A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants - Tabular View

Tracking Information

First Received Date ^ICMJE

May 16, 2007

Last Updated Date

October 22, 2009

Start Date ^ICMJE

March 2007

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Immunogenicity of routine infant vaccines when given concomitantly with MenACWY in a primary vaccine series and as a booster at 12 months of age as measured by serum bactericidal antibodies.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00474526 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Immunogenicity of Novertis MenACWY Conjugate Vaccine when given in an alternative primary or boost schedule
Safety and tolerability of Novartis MenACWY when given with concomitant vaccines during routine primary series or booster doses

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Vaccine In Infants

Official Title ^ICMJE

A Phase 3, Open-Label, Randomized, Parallel-Group, Multi-Center Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine When Administered With Routine Infant Vaccinations to Healthy Infants

Brief Summary

This study will evaluate the safety and immune response of the Novartis Meningococcal ACWY conjugate vaccine when administered with routine infant vaccinations to healthy infants

Detailed Description

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Meningitis, Meningococcal

Intervention ^ICMJE

Biological: Meningococcal ACWY Conjugate Vaccine

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

4500

Completion Date

Estimated Primary Completion Date

March 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Healthy term 2- month- old infants for whom a parent/legal representative has given written informed consent

Exclusion Criteria:

Subjects with a previous or suspected disease caused by Neisseria. meningitidies, Corynebacterium. diphtheriae, Clostridium. tetani, Poliovirus, Hepatitis B, Haemophilus influenzae type b (Hib), Pneumococcus or Bordetells. pertussis; previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s) or prior vaccination with Dipheria, Tetanus, Pertussis (acellular or whole cell), inactivated polio vaccineIPV or oral polio vaccineOPV, H. influenzae type b (Hib) or Pneumococcus; who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W-135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth; Any serious acute, chronic or progressive disease

Gender

Both

Ages

2 Months to 2 Months

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Argentina

Administrative Information

NCT ID ^ICMJE

NCT00474526

Responsible Party

Novartis, Novartis Vaccines

Study ID Numbers ^ICMJE

V59P14

Study Sponsor ^ICMJE

Novartis

Collaborators ^ICMJE

Novartis Vaccines

Investigators ^ICMJE

Study Chair:

Novartis - Vaccines

Novartis Vaccines & Diagnostics

Information Provided By

Novartis

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP