CompletedPhase 2

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

Poland992 participantsStarted 2011-09

Plain-language 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.

Who can participate

Age range12 Months – 23 Months

SexALL

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Inclusion criteria

✓. 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 criteria

✕. 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):
✕. History of seizure, any progressive neurological disease or Guillain Barré Syndrome (exception: one self-limited non-medicated febrile seizure is acceptable).

What they're measuring

Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination

Timeframe: 1 month postvaccination (day 29)

Trial details

NCT IDNCT01434680

SponsorNovartis

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-11

Results submitted2013-07-18

View on ClinicalTrials.gov More Meningococcal Disease trials