Status:

COMPLETED

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

Lead Sponsor:

Novartis

Collaborating Sponsors:

Novartis Vaccines

Conditions:

Prevention of Meningococcal Infection

Eligibility:

All Genders

11-15 years

Phase:

PHASE3

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

Eligibility Criteria

Inclusion

  • Healthy children of 11 to 15 weeks of age

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2004

Trial Type :

INTERVENTIONAL

End Date :

Estimated Enrollment :

150 Patients enrolled

Trial Details

Trial ID

NCT00310674

Start Date

September 1 2004

Last Update

March 13 2007

Active Locations (1)

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1

Istituto di Pediatria, Università degli Studi di Milano

Milan, Italy, 20122