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

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Meningococcal Infections	Biological: MenACWY-CRM; Biological: Licensed meningococcal ACWY vaccine	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	2907 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Prevention
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 Start Date :	March 2008
Actual Primary Completion Date :	April 2009
Actual Study Completion Date :	October 2009

Arms and Interventions

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Arm	Intervention/treatment
Experimental: MenACWY-CRM (1 dose); 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; 1 injection of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly; Other Name: Menveo
Active Comparator: Licensed polysaccharide vaccine; 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; 1 injection of the licensed meningococcal ACWY was administered intramuscularly; Other Name: Menactra
Experimental: MenACWY-CRM (2 doses); 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; 2 injections of the Novartis MenACWY-CRM conjugate vaccine administered intramuscularly to children 2 to 5 years of age; Other Name: Menveo

Outcome Measures

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Primary Outcome Measures :

1. Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age [ Time Frame: 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.

2. Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. [ Time Frame: 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.

Secondary Outcome Measures :

1. Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 10 Years of Age. [ Time Frame: 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.

2. Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 10 Years of Age [ Time Frame: 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.

3. Geometric Mean Titers (hSBA), in Healthy Children 2 to 10 Years of Age. [ Time Frame: 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.
4. Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 and 6 to 10 Years of Age. [ Time Frame: 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.
5. Geometric Mean Titers (hSBA), in Healthy Children 2 to 5 and 6 to 10 Years of Age. [ Time Frame: 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.
6. Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age (2 Doses vs 1 Dose) [ Time Frame: 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.

7. Percentages of Subjects With hSBA ≥ 1:8, in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) [ Time Frame: 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.

8. GMTs (hSBA) in Healthy Children 2 to 5 Years of Age (2 Doses v/s 1 Dose) [ Time Frame: 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.

9. Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 2 to 5 Years of Age - 1 Dose Vaccine Treatment. [ Time Frame: 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.
10. Percentages of Subjects With at Least One Reactogenicity Sign After Vaccination in Children 6 to 10 Years of Age - 1 Dose Vaccine Treatment. [ Time Frame: 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.
11. Percentages of Subjects With Unsolicited AEs Occurring Throughout the Study in Children Aged 2 to 10 Years - 1 Dose Vaccine Treatment. [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	2 Years to 10 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Sponsors and Collaborators

Novartis Vaccines

Investigators

Study Director:	Novartis Vaccines and Diagnostics	Novartis

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications of Results:

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.

Responsible Party:	Novartis Vaccines
ClinicalTrials.gov Identifier:	NCT00616421 History of Changes
Other Study ID Numbers:	V59P20; 11278
First Posted:	February 15, 2008
Results First Posted:	June 9, 2011
Last Update Posted:	February 15, 2016
Last Verified:	January 2016

Keywords provided by Novartis ( Novartis Vaccines ):

vaccine; children; healthy; meningitis	meningococcal; prevention of meningococcal disease serogroups ACWY; Menveo

Additional relevant MeSH terms:

Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Vaccines	Lactitol; Immunologic Factors; Physiological Effects of Drugs; Cathartics; Gastrointestinal Agents