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NCT03313037 · ClinicalTrials.gov registry record · Phase 2
Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age
A Phase 2 study, sponsored by Pfizer.
- Completed
- Registry status
- Phase 2
- Development phase
- 444
- Enrollment target
NCT03313037: Completed Phase 2 study, sponsored by Pfizer.
NCT03313037 is a Phase 2 study that has completed, run by Pfizer. The registered enrollment target is 444 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (234% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03313037, a Phase 2 study, has completed, sponsored by Pfizer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 444 participants
- Enrollment target
Study Summary
This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 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 followed 1 month later with a dose of saline or Prevnar 13 followed 1 month later with a dose of PPSV23 (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 centimeter (cm), moderate: 5.5 to 10.0 cm and severe: greater than or equal to (\>=) 10.5 cm. Pain was graded as mild: did not interfere with activity, moderate: interfered with ac
Interventions
- OTHER Saline
- BIOLOGICAL Prevnar 13
- BIOLOGICAL Multivalent
- BIOLOGICAL PPSV23
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Start Date | 2017-10-10 |
| Est. Completion | 2018-12-10 |
| Phase | Phase 2 |
What the finished NCT03313037 record still lists
NCT03313037 is an interventional study that assigns participants to a tested intervention. The registered 444 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 (234% higher).
The record links to 0 conditions, and to 4 interventions - of which Saline is the first listed.
NCT03313037 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03313037 about?
NCT03313037 is a clinical study titled "Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Adults 60 Through 64 Years of Age". This is a Phase 2, randomized, double-blinded study with a 2-arm parallel design. Healthy adults aged 60 through 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 followed...
What is the current status of trial NCT03313037?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 444 participants. The study started on 2017-10-10. Estimated completion is 2018-12-10.
What interventions are being tested in trial NCT03313037?
The interventions under investigation include: Saline (OTHER), Prevnar 13 (BIOLOGICAL), Multivalent (BIOLOGICAL), PPSV23 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03313037?
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 NCT03313037's enrollment target sits among peer trials
444 89th of 2000 higher than 1,912 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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