Previous studies have demonstrated the immunogenicity and safety of the co-administration of the trivalent inactivated influenza vaccine (IIV3) with the polysaccharide pneumococcal vaccine (PPV) or pneumococcal conjugate vaccine (PCV). However, there is no direct comparison study that evaluates the immunogenicity and safety of IIV3 given concomitantly with PCV13 or PPV23 in the elderly. This study is intended to compare the immunogenicity and safety of concomitant administration in the elderly subjects.
During the influenza vaccination period, 224 healthy elderly volunteers randomly received IIV3 given concomitantly with either PCV13 (PCV13+IIV3) or PPV23 (PPV23+IIV3) in a 1:1 ratio. Serum hemagglutination-inhibiting (HI) antibodies for IIV3 were measured at the time of vaccination and 1 month after vaccination. Adverse events were recorded prospectively in a clinical diary during a 7-day period.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
224
GCflu and Pneumovax-23
GCflu and Prevenar-13
Korea University Ansan Hospital
Ansan, Kyoungido, South Korea
Hallym University Gangnam Sacred Hospital
Seoul, Seoul, South Korea
Seroconversion rates (A/H1N1, A/H3N2, and B)
Seroconversion: a post-vaccination titer ≥1:40 in subjects with a pre-vaccination titer of \<1:10 or a ≥4-fold titer increase in subjects with a pre-vaccination titer of ≥1:10
Time frame: Change from baseline titer at 4 weeks
Seroprotection rates (A/H1N1, A/H3N2, and B)
Seroprotection rate: percentage of subjects with a post-vaccination titer ≥1:40
Time frame: Change from baseline titer at 4 weeks
GMT folds (A/H1N1, A/H3N2, and B)
GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer
Time frame: Change from baseline titer at 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.