BHARAT MOVIE NEAR ME REGAL TRIAL
The seven-month Phase 2/3 open label, multicenter, study enrolled 525 children ages 2 years to 18 from 6 clinical trial sites across India.
BHARAT MOVIE NEAR ME REGAL FULL
Bharat Biotech intends to submit data from the full Phase 3 trial to a peer-reviewed scientific publication soon.Ībout the Phase 2/3 Trial in Children (BBIL/BBV152/2021) The data were also submitted to the Drugs Controller General of India (DCGI) to support a pediatric indication as recommended by an independent committee, known as the Subject Expert Committee (SEC), that advises the Indian regulatory agency. Mild to moderate adverse events resolved within 24 hours. The majority of adverse events noted (49%, n=374) were mild (e.g., injection site pain) and a small proportion (19%, n=6) were moderate (e.g., fever, headache). Participants were not reported to have experienced any severe adverse events.
In each case a more than 4-fold increase in neutralizing antibody titers versus baseline (titers measured in the same participants before being vaccinated) was seen in all age groups after the second dose. The study also showed increased antibody titers against 3 viral antigens (Spike – S1, Receptor Binding Domain - RBD and Nucleocapsid - NP) providing a broad immune response to COVID-19. These data demonstrate children 2-18 generate antibody response comparable to adults fully vaccinated with COVAXIN ™ (BBV152). At Day 56, across all ages, the mean SARS-CoV-2 antibody GMT was more than 30% higher in children aged 2-18 than the mean GMT from Phase 3 clinical trial involving 25,800 adult subjects aged 18+. To be considered equivalent, pediatric participants needed to achieve comparable GMT’s to those generated by adults in a large phase 3 clinical trial. This immunobridging trial was intended to determine if COVAXIN™ generates the same protective immunity in children as it does in adults. There were no serious adverse events such as myocarditis, pericarditis, or blood clots, reported in any of the three age groups. GMT was measured across three age groups and demonstrated strong immune response after the second dose. In the study, immunogenicity against key COVID-19 proteins was measured using geometric mean titer (GMT), a test that measures the amount of antibodies in the blood in response to the presence of the virus.
BHARAT MOVIE NEAR ME REGAL SERIES
“The results suggest that COVAXIN™, which is made on the same platform used in traditional polio pediatric vaccines for decades, when administered in a two-dose series to children between 2-18, may offer an option that is safe while delivering a robust immune response.” “These data represent the first positive vaccine data in children as young as two years of age and come at an important time as COVID-19 infections are seeing a spike across the globe,” said Shankar Musunuri, PhD, MBA, Chairman of the Board, Chief Executive Officer and Co-Founder of Ocugen. These pediatric data were the basis of Ocugen’s pediatric Emergency Use Authorization (EUA) submission in the United States for children 2-18 on November 5, 2021. Those results demonstrated a greater than 93% reduction in severe disease. Using a two-dose regimen administered 28-days apart, antibody responses in subjects were comparable to adult data from a previous phase 3 study. (Nasdaq: OCGN), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics and vaccines, announced today that its partner, Bharat Biotech, posted results from a Phase 2/3 trial conducted in India of candidate vaccine, COVAXIN™ (BBV152), in children, aged 2 – 18 years, demonstrating a robust neutralizing antibody response and favorable safety profile on the pre-print server, medRXiv. No cases of myocarditis or blood clots were reported, as expected with inactivated vaccines Immunobridging trial demonstrated safety, reactogenicity and immunogenicity of COVAXIN™ in children from 2 years old and up COVAXIN™ whole virus inactivated vaccine generated broad antibody response comparable to those seen in a large phase 3 trial in adults 18+Īdverse events were primarily mild, and no serious adverse events (SAEs) were noted
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