Clinical trial NCT00616421: Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
Official title: A Phase 3, Randomized, Observer-blind, Multi-Center Study to Compare the Safety and Immunogenicity of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With One Dose of Licensed Meningococcal ACWY Conjugate Vaccine Administered to Healthy Children 2-10 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Infections
Keywords: vaccine
children
healthy
meningitis
meningococcal
prevention of meningococcal disease serogroups ACWY
Menveo
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-02-15
Enrollment: 2907
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To evaluate the safety and immune response of Novartis MenACWY conjugate vaccine when given to healthy children compared to a licensed Meningococcal ACWY polysaccharide-protein conjugate vaccine.


Eligibility criteria: Inclusion Criteria:

* healthy 2-10 years of age children, inclusive and for whom, after the nature of the study has been explained, the parent or legal guardian has provided written informed consent
* who are available for all visits and telephone calls scheduled for the study
* who are up-to-date with age-appropriate routine childhood vaccinations

Exclusion Criteria:

* whose parent or legal guardian is unwilling or unable to give written informed consent
* who had a previous or suspected disease caused by N. meningitidis;
* who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s)
* who have received any investigational agents or vaccines within 90 days prior to enrollment
* who have any serious acute, chronic or progressive disease
* who have epilepsy or any progressive neurological disease or history of Guillain Barré Syndrome
* who have a history of anaphylaxis, serious vaccine reactions
* who have a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from
* who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time
* who have Down's syndrome or other known cytogenic disorders

