Completed PHASE3 INTERVENTIONAL 2-arm NCT01000311

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

Sponsor: Novartis Vaccines

Conditions Meningococcal Disease

Interventions DTaP-IPV/Hib HBV MMR MenACWY-CRM PCV

Updated 7 times since 2017 Last updated: Apr 3, 2014 Started: Nov 30, 2009 Primary completion: Nov 30, 2011 Completion: Nov 30, 2011

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

This PHASE3 trial investigates Meningococcal Disease and is currently completed. Novartis Vaccines leads this study, which shows 7 recorded versions since 2009 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

7 versions recorded

Sep 2025 — Present [monthly]

Completed PHASE3
Sep 2024 — Sep 2025 [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 2 earlier versions

Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Nov 2009

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

Amarillo, United States , Bardstown, United States , Birmingham, United States , Canoga Park, United States , Carlton, Australia , Charleston, United States , Cleveland, United States , Clinton, United States , Dayton, United States , Fayetteville, United States and 30 more locations