Clinical trial NCT01434680: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Meningococcal Disease
Meningococcal Meningitis
Keywords: Meningococcal disease
vaccines
toddlers
prevention
Meningitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: Novartis Vaccines
First posted: 2011-09-15
Enrollment: 992
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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).

Primary outcomes:
measure: Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination
timeFrame: 1 month postvaccination (day 29)
Secondary outcomes:
measure: Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination
timeFrame: 1 month postvaccination (day 29)
measure: Number Of Subjects Reporting Solicited Local And Systemic Adverse Events
timeFrame: From day 1 through day 7
Other outcomes:
Locations:
city: ul Czerkaska
country: Poland
facility: NZOZ Bioscience Sp zoo
state: Bydgoszcz
city: Dept Infection Disease ZOZ
country: Poland
facility: Department Infection Disease ZOZ
state: Debica
city: ul Graniczna 45
country: Poland
facility: Centrum Medyczne Graniczna Sp zoo
state: Katowice
city: Ul Strzelecka 2
country: Poland
facility: NZOZ HIPOKRATES IIspzoo
state: Krakow
city: ul. Kniaziewicza 1-5
country: Poland
facility: Wojewodzki Specjalistyczny Szpital im dr Wl Bieganskiego
state: Lodz
city: Ul Krysiewicza
country: Poland
facility: Specjalistyczny Zespol
state: Poznan
city: NZLA Michalkowice Jarosz Partnerzy Spolka Lekarska
country: Poland
facility: NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska
state: Siemianowice Slaskie
city: E Szczeklik Hospital
country: Poland
facility: Zespol Przychodni Specjalistycznych SP ZOZ w Tarnowie
state: Tarnów
city: Ul Prusicka 5355
country: Poland
facility: Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej w
state: Trzebnica
city: Ceglowska 80
country: Poland
facility: Klinika Pediatrii Centrum Medycznego Ksztalcenia Podyplomowe
state: Warszawa
city: Ul O Bujwida
country: Poland
facility: Amicur_Krystyna Lechka-Florianska i Partnerzy
state: Wroclaw
Study officials:
affiliation: Novartis
name: Novartis Vaccines
role: STUDY_CHAIR
References: