Completed PHASE2 INTERVENTIONAL 3-arm NCT00310856

Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)

A Phase 2, Partially Randomized, Open Label, Multicenter Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Young Children

Sponsor: Novartis Vaccines

Conditions Meningococcal Meningitis

Interventions DTaP-Hib-IPV MMR MenACWY-CRM MenC-CRM PC7 Varicella

Updated 7 times since 2017 Last updated: Sep 10, 2018 Started: Jun 30, 2005 Primary completion: Nov 30, 2006 Completion: Nov 30, 2006

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00310856, this PHASE2 trial focuses on Meningococcal Meningitis and remains completed. Sponsored by Novartis Vaccines, it has been updated 7 times since 2005, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

7 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE2
Jul 2024 — Sep 2024 [monthly]

Completed PHASE2
Jan 2021 — Jul 2024 [monthly]

Completed PHASE2
Nov 2018 — Jan 2021 [monthly]

Completed PHASE2
Jun 2018 — Nov 2018 [monthly]

Completed PHASE2

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE2
Jan 2017 — Feb 2017 [monthly]

Completed PHASE2

First recorded

Jun 2005

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Novartis Vaccines

Data source: Novartis

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Halifax, Canada
• Ottawa, Canada