Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in Healthy Children

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

NCT00311415

M14P6

Impact N° 919

Details and patient eligibility

About

Immunogenicity, Safety, Tolerability and Ability to Prime for Memory of Meningococcal C Conjugate Vaccine in healthy children

Full description

The aim of this study is to investigate the immunogenicity offered by MenCC vaccine when administered in different schedules at different years of life: 2 doses in the first year of life given 2 months apart (at 2 and 4 months of age), with a booster in the second year of life, or 1 dose in the first year of life (at 2 or 6 months of age), with a booster in the second year of life, or only 1 dose in the second year of life.

Enrollment: 257 patients

Sex: All

Ages: 7 to 16 weeks old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy infants

Exclusion criteria

• known hypersensitivity to any vaccine component
• significant acute or chronic infections
• previously ascertained or suspected disease caused by N. meningitidis
• previous household contact with an individual with a positive culture of N. meningitidis serogroup C

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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257 participants in 4 patient groups

Group 1: 2+4 Months (2-doses)

Experimental group

Treatment:

Biological: Meningococcal C conjugate vaccine

Group 2: 2 Months (1-dose)

Experimental group

Treatment:

Biological: Meningococcal C conjugate vaccine

Group 3: 6 Months (1-dose)

Experimental group

Treatment:

Biological: Meningococcal C conjugate vaccine

Group 4: 12-16 Months (1 dose in the second year of life)

Active Comparator group

Treatment:

Biological: Meningococcal C conjugate vaccine