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

NCT ID: NCT01434680

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 992 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-09-30
• Study Completion Date: 2012-11-30

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.

Conditions

Meningococcal Disease; Meningococcal Meningitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

MenC-CRM LIQ (Liquid Formulation)

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

Group Type: EXPERIMENTAL

MenC-CRM LIQ

Intervention Type: BIOLOGICAL

One dose of MenC-CRM vaccine, liquid formulation

MenC-CRM ROS (Rosia)

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

Group Type: EXPERIMENTAL

MenC-CRM ROS

Intervention Type: BIOLOGICAL

One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.

MenC-CRM EMV (Emeryville)

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

Group Type: ACTIVE_COMPARATOR

MenC-CRM EMV

Intervention Type: BIOLOGICAL

One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.

Interventions

MenC-CRM LIQ

One dose of MenC-CRM vaccine, liquid formulation

Intervention Type: BIOLOGICAL

MenC-CRM ROS

One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.

Intervention Type: BIOLOGICAL

MenC-CRM EMV

One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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).

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 23 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: collaborator

Novartis

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines

Role: STUDY_CHAIR

Novartis

Locations

NZOZ Bioscience Sp zoo

Ul Czerkaska, Bydgoszcz, Poland

Department Infection Disease ZOZ

Dept Infection Disease ZOZ, Debica, Poland

Centrum Medyczne Graniczna Sp zoo

Ul Graniczna 45, Katowice, Poland

NZOZ HIPOKRATES IIspzoo

Ul Strzelecka 2, Krakow, Poland

Specjalistyczny Zespol

Ul Krysiewicza, Poznan, Poland

NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska

NZLA Michalkowice Jarosz Partnerzy Spolka Lekarska, Siemianowice Slaskie, Poland

Zespol Przychodni Specjalistycznych SP ZOZ w Tarnowie

E Szczeklik Hospital, Tarnów, Poland

Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej w

Ul Prusicka 5355, Trzebnica, Poland

Klinika Pediatrii Centrum Medycznego Ksztalcenia Podyplomowe

Ceglowska 80, Warszawa, Poland

Amicur_Krystyna Lechka-Florianska i Partnerzy

Ul O Bujwida, Wroclaw, Poland

Wojewodzki Specjalistyczny Szpital im dr Wl Bieganskiego

Ul. Kniaziewicza 1-5, Łódź Voivodeship, Poland

Countries

Poland

Other Identifiers

V14_57

Identifier Type: -

Identifier Source: org_study_id