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

Phase 2

Completed

• Conditions: Prevention of Meningococcal Disease
• Interventions: Biological: MenACWY polysaccharide vaccine; Biological: MenACWY-CRM conjugate vaccine, adjuvanted; Biological: MenACWY-CRM conjugate vaccine, unadjuvanted

• Registration Number: NCT00262041
• Lead Sponsor: Novartis Vaccines

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-10
• Study First Submitted: 2005-12-02
• Study First Submitted QC: 2005-12-02
• Study First Posted: 2005-12-06
• Primary Completion: 2006-03
• Study Completion: 2006-03
• Results First Submitted: 2013-09-09
• Results First Submitted QC: 2013-09-09
• Results First Posted: 2013-11-20
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-06-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 524

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MenACWY- PS	MenACWY polysaccharide vaccine	Subjects received one single dose of the polysaccharide vaccine.
MenACWY-CRM(Ad+)	MenACWY-CRM conjugate vaccine, adjuvanted	Subjects received one single dose of adjuvanted formulation of conjugate vaccine.
MenACWY-CRM(Ad-)	MenACWY-CRM conjugate vaccine, unadjuvanted	Subjects received one single dose of unadjuvanted formulation of conjugate vaccine.

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine	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.
hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine	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.The endpoint compares only data of unadjuvanted formulation of the conjugate vaccine to the polysaccharide vaccine.
Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination	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.
hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine	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.