NCT00310674

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P25-P50 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 3, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 4, 2006

Completed
Last Updated

March 13, 2007

Status Verified

March 1, 2007

First QC Date

April 3, 2006

Last Update Submit

March 12, 2007

Conditions

Prevention of Meningococcal Infection

Keywords

Prevention of Meningococcal Meningitismeningococcal vaccinesconjugateImmunologyinfant

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • 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.

Interventions

Meningococcal C Conjugate VaccineBIOLOGICAL

Eligibility Criteria

Age11 Weeks - 15 Weeks
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Healthy children of 11 to 15 weeks of age

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istituto di Pediatria, Università degli Studi di Milano

Milan, 20122, Italy

Location

MeSH Terms

Interventions

serogroup C meningococcal conjugate vaccine

Study Officials

  • Novartis - Information Services

    Novartis Vaccines & Diagnostics

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

April 3, 2006

First Posted

April 4, 2006

Study Start

September 1, 2004

Last Updated

March 13, 2007

Record last verified: 2007-03

Locations

IT(1)