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NCT01621802 · ClinicalTrials.gov registry record · Phase 3

Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age

A Phase 3 study, sponsored by GlaxoSmithKline.

Completed
Registry status
Phase 3
Development phase
4,011
Enrollment target

NCT01621802 is a Phase 3 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 4,011 participants.

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The verdict

NCT01621802, a Phase 3 study, has completed, sponsored by GlaxoSmithKline.

COMPLETED
Registry status
Phase 3
Development phase
4,011 participants
Enrollment target

Study Summary

The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.

Interventions

  • BIOLOGICAL Priorix
  • BIOLOGICAL M-M-R II
  • BIOLOGICAL Kinrix
  • BIOLOGICAL ProQuad

Trial Details

FieldValue
Enrollment Target 4,011 participants
Start Date 2012-06-21
Est. Completion 2015-11-09
Phase Phase 3

Sponsor

GlaxoSmithKline

1,345 total trials

What the Registry Record Tells You About NCT01621802

The ClinicalTrials.gov registry entry for NCT01621802 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 4,011 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 4 interventions - of which Priorix is the first listed.

NCT01621802 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01621802 about?

NCT01621802 is a clinical study titled "Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Combined Measles-mumps-rubella (MMR) Vaccine in Subjects Four to Six Years of Age". The purpose of this study is to support licensure of GSK Biologicals' MMR vaccine (Priorix®) in the US by generating immunogenicity and safety data in contrast to the US standard of care, Merck's MMR vaccine (M-M-R®II), when given as a second dose to children four to six years of age.

What is the current status of trial NCT01621802?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 4,011 participants. The study started on 2012-06-21. Estimated completion is 2015-11-09.

What interventions are being tested in trial NCT01621802?

The interventions under investigation include: Priorix (BIOLOGICAL), M-M-R II (BIOLOGICAL), Kinrix (BIOLOGICAL), ProQuad (BIOLOGICAL).

Who is sponsoring clinical trial NCT01621802?

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.