Meningococcal DiseasePhase 2NCT01434680
Evaluating the Comparative Safety and Immunogenicity of Three Lots of Novartis Meningococcal C Conjugate Vaccine in Healthy Toddlers
A Phase 2 study testing MenC-CRM LIQ, MenC-CRM ROS and MenC-CRM EMV in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis at 11 sites in Poland.
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. Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Meningococcal Disease, Meningococcal Meningitis
- What is being tested?
- MenC-CRM LIQ, MenC-CRM ROS and MenC-CRM EMV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 992 participants
- Where
- 11 sitesPoland
- Study dates
- Sep 2011to Nov 2012
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 21Show fewer
- 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.
- 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).
- 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.
- 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.
- Family members or household members of site research staff.
- 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.
- Any serious chronic or progressive disease according to judgment of the investigator (neoplasm, insulin dependent diabetes, cardiac, renal or hepatic disease).
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Poland11 sites
Klinika Pediatrii Centrum Medycznego Ksztalcenia Podyplomowe
Ceglowska 80, Warszawa
Department Infection Disease ZOZ
Dept Infection Disease ZOZ, Debica
Zespol Przychodni Specjalistycznych SP ZOZ w Tarnowie
E Szczeklik Hospital, Tarnów
NZLA Michalkowice Jarosz i Partnerzy Spolka Lekarska
NZLA Michalkowice Jarosz Partnerzy Spolka Lekarska, Siemianowice Slaskie
NZOZ Bioscience Sp zoo
Ul Czerkaska, Bydgoszcz
Centrum Medyczne Graniczna Sp zoo
Ul Graniczna 45, Katowice
Specjalistyczny Zespol
Ul Krysiewicza, Poznan
Amicur_Krystyna Lechka-Florianska i Partnerzy
Ul O Bujwida, Wroclaw
Samodzielny Zespol Publicznych Zakladow Opieki Zdrowotnej w
Ul Prusicka 5355, Trzebnica
NZOZ HIPOKRATES IIspzoo
Ul Strzelecka 2, Krakow
Wojewodzki Specjalistyczny Szpital im dr Wl Bieganskiego
Ul. Kniaziewicza 1-5, Łódź Voivodeship
About this study
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
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
- Being tested
- MenC-CRM LIQ, MenC-CRM ROS, MenC-CRM EMV
- Keywords
- Meningococcal disease, vaccines, toddlers, prevention, Meningitis
- Medical subject headings
- Meningococcal Infections, Meningitis, Meningococcal, Meningitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MenC-CRM LIQBiological
One dose of MenC-CRM vaccine, liquid formulation
MenC-CRM ROSBiological
One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy.
MenC-CRM EMVBiological
One dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA.
| Study group | Role | What they receive |
|---|---|---|
| MenC-CRM LIQ (Liquid Formulation) | Experimental | Subjects received 1 injection of MenC-CRM vaccine,liquid formulation. Receives: 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 Receives: 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 Receives: Biological: MenC-CRM EMV |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 month postvaccination (day 29)
Secondary outcomes (2)
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.
Measured: 1 month postvaccination (day 29)
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.
Measured: From day 1 through day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Meningococcal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 992 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Responsible party
- Sponsor
- Investigators
- Novartis Vaccines, Study chair, Novartis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01434680
- Sponsor's protocol ID
- V14_57
- Status last verified
- Mar 2017
- First submitted
- 14 Sep 2011
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01434680
- Acronym / sponsor ID
- V14_57
- Conditions
- Meningococcal Disease, Meningococcal Meningitis
- Keywords
- Meningococcal disease, vaccines, toddlers, prevention, Meningitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 992 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Collaborators
- Novartis Vaccines
- Study start
- Sep 2011
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 15 Sep 2011 (estimated)
- Results
- Posted 26 Mar 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MenC-CRM LIQ (Liquid Formulation) | Experimental | Biological: MenC-CRM LIQSubjects received 1 injection of MenC-CRM vaccine,liquid formulation. |
| MenC-CRM ROS (Rosia) | Experimental | Biological: MenC-CRM ROSSubjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy |
| MenC-CRM EMV (Emeryville) | Active comparator | Biological: MenC-CRM EMVSubjects received 1 injection of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (21 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MenC-CRM LIQOne dose of MenC-CRM vaccine, liquid formulation | Biological | MenC-CRM LIQ (Liquid Formulation) |
| MenC-CRM ROSOne dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Rosia, Italy. | Biological | MenC-CRM ROS (Rosia) |
| MenC-CRM EMVOne dose of MenC-CRM vaccine, lyophilized formulation produced with drug substance manufactured at Emeryville, USA. | Biological | MenC-CRM EMV (Emeryville) |
Primary outcome
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination
Time frame: 1 month postvaccination (day 29)
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.
2 secondary outcomes
Geometric Mean hSBA Titers Against N Meningitidis Serogroup C 28 Days After Vaccination
Time frame: 1 month postvaccination (day 29)
Number Of Subjects Reporting Solicited Local And Systemic Adverse Events
Time frame: From day 1 through day 7
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Novartis Vaccines study chair
Novartis
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MenC-CRM LIQ, MenC-CRM ROS and MenC-CRM EMV in people with Meningococcal Disease and Meningococcal Meningitis, run by Novartis at 11 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric Mean Human Serum Bactericidal Activity Titers Against N Meningitidis Serogroup C 28 Days After Vaccination (time frame: 1 month postvaccination (day 29)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2017.