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NCT03828617 · ClinicalTrials.gov registry record · Phase 3
Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults
A Phase 3 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,710
- Enrollment target
NCT03828617: Completed Phase 3 study, sponsored by Pfizer.
NCT03828617 is a Phase 3 study that has completed, run by Pfizer. The registered enrollment target is 1,710 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (122% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03828617, a Phase 3 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,710 participants
- Enrollment target
Study Summary
This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.
Primary Outcome
Local reactions were recorded using an electronic diary. Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than \[\>\] 2.0 to 5.0 cm), moderate (\>5.0 to 10.0 cm) and severe (\>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and
Interventions
- BIOLOGICAL 13vPnC
- BIOLOGICAL 20vPnC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,710 participants |
| Start Date | 2019-02-14 |
| Est. Completion | 2019-10-09 |
| Phase | Phase 3 |
What the finished NCT03828617 record still lists
NCT03828617 is an interventional study that assigns participants to a tested intervention. Its 1,710 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 (122% higher).
The record links to 0 conditions, and to 2 interventions - of which 13vPnC is the first listed.
NCT03828617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03828617 about?
NCT03828617 is a clinical study titled "Trial to Evaluate the Safety and Immunogenicity of 3 Lots of 20-valent Pneumococcal Conjugate Vaccine in Pneumococcal Vaccine-Naïve Adults". This is a Phase 3, randomized, double-blind study with a 4-arm parallel design. Adults 18 through 49 years of age with no history of pneumococcal vaccination will be randomized in a 2:2:2:1 ratio to receive a single dose of: 20vPnC Lot 1; 20vPnC Lot 2; 20vPnC Lot 3; or 13vPnC.
What is the current status of trial NCT03828617?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,710 participants. The study started on 2019-02-14. Estimated completion is 2019-10-09.
What interventions are being tested in trial NCT03828617?
The interventions under investigation include: 13vPnC (BIOLOGICAL), 20vPnC (BIOLOGICAL).
Who is sponsoring clinical trial NCT03828617?
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 NCT03828617's enrollment target sits among peer trials
1,710 132nd of 2000 higher than 1,869 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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