Influenza, Human, Pneumococcal Infections
Conditions
Keywords
influenza vaccine, pneumococcal vaccine, simultaneous vaccination
Brief summary
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.
Detailed description
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.
Interventions
BIOLOGICALInfluenza vaccination with PPV23
GCflu and Pneumovax-23
BIOLOGICALInfluenza vaccination with PCV13
GCflu and Prevenar-13
Sponsors
Korea University Guro Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults aged ≥65 years who signed the informed consent
Exclusion criteria
* Previous pneumococcal vaccine recipients * Egg allergy * History of serious adverse event after vaccination * Any acute disease or infection * History of neurological symptoms or signs * Impairment of immune function or immunosuppressant use * Bleeding diathesis * Fever (defined as axillary temperature ³38.0°C) within 3 days * History of Streptococcal pneumoniae infection within the previous 5 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rates (A/H1N1, A/H3N2, and B) | Change from baseline titer at 4 weeks | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Seroprotection rates (A/H1N1, A/H3N2, and B) | Change from baseline titer at 4 weeks | Seroprotection rate: percentage of subjects with a post-vaccination titer ≥1:40 |
| GMT folds (A/H1N1, A/H3N2, and B) | Change from baseline titer at 4 weeks | GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency and duration of local and systemic adverse events | Monitor using a clinical diary for seven days after vaccination | the Food and Drug Administration Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials |
Countries
South Korea
Outcome results
None listed