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

NCT00310856 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 175

Last updated 2018-10-09

Study results available
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Summary

To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.

Conditions

  • Meningococcal Meningitis

Interventions

BIOLOGICAL

MenACWY-CRM

Subjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh.

BIOLOGICAL

MenC-CRM

One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region.

BIOLOGICAL

DTaP-Hib-IPV

BIOLOGICAL

PC7

One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh.

BIOLOGICAL

MMR

BIOLOGICAL

Varicella

Sponsors & Collaborators

  • Novartis Vaccines

    lead INDUSTRY

Principal Investigators

  • Scott Halperin, Dr. · Novartis Vaccines & Diagnostics

  • Francisco Diaz-Mitoma, Dr. · Novartis Vaccines

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2005-06-30
Primary Completion
2006-11-30
Completion
2006-11-30

Countries

  • Canada

Study Locations

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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 NCT00310856 on ClinicalTrials.gov