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NCT00806195 · ClinicalTrials.gov registry record · Phase 3

Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

A Phase 3 study, sponsored by Novartis.

Completed
Registry status
Phase 3
Development phase
7,744
Enrollment target

NCT00806195 is a Phase 3 study that has completed, run by Novartis. The registered enrollment target is 7,744 participants.

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The verdict

NCT00806195, a Phase 3 study, has completed, sponsored by Novartis.

COMPLETED
Registry status
Phase 3
Development phase
7,744 participants
Enrollment target

Study Summary

The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants

Interventions

  • BIOLOGICAL MenACWY-CRM197
  • BIOLOGICAL DTaP (Diptheria, Tetanus, Pertussis) Vaccine
  • BIOLOGICAL Hib (Haemophilus influenza b) Vaccine
  • BIOLOGICAL IPV (Inactivated Polio Vaccine) Vaccine
  • BIOLOGICAL Pneumococcal conjugate Vaccine

Trial Details

FieldValue
Enrollment Target 7,744 participants
Start Date 2008-12
Est. Completion 2011-11
Phase Phase 3

Sponsor

Novartis

265 total trials

What the Registry Record Tells You About NCT00806195

The ClinicalTrials.gov registry entry for NCT00806195 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 7,744 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis, which has 265 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 5 interventions - of which MenACWY-CRM197 is the first listed.

NCT00806195 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00806195 about?

NCT00806195 is a clinical study titled "Study to Evaluate the Safety of Novartis MenACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants". The primary objective of this phase 3b study is to evaluate the safety and tolerability of Novartis MenACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants

What is the current status of trial NCT00806195?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,744 participants. The study started on 2008-12. Estimated completion is 2011-11.

What interventions are being tested in trial NCT00806195?

The interventions under investigation include: MenACWY-CRM197 (BIOLOGICAL), DTaP (Diptheria, Tetanus, Pertussis) Vaccine (BIOLOGICAL), Hib (Haemophilus influenza b) Vaccine (BIOLOGICAL), IPV (Inactivated Polio Vaccine) Vaccine (BIOLOGICAL), Pneumococcal conjugate Vaccine (BIOLOGICAL).

Who is sponsoring clinical trial NCT00806195?

This trial is sponsored by Novartis, which has 265 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.