The study was to evaluate the safety and and immune response of each of three lots of Novartis Meningococcal C Conjugate Vaccine (MenC-CRM Liquid) when administered to Healthy Toddlers.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
992
One dose of MenC-CRM vaccine, liquid formulation
One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
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
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination
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.
Time frame: 1 month postvaccination (day 29)
Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination
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.
Time frame: 1 month postvaccination (day 29)
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events
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.
Time frame: From day 1 through day 7
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NZOZ HIPOKRATES IIspzoo
Ul Strzelecka 2, Krakow, Poland
Specjalistyczny Zespol
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
...and 1 more locations