Sefako Makgatho Health Sciences University in collaboration with MeCRU and Sinovac/Numolux Group, has successfully conducted and concluded the enrolment of the target total number of 270 children for the Sinovac/Numolux Group Vaccine trial which was launched at SMU.
According to the Principal Investigator (PI) of the Phase 3 Paediatric Covid-19 trial conducted at Sefako Makgatho Health Sciences University’s MeCRU has confirmed that the two children who were the first to receive the vaccine on 10 September 2021 were in good state of health.
“MeCRU has been in constant contact with the two children since they received the jabs. In line with the study protocol, they called thr children within seven days in the first week after they were inoculated and make follow up calls once every week,” this was according to Dr Maluleka.
He further revealed that the second dose was given after 28 days and the same follow up procedures were followed.
“The parents of the children were also engaged and they too confirmed that the children are in a good state of health. As a result, the parents also gave them permission to return tp school when the September school vacation ended,” added Dr Maluleka.
In case of any emergency, the participants were provided with 2 different landline phone numbers of the clinic and two mobile numbers belonging to Dr Maluleka who is the Principal Investigator (PI) and Sister Mabaso who is the coordinator of the study.
“MeCRU has since ramped up the numbers and to date has completed enrolment of the target total of number of 270 children. This includes 157 (12 – 17 years), 76 (6 – 11 years), 37 (3 – 5 years) participants and 237 of these have already received the second dose,” he added.
It was envisaged that the remaining participants would have received their second dose by the second week of December 2021. And MeCRU has also confirmed that they will not be enrolling the 6 months to 3 years group.
“All vaccinated children are being strictly monitored in line with the research project protocols and will be followed up for a year”.
“Monitoring the children constantly is in compliance with research protocols governing the phase 3 COVID-19 Vaccine trial. The trial currently being conducted at MeCRU is part of the worldwide study that will have a total enrolment of 14 000 children and adolescents in various Paediatric age cohorts across 5 countries namely, South Africa, Chile, Philippines, Malaysia and Kenya.
“MeCRU is one of the 7 Clinical Research sites across South Africa which is targeting to enrol 2000 participants from 6 months to 17 years. The study is a multi-centre, randomized, double-blind, Placebo-controlled Phase 3 Clinical Trial to evaluate the Efficacy, Immunogenicity, and Safety of Sinovac Inactivated Covid-19 Vaccine (CoronaVac) in children and adolescents aged 6 months to 17 years,” he emphasized.
In conclusion, the statement further revealed that the study will also be looking to evaluate Efficacy against hospitalization and severe COVID-19 cases, the study’s timelines were set to be 8-10 weeks from the first participant enrolled.