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This Phase I, randomized, double-blind, parallel-controlled study is to be conducted in healthy adults aged 60 and above. Participants will be randomly assigned in a 1:1 ratio to receive either 26-valent Pneumococcal Conjugate Vaccine (PCV26) or the comparator (PCV13) on Day 1 (Visit 1). Solicited adverse events (AEs) will be collected for 7 days post-vaccination and unsolicited AEs for 28 days post-vaccination, with safety data limited to serious adverse events (SAEs), and newly diagnosed chronic medical conditions (NDCMCs) collected up to 6 months post-vaccination.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine group | Experimental | 30 subjects aged ≥60 are enrolled in this group. |
|
| Active control group | Active Comparator | 30 subjects aged ≥ 60 years are enrolled in this group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 26-valent Pneumococcal Conjugate Vaccine | Biological | Subjects were treated with a single intramuscular injection of 26-valent Pneumococcal Conjugate Vaccine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Solicited AEs within 0-7 days after vaccination | The frequencies and percentages of participants reporting solicited AEs in injection within 7 days after vaccination in each group | Within 0-7 days after vaccination. |
| Solicited systemic AEs within 0-7 days after vaccination | The frequencies and percentages of participants reporting solicited systemic AEs within 7 days after vaccination in each group. | Within 0-7 days after vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| Unsolicited AEs within 0-28 days after vaccination | The frequencies and percentages of participants reporting unsolicited AEs within 0-28 days after vaccination in each group. | Within 0-28 days after vaccination. |
| SAEs and newly diagnosed chronic medical conditions (NDCMCs) within 6 months after vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenjian Fang | Contact | +86-18611630252 | fangwenjian@zhifeishengwu.com |
| Name | Affiliation | Role |
|---|---|---|
| Lin Du | Beijing Zhifei Lvzhu Biopharmaceutical Co., Ltd | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emeritus Research | Melbourne | Victoria | 3124 | Australia |
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| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| 13-valent Pneumococcal Conjugate Vaccine | Biological | Subjects were treated with a single intramuscular injection of 13-valent Pneumococcal Conjugate Vaccine. |
|
The frequencies and percentages of participants reporting SAEs and NDCMCs within 6 months after vaccination. |
| Within 0-6 months after vaccination. |
| Laboratory testing clinically abnormalities on the 7th day after vaccination | The frequencies and percentages of participants with laboratory testing clinically abnormalities on the 7th day after vaccination in each group. | On the 7th day after vaccination |
| D007239 | Infections |