Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningococcal Infections

Treatments: Biological: Licensed meningococcal ACWY vaccine; Biological: MenACWY-CRM

Study type: Interventional

Funder types: Industry

Identifiers

NCT00616421

11278 (Registry Identifier)

V59P20

Details and patient eligibility

About

To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.

Enrollment: 2,907 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
• who are available for all visits and telephone calls scheduled for the study
• who are up-to-date with age-appropriate routine childhood vaccinations

Exclusion criteria

• whose parent or legal guardian is unwilling or unable to give written informed consent
• who had a previous or suspected disease caused by N. meningitidis;
• who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
• who have received any investigational agents or vaccines within 90 days prior to enrollment
• who have any serious acute, chronic or progressive disease
• who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
• who have a history of anaphylaxis, serious vaccine reactions
• who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
• who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
• who have Down's syndrome or other known cytogenic disorders

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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2,907 participants in 3 patient groups

MenACWY-CRM (1 dose)

Experimental group

Description:

1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1.

Treatment:

Biological: MenACWY-CRM

Biological: MenACWY-CRM

Licensed polysaccharide vaccine

Active Comparator group

Description:

1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1

Treatment:

Biological: Licensed meningococcal ACWY vaccine

MenACWY-CRM (2 doses)

Experimental group

Description:

2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61.

Treatment:

Biological: MenACWY-CRM

Biological: MenACWY-CRM