Influenza Clinical Trial
Official title:
Immunogenicity and Safety of 13-valent Pneumococcal Conjugate Vaccine (PCV13) and MF59-adjuvanted Influenza Vaccine (Fluad) After Concomitant Vaccination in Adults Aged ≥60 Years
Recent reviews have highlighted the unpredictability and complexity of immune interference
when multivalent conjugate vaccines are co-administered with other pediatric vaccines. It
has become evident that the likelihood of immune interference (in response to conjugated- or
co-administered antigens) increases in proportional to the number of glyco-conjugates
(valencies) and dosages of carrier proteins. There are many kinds of carrier proteins:
tetanus toxoid (TT), diphtheria toxoid (DT), CRM197 (non-toxic variant of DT), OMP (complex
outer-membrane protein mixture from Neisseria meningitidis) and non-typeable Hemophilus
influenza-derived protein D. Among them, TT is a more potent inducer of T-helper immunity,
but carrier-induced-epitopic suppression (dose-dependent carrier antibody and carrier B cell
dominance) may occur with TT. In comparison, DT and CRM197 are weaker B-cell immunogens, but
apparently trigger more T-regulatory mechanism. Recent pediatric studies of PCV13
co-administered with DTaP vaccines showed 6B GMT (geometric mean titer) to be somewhat
reduced compared to the results with PCV13 alone.
Similar to children, adults frequently visit outpatient clinics to get two or more kinds of
vaccines at the same time: pneumococcal vaccine, influenza vaccine, Td (diphtheria and
tetanus) vaccine, HPV (human papilloma virus) vaccine, meningococcal vaccine, zoster
vaccine, etc. PCV13 has limited co-administration information for adjuvanted influenza
vaccine.
This study is designed to evaluate the immunogenicity and safety of PCV13 and
MF59-adjuvanted influenza vaccine (Fluad) after concomitant administration in adults aged 60
years or older.
This study is a multi-centered, randomized controlled clinical trial: Korea University Guro
Hospital, Korea University Ansan Hospital, Hallym University Gangnam Sacred Hospital and
Catholic University Medical College, St. Vincent's Hospital.
The primary objective is to evaluate the immunogenicity of Fluad after concomitant
administration of Fluad and PCV13 in adults aged 60 years or more. This study is designed to
demonstrate non-inferiority of sero-conversion rate after Fluad vaccination: Fluad-PCV13
co-administration group versus Fluad alone group
The secondary objective is to evaluate the immunogenicity of PCV13 after concomitant
administration in adults aged 60 years or more. This study is designed to demonstrate
non-inferiority of PCV13 when co-administered with Fluad compared with PCV13 alone.
This study is also designed to evaluate the safety of concomitant PCV13-Fluad administration
in adults aged 60 years or more. All the participants will be followed for the duration of
an expected average of 4 weeks after vaccination.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
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