Study of the Safety and Immune Response of a Meningococcal Conjugate Vaccine Administered to Healthy Adolescents

Study Description

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

Brief Summary:

The purpose of this study is to evaluate the safety and immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in comparison to licensed meningococcal polysaccharide vaccine administered to healthy adolescents ages 11 to 17 years.

Condition or disease	Intervention/treatment	Phase
Prevention of Meningococcal Disease	Biological: MenACWY-CRM conjugate vaccine, adjuvanted; Biological: MenACWY-CRM conjugate vaccine, unadjuvanted; Biological: MenACWY polysaccharide vaccine	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	524 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single
Primary Purpose:	Prevention
Official Title:	A Phase 2, Randomized, Single-blind, Controlled, Multicenter Study to Compare the Safety and Immune Response of One Dose of Novartis Meningococcal ACWY Conjugate Vaccine With the Safety and Immune Response of One Dose of Licensed Meningococcal ACWY Polysaccharide Vaccine Administered to Healthy Adolescents 11 to 17 Years of Age
Study Start Date :	October 2004
Actual Primary Completion Date :	March 2006
Study Completion Date :	March 2006

Arms and Interventions

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

Arm	Intervention/treatment
Experimental: MenACWY-CRM(Ad+); Subjects received one single dose of adjuvanted formulation of conjugate vaccine.	Biological: MenACWY-CRM conjugate vaccine, adjuvanted
Experimental: MenACWY-CRM(Ad-); Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.	Biological: MenACWY-CRM conjugate vaccine, unadjuvanted
Active Comparator: MenACWY- PS; Subjects received one single dose of the polysaccharide vaccine.	Biological: MenACWY polysaccharide vaccine

Outcome Measures

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Primary Outcome Measures :

1. Percentages of Subjects With N.Meningitidis Human Serum Bactericidal Activity (hSBA) Titers≥ 1:4, After One Dose of Either MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant, or MenACWY-PS Vaccine [ Time Frame: 1 month after vaccination ]
   Immune response of a single dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant compared to that of one dose of MenACWY polysaccharide (PS) vaccine, one month after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with hSBA titers >1:4 directed against N meningitidis serogroups A, C, W and Y

Secondary Outcome Measures :

1. hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine [ Time Frame: 1 month after vaccination ]
   Immune response of one dose of MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine, one month after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.
2. Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine [ Time Frame: 12 months after vaccination ]
   Immune response of one dose of MenACWY-CRM(Ad-) compared to that of one dose of MenACWY polysaccharide(MenACWY-PS) vaccine, 12 months after administration to subjects aged 11 to 17 years, as measured by the percentage of subjects with human complement serum bactericidal activity (hSBA) titers≥1:4 against N meningitidis serogroups A, C, W, and Y. The endpoint point compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.
3. hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine [ Time Frame: 12 months after vaccination ]
   Immune response of one dose of MenACWY-CRM(Ad-) conjugate vaccine compared with that of MenACWY-PS vaccine, 12 months after administration in subjects 11 to 17 years of age, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W, and Y.
4. Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination [ Time Frame: Day 1 to Day 7 ]
   Safety was assessed as the number of subjects 11 to 17 years of age who reported solicited local and systemic adverse events from day 1 up to and including day 7 after the vaccination of either MenACWY-CRM conjugate vaccine, with adjuvant or without adjuvant or MenACWY-PS vaccine.

Eligibility Criteria

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Ages Eligible for Study:	11 Years to 17 Years (Child)
Sexes Eligible for Study:	All

Criteria

Inclusion Criteria:

• Healthy adolescents between and including 11-17 years of age, who provide written informed consent

Exclusion Criteria:

• Subjects with a previous or suspected disease caused by N. meningitidis; or previous immunization with a meningococcal vaccine or vaccine containing meningococcal antigen(s); Any serious acute, chronic or progressive disease

Contacts and Locations

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Locations

United States, Minnesota
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Pittsburgh, Pennsylvania, United States, 15241
United States, Washington
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Novartis Vaccines

Novartis

Investigators

Study Director:	Novartis Vaccines	Novartis

More Information

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

Publications:

Jackson LA, Jacobson RM, Reisinger KS, Anemona A, Danzig LE, Dull PM. A randomized trial to determine the tolerability and immunogenicity of a quadrivalent meningococcal glycoconjugate vaccine in healthy adolescents. Pediatr Infect Dis J. 2009 Feb;28(2):86-91. doi: 10.1097/INF.0b013e31818a0237.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Jacobson RM, Jackson LA, Reisinger K, Izu A, Odrljin T, Dull PM. Antibody persistence and response to a booster dose of a quadrivalent conjugate vaccine for meningococcal disease in adolescents. Pediatr Infect Dis J. 2013 Apr;32(4):e170-7. doi: 10.1097/INF.0b013e318279ac38.

Responsible Party:	Novartis Vaccines
ClinicalTrials.gov Identifier:	NCT00262041 History of Changes
Other Study ID Numbers:	V59P6; BB-IND 11278
First Posted:	December 6, 2005
Results First Posted:	November 20, 2013
Last Update Posted:	October 27, 2016
Last Verified:	September 2016

Additional relevant MeSH terms:

Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections	Vaccines; Immunologic Factors; Physiological Effects of Drugs