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| ID | Type | Description | Link |
|---|---|---|---|
| NCT05512819 | Registry Identifier | ClinicalTrials.gov |
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The purpose of this study is to understand the safety and effects of a study vaccine (20vPnC) in infants and toddlers.
This study is enrolling participants who are:
Participants will receive either the study vaccine (20vPnC) or a licensed vaccine (13vPnC) as a 4-dose schedule as a shot in the muscle. Participants will receive Dose 1 on study day 1. Dose 2 will be given 28-70 days after Dose 1, and Dose 3 will be given 28-70 days after Dose 2. Dose 4 will be given at 365-455 days (approximately 12-15 months) of age.
Participation in the study will take approximately 15 months, during which participants will come to the study clinic for 6 times. The study team will ask questions about the participant's health and take some blood samples during the visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 20-valent pneumococcal conjugate vaccine | Experimental | Pneumococcal conjugate vaccine (20vPnC) |
|
| 13-valent pneumococcal conjugate vaccine | Active Comparator | Pneumococcal conjugate vaccine (13vPnC) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20-valent pneumococcal conjugate vaccine | Biological | 20-valent pneumococcal conjugate vaccine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants in India and Taiwan with local reactions (redness, swelling, and pain at the injection site), separately by country | Prompted local reactions after each dose | Day 7 |
| Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country | Prompted systemic reactions after each dose | Day 7 |
| Percentage of participants in India and Taiwan with adverse events (AEs) from Dose 1 through 1 month after Dose 3 in each group, separately by country | Adverse events occurring from Dose 1 to 1 month after Dose 3 in each group | Dose 1 to 1 month after Dose 3 |
| Percentage of participants from India and Taiwan with AEs from Dose 4 through 1 month after Dose 4 in each group, separately by country | Adverse events occurring from Dose 4 to 1 month after Dose 4 in each group | Dose 4 to 1 month after Dose 4 |
| Percentage of participants in India and Taiwan with SAEs from Dose 1 through 1 month after Dose 4 in each group, separately by country | SAEs occurring up to 1 month after Dose 4 in each group | Dose 1 to 1 month after Dose 4 |
| GMCs of serotype-specific IgG concentrations in Indian participants 1 month after Dose 4 in each vaccine group | IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Indian participants only | 1 month after Dose 4 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric mean concentrations (GMCs) of serotype-specific IgG concentrations 1 month after Dose 3 in each vaccine group, separately by country | IgG GMCs for the 20vPnC serotypes 1 month after Dose 3 | 1 month after Dose 3 |
| Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentration for the 20vPnC serotypes at approximately 1 month after Dose 3 in each vaccine group, separately by country |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nirmal Hospital Pvt Ltd. | Surat | Gujarat | 395002 | India | ||
| BGS Global Institute of Medical Sciences (BGSGIMS) |
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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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| 13-valent pneumococcal conjugate vaccine | Biological | 13-valent pneumococcal conjugate vaccine |
|
IgG concentrations for 20vPnC serotypes 1 month after Dose 3 |
| 1 month after Dose 3 |
| GMCs of serotype-specific IgG concentrations in Taiwanese participants 1 month after Dose 4 in each vaccine group | IgG GMCs for the 20vPnC serotypes 1 month after Dose 4, Taiwanese participants only | 1 month after Dose 4 |
| Percentages of participants in India and Taiwan with predefined serotype-specific IgG concentrations for the 20vPnC serotypes at approximately 1 month after Dose 4 in each vaccine group, separately by country | IgG concentrations for 20vPnC serotypes 1 month after Dose 4 | 1 month after Dose 4 |
| Bangalore |
| Karnataka |
| 560060 |
| India |
| Bharati Vidyapeeth {Deemed to be University) Medical College Hospital & Research Centre | Pune | Maharashtra | 411043 | India |
| Maulana Azad Medical College and Associated with Lok Nayak Hospital | New Delhi | National Capital Territory of Delhi | 110002 | India |
| Jawahar Lal Nehru Medical College | Ajmer | Rajasthan | 305001 | India |
| Institute of Child Health | Kolkata | West Bengal | 700017 | India |
| Hsinchu Mackay Memorial Hospital | Hsinchu | Hsinchu | 30071 | Taiwan |
| Taichung Veterans General Hospital | Taichung | 407219 | Taiwan |
| National Taiwan University Hospital | Taipei | 10002 | Taiwan |
| Mackay Memorial Hospital | Taipei | 10449 | Taiwan |
| Chang Gung Medical Foundation-Linkou Branch | Taoyuan | 333 | Taiwan |
| ID | Term |
|---|---|
| D011008 | Pneumococcal Infections |
| ID | Term |
|---|---|
| D013290 | Streptococcal Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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