Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01434680
First received: September 14, 2011
Last updated: February 24, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Meningococcal Disease
Meningococcal Meningitis
Biological: MenC-CRM LIQ
Biological: MenC-CRM ROS
Biological: MenC-CRM EMV
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination [ Time Frame: 1 month postvaccination (day 29) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination [ Time Frame: 1 month postvaccination (day 29) ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]

    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.



Enrollment: 992
Study Start Date: September 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   12 Months to 23 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy 12 - 23 (inclusive) month-old male or female toddlers.
  2. A parent/legal guardian was given written informed consent after the nature of the study has been explained.
  3. Available for both the visits scheduled in the study.
  4. In good health as determined by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

  1. History of any meningococcal vaccine administration.
  2. Previous known or suspected disease caused by N. meningitidis.
  3. Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
  4. History of severe allergic reaction after previous vaccinations, allergy to Latex, or hypersensitivity to any component of the vaccine.
  5. Significant acute or chronic infection within the previous 7 days or axillary temperature ≥38.0°C within the previous 3 days.
  6. Individuals who have received antibiotics within 6 days before vaccination.
  7. Known or suspected autoimmune disease or impairment/alteration of the immune system resulting from (for example):

    • Receipt of any immunosuppressive therapy at any time since birth.
    • Receipt of any immunostimulants at any time since birth.
    • Receipt of any systemic corticosteroids or chronic use of inhaled high-potency corticosteroids since birth (use of topical corticosteroids administered in limited areas of the body [for example, eczema on knees or face or elbows] is allowed).
    • Immune deficiency disorder, or known HIV infection.
  8. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited non-medicated febrile seizure is acceptable).
  9. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
  10. Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
  11. Taken any antipyretic medication in the previous 6 hours.
  12. Received any other vaccines within 30 days prior to enrollment or intent to receive any other vaccine during the study (Exception: Inactivated influenza vaccine may be administered up to 15 days prior to study immunization and no less than 15 days after study immunization).
  13. Toddler's parent(s) or legal guardian(s) are not able to comprehend and to follow all required study procedures for the whole period of the study.
  14. Participation in any clinical trial with another investigational product 30 days prior to first study visit or intent to participate in another clinical study during this study.
  15. Family members or household members of site research staff.
  16. History or any illness/condition that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study.
  17. Any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01434680

Locations
Poland
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
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
Sponsors and Collaborators
Novartis
Novartis Vaccines
Investigators
Study Chair: Novartis Vaccines Novartis
  More Information

No publications provided

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01434680     History of Changes
Other Study ID Numbers: V14_57
Study First Received: September 14, 2011
Results First Received: July 18, 2013
Last Updated: February 24, 2014
Health Authority: Poland: The Central Register of Clinical Trials

Keywords provided by Novartis:
Meningococcal disease
vaccines
toddlers
prevention
Meningitis

Additional relevant MeSH terms:
Meningitis
Meningitis, Meningococcal
Meningococcal Infections
Central Nervous System Infections
Central Nervous System Diseases
Nervous System Diseases
Meningitis, Bacterial
Central Nervous System Bacterial Infections
Bacterial Infections
Neisseriaceae Infections
Gram-Negative Bacterial Infections

ClinicalTrials.gov processed this record on September 14, 2014