A Phase 4 interventional study of Influenza vaccination with PPV23 and Influenza vaccination with PCV13 in Influenza, Human and Pneumococcal Infections, sponsored by Korea University Guro Hospital. Completed at 2 sites in Korea, Republic of. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-10-21.
Sponsored by Korea University Guro Hospital · Phase 4, Interventional, and Prevention
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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 224 is close to the median of 238 across 1,853 interventional studies indexed under Influenza, Human.
Browse Influenza, Human studies →Korea University Guro Hospital is the lead sponsor of 83 studies on the registry; 15 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
concomitant vaccination with trivalent inactivated influenza vaccine and 23-valent polysaccharide pneumococcal vaccine
Biological: Influenza vaccination with PPV23
concomitant vaccination with trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine
Biological: Influenza vaccination with PCV13
GCflu and Pneumovax-23
GCflu and Prevenar-13
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
Frequency and duration of local and systemic adverse events
the Food and Drug Administration Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials
Time frame: Monitor using a clinical diary for seven days after vaccination
This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Korea University Guro Hospital