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

Primary Purpose

Meningococcal Disease, Meningococcal Meningitis

Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
MenC-CRM LIQ
MenC-CRM ROS
MenC-CRM EMV
Sponsored by
Novartis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Disease focused on measuring Meningococcal disease, vaccines, toddlers, prevention, Meningitis

Eligibility Criteria

12 Months - 23 Months (Child)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • NZOZ Bioscience Sp zoo
  • Department Infection Disease ZOZ
  • Centrum Medyczne Graniczna Sp zoo
  • NZOZ HIPOKRATES IIspzoo
  • Wojewodzki Specjalistyczny Szpital im dr Wl Bieganskiego
  • Specjalistyczny Zespol
  • NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska
  • Zespol Przychodni Specjalistycznych SP ZOZ w Tarnowie
  • Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej w
  • Klinika Pediatrii Centrum Medycznego Ksztalcenia Podyplomowe
  • Amicur_Krystyna Lechka-Florianska i Partnerzy

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

MenC-CRM LIQ (Liquid Formulation)

MenC-CRM ROS (Rosia)

MenC-CRM EMV (Emeryville)

Arm Description

Subjects received 1 injection of MenC-CRM vaccine,liquid formulation.

Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy

Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
September 14, 2011
Last Updated
March 13, 2017
Sponsor
Novartis
Collaborators
Novartis Vaccines
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1. Study Identification

Unique Protocol Identification Number
NCT01434680
Brief Title
Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis
Collaborators
Novartis Vaccines

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Disease, Meningococcal Meningitis
Keywords
Meningococcal disease, vaccines, toddlers, prevention, Meningitis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
992 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MenC-CRM LIQ (Liquid Formulation)
Arm Type
Experimental
Arm Description
Subjects received 1 injection of MenC-CRM vaccine,liquid formulation.
Arm Title
MenC-CRM ROS (Rosia)
Arm Type
Experimental
Arm Description
Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy
Arm Title
MenC-CRM EMV (Emeryville)
Arm Type
Active Comparator
Arm Description
Subjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA
Intervention Type
Biological
Intervention Name(s)
MenC-CRM LIQ
Intervention Description
One dose of MenC-CRM vaccine, liquid formulation
Intervention Type
Biological
Intervention Name(s)
MenC-CRM ROS
Intervention Description
One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
Intervention Type
Biological
Intervention Name(s)
MenC-CRM EMV
Intervention Description
One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
Primary Outcome Measure Information:
Title
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination
Description
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)
Secondary Outcome Measure Information:
Title
Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination
Description
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)
Title
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Months
Maximum Age & Unit of Time
23 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
NZOZ Bioscience Sp zoo
City
ul Czerkaska
State/Province
Bydgoszcz
Country
Poland
Facility Name
Department Infection Disease ZOZ
City
Dept Infection Disease ZOZ
State/Province
Debica
Country
Poland
Facility Name
Centrum Medyczne Graniczna Sp zoo
City
ul Graniczna 45
State/Province
Katowice
Country
Poland
Facility Name
NZOZ HIPOKRATES IIspzoo
City
Ul Strzelecka 2
State/Province
Krakow
Country
Poland
Facility Name
Wojewodzki Specjalistyczny Szpital im dr Wl Bieganskiego
City
ul. Kniaziewicza 1-5
State/Province
Lodz
Country
Poland
Facility Name
Specjalistyczny Zespol
City
Ul Krysiewicza
State/Province
Poznan
Country
Poland
Facility Name
NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska
City
NZLA Michalkowice Jarosz Partnerzy Spolka Lekarska
State/Province
Siemianowice Slaskie
Country
Poland
Facility Name
Zespol Przychodni Specjalistycznych SP ZOZ w Tarnowie
City
E Szczeklik Hospital
State/Province
Tarnów
Country
Poland
Facility Name
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej w
City
Ul Prusicka 5355
State/Province
Trzebnica
Country
Poland
Facility Name
Klinika Pediatrii Centrum Medycznego Ksztalcenia Podyplomowe
City
Ceglowska 80
State/Province
Warszawa
Country
Poland
Facility Name
Amicur_Krystyna Lechka-Florianska i Partnerzy
City
Ul O Bujwida
State/Province
Wroclaw
Country
Poland

12. IPD Sharing Statement

Learn more about this trial

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

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