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The purpose of this study is to learn about the safety of the 20-valent pneumococcal conjugate vaccine (20vPnC) among adults, children, and infants, as well as the immunogenicity of 20vPnC among infants and children under 2 years of age in China. This vaccine will be given as per the age-specific dosing schedules among healthy adults, children and infants in China.
This study is seeking healthy participants of 6 groups:
All participants in Group 1 to 5, in this study will receive 20vPnC as per the age-specific dosing schedules:
Participants in Group 6 will be randomized in a 1:1 ratio to received either 20vPnC or 13vPnC:
- Group 6: participants will receive 4 doses of 20vPnC or 13vPnC. Dose 2 will be given 42 to 63 days after Dose 1, and Dose 3 should be given 42 to 63 days after Dose 2, and Dose 4 should be given at 365 to <455 days of age.
The study will look at the experiences of people receiving the study vaccine. The study will also look at the immune response of some people receiving the study vaccine. This will help decide if the study vaccine is safe.
The total duration of taking part in the study from each group is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | Participants will receive 1 dose of 20vPnC Vaccine. |
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| Cohort 2 | Experimental | Participants will receive 1 dose of 20vPnC Vaccine. |
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| Cohort 3 | Experimental | Participants will receive 2 doses of 20vPnC Vaccine on Day 1 (Vaccination 1) and 56 to 70 days after Vaccination 1 (Vaccination 2). |
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| Cohort 4 | Experimental | Participants will receive 3 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 28 to 56 days after Vaccination 1 (Vaccination 2), and at 365 to <455 days of age and at least 56 days after Vaccination 2 (Vaccination 3). |
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| Cohort 5 | Experimental | Participants will receive 4 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to <455 days of age (Vaccination 4). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20vPnC | Biological | 20vPnC vaccine |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting prespecified local reactions within 7 days following each study intervention | Prespecified local reactions following each study intervention | Within 7 days of each study intervention |
| Percentage of participants reporting prespecified systemic events within 7 days following each study intervention | Prespecified systemic events following each study intervention | Within 7 days of each study intervention |
| Percentage of participants reporting adverse events (AEs) from the first study intervention through 1 month following the last study intervention administration | AEs occurring through 1 month following the last study intervention administration for participants of adults ≥18 to <50 years of age at the time of consent, and children and infants ≥7 months to <6 years of age at the time of consent. | 1 month after the last vaccination |
| Percentage of participants reporting AEs from the first study intervention through 1 month following the third study intervention. | AEs occurring from the first study intervention through 1 month following the third study intervention in infants ≥42 to ≤98 days of age at the time of consent. | From the first study intervention to 1 month after the third study intervention |
| Percentage of participants reporting AEs from the fourth study intervention to 1 month following the fourth study intervention. | AEs occurring from the fourth study intervention to 1 month following the fourth study intervention in infants ≥42 to ≤98 days of age at the time of consent. | From the fourth study intervention to 1 month after the fourth study intervention |
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Key inclusion criteria:
Male or female participants:
Healthy participants determined by clinical assessment and clinical judgment, to be eligible for the study.
Key exclusion criteria:
Please refer to the study contact for further eligibility details.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Guangxi Zhuang Autonomous Region Center for Disease Control and Prevention | Nanning | Guangxi | 530021 | China | ||
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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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This is an open label study. Participant, investigators, and sponsor will be unblinded to the participant's assigned study intervention.
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| Cohort 6 (20vPnC) |
| Experimental |
Participants will receive 4 doses of 20vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to <455 days of age (Vaccination 4). |
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| Cohort 6 (13vPnC) | Active Comparator | Participants will receive 4 doses of 13vPnC Vaccine on Day 1 (Vaccination 1), 42 to 63 days after Vaccination 1 (Vaccination 2), 42 to 63 days after Vaccination 2 (Vaccination 3), and at 365 to <455 days of age (Vaccination 4). |
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| 13vPnC | Biological | 13vPnC vaccine |
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| Percentage of participants reporting serious adverse events (SAEs) throughout the study | SAEs through 6 months following last study intervention | From the first study intervention to 6 months after the last study intervention |
| Wuming District Center for Disease Control and Prevention |
| Chengxiang |
| Nanning |
| 530199 |
| China |
| D007239 | Infections |