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

This study is ongoing, but not recruiting participants.

First Received: May 16, 2007 Last Updated: October 22, 2009 History of Changes

Sponsor:	Novartis
Collaborator:	Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00474526

Purpose

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

Condition	Intervention	Phase
Meningitis, Meningococcal	Biological: Meningococcal ACWY Conjugate Vaccine	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	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

Resource links provided by NLM:

MedlinePlus related topics: Meningitis

U.S. FDA Resources

Further study details as provided by Novartis:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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

Estimated Enrollment:	4500
Study Start Date:	March 2007
Estimated Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	2 Months to 2 Months
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474526

Show 54 Study Locations

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Study Chair:

Novartis - Vaccines

Novartis Vaccines & Diagnostics

More Information

No publications provided

Responsible Party:	Novartis Vaccines ( Novartis )
Study ID Numbers:	V59P14
Study First Received:	May 16, 2007
Last Updated:	October 22, 2009
ClinicalTrials.gov Identifier:	NCT00474526 History of Changes
Health Authority:	United States: Food and Drug Administration; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Colombia: INVIMA

Keywords provided by Novartis:

Meningococcal
meningitis
vaccine

infants
Meningococcal meningitis
Meningococcal disease

Additional relevant MeSH terms:

Bacterial Infections
Central Nervous System Infections
Meningococcal Infections
Meningitis, Bacterial
Nervous System Diseases
Central Nervous System Bacterial Infections

Meningitis, Meningococcal
Central Nervous System Diseases
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

ClinicalTrials.gov processed this record on February 08, 2010