Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 3

Conditions: Infections, Meningococcal; Meningococcal Disease

Treatments: Biological: MenACWY-CRM

Study type: Interventional

Funder types: Industry

Identifiers

NCT01682876

V59_57 (Other Identifier)

205238

2011-004421-27 (EudraCT Number)

Details and patient eligibility

About

This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.

Enrollment: 715 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations

Exclusion criteria

1. Unwilling or unable to give written informed assent or consent to participate in the study.

2. Perceived to be unreliable or unavailable for the duration of the study period.

3. Previous confirmed or suspected disease caused by N. meningitidis.

4. Previously immunized with a meningococcal vaccine (licensed or investigational).

5. Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.

6. Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine.

   (certain exceptions influenza vaccines apply)

7. Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment.

8. Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.

9. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components

10. Impairment/alteration of immune function, either congenital or acquired or resulting from (for example):

    • receipt of immunosuppressive therapy,
    • receipt of immunostimulants,
    • receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.

11. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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715 participants in 4 patient groups, including a placebo group

2 through 5 years (1 Vac) MenACWY-CRM 1

Placebo Comparator group

Description:

Subjects 2 through 5 years received one vaccination of MenACWY-CRM

Treatment:

Biological: MenACWY-CRM

2 through 5 years (2 Vac) MenACWY-CRM 2

Active Comparator group

Description:

Subjects 2 through 5 years received two vaccinations of MenACWY-CRM

Treatment:

Biological: MenACWY-CRM

6 through 10 years (1 Vac) MenACWY-CRM 3

Placebo Comparator group

Description:

Subjects 6 through 10 years received one vaccination of MenACWY-CRM

Treatment:

Biological: MenACWY-CRM

6 through 10 years (2 Vac) MenACWY-CRM 4

Active Comparator group

Description:

Subjects 6 through 10 years received two vaccinations of MenACWY-CRM

Treatment:

Biological: MenACWY-CRM