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: 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 exposed to meningococcal disease/ bacterial meningitis. 5. Previously immunized with a meningococcal vaccine (licensed or investigational). 6. 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. 7. 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) 8. Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment. 9. Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome. 10. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components 11. 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. 12. 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.