Absolute contraindications to further administration of vaccine
Clinically significant decreased liver or renal function
boolean
Immunodeficient condition
boolean
Pregnancy
boolean
Hypersensitivity reaction following vaccine administration
boolean
Anaphylactic reaction following the administration of study/ control vaccine(s).
boolean
A serious adverse event (SAE) is any untoward medical occurrence that: results in death, is life threatening, results in persistent or significant disability / incapacity, requires in-patient hospitalization, prolongation of existing hospitalization or is a congenital anomaly / birth defect in the offspring of a study subject. In addition, important medical events that may jeopardize the subject or may require intervention to prevent one of the other outcomes listed above should be considered serious. (Examples of such events are invasive or malignant cancers, intensive treatment in an emergency room or at home for allergic bronchospasm; blood dyscrasias or convulsions that do not result in hospitalization.) For each serious adverse event the investigator becomes aware of, please fill in a Serious Adverse Event (SAE) report.
boolean
Other significant reactions which in the opinion of the investigator (or designate) preclude further administration of the study/ control vaccine
boolean
Contraindications to administration of vaccine at current time
Acute disease is defined as the presence of a moderate or severe illness with or without fever. Enrolment will be deferred until condition is resolved. All vaccines can be administered to persons with a minor illness such as diarrhoea, mild upper respiratory infection with or without low-grade febrile illness, i.e. oral temperature < 37.5 °C (99.5 °F)/axillary temperature < 37.5 °C (99.5 °F).
boolean
Oral/axillary temperature ≥37.5 °C (99.5 °F) at the time of vaccination
boolean