The 23-valent pneumococcal Polysaccharide vaccine (23vPPV) has been developed for children and adults to prevent pneumococcal diseases such as pneumonia (inflammation of the lungs), meningitis (inflammation of the brain lining), and septicemia (blood poisoning) since 2006 in China. Also, the trivalent influenza vaccine (TIV) is frequently administered to the children and adults. The main objective of this study is to show that both vaccines can safely be administered together without affecting the immune response of protecting against disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
2,225
Single 0.5ml 23-valent pneumococcal polysaccharide vaccine was administered intramuscularly (IM)
Single 0.5ml trivalent influenza vaccine was administered IM
Single 0.5 ml 23-valent pneumococcal polysaccharide vaccine (23vPPV) and a single 0.5 ml trivalent inactivated influenza vaccine (TIV) were administered IM, in one day.
Yangzhong Center for Disease Control and Prevention
Zhenjiang, Jiangsu, China
Immunogenicity of 23vPPV
IgG GMC measured by enzyme-linked immunosorbent assay (ELISA) and expressed in micrograms per mL (mcg/mL) for serotypes 1,2,5,6B,14,19F,23F,which were frequently detected in patients in Chinese.
Time frame: 1 month after 23vPPV vaccination
Immunogenicity of TIV
Percentage of participants achieving at Least a 4-fold Increase in the Titer of the Standard Hemagglutination Inhibition Assay (HAI)
Time frame: 1 month after TIV vaccination
adverse events following the immunization (AEFI)
Time frame: 28 days after 23vPPV and TIV vaccination
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