Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers
|ClinicalTrials.gov Identifier: NCT01434680|
Recruitment Status : Completed
First Posted : September 15, 2011
Results First Posted : March 26, 2014
Last Update Posted : April 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Meningococcal Disease Meningococcal Meningitis||Biological: MenC-CRM LIQ Biological: MenC-CRM ROS Biological: MenC-CRM EMV||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||992 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||A Phase 2, Randomized, Comparative, Multicenter Observer-Blind Study Evaluating the Safety and Immunogenicity of the New Liquid Formulation of Novartis Meningococcal C Conjugate Vaccine and of the Novartis Lyophilized Meningococcal C Conjugate Vaccine Manufactured at Two Different Sites, in Healthy Toddlers|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
Experimental: MenC-CRM LIQ (Liquid Formulation)
Subjects received 1 injection of MenC-CRM vaccine,liquid formulation.
Biological: MenC-CRM LIQ
One dose of MenC-CRM vaccine, liquid formulation
Experimental: MenC-CRM ROS (Rosia)
Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy
Biological: MenC-CRM ROS
One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
Active Comparator: MenC-CRM EMV (Emeryville)
Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA
Biological: MenC-CRM EMV
One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
- Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination [ Time Frame: 1 month postvaccination (day 29) ]Immunogenicity was measured by human serum bactericidal activity (hSBA) geometric mean titers (GMTs)against N meningitidis type C, at day 29 after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM EMV and MenC-CRM ROS to MenC-CRM EMV.
- Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination [ Time Frame: 1 month postvaccination (day 29) ]Immunogenicity was measured by hSBA GMTs against N meningitidis type C, approximately 28 days (at day 29) after a single vaccination when administered to toddlers to assess the equivalence of MenC-CRM LIQ to MenC-CRM ROS.
- Number Of Subjects Reporting Solicited Local And Systemic Adverse Events [ Time Frame: From day 1 through day 7 ]
Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following a single injection with either MenC-CRM LIQ or MenC-CRM ROS or MenC-CRM EMV.
Safety was also assessed in subjects who mistakenly received MenC-CRM EMV instead of MenC-CRM ROS.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01434680
|NZOZ Bioscience Sp zoo|
|ul Czerkaska, Bydgoszcz, Poland|
|Department Infection Disease ZOZ|
|Dept Infection Disease ZOZ, Debica, Poland|
|Centrum Medyczne Graniczna Sp zoo|
|ul Graniczna 45, Katowice, Poland|
|NZOZ HIPOKRATES IIspzoo|
|Ul Strzelecka 2, Krakow, Poland|
|Wojewodzki Specjalistyczny Szpital im dr Wl Bieganskiego|
|ul. Kniaziewicza 1-5, Lodz, Poland|
|Ul Krysiewicza, Poznan, Poland|
|NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska|
|NZLA Michalkowice Jarosz Partnerzy Spolka Lekarska, Siemianowice Slaskie, Poland|
|Zespol Przychodni Specjalistycznych SP ZOZ w Tarnowie|
|E Szczeklik Hospital, Tarnów, Poland|
|Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej w|
|Ul Prusicka 5355, Trzebnica, Poland|
|Klinika Pediatrii Centrum Medycznego Ksztalcenia Podyplomowe|
|Ceglowska 80, Warszawa, Poland|
|Amicur_Krystyna Lechka-Florianska i Partnerzy|
|Ul O Bujwida, Wroclaw, Poland|
|Study Chair:||Novartis Vaccines||Novartis|