Status:
COMPLETED
Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers
Lead Sponsor:
Novartis
Collaborating Sponsors:
Novartis Vaccines
Conditions:
Meningococcal Disease
Meningococcal Meningitis
Eligibility:
All Genders
12-23 years
Phase:
PHASE2
Brief Summary
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.
Eligibility Criteria
Inclusion
- Healthy 12 - 23 (inclusive) month-old male or female toddlers.
- A parent/legal guardian was given written informed consent after the nature of the study has been explained.
- Available for both the visits scheduled in the study.
- In good health as determined by medical history, physical examination and clinical judgment of the investigator.
Exclusion
- History of any meningococcal vaccine administration.
- Previous known or suspected disease caused by N. meningitidis.
- Household contact with and/or intimate exposure to an individual with laboratory confirmed N. meningitidis infection or colonization.
- History of severe allergic reaction after previous vaccinations, allergy to Latex, or hypersensitivity to any component of the vaccine.
- Significant acute or chronic infection within the previous 7 days or axillary temperature ≥38.0°C within the previous 3 days.
- Individuals who have received antibiotics within 6 days before vaccination.
- 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.
- History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited non-medicated febrile seizure is acceptable).
- Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Receipt of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks.
- Taken any antipyretic medication in the previous 6 hours.
- 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).
- 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.
- 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.
- Family members or household members of site research staff.
- 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.
- Any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2012
Estimated Enrollment :
992 Patients enrolled
Trial Details
Trial ID
NCT01434680
Start Date
September 1 2011
End Date
November 1 2012
Last Update
April 25 2017
Active Locations (11)
Enter a location and click search to find clinical trials sorted by distance.
1
NZOZ Bioscience Sp zoo
Ul Czerkaska, Bydgoszcz, Poland
2
Department Infection Disease ZOZ
Dept Infection Disease ZOZ, Debica, Poland
3
Centrum Medyczne Graniczna Sp zoo
Ul Graniczna 45, Katowice, Poland
4
NZOZ HIPOKRATES IIspzoo
Ul Strzelecka 2, Krakow, Poland