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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza vaccination with PPV23 | Active Comparator | concomitant vaccination with trivalent inactivated influenza vaccine and 23-valent polysaccharide pneumococcal vaccine |
|
| Influenza vaccination with PCV13 | Active Comparator | concomitant vaccination with trivalent inactivated influenza vaccine and 13-valent pneumococcal conjugate vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccination with PPV23 | Biological | GCflu and Pneumovax-23 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Change from baseline titer at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Seroprotection rates (A/H1N1, A/H3N2, and B) | Seroprotection rate: percentage of subjects with a post-vaccination titer ≥1:40 | Change from baseline titer at 4 weeks |
| GMT folds (A/H1N1, A/H3N2, and B) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Monitor using a clinical diary for seven days after vaccination |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hee Jin Cheong, MD, PhD | Korea University Guro Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Korea University Ansan Hospital | Ansan | Kyoungido | 15355 | South Korea | ||
| Hallym University Gangnam Sacred Hospital |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Influenza vaccination with PCV13 |
| Biological |
GCflu and Prevenar-13 |
|
GMT-fold change: GMT ratio of the post-vaccination titer to pre-vaccination titer
| Change from baseline titer at 4 weeks |
| Seoul |
| Seoul |
| 07441 |
| South Korea |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |