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

Phase 3

Completed

Conditions: Meningococcal Infections

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

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

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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): Children's Investigational Reserach Program
🇺🇸
Bentonville, Arkansas, United States
Arkansas Pediatric Research Group
🇺🇸
Little Rock, Arkansas, United States
Premier Health Research Center
🇺🇸
Downey, California, United States
Kaiser Permanente - Fremont
🇺🇸
Fremont, California, United States
Kaiser Permanente - Fresno
🇺🇸
Fresno, California, United States
Kaiser Permanente - Hayward
🇺🇸
Hayward, California, United States
Kaiser Permanente - Oakland
🇺🇸
Oakland, California, United States
Kaiser Permanente - Pleasanton
🇺🇸
Pleasanton, California, United States
Kaiser Permanente - San Francisco
🇺🇸
San Francisco, California, United States
Kaiser Permanente - San Jose
🇺🇸
San Jose, California, United States
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Children's Investigational Reserach Program
🇺🇸Bentonville, Arkansas, United States