A Study to Describe the Safety and Immunogenicity of 20vPnC in Infants in India and Taiwan
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Randomized · Quadruple · Prevention
Enrollment
541actual
Sites
11
Countries
India, Taiwan
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-09-16 | actual | When the study began enrolling |
| Primary completion | 2025-09-20 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-20 | actual | The whole study's end, after follow-up |
| First posted | 2022-08-23 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-12-15 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Pneumococcal Disease
Interventions
- Biological: 20-valent pneumococcal conjugate vaccine
- Biological: 13-valent pneumococcal conjugate vaccine
Primary outcomes
what the primary-completion date above is the date OFPercentage of participants in India and Taiwan with local reactions (redness, swelling, and pain at the injection site), separately by country
measured Day 7
Percentage of participants in India and Taiwan with systemic events (fever, decreased appetite, drowsiness/increased sleep, and irritability), separately by country
measured 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
measured 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
measured 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
measured 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
measured 1 month after Dose 4
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