deltatrials
Completed PHASE2 INTERVENTIONAL 7-arm NCT00262002

Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants

A Phase II, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age

Sponsor: Novartis

Conditions Prevention of Meningococcal Disease
Interventions DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine) HBV (Hepatitis B vaccine) MMR (Measles, Mumps and Rubella vaccine) MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation) MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation) MenACWY PS (MenACWY-CRM, polysaccharide vaccine) Menjugate (Men C conjugated vaccine) Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)
Updated 6 times since 2017 Last updated: Jun 16, 2014 Started: Sep 30, 2004 Primary completion: Jul 31, 2005 Completion: Oct 31, 2006
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2 trial investigates Prevention of Meningococcal Disease and is currently completed. Novartis leads this study, which shows 6 recorded versions since 2004 — indicating limited longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotCompleted~Feb 2017 – ~Jun 2018 · 16 months · monthly snapshotCompleted~Jun 2018 – ~Jan 2021 · 31 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – present · 22 months · monthly snapshotCompleted

Change History

6 versions recorded

  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

  4. Jun 2018 — Jan 2021 [monthly]

    Completed PHASE2

  5. Feb 2017 — Jun 2018 [monthly]

    Completed PHASE2

▶ Show 1 earlier version

  1. Jan 2017 — Feb 2017 [monthly]

    Completed PHASE2

    First recorded

Sep 2004

Trial started

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

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Novartis
  • Novartis Vaccines
Data source: Novartis

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

Study Locations