A clinical trial of Sputnik V vaccine for adolescents aged 12-17 years has begun in Moscow on the basis of two children’s hospitals; the first volunteers are already undergoing a medical examination before the drug is administered, TASS reports with reference to Anastasia Rakova, Moscow’s deputy mayor for social development.
“Together with the Gamaleya Center, we have started a clinical trial of the Sputnik V vaccine for adolescents aged 12-17 years. Now the first and second phases of the study are being conducted at two leading children’s hospitals: the Morozovskaya Children’s Hospital and the Bashlyaeva Children’s Hospital. To do this, we have already recruited the planned number of participants, 100 people. Today, a medical examination of the first volunteers has begun, which includes a mandatory PCR test,” Rakova said.
She mentioned that the vaccination is carried out with Sputnik V, which is already used for vaccination of people over 18 years old, but in a lower dosage. The trial will last a year. During the entire period, the teenagers will be under the constant medical supervision.
Rakova said that after the introduction of the first and second components of the vaccine, the teenagers will be hospitalized in isolated care units for three days, where they will be examined once again before vaccination, and after vaccination, their general condition will be monitored. After that, they will have to visit the hospital several more times for tests. The test participants will keep a diary of self-observation in a special mobile application, and doctors will monitor their general condition over the phone.
“The third phase of the study will be held in children’s polyclinics in Moscow. 250 people will take part in it, their recruitment beginning at the end of the summer. Based on the results of the study, it will be possible to make a decision on the inclusion of adolescents in the vaccination program against the novel coronavirus,” Rakova added.
According to her, the study involves adolescents who have not had COVID-19, do not have contraindications to the vaccine or other medical contraindications. A temporary contraindication may be ARVI within two weeks before the expected date of vaccination, or a vaccination against another disease administered 30 days before the Sputnik V vaccination or earlier.