Overview

This trial is active, not recruiting.

Condition meningococcal disease
Treatments menacwy, placebo-menacwy
Phase phase 3
Sponsor Novartis Vaccines
Start date October 2012
End date July 2013
Trial size 716 participants
Trial identifier NCT01682876, V59_57

Summary

This study is 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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
2-5 years of age
menacwy
2 dose vaccination schedule
(Active Comparator)
2-5 years of age
placebo-menacwy
1 dose vaccination schedule
(Experimental)
6-10 years of age
menacwy
2 dose vaccination schedule
(Active Comparator)
6-10 years of age
placebo-menacwy
1 dose vaccination schedule

Primary Outcomes

Measure
Percentage of subjects with hSBA seroresponse
time frame: Day 29 post dose 2

Secondary Outcomes

Measure
Percentage of subjects with hSBA ≥1:8
time frame: Day 365 post dose 2
hSBA GMTs
time frame: Day 29 and Day 365 post dose 2
Solicited local and systemic reactions
time frame: Days 1-7 postvaccination
Unsolicited Adverse Events
time frame: Days 1-28 postvaccination
Medically attended Adverse Events
time frame: Day 365 post dose 2
Adverse Events leading to premature withdrawal
time frame: Day 365 post dose 2
Serious Adverse Events
time frame: Day 365 post dose 2

Eligibility Criteria

Male or female participants from 2 years up to 10 years old.

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

  • Unwilling or unable to give written informed assent or consent to participate in the study.
  • Perceived to be unreliable or unavailable for the duration of the study period.
  • Previous confirmed or suspected disease caused by N. meningitidis.
  • Previously exposed to meningococcal disease/ bacterial meningitis.
  • Previously immunized with a meningococcal vaccine (licensed or investigational).
  • 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.
  • 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)
  • Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment.
  • Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
  • History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components
  • 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.
  • Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

Additional Information

Official title A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, Administered to Healthy Children 2 to 10 Years of Age.
Trial information was received from ClinicalTrials.gov and was last updated in December 2013.
Information provided to ClinicalTrials.gov by Novartis.