Immunogenicity and Safety of Live Attenuated Influenza Vaccine (Flumist) Administered by Nasal and Sublingual Route

This is an interventional basic science trial for Healthy focused on measuring Influenza vaccine, nasal route, sublingual route, immunogenicity, safety Read More

Inclusion Criteria:

• Healthy volunteers who are able and willing to give informed consent, following a detailed explanation of participation in the study.
• Volunteers who will be available for the duration of the study and available for scheduled and potential additional visits

Exclusion Criteria:

• Subjects with any clinically significant medical or psychiatric condition or clinically significant abnormal serum biochemistry or haematology results that, in opinion of the Investigator, preclude participation in the study.
• Female subjects who are pregnant (using urine test) or breast-feeding, or of childbearing potential and unwilling to use a reliable method of contraception (e.g. oral contraceptives or contraceptive during sexual activities such as a condom, contraceptive diaphragm, intrauterine device, hormonal contraceptive, or intercourse with a male partner who has had a vasectomy etc.) throughout the study period.
• Subjects who have known airway hypersensitivity to one of Flu vaccine excipients within 14 days prior to administration of study medication.
• Subjects who have known buccal hypersensitivity to any component of the vaccine or buffer solution used in this study, including subjects with phenylketonuria.
• Subjects with direct contact with at risk groups (e.g. patients in special care units, immuno-compromised individuals, pregnant women, children under 2 years of age and individuals over 70 years).
• Subjects with a known impairment of immune function including seropositive for HIV or those receiving (or have received in the 6 months prior to study entry) cytotoxic drugs immunosuppressive therapy (including systemic corticosteroids).
• Subjects with a significant acute febrile illness (fever of 38.0 Celsius degree or more) at time of dosing.
• Subjects who have chronic diseases: Chronic diseases will include all autoimmune and immuno-compromising conditions and any other chronic condition, which at the judgement of the Investigator, may put the subject at higher risk of side effects from the study vaccine. Conditions in the latter category might include unexplained anaemia, hepato-biliary disease, uncontrolled hypertension, subjects with prosthetic joints or heart valves, etc.
• Subjects with a current problem, based on history, with substance abuse or with a history of substance abuse
• Subjects who are currently involved in a clinical trial, have taken an investigational drug or have received investigational or licensed vaccines in the preceding 4 weeks or anticipate receiving a vaccine other than study medication during the first 4 weeks of the study
• Subjects who have known hypersensitivity to eggs or egg proteins
• Subjects who have chronic respiratory infections or syndromes
• Unable to receive oral (sublingual) administration.
• Receiving anti-viral agents.
• Subjected to contraindications and/or precautions described in drug information