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NCT01000311 · ClinicalTrials.gov registry record · Phase 3

A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months

A Phase 3 study, sponsored by Novartis Vaccines.

Completed
Registry status
Phase 3
Development phase
529
Enrollment target

NCT01000311 is a Phase 3 study that has completed, run by Novartis Vaccines. The registered enrollment target is 529 participants.

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The verdict

NCT01000311, a Phase 3 study, has completed, sponsored by Novartis Vaccines.

COMPLETED
Registry status
Phase 3
Development phase
529 participants
Enrollment target

Study Summary

This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.

Interventions

  • BIOLOGICAL MenACWY-CRM
  • BIOLOGICAL DTaP-IPV/Hib
  • BIOLOGICAL HBV
  • BIOLOGICAL PCV
  • BIOLOGICAL MMR

Trial Details

FieldValue
Enrollment Target 529 participants
Start Date 2009-11
Est. Completion 2011-11
Phase Phase 3

Sponsor

Novartis Vaccines

32 total trials

What the Registry Record Tells You About NCT01000311

The ClinicalTrials.gov registry entry for NCT01000311 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 529 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Vaccines, which has 32 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which MenACWY-CRM is the first listed.

NCT01000311 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01000311 about?

NCT01000311 is a clinical study titled "A Study to Evaluate the Safety and Immunogenicity of 4 Doses of MenACWY Conjugate Vaccine, Administered Concomitantly With Routine Vaccines, Among Infants Aged 2 Months". This Phase 3 study is designed to demonstrate the safety and immunogenicity of MenACWY and non-interference of concomitant routine vaccines by MenACWY in an infant age group.

What is the current status of trial NCT01000311?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 529 participants. The study started on 2009-11. Estimated completion is 2011-11.

What interventions are being tested in trial NCT01000311?

The interventions under investigation include: MenACWY-CRM (BIOLOGICAL), DTaP-IPV/Hib (BIOLOGICAL), HBV (BIOLOGICAL), PCV (BIOLOGICAL), MMR (BIOLOGICAL).

Who is sponsoring clinical trial NCT01000311?

This trial is sponsored by Novartis Vaccines, which has 32 total clinical trials registered on ClinicalTrials.gov.

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

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.