A5018091807- Viral gastroenteritis research and epidemiology
- Viral Infections and Immunology Research
- Respiratory viral infections research
- SARS-CoV-2 and COVID-19 Research
- COVID-19 Clinical Research Studies
- Vaccine Coverage and Hesitancy
- Pneumocystis jirovecii pneumonia detection and treatment
- Pneumonia and Respiratory Infections
- Heparin-Induced Thrombocytopenia and Thrombosis
Sinovac Biotech
2018-2023
With the unprecedented morbidity and mortality associated with COVID-19 pandemic, a vaccine against is urgently needed. We investigated CoronaVac (Sinovac Life Sciences, Beijing, China), an inactivated candidate COVID-19, containing severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), for its safety, tolerability immunogenicity.In this randomised, double-blind, placebo-controlled, phase 1/2 clinical trial, healthy adults aged 18-59 years were recruited from community in Suining...
ABSTRACT BACKGROUND The top priority for the control of COVID-19 pandemic currently is development a vaccine. A phase 2 trial conducted to further evaluate immunogenicity and safety SARS-CoV-2 inactivated vaccine (CoronaVac). METHODS We randomized, double-blind, placebo-controlled optimal dose, CoronaVac. total 600 healthy adults aged 18-59 years were randomly assigned receive injections at dose 3 μg/0.5 mL or 6 μg /0.5mL, placebo on Day 0,14 schedule 0,28 schedule. For evaluation, solicited...
The National Immunization Program allows using a different manufacturer's vaccine for follow-up doses when the same is unavailable. This study aimed to evaluate safety and immunogenicity of administering third dose Sabin strain (sIPV) from manufacturer in infants who had previously received two sIPV. randomized, blinded, controlled trial enrolled 200 healthy (≤12 months) o assess sequential vaccination, were randomly assigned receive sIPV either (experimental group) or as first (control...
The longevity of antibodies induced by inactivated enterovirus 71 type (EV71) vaccine is not well studied. To estimate the immunity persistence following two-dose vaccination EV71 vaccine, a five-year follow-up study was conducted as an extension Phase III clinical trial. In this study, sub-cohort volunteers who eligible for enrollment and randomly administrated either 2 dose or placebo in phase trial selected, then further observed 64 months post 1st vaccination. 211 Subjects (106 subjects...
A new Sabin strain inactivated poliovirus vaccine (sIPV) proved to be immunogenic and safe in all IPV primary immunization the previous study, with corresponding profiles sequential immunizations unclear.Two clinical trials on "IPV + 2 bivalent oral polio (2bOPV)" (Trial A) "2IPV bOPV" B) vaccination were conducted. Both randomized, controlled, double-blinded, noninferiority trials, wild-strain (wIPV) was adopted as control vaccine. In each trial, 240 healthy infants enrolled randomly...
To evaluate the safety and immunogenicity of a newly 23-valent pneumococcal polysaccharide vaccine (PPV23), phase Ⅲ clinical trial was conducted in population aged ≥ 2 years. We randomized, double-blinded, active controlled trial, which 1760 participants were randomly assigned 1:1 ratio to receive one dose either test or control commercial vaccine. The surveillance period 28 days. 2-fold increase rate anti-pneumococcal for 23 serotypes varied from 49.71% 90.96% treatment group 44.52% 88.24%...
To evaluate the safety, immunogenicity, and lot-to-lot consistency of Sabin strain-based inactivated polio vaccine (sIPV) in a five-dose vial presentation.Stage I was an open-label safety observation, which 72 healthy subjects (including 24 adults, children, infants each) were given one or three doses sIPV; stage II randomized, blinded, positive-control study, 1500 randomized at ratio 1: 1 into five groups to receive either sIPV lots, conventional poliovirus vaccine, single-dose as controls,...
The Sabin-strain-based inactivated poliovirus vaccine (sIPV) plays an important role in poliomyelitis eradication developing countries. As part of the phase III clinical development program, this study aimed to evaluate safety, immunogenicity and lot-to-lot consistency sIPV 2-month-old infants.We conducted a III, randomized, double-blind, positive-controlled trial which 1300 healthy infants were randomly assigned four groups 1:1:1:1 ratio receive one three lots or control IPV at 2, 3 4...
Introduction: Sabin strain inactivated poliovirus vaccine (sIPV) developed by Sinovac Biotech Co., Ltd., has shown good safety and immunogenicity against parental strains among infants in several finished pre-licensure clinical trials.Areas covered: To further study the neutralizing capacity of investigational sIPV immune serum Sabin, Salk recently circulating strains, neutralization assay ten individual was performed on backup collected from 250 infant participants phase II trial.Expert...