Determining Long-Term Safety and Efficacy of Japanese Encephalitis Vaccine When Given With Measles...
EncephalitisJapanese BThe previously conducted JEV01 study looked at the immunogenicity and safety of the concurrent administration of Japanese Live Attenuated SA 14-14-2 and measles vaccines at the one month post vaccination time point. The purpose of the JEV01 study was to help ensure the safety of SA 14-14-2 simultaneously administered with measles vaccine, paving the way for its use in routine EPI programs. As a follow-on to JEV01, this study will enroll those infants who received both vaccines and completed the JEV01 study. This study, however, will provide crucial data to help ensure the long-term immunogenicity of the concurrent administration of these vaccines and provide valuable information to determine the use of these vaccines in routine immunization programs. This study is planned because in the original protocol for JEV01, long-term data points were not included. The hypothesis is that children who receive JE live attenuated SA 14-14-2 vaccine and measles vaccine at the same time have long-term (24 and 36 months post vaccination) protection against these diseases at the same level as those who receive the vaccines at different intervals.
Safety Study of ChimeriVax™-JE Vaccine to Prevent Japanese Encephalitis.
EncephalitisJapanese EncephalitisThe purpose of this study is to assess whether ChimeriVax™ JE vaccine (a new vaccine to be used for vaccination against Japanese encephalitis) is safe and well tolerated when compared to placebo (dummy) vaccination.
Immunogenicity of a JE-CV as a Booster Dose After a Primary Vaccination With SA14-14-2 Vaccine
Japanese EncephalitisThe objective of this study is to measured the Geometric mean titer (GMT) of Japanese Encephalitis neutralizing antibody and proportion of seroprotection among the children who received a booster dose of JE-CV after the first dose of SA14-14-2 vaccine.
Ixiaro as Booster After Mouse-brain Derived Vaccines for Japanese Encephalitis
Japanese EncephalitisThe old mouse brain derived Japanese encephalitis vaccines (MBJEV) have been reported to cause serious adverse effects and are therefore replaced with the novel Ixiaro vaccine. The present study investigates whether vaccinees primed with MBJEV can be boosted with Ixiaro. Travellers receiving Japanese encephalitis vaccines are enrolled for a follow-up of immune responses in four groups: A) primary immunization with BMJEV, B) primary and secondary immunizations with MBJEV, C) primary immunizations with Ixiaro and S) Primary immunization with MBJEV and secondary immunization with Ixiaro. Immune responses are followed with help of serum samples collected before and after vaccination.
Lot-to-lot Consistency Trial of Japanese Encephalitis Live Attenuated SA 14-14-2 Vaccine
Japanese EncephalitisThe proposed study is a four-arm double-blind randomized controlled single center trial to evaluate, by examining post-vaccination seroprotection titers, the lot-to-lot consistency of three lots of Japanese Encephalitis live attenuated SA 14-14-2 vaccine (LJEVac) manufactured in a new good manufacture practice (GMP) facility, and to establish non-inferiority of the new vaccine in comparison to a single lot of the same vaccine manufactured in the existing facility. The study aimed to enroll a total of 1,000 Bangladeshi infants aged 10 to 12 months. In addition to providing immunogenicity data, this study provided local safety data of JE live attenuated SA 14-14-2 vaccine among Bangladeshi children. This is the first step to secure licensure for this life-saving vaccine in Bangladesh as well as provide data to support WHO prequalification of JE live attenuated SA 14-14-2 vaccine.
Study of Live Attenuated ChimeriVax™-Japanese Encephalitis Vaccine
Japanese EncephalitisThe purpose of this study is to assess the safety, tolerability, and immunogenicity of a new formulation of lyophilised ChimeriVax™-JE, given at three dose levels, compared with placebo. Primary Objectives: Safety: To obtain safety and tolerability data for a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels, in healthy adult volunteers (18-49 years old). Immunogenicity: To obtain data on the antibody response to a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels, in healthy adult volunteers without prior Japanese encephalitis immunity. To assess the durability of immune response up to 12 months following a single subcutaneous vaccination with ChimeriVax™-JE, at three dose levels.
Evalution of Immunogenicity, Safety and Booster Response of a Rabies Vaccine Administered Concomitantly...
RabiesJapanese Encephalitis1 moreThis study evaluated the safety and immunogenicity of rabies vaccine and Japanese encephalitis vaccine in toddlers. All children developed adequate immune responses. Rabies vaccination with PCECV did not interfere with the antibody response to Japanese encephalitis vaccine. The rabies vaccine PCECV and Japanese encephalitis vaccine are safe and immunogenic when administered concomitantly to toddlers.
Comparison of Three Batches of the Japanese Encephalitis Vaccine IC51
Japanese EncephalitisThe objective is to demonstrate equivalence of three IC51 batches in terms of Geometric Mean Titers for anti-JEV neutralizing antibody.
Long Term Persistence and Effect of a Booster Dose of the Japanese Encephalitis Vaccine IC51
Japanese EncephalitisThe study investigates the long term persistence the Japanese encephalitis vaccine IC51 and the need of a booster dose
Rapid Immunization Study of the Japanese Encephalitis Vaccine IC51
Japanese EncephalitisThe study investigates a rapid immunization regime of the Japanese Encephalitis vaccine IC51 (JE-PIV) in healthy subjects aged > or = 18 years