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

Novartis

Status and phase: Completed; Phase 3

Conditions: Prevention of Meningococcal Infection

Treatments: Biological: Meningococcal C Conjugate Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00310674

Impact N° 926

M14P3

Details and patient eligibility

About

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

Sex: All

Ages: 11 to 15 weeks old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)