NCT01434680 is a Phase 2 clinical trial of MenC-CRM LIQ in Meningococcal Disease, sponsored by Novartis.

Who is sponsoring NCT01434680?

NCT01434680 is sponsored by Novartis.

What drugs are being tested in NCT01434680?

Interventions in NCT01434680: MenC-CRM LIQ, MenC-CRM ROS, MenC-CRM EMV.

What condition does NCT01434680 study?

NCT01434680 studies Meningococcal Disease, Meningococcal Meningitis.

Is NCT01434680 still recruiting?

NCT01434680 is currently completed. Last updated 13 March 2017.

Are results published for NCT01434680?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2017-03-13 · How we verify

NCT01434680

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Phase 2, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of the New Liquid Formulation of Novartis Meningococcal C Conjugate Vaccine and of the Novartis Lyophilized Meningococcal C Conjugate Vaccine Manufactured at Two Different Sites, in Healthy Toddlers

Completed Phase 2 Results posted Last updated 13 March 2017

What this trial tests

Phase 2 trial testing MenC-CRM LIQ in Meningococcal Disease in 992 participants. Completed in 1 November 2012.

Timeline

1 September 2011

Primary endpoint
1 November 2012

1 November 2012

Quick facts

Lead sponsor	Novartis
Phase	Phase 2
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	prevention
Enrollment	992
Start date	1 September 2011
Primary completion	1 November 2012
Estimated completion	1 November 2012
Sites	11 locations across Poland

Drugs / interventions tested

MenC-CRM LIQ — full drug profile →
MenC-CRM ROS — full drug profile →
MenC-CRM EMV — full drug profile →

Conditions studied

Meningococcal Disease — all drugs for Meningococcal Disease →
Meningococcal Meningitis — all drugs for Meningococcal Meningitis →

Sponsor

Novartis — full company profile →

Who can join

Adults 12 Months to 23 Months, any sex, with Meningococcal Disease or Meningococcal Meningitis. Healthy volunteers can join.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination
Time frame: 1 month postvaccination (day 29)
Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs)against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV.

Sponsor's own description

The study was to evaluate the safety and and immune response of each of three lots of Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy Toddlers.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other Novartis trials

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01434680 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Novartis
Last refreshed: 13 March 2017

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01434680.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing