Trial reportThe Journal of infectious diseases2019
Immunogenicity and Safety of a Sabin Strain-Based Inactivated Polio Vaccine: A Phase 3 Clinical Trial.
Trial report in The Journal of infectious diseases, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03526978 (A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Sabin Inactivated Poliovirus Vaccine), which is not on this map. Cited by 25 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Randomized, Double-blind, Controlled Clinical Trial to Evaluate the Immunogenicity and Safety of Sabin Inactivated Poliovirus Vaccine (Vero Cell) in 2-month-old Infants
Who cites it
25 citing papers in PubMed, 35 citations in OpenAlex.
- Effects of maternal antibodies in infants on the immunogenicity and safety of inactivated polio vaccine in infants.Human vaccines & immunotherapeutics · 2022Trial
- Safety and immunogenicity of 3 formulations of a Sabin inactivated poliovirus vaccine produced on the PER.C6® cell line: A phase 2, double-blind, randomized, controlled study in infants vaccinated at 6, 10 and 14 weeks of age.Human vaccines & immunotherapeutics · 2022Trial
- Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study.The Journal of infectious diseases · 2022Trial
- Immunogenicity and safety of concomitant administration of the chinese inactivated poliovirus vaccine with the diphtheria-tetanus-acellular pertussis (DTaP) vaccine in children: A multicenter, randomized, non-inferiority, controlled trial.Frontiers in immunology · 2022Trial
- A phase Ⅱ, randomized, controlled trial to evaluate the safety and immunogenicity of a Sabin strain-based inactivated polio vaccine.Human vaccines & immunotherapeutics · 2020Trial
- Safety evaluation of inactivated poliomyelitis vaccine.Human vaccines & immunotherapeutics · 2026Article
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- Immune and Safety Analysis ofViruses · 2025Article
- Poliovirus shedding after sequential immunization of Sabin-strain inactivated polio vaccines and oral attenuated polio vaccines.NPJ vaccines · 2025Article
- Sustained Immune Persistence Five Years Post-Completion of Four-Dose sIPV Vaccination.Vaccines · 2025Article
- A highly immunogenic UVC inactivated Sabin based polio vaccine.NPJ vaccines · 2024Article
- Evaluation of the immunization effectiveness of bOPV booster immunization and IPV revaccination.NPJ vaccines · 2023Article
- Safety evaluation on concomitant immunization with inactivated poliomyelitis vaccine produced from Sabin strains and other vaccines (from 2015 to 2020).Human vaccines & immunotherapeutics · 2022Article
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Corrections and comments
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Authors and funding
11 authors at 4 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe Sabin strain-based inactivated polio vaccine (sIPV) plays a vital role in eradicating poliomyelitis in developing countries.
methodsThe 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.
resultsA 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).
conclusionsThe sIPV demonstrated an immunogenicity profile noninferior to that of the conventional IPV and had a good safety profile. CLINICAL TRIALS REGISTRATION: NCT03526978.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.