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

Meningococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01434680
• Other study ID #: V14_57
• 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

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Disease
• Meningococcal Infections
• Meningococcal Meningitis

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