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NCT04379713 · ClinicalTrials.gov registry record · Phase 3
20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,511
- Enrollment target
NCT04379713: Completed Phase 3 study, sponsored by Pfizer.
NCT04379713 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 1,511 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04379713, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,511 participants
- Enrollment target
Study Summary
This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.
Primary Outcome
Local reactions included pain at injection site, redness and swelling, recorded by parent's/legal guardians of participants in an electronic diary (e-diary). Redness and swelling were measured and recorded in measuring device (caliper) units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild: greater than (\>) 0.0 to 2.0 cm; moderate: \>2.0 to 7.0 cm; and severe: \>7.0 cm. Pain at injection site was graded as mild: hurt if gently touched; moderate: hurt if ge
Interventions
- BIOLOGICAL 20-valent pneumococcal conjugate vaccine
- BIOLOGICAL 13-valent pneumococcal conjugate vaccine
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,511 participants |
| Start Date | 2020-05-21 |
| Est. Completion | 2022-08-31 |
| Phase | Phase 3 |
What the finished NCT04379713 record still lists
NCT04379713 is an interventional study that assigns participants to a tested intervention. Its 1,511 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (96% higher).
The record links to 0 conditions, and to 2 interventions - of which 20-valent pneumococcal conjugate vaccine is the first listed.
NCT04379713 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04379713 about?
NCT04379713 is a clinical study titled "20-valent Pneumococcal Conjugate Vaccine Safety Study in Healthy Infants". This study is designed to evaluate the safety and tolerability of 20vPnC in healthy infants.
What is the current status of trial NCT04379713?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,511 participants. The study started on 2020-05-21. Estimated completion is 2022-08-31.
What interventions are being tested in trial NCT04379713?
The interventions under investigation include: 20-valent pneumococcal conjugate vaccine (BIOLOGICAL), 13-valent pneumococcal conjugate vaccine (BIOLOGICAL).
Who is sponsoring clinical trial NCT04379713?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04379713's enrollment target sits among peer trials
1,511 157th of 2000 higher than 1,844 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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