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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Meningococcal Infections

Intervention / Treatment
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* Biological: MenACWY-CRM
* Biological: MenACWY-CRM
* Biological: Licensed meningococcal ACWY vaccine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MenACWY-CRM (1 dose)<br>1 injection of the Novartis MenACWY-CRM (a nontoxic mutant of diptheria toxin) conjugate vaccine administered by intramuscular (IM) injection on study day 1. | Biological: MenACWY-CRM<br>* 1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly<br>* Other names: Menveo;|
| Active Comparator: Licensed polysaccharide vaccine<br>1 injection of a licensed meningococcal MenACWY polysaccharide-protein conjugate vaccine administered by intramuscular (IM) injection on study day 1 | Biological: Licensed meningococcal ACWY vaccine<br>* 1 injection of the licensed meningococcal ACWY was administered intramuscularly<br>* Other names: Menactra;|
| Experimental: MenACWY-CRM (2 doses)<br>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. | Biological: MenACWY-CRM<br>* 2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age<br>* Other names: Menveo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaccine, children, healthy, meningitis, meningococcal, prevention of meningococcal disease serogroups ACWY, Menveo