Safety and Immune Response of Novartis of MenACWY Conjugate Vaccine When Given to Healthy Children

Meningococcal Infections Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616421
• Other study ID #: V59P20
• Secondary ID: 11278
• Status: Completed
• Phase: Phase 3
• First received: January 31, 2008
• Last updated: January 19, 2016
• Start date: March 2008
• Est. completion date: October 2009

Study information

• Verified date: January 2016
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2907
• Est. completion date: October 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 2 Years to 10 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Meningococcal Infections

Intervention

Biological:
• MenACWY-CRM
1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly
• MenACWY-CRM
2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age
• Licensed meningococcal ACWY vaccine
1 injection of the licensed meningococcal ACWY was administered intramuscularly

Locations

Country	Name	City	State
Canada	Queen Elizabeth Hospital	Charlottetown	Prince Edward Island
Canada	Albion Finch Medical Centre	Etobicoke	Ontario
Canada	Clinical Trials Research Center	Halifax	Nova Scotia
Canada	Children's Hospital of Western Ontario	London	Ontario
Canada	Commonwealth Medical Clinic	Mount Pearl
Canada	SKDS Research In.	Newmarket	Ontario
Canada	Herridge Community Health Clinic	Ottawa	Ontario
Canada	White Hills Medical Clinic	Saint John's
Canada	Sarnia Institute of Clinical Research	Sarnia	Ontario
Canada	Royal University Hospital	Saskatoon	Saskatchewan
Canada	Medicor Research Inc.	Sudbury	Ontario
Canada	TASC Research Services Inc.	Surrey	British Columbia
Canada	Resolve Research Solutions	Toronto	Ontario
Canada	Resolve Research Solutions	Toronto	Ontario
Canada	Colchester Regional Hospital	Truro	Nova Scotia
Canada	Manitoba Clinic	Winnipeg	Manitoba
United States	Kaiser Permanente - Aurora	Aurora	Colorado
United States	Kentucky Pediatric Research Center	Bardstown	Kentucky
United States	Children's Investigational Reserach Program	Bentonville	Arkansas
United States	1st Allergy & Clinical Research	Centennial	Colorado
United States	Dr. Senders and Associates	Cleveland	Ohio
United States	Jean Brown Research	Clinton	Utah
United States	Premier Health Research Center	Downey	California
United States	Duke University Medical Center	Durham	North Carolina
United States	Durham Pediatrics	Durham	North Carolina
United States	Regional Pediatric Associates PA	Durham	North Carolina
United States	Children's Health Care - West	Erie	Pennsylvania
United States	Odyssey Research	Fargo	North Dakota
United States	Benchmark Research Ft. Worth	Fort Worth	Texas
United States	Kaiser Permanente - Fremont	Fremont	California
United States	Kaiser Permanente - Fresno	Fresno	California
United States	University Of Pittsburgh Medical Center	Greenville	Pennsylvania
United States	Calcagno Research & Development	Gresham	Oregon
United States	Family Healthcare Partners	Grove City	Pennsylvania
United States	Kaiser Permanente - Hayward	Hayward	California
United States	Jackson Clinic Professional Association	Jackson	Tennessee
United States	Pediatric Associates of Latrobe	Latrobe	Pennsylvania
United States	Wee Care Pediatrics	Layton	Utah
United States	Arkansas Pediatric Research Group	Little Rock	Arkansas
United States	Longmont Medical Research Network	Longmont	Colorado
United States	Benchmark Research	Metairie	Louisiana
United States	Cottonwood Pediatrics	Murray	Utah
United States	Kaiser Permanente - Oakland	Oakland	California
United States	Meridian Clinical Research LLC	Omaha	Nebraska
United States	Primary Physicians Research Inc.	Pittsburg	Pennsylvania
United States	Pediatric Alliance PC	Pittsburgh	Pennsylvania
United States	Pediatric Alliance PC	Pittsburgh	Pennsylvania
United States	Pediatric Alliance PC	Pittsburgh	Pennsylvania
United States	Primary Physicians Research Inc.	Pittsburgh	Pennsylvania
United States	South Hills Pediatrics	Pittsburgh	Pennsylvania
United States	Kaiser Permanente - Pleasanton	Pleasanton	California
United States	Legacy Pediatrics	Rochester	New York
United States	J. Lewis Research Inc.	Salt Lake City	Utah
United States	J. Lewis Research Inc.	Salt Lake City	Utah
United States	Jean Brown Research	Salt Lake City	Utah
United States	Benchmark Research San Angelo	San Angelo	Texas
United States	Kaiser Permanente - San Francisco	San Francisco	California
United States	Kaiser Permanente - San Jose	San Jose	California
United States	Copperview Medical Center	South Jordan	Utah
United States	Rockwood Clinic	Spokane	Washington
United States	Rockwood Clinic North	Spokane	Washington
United States	Physicians to Children & Adolescents	Springfield	Kentucky
United States	St. Louis University School of Medicine	St. Louis	Missouri
United States	1st Allergy & Clinical Research	Thornton	Colorado
United States	Laurel Pediatrics	Uniontown	Pennsylvania
United States	Family Practice Medical Associates South	Upper St. Clair	Pennsylvania
United States	Kaiser Permanente - Westminister	Westminister	Colorado
United States	Children's Community Pediatrics	Wexford	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

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. Vac — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age	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.	1 month postvaccination	No
Primary	Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age.	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.	1 month postvaccination	No
Secondary	Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age.	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.	1 month postvaccination	No
Secondary	Percentages of Subjects With hSBA = 1:8, in Healthy Children 2 to 10 Years of Age	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.	1 month postvaccination	No
Secondary	Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age.	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.	1 month postvaccination	No
Secondary	Percentages of Subjects With hSBA = 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age.	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.	1 month postvaccination	No
Secondary	Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age.	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.	1 month postvaccination	No
Secondary	Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose)	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.	1 month postvaccination	No
Secondary	Percentages of Subjects With hSBA = 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)	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.	1 month postvaccination	No
Secondary	GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose)	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.	1 month postvaccination	No
Secondary	Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment.	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.	Study days 1 to 7	Yes
Secondary	Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment.	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.	Study days 1 to 7	Yes
Secondary	Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment.	Safety was assessed in terms of the percentage of subjects with unsolicited AEs occurring throughout the entire study period, after 1 dose treatment.	day 1 to study termination (day 240)	Yes