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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01434680
Other study ID # V14_57
Secondary ID
Status Completed
Phase Phase 2
First received September 14, 2011
Last updated February 24, 2014
Start date September 2011
Est. completion date November 2012

Study information

Verified date February 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Poland: The Central Register of Clinical Trials
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 992
Est. completion date November 2012
Est. primary completion date November 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Months to 23 Months
Eligibility 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).

Study Design

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


Intervention

Biological:
MenC-CRM LIQ
One dose of MenC-CRM vaccine, liquid formulation
MenC-CRM ROS
One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
MenC-CRM EMV
One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.

Locations

Country Name City State
Poland Klinika Pediatrii Centrum Medycznego Ksztalcenia Podyplomowe Ceglowska 80 Warszawa
Poland Department Infection Disease ZOZ Dept Infection Disease ZOZ Debica
Poland Zespol Przychodni Specjalistycznych SP ZOZ w Tarnowie E Szczeklik Hospital Tarnów
Poland NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska NZLA Michalkowice Jarosz Partnerzy Spolka Lekarska Siemianowice Slaskie
Poland NZOZ Bioscience Sp zoo ul Czerkaska Bydgoszcz
Poland Centrum Medyczne Graniczna Sp zoo ul Graniczna 45 Katowice
Poland Specjalistyczny Zespol Ul Krysiewicza Poznan
Poland Amicur_Krystyna Lechka-Florianska i Partnerzy Ul O Bujwida Wroclaw
Poland Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej w Ul Prusicka 5355 Trzebnica
Poland NZOZ HIPOKRATES IIspzoo Ul Strzelecka 2 Krakow
Poland Wojewodzki Specjalistyczny Szpital im dr Wl Bieganskiego ul. Kniaziewicza 1-5 Lodz

Sponsors (2)

Lead Sponsor Collaborator
Novartis Novartis Vaccines

Country where clinical trial is conducted

Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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) No
Secondary 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) No
Secondary 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 Yes
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