The purpose of this study is to evaluate the immunogenicity and the kinetics of the anti-Vi antibody response following secondary vaccination with the Novartis Vaccines Institute for Global Health (NVGH) Vi-CRM197 vaccine in healthy adults previously vaccinated with either the NVGH Vi-CRM197 or Vi-polysaccharide (Typherix) in the H01\_04TP study (NCT01193907) and the immunogenicity and the kinetics of the anti-Vi antibody response following primary vaccination with the NVGH Vi-CRM197 vaccine in naïve healthy adults.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
51
Vi-CRM197 glycoconjugated vaccine
Centre for the Evaluation of Vaccination (CEV)
Antwerp, Wilrijk, Belgium
Anti-Vi ELISA Geometric Mean Concentration (GMC)
To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3 after vaccination as as measured by enzyme-linked immunosorbent assay (ELISA)
Time frame: At 3 days after vaccination
Anti-Vi ELISA GMC
To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 7 after vaccination as as measured by ELISA
Time frame: At 7 days after vaccination
Anti-Vi ELISA GMC
To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 28 after vaccination as as measured by ELISA
Time frame: At 28 days after vaccination
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers
Time frame: At 3 days after vaccination as compared to baseline
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers
Time frame: At 7 days after vaccination as compared to baseline
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers
Time frame: At 28 days after vaccination as compared to baseline
Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction
Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia, fatigue and fever.
Time frame: During the 7-day period after vaccination
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Number of Subjects Reporting AE
AE during 28 days after vaccination(including solicited reactions during 7 days after vaccination)
Time frame: During the 28-day period after vaccination
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: During the 28-day period after vaccination