Primary outcomes:
measure: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age
timeFrame: 1 month postvaccination
measure: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.
timeFrame: 1 month postvaccination
Secondary outcomes:
measure: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.
timeFrame: 1 month postvaccination
measure: Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age
timeFrame: 1 month postvaccination
measure: Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.
timeFrame: 1 month postvaccination
measure: Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.
timeFrame: 1 month postvaccination
measure: Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.
timeFrame: 1 month postvaccination
measure: Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)
timeFrame: 1 month postvaccination
measure: Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
timeFrame: 1 month postvaccination
measure: GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)
timeFrame: 1 month postvaccination
measure: Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.
timeFrame: Study days 1 to 7
measure: Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.
timeFrame: Study days 1 to 7
measure: Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.
timeFrame: day 1 to study termination (day 240)
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: Children's Investigational Reserach Program
state: Arkansas
city: Little Rock
country: United States
facility: Arkansas Pediatric Research Group
state: Arkansas
city: Downey
country: United States
facility: Premier Health Research Center
state: California
city: Fremont
country: United States
facility: Kaiser Permanente - Fremont
state: California
city: Fresno
country: United States
facility: Kaiser Permanente - Fresno
state: California
city: Hayward
country: United States
facility: Kaiser Permanente - Hayward
state: California
city: Oakland
country: United States
facility: Kaiser Permanente - Oakland
state: California
city: Pleasanton
country: United States
facility: Kaiser Permanente - Pleasanton
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente - San Francisco
state: California
city: San Jose
country: United States
facility: Kaiser Permanente - San Jose
state: California
city: Aurora
country: United States
facility: Kaiser Permanente - Aurora
state: Colorado
city: Centennial
country: United States
facility: 1st Allergy & Clinical Research
state: Colorado
city: Longmont
country: United States
facility: Longmont Medical Research Network
state: Colorado
city: Thornton
country: United States
facility: 1st Allergy & Clinical Research
state: Colorado
city: Westminister
country: United States
facility: Kaiser Permanente - Westminister
state: Colorado
city: Bardstown
country: United States
facility: Kentucky Pediatric Research Center
state: Kentucky
city: Springfield
country: United States
facility: Physicians to Children & Adolescents
state: Kentucky
city: Metairie
country: United States
facility: Benchmark Research
state: Louisiana
city: St. Louis
country: United States
facility: St. Louis University School of Medicine
state: Missouri
city: Omaha
country: United States
facility: Meridian Clinical Research LLC
state: Nebraska
city: Rochester
country: United States
facility: Legacy Pediatrics
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Durham
country: United States
facility: Durham Pediatrics
state: North Carolina
city: Durham
country: United States
facility: Regional Pediatric Associates PA
state: North Carolina
city: Fargo
country: United States
facility: Odyssey Research
state: North Dakota
city: Cleveland
country: United States
facility: Dr. Senders and Associates
state: Ohio
city: Gresham
country: United States
facility: Calcagno Research & Development
state: Oregon
city: Erie
country: United States
facility: Children's Health Care - West
state: Pennsylvania
city: Greenville
country: United States
facility: University Of Pittsburgh Medical Center
state: Pennsylvania
city: Grove City
country: United States
facility: Family Healthcare Partners
state: Pennsylvania
city: Latrobe
country: United States
facility: Pediatric Associates of Latrobe
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pediatric Alliance PC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pediatric Alliance PC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: South Hills Pediatrics
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Pediatric Alliance PC
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Primary Physicians Research Inc.
state: Pennsylvania
city: Pittsburg
country: United States
facility: Primary Physicians Research Inc.
state: Pennsylvania
city: Uniontown
country: United States
facility: Laurel Pediatrics
state: Pennsylvania
city: Upper St. Clair
country: United States
facility: Family Practice Medical Associates South
state: Pennsylvania
city: Wexford
country: United States
facility: Children's Community Pediatrics
state: Pennsylvania
city: Jackson
country: United States
facility: Jackson Clinic Professional Association
state: Tennessee
city: Fort Worth
country: United States
facility: Benchmark Research Ft. Worth
state: Texas
city: San Angelo
country: United States
facility: Benchmark Research San Angelo
state: Texas
city: Clinton
country: United States
facility: Jean Brown Research
state: Utah
city: Layton
country: United States
facility: Wee Care Pediatrics
state: Utah
city: Murray
country: United States
facility: Cottonwood Pediatrics
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc.
state: Utah
city: Salt Lake City
country: United States
facility: J. Lewis Research Inc.
state: Utah
city: Salt Lake City
country: United States
facility: Jean Brown Research
state: Utah
city: South Jordan
country: United States
facility: Copperview Medical Center
state: Utah
city: Spokane
country: United States
facility: Rockwood Clinic
state: Washington
city: Spokane
country: United States
facility: Rockwood Clinic North
state: Washington
city: Surrey
country: Canada
facility: TASC Research Services Inc.
state: British Columbia
city: Winnipeg
country: Canada
facility: Manitoba Clinic
state: Manitoba
city: Halifax
country: Canada
facility: Clinical Trials Research Center
state: Nova Scotia
city: Truro
country: Canada
facility: Colchester Regional Hospital
state: Nova Scotia
city: Etobicoke
country: Canada
facility: Albion Finch Medical Centre
state: Ontario
city: London
country: Canada
facility: Children's Hospital of Western Ontario
state: Ontario
city: Newmarket
country: Canada
facility: SKDS Research In.
state: Ontario
city: Ottawa
country: Canada
facility: Herridge Community Health Clinic
state: Ontario
city: Sarnia
country: Canada
facility: Sarnia Institute of Clinical Research
state: Ontario
city: Sudbury
country: Canada
facility: Medicor Research Inc.
state: Ontario
city: Toronto
country: Canada
facility: Resolve Research Solutions
state: Ontario
city: Toronto
country: Canada
facility: Resolve Research Solutions
state: Ontario
city: Charlottetown
country: Canada
facility: Queen Elizabeth Hospital
state: Prince Edward Island
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Mount Pearl
country: Canada
facility: Commonwealth Medical Clinic
city: Saint John's
country: Canada
facility: White Hills Medical Clinic
Study officials:
affiliation: Novartis
name: Novartis Vaccines and Diagnostics
role: STUDY_DIRECTOR
References:
citation: Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29.