Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningococcal Disease

Treatments: Biological: MenACWY-CRM

Study type: Interventional

Funder types: Industry

Identifiers

NCT01345721

V59P22E1

Details and patient eligibility

About

The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the response one month post an additional dose of Novartis MenACWY will be measured by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.

Enrollment: 205 patients

Sex: All

Ages: 22 to 45 months old

Volunteers: No Healthy Volunteers

Inclusion criteria

Children eligible to be enrolled in the study were those

• whose parents provide written informed consent;
• were in generally good health based on the clinical judgment of the investigators;
• subjects were 22-45 months of age at the time of enrollment into V59P22E1;
• subject who had participated in the parent V59P22 study.

Exclusion criteria

Main exclusion criteria:

• Subjects with serious, acute, or chronic illnesses
• Subjects who had received any other licensed vaccines within 28 days (Exception: Influenza vaccine was allowed up to 14 days prior to and no less than 14 days after the study immunization) prior to enrolment and any study visit
• Subjects who had received any Meningococcal vaccine since the study dose of MenACWY or Men C at 12 months of age in V59P22 trial.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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205 participants in 3 patient groups

MenACWY (2 primary + 1 booster dose)

Experimental group

Description:

Subjects who had previously received two primary doses of MenACWY-CRM vaccine (at 6-8 months and 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.

Treatment:

Biological: MenACWY-CRM

MenACWY (1 primary + 1 booster dose)

Experimental group

Description:

Subjects who had previously received one primary dose of MenACWY-CRM vaccine (at 12 months of age) in parent study, were administered one booster dose of the same vaccine in this extension study.

Treatment:

Biological: MenACWY-CRM

MenC (1 primary dose)+MenACWY (1 booster dose)

Experimental group

Description:

Subjects who had previously received one primary dose of the comparator MenC vaccine (at 12 months of age) in parent study, were administered one booster dose MenACWY-CRM vaccine in this extension study.

Treatment:

Biological: MenACWY-CRM