety populations, respectively. RESULTS:A total of 553 and 562 participants in the sIPV and IPV groups, respectively, were included in the per-protocol population. Seroconversion rates in the sIPV and IPV groups were 98.0% and 94.1%, respectively, for type 1 poliovirus (P < .01); 94.8% and 84.0%, respectively, for type 2 (P < .01); and 98.9% and 97.7%, respectively, for type 3 (P = .11). A total of 599 and 600 participants in the sIPV and IPV groups, respectively, were included in the safety population. Fever was the most common adverse event, occurring in 61.6% and 49.8% of participants in the experimental and control arms, respectively (P < .01). CONCLUSIONS: The sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile. CLINICAL TRIALS REGISTRATION: NCT03526978.
RCT Entities:
BACKGROUND: The Sabin strain-based inactivated polio vaccine (sIPV) plays a vital role in eradicating poliomyelitis in developing countries. METHODS: The study was designed as a randomized, controlled, double-blinded, noninferiority trial. A total of 1200 healthy infants aged 60-90 days were enrolled and randomly assigned to receive 3 doses of either sIPV (the experimental arm) or IPV (the control arm) at days 0, 30, and 60. Immunogenicity and safety outcomes were assessed using the per-protocol and safety populations, respectively. RESULTS: A total of 553 and 562 participants in the sIPV and IPV groups, respectively, were included in the per-protocol population. Seroconversion rates in the sIPV and IPV groups were 98.0% and 94.1%, respectively, for type 1 poliovirus (P < .01); 94.8% and 84.0%, respectively, for type 2 (P < .01); and 98.9% and 97.7%, respectively, for type 3 (P = .11). A total of 599 and 600 participants in the sIPV and IPV groups, respectively, were included in the safety population. Fever was the most common adverse event, occurring in 61.6% and 49.8% of participants in the experimental and control arms, respectively (P < .01). CONCLUSIONS: The sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile. CLINICAL TRIALS REGISTRATION: NCT03526978.
Authors: Anna Lisa Ong-Lim; Georgi Shukarev; Mitzi Trinidad-Aseron; Delia Caparas-Yu; Astrid Greijer; Michel Duchene; Gert Scheper; Vitalija van Paassen; Mathieu Le Gars; Conor P Cahill; Hanneke Schuitemaker; Macaya Douoguih; Jeanne-Marie Jacquet Journal: Hum Vaccin Immunother Date: 2022-03-28 Impact factor: 4.526