Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine

Novartis

Status and phase: Completed; Phase 3

Conditions: Meningococcal Meningitis

Treatments: Biological: Licensed comparator; Biological: MenACWY-CRM conjugate vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT00856297

V59P13E1

Details and patient eligibility

About

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

Enrollment: 389 patients

Sex: All

Ages: 11 to 18 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Subjects enrolled in V59P13:

• healthy subjects who have completed the V59P13 study.

Naïve subjects:

• healthy subjects aged-matched with subjects who had completed the V59P13 trial.(currently 16-23 years old).

Exclusion criteria

Subjects who had completed the V59P13 study:

• who received any meningococcal vaccine after the V59P13 trial;
• who have had previous confirmed or suspected disease caused by N. meningitidis;
• who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
• subjects with any serious, acute or chronic progressive disease.

Naïve subjects:

• who previously received any meningococcal vaccine;
• who have had previous confirmed or suspected disease caused by N. meningitidis;
• who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
• subjects with any serious, acute or chronic progressive disease.

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

389 participants in 5 patient groups

MenACWY-CRM

Experimental group

Description:

Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.

Treatment:

Biological: MenACWY-CRM conjugate vaccine

Licensed comparator

Active Comparator group

Description:

Subjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.

Treatment:

Biological: Licensed comparator

Naive

Other group

Description:

Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.

Treatment:

Biological: MenACWY-CRM conjugate vaccine

Biological: Licensed comparator

MenACWY-CRM/MenACWY-CRM

Experimental group

Description:

Subjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.

Treatment:

Biological: MenACWY-CRM conjugate vaccine

Licensed comparator/MenACWY-CRM

Experimental group

Description:

Subjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.

Treatment:

Biological: MenACWY-CRM conjugate vaccine

Biological: Licensed comparator