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

Prevention of Meningococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00262041
• Other study ID #: V59P6
• Secondary ID: BB-IND 11278
• Status: Completed
• Phase: Phase 2
• Start date: October 2004
• Est. completion date: March 2006

Study information

• Verified date: May 2018
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 524
• Est. completion date: March 2006
• Est. primary completion date: March 2006
• Gender: All
• Age group: 11 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Meningococcal Infections
• Prevention of Meningococcal Disease

Intervention

Biological:
• MenACWY-CRM conjugate vaccine, adjuvanted

• MenACWY-CRM conjugate vaccine, unadjuvanted

• MenACWY polysaccharide vaccine

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Novartis Vaccines	Novartis

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	1 month after vaccination
Secondary	hSBA Geometric Mean Titers (GMT) After One Dose Of MenACWY-CRM Vaccine, With Adjuvant or Without Adjuvant or MenACWY-PS Vaccine	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.	1 month after vaccination
Secondary	Percentages of Subjects With hSBA Titers= 1:4, After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine	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.	12 months after vaccination
Secondary	hSBA Geometric Mean Titers (GMT) After One Dose Of Either MenACWY-CRM(Ad-) or MenACWY-PS Vaccine	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.	12 months after vaccination
Secondary	Numbers of Subjects 11 to 17 Years of Age Who Reported Solicited Local and Systemic Adverse Events After the Vaccination	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.	Day 1 to Day 7