Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers
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|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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|