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This Phase 1, randomized, double-blind, third-party-unblinded study will be conducted at investigational sites in China. The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC in Chinese adults 50 years of age and older who did not receive any of pneumococcal vaccine in the past
The purpose of the study is to learn about the safety and immune response of 20vPnC and 13vPnC vaccines in Chinese adults. This study is seeking for participants who:
The participants will be grouped by three age groups:
All participants in this study will receive a single dose of 20vPnC or 13vPnC at study clinic. The study will look at the experiences of people receiving 20vPnC and 13vPnC. This will help decide if the study vaccine is safe.
The total duration of taking part in the study will be around 6 months, with 6 visits.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20vPnC | Experimental | Single dose of 20-valent pneumococcal conjugate vaccine |
|
| 13vPnC | Experimental | Single dose of 13-valent pneumococcal conjugate vaccine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20vPnC | Biological | 20 valent pneumococcal conjugate vaccine |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting prompted local reactions within 7 days following investigational product administration | Prespecified local reactions (redness, swelling, and pain at the injection site) | Within 7 days after vaccination |
| Percentage of participants reporting prompted systemic events within 7 days following investigational product administration | Prespecified systemic events (fever, headache, fatigue, muscle pain, and joint pain) | Within 7 days after vaccination |
| Percentage of participants reporting adverse events (AEs) through 1 month following investigational product administration | Adverse events occurring within 1 month after vaccination | Within 1 month after vaccination |
| Percentage of participants reporting serious adverse events (SAEs) throughout the study | SAEs occurring within 6 months after vaccination | Within 6 months after vaccination |
| Percentage of participants reporting abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values | Abnormal hematology, biochemistry, and urinalysis and microscopy laboratory values | 3 to 5 days after vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Pneumococcal serotype-specific Opsonophagocytic activity (OPA) geometric mean titer (GMT) | Pneumococcal serotype-specific OPA GMTs | 1 month after vaccination |
| Pneumococcal serotype-specific OPA geometric mean fold rise (GMFR) |
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Key inclusion criteria:
1.Generally healthy adults including those with preexisting stable disease determined to be eligible based on clinical assessment, medical history and clinical judgment.
Key exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhejiang provincial center for disease control and prevention | Hangzhou | Zhejiang | 310051 | China | ||
| Kaihua County Center For Disease Prevention and Control |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
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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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| 13vPnC |
| Biological |
13 valent pneumococcal conjugate vaccine |
|
Pneumococcal serotype-specific OPA GMFRs
| Before vaccination to 1 month after vaccination |
| Kaihua |
| Zhejiang |
| 324300 |
| China |
| Kaihua County Center For Disease Prevention and Control | Quzhou | Zhejiang | 324300 | China |
| D007239 | Infections |