Who is sponsoring NCT00616421?

NCT00616421 is sponsored by Novartis Vaccines.

What condition does NCT00616421 study?

NCT00616421 studies Meningococcal Infections.

What drugs are being tested in NCT00616421?

Interventions: MenACWY-CRM, MenACWY-CRM, Licensed meningococcal ACWY vaccine.

What is the status of NCT00616421?

NCT00616421 is currently COMPLETED.

Last reviewed 2016-01-19 · How we verify

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

NCT00616421 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 3
Status	COMPLETED
Enrolment	2907
Start date	2008-03
Completion	2009-10

Conditions

Meningococcal Infections

Interventions

MenACWY-CRM
MenACWY-CRM
Licensed meningococcal ACWY vaccine

Primary outcomes

Percentages of Subjects With hSBA Seroresponse, in Healthy Children 2 to 5 Years of Age — 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.
Percentages of Subjects With hSBA Seroresponse, in Healthy Children 6 to 10 Years of Age. — 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.

Countries

United States, Canada