NCT01434680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
992

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

11 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

September 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

March 26, 2014

Completed
Last Updated

April 25, 2017

Status Verified

March 1, 2017

Enrollment Period

1.2 years

First QC Date

September 14, 2011

Results QC Date

July 18, 2013

Last Update Submit

March 13, 2017

Conditions

Meningococcal DiseaseMeningococcal Meningitis

Keywords

Meningococcal diseasevaccinestoddlerspreventionMeningitis

Outcome Measures

Primary Outcomes (1)

  • 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)

Secondary Outcomes (2)

  • Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination

    1 month postvaccination (day 29)

  • Number Of Subjects Reporting Solicited Local And Systemic Adverse Events

    From day 1 through day 7

Study Arms (3)

MenC-CRM LIQ (Liquid Formulation)

EXPERIMENTAL

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

Biological: MenC-CRM LIQ

MenC-CRM ROS (Rosia)

EXPERIMENTAL

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

Biological: MenC-CRM ROS

MenC-CRM EMV (Emeryville)

ACTIVE COMPARATOR

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

Biological: MenC-CRM EMV

Interventions

MenC-CRM LIQBIOLOGICAL

One dose of MenC-CRM vaccine, liquid formulation

MenC-CRM LIQ (Liquid Formulation)
MenC-CRM ROSBIOLOGICAL

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

MenC-CRM ROS (Rosia)
MenC-CRM EMVBIOLOGICAL

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

MenC-CRM EMV (Emeryville)

Eligibility Criteria

Age12 Months - 23 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

NZOZ Bioscience Sp zoo

Ul Czerkaska, Bydgoszcz, Poland

Location

Department Infection Disease ZOZ

Dept Infection Disease ZOZ, Debica, Poland

Location

Centrum Medyczne Graniczna Sp zoo

Ul Graniczna 45, Katowice, Poland

Location

NZOZ HIPOKRATES IIspzoo

Ul Strzelecka 2, Krakow, Poland

Location

Specjalistyczny Zespol

Ul Krysiewicza, Poznan, Poland

Location

NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska

NZLA Michalkowice Jarosz Partnerzy Spolka Lekarska, Siemianowice Slaskie, Poland

Location

Zespol Przychodni Specjalistycznych SP ZOZ w Tarnowie

E Szczeklik Hospital, Tarnów, Poland

Location

Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej w

Ul Prusicka 5355, Trzebnica, Poland

Location

Klinika Pediatrii Centrum Medycznego Ksztalcenia Podyplomowe

Ceglowska 80, Warszawa, Poland

Location

Amicur_Krystyna Lechka-Florianska i Partnerzy

Ul O Bujwida, Wroclaw, Poland

Location

Wojewodzki Specjalistyczny Szpital im dr Wl Bieganskiego

Ul. Kniaziewicza 1-5, Łódź Voivodeship, Poland

Location

MeSH Terms

Conditions

Meningococcal InfectionsMeningitis, MeningococcalMeningitis

Condition Hierarchy (Ancestors)

Neisseriaceae InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsMeningitis, BacterialCentral Nervous System Bacterial InfectionsCentral Nervous System InfectionsCentral Nervous System DiseasesNervous System DiseasesNeuroinflammatory Diseases

Results Point of Contact

Title
Posting Director
Organization
Novartis Vaccines and Diagnostics
RegistryContactVaccinesUS@novartis.com

Study Officials

  • Novartis Vaccines

    Novartis

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2011

First Posted

September 15, 2011

Study Start

September 1, 2011

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

April 25, 2017

Results First Posted

March 26, 2014

Record last verified: 2017-03

Locations

PL(11)