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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 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 630 participants.

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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.

Interventions

  • BIOLOGICAL PCV13
  • BIOLOGICAL PPSV23
  • BIOLOGICAL ASP3772

Trial Details

FieldValue
Enrollment Target 630 participants
Start Date 2019-01-24
Est. Completion 2020-09-28
Phase Phase 1

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT03803202

The ClinicalTrials.gov registry entry for NCT03803202 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 630 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is GlaxoSmithKline, which has 1,345 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which PCV13 is the first listed.

NCT03803202 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.