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NCT03313050 · ClinicalTrials.gov registry record · Phase 2
A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 511
- Enrollment target
NCT03313050: Completed Phase 2 study, sponsored by Pfizer.
NCT03313050 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 511 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (284% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03313050, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 511 participants
- Enrollment target
Study Summary
This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage. In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular pertussis combination vaccine (Tdap) (control group). In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 \>=2 months prior to investigational product administration will be randomized equally to receive either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the licensed 23-valent pneumococcal polysaccharide vaccine (control group).
Primary Outcome
Local reactions included pain at injection site, swelling and redness recorded by participants in an electronic diary (e-diary). 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 severe: pr
Interventions
- BIOLOGICAL Multivalent
- BIOLOGICAL Tdap
- BIOLOGICAL polysaccharide
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 511 participants |
| Start Date | 2017-10-12 |
| Est. Completion | 2019-05-24 |
| Phase | Phase 2 |
What the finished NCT03313050 record still lists
NCT03313050 is an interventional study that assigns participants to a tested intervention. The registered 511 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (284% higher).
The record links to 0 conditions, and to 3 interventions - of which Multivalent is the first listed.
NCT03313050 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03313050 about?
NCT03313050 is a clinical study titled "A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age". This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a 2-arm parallel design in each stage. In Stage 1 healthy adults 50 to 64 years of age with no history of pneumococcal vaccination will be randomized equally to receive either a single intramuscular dose of mul...
What is the current status of trial NCT03313050?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 511 participants. The study started on 2017-10-12. Estimated completion is 2019-05-24.
What interventions are being tested in trial NCT03313050?
The interventions under investigation include: Multivalent (BIOLOGICAL), Tdap (BIOLOGICAL), polysaccharide (BIOLOGICAL).
Who is sponsoring clinical trial NCT03313050?
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 NCT03313050's enrollment target sits among peer trials
511 68th of 2000 higher than 1,933 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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