Who is sponsoring NCT01466387?

NCT01466387 is sponsored by Novartis.

What condition does NCT01466387 study?

NCT01466387 studies Meningococcal Disease, Meningococcal Meningitis, Typhoid, Yellow Fever, Rabies, Japanese Encephalitis.

What drugs are being tested in NCT01466387?

Interventions: Typhoid Vi Polysaccharide Vaccine, Yellow Fever Vaccine, Japanese Encephalitis Vaccine, Rabies Vaccine, MenACWY-CRM Vaccine.

What is the status of NCT01466387?

NCT01466387 is currently COMPLETED.

Last reviewed 2014-02-07 · How we verify

A Phase 3b, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of Select Travel Vaccines When Administered Concomitantly With Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Adults

NCT01466387 Phase 3 COMPLETED Results posted

This study compares the safety and immunogenicity profile of several travel vaccines given alone or concomitantly with MenACWY-CRM to healthy adults.

Details

Lead sponsor	Novartis
Phase	Phase 3
Status	COMPLETED
Enrolment	552
Start date	2011-11
Completion	2012-04

Conditions

Meningococcal Disease
Meningococcal Meningitis
Typhoid
Yellow Fever
Rabies
Japanese Encephalitis

Interventions

Typhoid Vi Polysaccharide Vaccine
Yellow Fever Vaccine
Japanese Encephalitis Vaccine
Rabies Vaccine
MenACWY-CRM Vaccine

Primary outcomes

Geometric Mean Anti-typhoid Vi Antibody Concentrations — Baseline and 1 month postvaccination (day 29).
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-typhoid Vi antibody concentrations, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.
Geometric Mean Anti-Yellow Fever Antibody Titer — Baseline and 1 month postvaccination (day 29).
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-yellow fever antibody titers, 28 days after the vaccination of typhoid Vi polysaccharide (TF) and yellow fever (YF) vaccines given concomitantly with MenACWY-CRM197 to typhoid Vi polysaccharide and yellow fever vaccines given alone in healthy adults aged ≥18 years to ≤60 years.
Geometric Mean Anti-Japanese Encephalitis Neutralizing Antibody Titers — Baseline and 1 month post last vaccination (day 57).
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-Japanese encephalitis neutralizing antibody titers, 28 days after the vaccination of the second dose of Japanese Encephalitis vaccine and third dose of the rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.
Geometric Mean Anti-Rabies Virus Neutralizing Antibody Concentration — Baseline and 1 month post last vaccination (day 57).
Assessment was made to demonstrate the non-inferiority of the geometric mean anti-rabies virus neutralizing antibody concentrations, 28 days after the vaccination of the second dose of Japanese encephalitis vaccine and third dose of rabies virus vaccine given concomitantly with MenACWY-CRM197 or alone in healthy adults aged ≥18 years to ≤60 years.

Countries

Czechia, Germany