Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

Novartis

Status and phase: Completed; Phase 2

Conditions: Meningococcal Meningitis

Treatments: Biological: MenACWY-CRM conjugate vaccine, adjuvanted; Biological: MenACWY polysaccharide vaccine; Biological: MenACWY-CRM conjugate vaccine, unadjuvanted

Study type: Interventional

Funder types: Industry

Identifiers

NCT00310817

EUDRACT NUMBER: 2004-001896-21

V59P7

Details and patient eligibility

About

To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine

Enrollment: 623 patients

Sex: All

Ages: 12 to 59 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy 12-<60 month old children;

Exclusion criteria

• subjects who have previously received any meningococcal vaccine
• subjects with any serious acute or chronic progressive disease

Trial design

623 participants in 4 patient groups

MenACWY-CRM(Ad+) 12 to 35 Months

Experimental group

Description:

Subjects received one dose of MenACWY-CRM conjugate vaccine with adjuvant (Ad+) on day 1 and second dose at 28 days or at 6 months or at 12 months after the first vaccination.

Treatment:

Biological: MenACWY-CRM conjugate vaccine, adjuvanted

MenACWY-CRM(Ad-) 12 to 35 Months

Experimental group

Description:

Subjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant (Ad-) on day 1 and second dose either at 28 days or at 6 months or at 12 months after the first vaccination.

Treatment:

Biological: MenACWY-CRM conjugate vaccine, unadjuvanted

MenACWY-CRM(Ad-) 36 to 59 Months

Experimental group

Description:

Subjects received one dose of MenACWY-CRM conjugate vaccine without adjuvant on day 1 and second dose on day 169 or day 337.

Treatment:

Biological: MenACWY-CRM conjugate vaccine, unadjuvanted

MenACWY-PS (36 to 59 Months)

Active Comparator group

Description:

Subjects received one dose of MenACWY polysaccharide (PS) vaccine on day 1 and second dose of MenACWY-CRM conjugate vaccine without adjuvant on day 169 or day 337.

Treatment:

Biological: MenACWY polysaccharide vaccine