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NCT03803202 · ClinicalTrials.gov registry record · Phase 1
A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 630
- Enrollment target
NCT03803202: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT03803202 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 630 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (950% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03803202, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 630 participants
- Enrollment target
Study Summary
The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in adults 18 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator PCV13 in elderly 65 to 85 years of age. In addition, Stage 2 will evaluate the immunogenicity of 3 different dose levels of ASP3772 relative to the response seen following administration of Pneumovax® 23 (PPSV23) for the serotypes not included in PCV13.
Primary Outcome
An AE is any untoward medical occurrence in a participant administered a study vaccine, and which does not necessarily have to have a causal relationship with this vaccination. A TEAE is defined as any AE with onset within 30 days from study vaccine administration. Medically attended TEAEs (MAAEs) are AEs for which the participant has received medical attention by medical personnel, or in an emergency room, or which led to hospitalization. A new-onset chronic disease TEAEs (NOCD) is defined as
Interventions
- BIOLOGICAL PCV13
- BIOLOGICAL PPSV23
- BIOLOGICAL ASP3772
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 630 participants |
| Start Date | 2019-01-24 |
| Est. Completion | 2020-09-28 |
| Phase | Phase 1 |
What the finished NCT03803202 record still lists
NCT03803202 is an interventional study that assigns participants to a tested intervention. The registered 630 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (950% higher).
The record links to 0 conditions, and to 3 interventions - of which PCV13 is the first listed.
NCT03803202 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03803202 about?
NCT03803202 is a clinical study titled "A Single Ascending Dose Study in Adults (Stage 1) and Single Ascending Dose-Finding Study (Stage 2) in Elderly Subjects With ASP3772, A Pneumococcal Vaccine". The purpose of the study is to evaluate the safety, tolerability, and immunogenicity of 3 different dose levels of ASP3772 in comparison to the active comparator Prevnar 13® (PCV13) in adults 18 to 64 years of age in Stage 1. Stage 2 will evaluate the safety, tolerability, and immunogenicity of 3 di...
What is the current status of trial NCT03803202?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 630 participants. The study started on 2019-01-24. Estimated completion is 2020-09-28.
What interventions are being tested in trial NCT03803202?
The interventions under investigation include: PCV13 (BIOLOGICAL), PPSV23 (BIOLOGICAL), ASP3772 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03803202?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03803202's enrollment target sits among peer trials
630 22nd of 2000 higher than 1,978 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 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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