Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 Months of Age

This study has been completed.

First Received: April 3, 2006 Last Updated: March 12, 2007 History of Changes

Sponsors and Collaborators:	Novartis Novartis Vaccines
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00310674

Purpose

Immunogenicity, Safety and Tolerability, of Chiron Meningococcal C Conjugate Vaccine Administered to Healthy Premature and Non Premature Children of 3 months of age

Condition	Intervention	Phase
Prevention of Meningococcal Infection	Biological: Meningococcal C Conjugate Vaccine	Phase III

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	A Phase III, Single Center, Open Label, Uncontrolled Study to Evaluate the Immunogenicity, Safety and Tolerability, of the Chiron Meningococcal C Conjugate Vaccine When Administered to Healthy Premature and Non Premature Children at 3, 5, 11 Months of Age Concomitantly With a Hexavalent Infant Vaccine

Further study details as provided by Novartis:

Primary Outcome Measures:

antibody response, as measured by ELISA, to N. meningitidis serogroup C at one month following three doses of MenC Conjugate Vaccine administered at 3, 5, 11 months of age, together with a hexavalent vaccine.
safety and tolerability

Secondary Outcome Measures:

antibody response as measured by ELISA at 1 month after second dose of MenC Vaccine and before third dose with hexavalent vaccine
antibody response as measured by BCA in subset of subjects in each group, at 1 month after second dose, immediately before the third and at 1 month following the third dose of MenC Vaccine together with a hexavalent vaccine.

Estimated Enrollment:	150
Study Start Date:	September 2004

Eligibility

Ages Eligible for Study:	11 Weeks to 15 Weeks
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy children of 11 to 15 weeks of age

Exclusion Criteria:

Children who previously received any kind of Meningococcal C vaccine, DTaP-IPV-HBV-Hib vaccine or a Hepatitis B vaccine at birth
Children who have a previous ascertained or suspected disease caused by N. meningitidis, Corynebacterium diphtheriae, Clostridium tetani, poliovirus, Hepatitis B or H. influenzae type b, culture proven Bordetella pertussis, or clinical condition of spasmodic cough for a period longer than or equal to 2 weeks associated with apnea or whooping
Children who have had household contact with and/or intimate exposure to an individual with culture proven N. meningitidis serogroup C or Bordetella pertussis, within the previous 60 days

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00310674

Locations

Italy
Istituto di Pediatria, Università degli Studi di Milano
Milano, Italy, 20122

Sponsors and Collaborators

Novartis

Novartis Vaccines

Investigators

Principal Investigator:

Novartis - Information Services

Novartis Vaccines & Diagnostics

More Information

No publications provided

Study ID Numbers:	M14P3, Impact N° 926
Study First Received:	April 3, 2006
Last Updated:	March 12, 2007
ClinicalTrials.gov Identifier:	NCT00310674 History of Changes
Health Authority:	Italy: Ministry of Health

Keywords provided by Novartis:

Prevention of Meningococcal Meningitis
meningococcal vaccines
conjugate
Immunology
infant

Study placed in the following topic categories:

Bacterial Infections
Meningococcal Infections
Meningitis, Meningococcal
Meningococcal Infection

Healthy
Gram-Negative Bacterial Infections
Neisseriaceae Infections
Meningitis

Additional relevant MeSH terms:

Bacterial Infections
Meningococcal Infections
Infection
Gram-Negative Bacterial Infections
Neisseriaceae Infections

ClinicalTrials.gov processed this record on May 07, 2009