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When two or more vaccines are administered concurrently, there is a concern on vaccine interaction, which can either enhance or suppress immune response to vaccine antigens. This study is designed to evaluate the immunogenicity and safety of tetanus-diphtheria (Td) and pneumococcal vaccines after concomitant administration in adults aged 50 years and older.
Vaccination would be the most effective strategy to prevent diverse infectious diseases. Actually, The World Health Organization (WHO) estimate that vaccination averts 2-3 million deaths per year. In adults, several vaccines are recommended based on age and medical conditions if they have not receive vaccination before, and lack evidence of past infection: influenza, measles-mumps-rubella (MMR), varicella, human papilloma virus (HPV), tetanus-diphtheria (Td), pneumococcl vaccines and etc. In particular, when the patient visits a vaccination clinic, Td and the pneumococcal vaccines are commonly administered at the same time. In this study, we aimed to evaluate the immunogenicity and safety of Td vaccine and PCV13 after concomitant administration in adults aged 50 years. This single-center, open label randomized trial was conducted (Clinical Trial Number - NCT02215863) at Korea University Guro Hospital from November 2013 to April 2016. Adults ≥50 years of age were randomized in a 1:1:1 ratio to receive Td + PCV13 (Group 1), PCV13 alone (Group 2) or Td alone (Group 3).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tetanus-diphtheria (Td) and PCV13 | Active Comparator |
| |
| PCV13 alone | Active Comparator |
| |
| Td alone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tetanus-diphtheria (Td) and PCV13 | Biological | 154 concomitant Td-PCV13 recipients: one dose of each vaccine administered on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Tetanus antibody titers at day 28 post-vaccination | IgG antibody titers by enzyme linked immunosorbent assay (ELISA) Seroprotection rate: percentage of subjects with a post-vaccination antibody levels ≥0.1 IU/mL | 4 weeks after vaccination |
| Diphtheria antibody titers at day 28 post-vaccination | IgG antibody titers by enzyme linked immunosorbent assay (ELISA) | 4 weeks after vaccination |
| Tetanus seroprotection rate at day 28 post-vaccination | Proportion of IgG antibody titers ≥0.1 IU/mL | 4 weeks after vaccination |
| Diphtheria seroprotection rate at day 28 post-vaccination | Proportion of IgG antibody titers ≥0.1 IU/mL | 4 weeks after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Opsonophagocytic assay (OPA) titers for PCV13 | Four capsule serotypes: 1, 5, 18C and 19A | 4 weeks after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency and duration of local and systemic adverse events | The safety profiles of co-administration of Td and PCV13 will be compared to those of single vaccination. | During 4 weeks after vaccination |
Inclusion Criteria:
Exclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30518331 | Derived | Song JY, Cheong HJ, Noh JY, Choi MJ, Yoon JG, Lee SN, Kang SH, Jeong EJ, Jo YM, Kim WJ. Immunogenicity and safety of a tetanus-diphtheria vaccine and a 13-valent pneumococcal conjugate vaccine after concomitant vaccination in >/= 50-year-old adults. BMC Infect Dis. 2018 Dec 5;18(1):628. doi: 10.1186/s12879-018-3479-9. |
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| ID | Term |
|---|---|
| D013742 | Tetanus |
| D004165 | Diphtheria |
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D003015 | Clostridium Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| PCV13 alone | Biological | 154 PCV13 recipients: one vaccine injection administered on Day 0 |
|
| Td alone | Biological | 437 Td recipients: one vaccine injection administered on Day 0 |
|
| D007239 | Infections |
| D003354 | Corynebacterium Infections |
| D000193 | Actinomycetales Infections |
| D013290 | Streptococcal Infections |