Who is sponsoring NCT01339923?

NCT01339923 is sponsored by Novartis Vaccines.

What condition does NCT01339923 study?

NCT01339923 studies Meningococcal Disease, Meningococcal Meningitis.

What drugs are being tested in NCT01339923?

Interventions: rMenB + OMV NZ vaccine, rMenB + OMV NZ vaccine, rMenB + OMV NZ vaccine, rMenB + OMV NZ vaccine, Meningococcal C oligosaccharide conjugated vaccine, Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed., rMenB + OMV NZ vaccine, rMenB + OMV NZ vaccine.

What is the status of NCT01339923?

NCT01339923 is currently COMPLETED.

Last reviewed 2016-03-30 · How we verify

A Phase 3B, Open Label, Multi-Center Study to Evaluate the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine When Administered Alone to Healthy Infants According to Different Immunization Schedules and to Healthy Children Aged 2 to 10 Years

NCT01339923 Phase 3 COMPLETED Results posted

The proposed study is aimed at assessing the safety and immunogenicity of rMenB+OMV NZ when administered alone without routine infant vaccines to healthy infants in their first year of life according to different two and three dose immunization schedules, which are suitable to be adopted by various national programs. This study will also investigate antibody persistence post primary series and administration of a subsequent booster dose of rMenB+OMV NZ at 11 months of age. In addition, this study will assess the safety and immunogenicity of two catch-up doses of rMenB+OMV NZ when administered to healthy children 2 to 10 years of age. This study will also evaluate the safety and immunogenicity of the concomitant administration of rMenB+OMV NZ with meningococcal C conjugate vaccine (MenC-CRM) according to a 3, 5 and 12-month schedule.

Details

Lead sponsor	Novartis Vaccines
Phase	Phase 3
Status	COMPLETED
Enrolment	1409
Start date	2011-04
Completion	2014-12

Conditions

Meningococcal Disease
Meningococcal Meningitis

Interventions

rMenB + OMV NZ vaccine
rMenB + OMV NZ vaccine
rMenB + OMV NZ vaccine
rMenB + OMV NZ vaccine
Meningococcal C oligosaccharide conjugated vaccine
Pneumococcal polysaccharide conjugate vaccine, 10 valent adsorbed.
rMenB + OMV NZ vaccine
rMenB + OMV NZ vaccine

Primary outcomes

Percentages of Subjects With Serum Bactericidal Activity Using Human Serum (hSBA) Titers ≥ 4 or hSBA Titers ≥ 5 (Strain M10713) Following a 2-dose Primary Series of rMenB+OMV Vaccination. — 1 month after second vaccination
Immunogenicity was assessed in terms of percentages of subjects with hSBA titers ≥ 4 against N meningitidis serogroup B strains H44/76, 5/99, NZ98/254 and hSBA titers ≥ 5 against strain M10713 following 2-dose primary series of vaccination with rMenB+OMV NZ at 3.5 and 5 months of age or at 6 and 8 months of age. Analysis was done on Full analysis set (FAS)-Primary series.

Countries

Brazil, Hungary, Peru, Spain