Cervicovaginal Immune Responses to 3 Deltoid or Thigh Intramuscular (IM) TicoVac (CRC306)

Inclusion criteria

• Women aged between 18 and 49 years on the day of screening.
• Available for follow-up for the duration of the study.
• Willing and able to give written informed consent.
• Agree to abstain from donating blood during and for three months after the end of their participation in the trial, or longer if necessary.
• Willing to abstain from vaginal intercourse for 12 hours prior to cervico-vaginal secretions sampling.

Exclusion criteria

• Previous immunisation with a TBEV vaccine or history of TBEV infection.
• Previous immunisation with a Yellow Fever or Japanese B encephalitis vaccine, or history of infection with Yellow fever, Japanese B encephalitis, hepatitis C and dengue infection (as antibodies against these viruses cross react with TBE). Immunisation with Yellow Fever or Japanese B encephalitis vaccine or diagnosis of any of these infections during the study period will exclude the subject.
• Intention to travel to an area requiring immunisation against Japanese B encephalitis within 40 days and yellow fever within 10 days of the expected last visit(as Japanese B encephalitis vaccine requires two immunisations 28 days apart and must be completed within 10 days of departure. Yellow Fever vaccination becomes effective 10 days after a single immunisation)
• Any Intra Uterine Contraceptive Device (as this contraindicates with use of the Softcup).
• Pregnant or lactating at time of screening or immunisations.
• Known hypersensitivity to the vaccine active substance, any of the excipients, or the production residues (formaldehyde, neomycin, gentamicin, protamine sulphate).
• Latex allergy.
• Severe hypersensitivity to egg and chick proteins ("severe" means anaphylactic reaction after oral ingestion of egg protein - other reactions are not exclusions).
• Clinically relevant abnormality on history including uncontrolled infection; autoimmune disease, immunodeficiency, or pre-existing cerebral disorders.
• Any drugs and categories of drugs listed in Appendix 1, by the routes indicated, and at any time during the study period, or for the period preceding screening indicated in Appendix 1.

Any medications that are not listed in Appendix 1,or any over-the-counter treatments are not excluded.

Receipt of vaccines other than TBEV vaccines is not excluded. If other injectable vaccines are to be given during the study period, administration should preferably be into different limbs from the study vaccine.

• Receipt of blood products or immunoglobin within 3 months of screening.
• Participation in another trial of a medicinal product, completed less than 90 days prior to visit 2.
• Unable to read and speak English to a fluency level adequate for the full comprehension of procedures required in participation and consent.
• Unlikely to comply with protocol.