Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children
- Conditions
- Meningococcal Infections
- Interventions
- Biological: MenACWY-CRMBiological: Licensed meningococcal ACWY vaccine
- Registration Number
- NCT00616421
- Lead Sponsor
- Novartis Vaccines
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2907
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MenACWY-CRM (1 dose) MenACWY-CRM 1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1. Licensed polysaccharide vaccine Licensed meningococcal ACWY vaccine 1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1 MenACWY-CRM (2 doses) MenACWY-CRM 2 injections of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study days 1 and 61.
- Primary Outcome Measures
Name Time Method Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. 1 month postvaccination The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenatages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age 1 month postvaccination The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.
- Secondary Outcome Measures
Name Time Method Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) 1 month postvaccination The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. day 1 to study termination (day 240) Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.
Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. Study days 1 to 7 Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group after 1 dose treatment.
Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. 1 month postvaccination The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bactericidal Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.
Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. 1 month postvaccination The immunogenicity of a single dose of the Novartis MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the number of subjects with hSBA (human Serum Bacterial Activity) Geometric Mean Titers (GMTs) response against N. meningitidis serogroups A, C, W-135, and Y.
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age 1 month postvaccination The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. 1 month postvaccination The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percenategs of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) 1 month postvaccination The immunogenicity of two doses of the Novartis MenACWY-CRM, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM, directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. Study days 1 to 7 Safety was assessed in terms of the percentages of subjects with reported local and systemic reactions up to 7 days after each vaccination per vaccination group, after 1 dose treatment.
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. 1 month postvaccination The immunogenicity of a single dose of MenACWY-CRM is compared with the immunogenicity of a single dose of the licensed ACWY polysaccharide vaccine, in terms of the percentages of subjects with seroresponse directed against N. meningitidis serogroups A, C, W-135, and Y.
Seroresponse: For a subject with hSBA \<1:4 at baseline, seroresponse is defined as a postvaccination hSBA ≥ 1:8; for a subject with hSBA ≥ 1:4 at baseline, seroresponse is defined as a postvaccination hSBA titer of at least 4 times the baseline.GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) 1 month postvaccination The immunogenicity of two doses of the Novartis MenACWY-CRM vaccine, administered 2 months apart, is compared with the immunogenicity of a single dose of the Novartis MenACWY-CRM vaccine, in terms of hSBA (human Serum Bactericidal Activity) GMTs (Geometric Mean Titers) against N. meningitidis serogroups A, C, W-135, and Y.
ANOVA model used for the analysis of this outcome is different compare to ANOVA model used for the other outcome. The computed model components vary according to the variance observed due to the different datasets.
Trial Locations
- Locations (61)
Pediatric Alliance PC
🇺🇸Pittsburgh, Pennsylvania, United States
Benchmark Research
🇺🇸Metairie, Louisiana, United States
Children's Investigational Reserach Program
🇺🇸Bentonville, Arkansas, United States
Arkansas Pediatric Research Group
🇺🇸Little Rock, Arkansas, United States
Calcagno Research & Development
🇺🇸Gresham, Oregon, United States
Clinical Trials Research Center
🇨🇦Halifax, Nova Scotia, Canada
Kaiser Permanente - Hayward
🇺🇸Hayward, California, United States
Kaiser Permanente - Fremont
🇺🇸Fremont, California, United States
Premier Health Research Center
🇺🇸Downey, California, United States
South Hills Pediatrics
🇺🇸Pittsburgh, Pennsylvania, United States
Kaiser Permanente - San Jose
🇺🇸San Jose, California, United States
Meridian Clinical Research LLC
🇺🇸Omaha, Nebraska, United States
Wee Care Pediatrics
🇺🇸Layton, Utah, United States
Kentucky Pediatric Research Center
🇺🇸Bardstown, Kentucky, United States
Family Healthcare Partners
🇺🇸Grove City, Pennsylvania, United States
Pediatric Associates of Latrobe
🇺🇸Latrobe, Pennsylvania, United States
Cottonwood Pediatrics
🇺🇸Murray, Utah, United States
Herridge Community Health Clinic
🇨🇦Ottawa, Ontario, Canada
Physicians to Children & Adolescents
🇺🇸Springfield, Kentucky, United States
Benchmark Research Ft. Worth
🇺🇸Fort Worth, Texas, United States
Copperview Medical Center
🇺🇸South Jordan, Utah, United States
Albion Finch Medical Centre
🇨🇦Etobicoke, Ontario, Canada
Kaiser Permanente - Pleasanton
🇺🇸Pleasanton, California, United States
Commonwealth Medical Clinic
🇨🇦Mount Pearl, Canada
Children's Health Care - West
🇺🇸Erie, Pennsylvania, United States
Primary Physicians Research Inc.
🇺🇸Pittsburg, Pennsylvania, United States
White Hills Medical Clinic
🇨🇦Saint John's, Canada
TASC Research Services Inc.
🇨🇦Surrey, British Columbia, Canada
Colchester Regional Hospital
🇨🇦Truro, Nova Scotia, Canada
Sarnia Institute of Clinical Research
🇨🇦Sarnia, Ontario, Canada
Medicor Research Inc.
🇨🇦Sudbury, Ontario, Canada
Royal University Hospital
🇨🇦Saskatoon, Saskatchewan, Canada
1st Allergy & Clinical Research
🇺🇸Thornton, Colorado, United States
Longmont Medical Research Network
🇺🇸Longmont, Colorado, United States
Kaiser Permanente - Aurora
🇺🇸Aurora, Colorado, United States
Odyssey Research
🇺🇸Fargo, North Dakota, United States
Kaiser Permanente - Westminister
🇺🇸Westminister, Colorado, United States
Dr. Senders and Associates
🇺🇸Cleveland, Ohio, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
Kaiser Permanente - San Francisco
🇺🇸San Francisco, California, United States
Durham Pediatrics
🇺🇸Durham, North Carolina, United States
Regional Pediatric Associates PA
🇺🇸Durham, North Carolina, United States
J. Lewis Research Inc.
🇺🇸Salt Lake City, Utah, United States
Kaiser Permanente - Fresno
🇺🇸Fresno, California, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
University Of Pittsburgh Medical Center
🇺🇸Greenville, Pennsylvania, United States
Benchmark Research San Angelo
🇺🇸San Angelo, Texas, United States
Rockwood Clinic North
🇺🇸Spokane, Washington, United States
Kaiser Permanente - Oakland
🇺🇸Oakland, California, United States
St. Louis University School of Medicine
🇺🇸St. Louis, Missouri, United States
Laurel Pediatrics
🇺🇸Uniontown, Pennsylvania, United States
Family Practice Medical Associates South
🇺🇸Upper St. Clair, Pennsylvania, United States
Children's Community Pediatrics
🇺🇸Wexford, Pennsylvania, United States
Jackson Clinic Professional Association
🇺🇸Jackson, Tennessee, United States
Rockwood Clinic
🇺🇸Spokane, Washington, United States
Manitoba Clinic
🇨🇦Winnipeg, Manitoba, Canada
Resolve Research Solutions
🇨🇦Toronto, Ontario, Canada
SKDS Research In.
🇨🇦Newmarket, Ontario, Canada
Queen Elizabeth Hospital
🇨🇦Charlottetown, Prince Edward Island, Canada
Legacy Pediatrics
🇺🇸Rochester, New York, United States
Children's Hospital of Western Ontario
🇨🇦London, Ontario, Canada