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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Meningococcal Disease, Meningococcal Meningitis

Intervention / Treatment
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* Biological: MenC-CRM LIQ
* Biological: MenC-CRM ROS
* Biological: MenC-CRM EMV


Participation Criteria
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Eligibility Criteria
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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): 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).

Ages Eligible for Study
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Minimum Age: 12 Months
Maximum Age: 23 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MenC-CRM LIQ (Liquid Formulation)<br>Subjects received 1 injection of MenC-CRM vaccine,liquid formulation. | Biological: MenC-CRM LIQ<br>* One dose of MenC-CRM vaccine, liquid formulation<br>|
| Experimental: MenC-CRM ROS (Rosia)<br>Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy | Biological: MenC-CRM ROS<br>* One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.<br>|
| Active Comparator: MenC-CRM EMV (Emeryville)<br>Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA | Biological: MenC-CRM EMV<br>* One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 1 month postvaccination (day 29) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | From day 1 through day 7 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Meningococcal disease, vaccines, toddlers, prevention, Meningitis