Created at Source Raw Value Validated value
June 25, 2024, noon usa

- • withdrawal of informed consent by a volunteer and/or a parent of a volunteer; * the volunteer was included in violation of the inclusion/non-inclusion criteria of the protocol; * availability of inclusion/non-inclusion criteria before vaccination; * any condition of a volunteer that requires, in the reasoned opinion of a medical researcher, the withdrawal of a volunteer from the study; * the established fact of pregnancy before the second vaccination; * taking unauthorized medications (see section 6.2); * the volunteer's incompetence with the study procedures; * the volunteer refuses to cooperate or is undisciplined (for example, failure to attend a scheduled visit without warning the researcher and/or loss of communication with the volunteer), or dropped out of observation; * for administrative reasons (termination of the study by the sponsor or regulatory authorities), as well as in case of gross violations of the protocol that may affect the results of the study.

- • withdrawal of informed consent by a volunteer and/or a parent of a volunteer; * the volunteer was included in violation of the inclusion/non-inclusion criteria of the protocol; * availability of inclusion/non-inclusion criteria before vaccination; * any condition of a volunteer that requires, in the reasoned opinion of a medical researcher, the withdrawal of a volunteer from the study; * the established fact of pregnancy before the second vaccination; * taking unauthorized medications (see section 6.2); * the volunteer's incompetence with the study procedures; * the volunteer refuses to cooperate or is undisciplined (for example, failure to attend a scheduled visit without warning the researcher and/or loss of communication with the volunteer), or dropped out of observation; * for administrative reasons (termination of the study by the sponsor or regulatory authorities), as well as in case of gross violations of the protocol that may affect the results of the study.

Feb. 13, 2023, 8:44 a.m. usa

- • withdrawal of informed consent by a volunteer and/or a parent of a volunteer; the volunteer was included in violation of the inclusion/non-inclusion criteria of the protocol; availability of inclusion/non-inclusion criteria before vaccination; any condition of a volunteer that requires, in the reasoned opinion of a medical researcher, the withdrawal of a volunteer from the study; the established fact of pregnancy before the second vaccination; taking unauthorized medications (see section 6.2); the volunteer's incompetence with the study procedures; the volunteer refuses to cooperate or is undisciplined (for example, failure to attend a scheduled visit without warning the researcher and/or loss of communication with the volunteer), or dropped out of observation; for administrative reasons (termination of the study by the sponsor or regulatory authorities), as well as in case of gross violations of the protocol that may affect the results of the study.

- • withdrawal of informed consent by a volunteer and/or a parent of a volunteer; the volunteer was included in violation of the inclusion/non-inclusion criteria of the protocol; availability of inclusion/non-inclusion criteria before vaccination; any condition of a volunteer that requires, in the reasoned opinion of a medical researcher, the withdrawal of a volunteer from the study; the established fact of pregnancy before the second vaccination; taking unauthorized medications (see section 6.2); the volunteer's incompetence with the study procedures; the volunteer refuses to cooperate or is undisciplined (for example, failure to attend a scheduled visit without warning the researcher and/or loss of communication with the volunteer), or dropped out of observation; for administrative reasons (termination of the study by the sponsor or regulatory authorities), as well as in case of gross violations of the protocol that may affect the results of the study.