This is a comparative vaccination study of the reactogenicity and immunogenicity of a thiomersal-free formulation of Influsplit SSW® 2002/2003 versus the standard formulation of Influsplit SSW® 2002/2003 in individuals over 18 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
239
Single dose, intramuscular injection
Single dose, intramuscular injection
GSK Clinical Trials Call Center
Dresden, Germany
GMT of the haemagglutination-inhibiting antibodies (HIA) and calculation of seroconversion factor, seroconversion rate and seroprotection rate checked against the CHMP criteria. The seroprotection power will be calculated as well.
Time frame: On Day 21 (± 2) after vaccination
Descriptive comparison of the occurrence, severity and causal relationship to vaccination of solicited local and general symptoms
Time frame: Within 4 days after vaccination
Descriptive comparison of the occurrence and causal relationship to vaccination of unsolicited signs and symptoms
Time frame: Within 30 days after vaccination
Descriptive comparison of the occurrence, severity and causal relationship to vaccination of any serious adverse events (SAEs)
Time frame: During the entire study period.
Investigation of antibody persistence assessed by the criteria of the CHMP.
Time frame: 11, 19, 27 weeks after vaccination
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.