CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 601 enrolled
Drug / intervention
MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation) +7 morebiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

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Search/NCT00262002
NCT00262002Phase 2Completed
CompareCT.gov

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

Novartis Vaccines·interventional·Posted Dec 6, 2005·Updated Jun 18, 2014

In Brief

A Phase 2 clinical trial evaluating MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation), MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation), and 6 other interventions for Prevention of Meningococcal Disease. Completed, enrolled 601 participants across 3 sites in 2 countries.

Detailed Summary

The purpose of this study is to evaluate the safety, immunogenicity and induction of immune memory after two or three doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy infants.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrevention of Meningococcal Disease
CountriesCanada, United Kingdom
CollaboratorsNovartis

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 6, 2005
Enrollment StartSep 1, 2004
Primary CompletionJul 1, 2005
Study CompletionOct 1, 2006
TodayJul 2, 2026
Enrollment to primary: 10 monthsPosted 20.6 years ago

Interventions

MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)biological

MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.

MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)biological

MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.

MenACWY PS (MenACWY-CRM, polysaccharide vaccine)biological

MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.

HBV (Hepatitis B vaccine)biological

Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.

Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)biological

Prevnar was administered IM in the anterolateral area of the left thigh.

MMR (Measles, Mumps and Rubella vaccine)biological

MMR at 12 month of age, administered in the left arm.

DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)biological

DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.

Menjugate (Men C conjugated vaccine)biological

Menjugate was injected IM in the anterolateral area of the right thigh.