Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningococcal Meningitis

Treatments: Biological: MenACWY-CRM197 (one dose); Biological: MenC; Biological: PCV7; Biological: MenACWY-CRM197 (two doses); Biological: DTPa-IPV-HepB-Hib

Study type: Interventional

Funder types: Industry

Identifiers

NCT00667602

V59P22

2007-004754-82

Details and patient eligibility

About

The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).

Enrollment: 662 patients

Sex: All

Ages: 6 to 8 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• infants 6 to 8 months old inclusive, who were born after full term pregnancy and previously received three doses of both Prevenar and Infanrix-hexa vaccines at least 30 days before study entry

Exclusion criteria

• who previously received any meningococcal vaccine;
• who have had a previous confirmed or suspected disease caused by N. meningitidis, C. diphtheriae, C. tetani, Poliovirus, Hepatitis B, Hib, Pneumococcus or B. pertussis;
• who have had household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis (serogroups A, C, W135, or Y), B. pertussis, Hib, C. diphtheriae, Polio, or pneumococcal infection at any time since birth;
• Subjects with any serious, acute or chronic progressive disease

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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662 participants in 3 patient groups

MenACWY-CRM197 (2 doses) + Concomitant Vaccines

Experimental group

Description:

Infants received two doses of MenACWY-CRM197 at 6 to 8 and 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months.

Treatment:

Biological: DTPa-IPV-HepB-Hib

Biological: MenACWY-CRM197 (two doses)

Biological: PCV7

MenACWY-CRM197 (1 dose) + Concomitant Vaccines

Experimental group

Description:

Infants received one dose of MenACWY-CRM197 at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age.

Treatment:

Biological: DTPa-IPV-HepB-Hib

Biological: PCV7

Biological: MenACWY-CRM197 (one dose)

MenC (1 dose) + Concomitant Vaccines

Active Comparator group

Description:

Infants received one dose of MenC vaccine at 12 months of age and concomitant dose of PCV7 (Pneumococcal 7-valent Conjugate Vaccine) and DTPa-IPV-HepB-Hib (Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b) at 12 months of age.

Treatment:

Biological: DTPa-IPV-HepB-Hib

Biological: PCV7

Biological: MenC