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Meningococcal DiseasePhase 3NCT01725217

Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia

A Phase 3 study testing MenACWY-CRM in people with Meningococcal Disease, run by Novartis Vaccines at 4 sites in Russia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

To evaluate the immune response and safety following a single dose of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia. Read more about this study

Who is it for?
Ages 2 years and olderHealthy volunteers can take part
Conditions the study is for
Meningococcal Disease
What is being tested?
MenACWY-CRM
Could I receive a placebo?
No, everyone receives an active treatment
How many people
198 participants
Where
4 sitesRussia
Study dates
Nov 2012to Mar 2013
Phase
Phase 3
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 2 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • Individuals eligible for enrollment in this study were those:
  • Who were of any gender, from the age of 2 years and above at the time of visit 1, and to whom the nature of the study had been described and:
  • the parent/legal representative had provided written informed consent (≥2 to <18 years of age),
  • had provided written assent (≥11 to <18 years of age),
  • had provided written informed consent (≥18 years of age onwards).
  • Who the investigator believed that the subject and/or his or her parent/legal representative could and would comply with the requirements of the protocol (e.g., completion of the Diary Card, return for follow-up visit).
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  • Who were in good health as determined by
  • medical history
  • physical exam
  • clinical judgment of the investigator
  • Who had a negative urine pregnancy test for female subjects from 11 years of age.

Who cannot join

  • Individuals not eligible to be enrolled in the study were those:
  • Who were unwilling or unable to give written informed assent or consent to participate in the study.
  • Who were perceived to be unreliable or unavailable for the duration of the study period.
  • Who had a previous confirmed or suspected disease caused by N meningitidis.
  • Who had household contact with and/or intimate exposure to an individual with culture-proven N meningitidis infection within 60 days prior to enrollment.
  • Who had previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
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  • Who were pregnant or breast feeding (female subjects).
  • Who had received any investigational or non-registered product (drug or vaccine) within 28 days prior to enrollment or who expected to receive an investigational drug or vaccine prior to the completion of the study.
  • Who had received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study or who were planning to receive any vaccine within 30 days from the study vaccines.
  • (Exception: Influenza vaccine might be administered up to 15 days prior to study vaccination and at least 15 days after study vaccination).
  • Who had experienced within the 7 days prior to enrollment significant acute infection (for example requiring systemic antibiotic treatment or antiviral therapy) or had experienced fever (defined as body temperature ≥ 38°C) within 3 days prior to enrollment.
  • Who had any serious acute, chronic or progressive disease (e.g., any history of neoplasm, cancer, diabetes, cardiac disease, autoimmune disease, Human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS), or blood dyscrasias, with signs of cardiac or renal failure or severe malnutrition). Who had epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
  • Who had a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components including diphtheria toxin (CRM-197) and latex in the syringe.
  • Who had a known or suspected impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
  • receipt of immunosuppressive therapy within 30 days prior to enrollment (any systemic corticosteroid administered for more than 5 days, or in a daily dose > 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy)
  • receipt of immunostimulants
  • receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study
  • Who were known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

Trial locations and contacts

4 sites in 1 country.

Russia4 sites

  • Federal State Budgetary Institution 'State Scientific Center 'Institution of Immunology' of the Russian Federal Biomedical Agency'

    Kashirskoye Highway, Moscow, 115478

  • Institution of the Russian Academy of Sciences "Scientific Center for Children Health RAMS"

    Lomonosovskiy Avenue, Moscow, 119991

  • Federal Budgetary Institution of Science 'St-Petersburg Scientific-Research Institution of Epidemiology and Microbiology by name of Pasteur'

    Mira Street, Sankt-Peterburg, 197101

  • Federal State Institution 'Scientific-Research Institution of Children's Infections of the Russian Federal Biomedical Agency'

    Prof.Popova Street, Sankt-Peterburg, 197022

Other trials in Russia

About this study

Official title: A Phase 3, Multi-center, Open-label Study to Evaluate Immunogenicity and Safety of Novartis Meningococcal ACWY Conjugate Vaccine (MenACWY-CRM) in Healthy Children, Adolescents and Adults in Russia

To evaluate the immune response and safety following a single dose of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.

Being tested
MenACWY-CRM
Keywords
Meningitis, children, adolescents, adults, MenACWY
Medical subject headings
Meningococcal Infections, Meningitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MenACWY-CRMBiological

    1 vaccination at visit 1, conjugate vaccine, Intramuscular (IM) injection

Study groups in NCT01725217
Study groupRoleWhat they receive
MenACWY-CRMExperimentalMenACWY-CRM
Receives: Biological: MenACWY-CRM

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination

    Immunogenicity was measured as the percentages of overall subjects with hSBA (human serum bactericidal assay) seroresponse, directed against Neisseria meningitidis (N meningitidis) serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM (day 29).

    The seroresponse is defined as the percentages of subjects achieving hSBA ≥1:8 postvaccination with a prevaccination hSBA <1:4 and the percentages of subjects achieving at least four-fold increases in postvaccination hSBA from day 1 in subjects with a baseline hSBA ≥1:4

    Measured: Day 29

Secondary outcomes (6)

  1. Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group

    Immunogenicity was measured as the percentages of subjects stratified by age group with hSBA response, directed against N meningitidis serogroups A, C, W and Y, 28 days after one vaccination of MenACWY-CRM

    Measured: Day 29

  2. Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination

    Immunogenicity was measured as hSBA GMTs, against N meningitidis serogroups A, C, W and Y, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group

    Measured: Days 1 and 29

  3. Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination

    Immunogenicity was measured as the percentages of subjects with hSBA titer ≥1:8, at baseline (day 1) and 28 days after MenACWY-CRM vaccination (day 29), overall and by age group

    Measured: Days 1 and 29

  4. Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination

    Safety was assessed as the percentages of subjects aged 2 through 5 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination

    Measured: Within days 1 through 7 postvaccination

  5. Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination

    Safety was assessed as the percentages of subjects aged ≥6 years who reported solicited local and systemic AEs within days 1 through 7 after MenACWY-CRM vaccination, overall and by age group

    Measured: Within days 1 through 7 postvaccination

  6. Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination

    Safety was assessed in terms of percentages of subjects who reported all the adverse events (AEs) occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29, after MenACWY-CRM vaccination, overall and by age group

    Measured: AEs occurring from day 1 through 7, medically attended AEs, SAEs and AEs resulting in premature withdrawal, from day 1 through 29

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Nov 2012 (estimated)
  2. Study startNov 2012
  3. Primary completionMar 2013
  4. Study completionMar 2013

Resources

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 3
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
198 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01725217
Sponsor's protocol ID
V59_50
Status last verified
Apr 2023
First submitted
8 Nov 2012
Last updated
28 Apr 2023
Data monitoring committee
No

Publications

  • Trotter CL, Andrews NJ, Kaczmarski EB, Miller E, Ramsay ME. Effectiveness of meningococcal serogroup C conjugate vaccine 4 years after introduction. Lancet. 2004 Jul 24-30;364(9431):365-7. doi: 10.1016/S0140-6736(04)16725-1.

    PubMed 15276396

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MenACWY-CRM in people with Meningococcal Disease, run by Novartis Vaccines at 4 sites in Russia.

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 11 inclusion and 18 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 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 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?

Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination (time frame: Day 29). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01725217, which also lists 1 linked publication.

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 28 Apr 2023.

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