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

NCT00262002 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 601

Last updated 2014-06-18

Study results available
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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.

Conditions

  • Prevention of Meningococcal Disease

Interventions

BIOLOGICAL

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

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

BIOLOGICAL

MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)

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

BIOLOGICAL

MenACWY PS (MenACWY-CRM, polysaccharide vaccine)

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

BIOLOGICAL

HBV (Hepatitis B vaccine)

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

BIOLOGICAL

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

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

BIOLOGICAL

MMR (Measles, Mumps and Rubella vaccine)

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

BIOLOGICAL

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

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

BIOLOGICAL

Menjugate (Men C conjugated vaccine)

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

Sponsors & Collaborators

  • Novartis

    collaborator INDUSTRY

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Novartis Vaccines · Novartis Vaccines & Diagnostics

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Months
Max Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2004-09-30
Primary Completion
2005-07-31
Completion
2006-10-31

Countries

  • Canada
  • United Kingdom

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00262002 on ClinicalTrials.gov