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Meningococcal MeningitisPhase 3NCT00856297

Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine

A Phase 3 study testing MenACWY-CRM conjugate vaccine and Licensed comparator in people with Meningococcal Meningitis, run by Novartis Vaccines at 32 sites in United States.

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

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. Read more about this study

Who is it for?
Ages 11 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Meningococcal Meningitis
What is being tested?
MenACWY-CRM conjugate vaccine and Licensed comparator
Type of treatment
Vaccines
Could I receive a placebo?
No, everyone receives an active treatment
How many people
389 participants
Where
32 sitesUnited States
Study dates
Feb 2009to Nov 2012
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 11 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • Subjects enrolled in V59P13:
  • healthy subjects who have completed the V59P13 study.
  • Naïve subjects:
  • healthy subjects aged-matched with subjects who had completed the V59P13 trial.(currently 16-23 years old).

Who cannot join

  • Subjects who had completed the V59P13 study:
  • who received any meningococcal vaccine after the V59P13 trial;
  • who have had previous confirmed or suspected disease caused by N. meningitidis;
  • who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
  • subjects with any serious, acute or chronic progressive disease.
  • Naïve subjects:
Show all 10Show fewer
  • who previously received any meningococcal vaccine;
  • who have had previous confirmed or suspected disease caused by N. meningitidis;
  • who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
  • subjects with any serious, acute or chronic progressive disease.

Trial locations and contacts

32 sites in 1 country.

32 sites in 1 country

United States32 sites

  • 38 Akron Children's Hospital One Perkins Square

    Akron, Ohio, 44308

  • 53 Pediatric/Adult Research Inc. 201 South Fifth Street, Suite 102

    Bardstown, Kentucky, 40004

  • 37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615

    Birmingham, Alabama, 35205

  • 19 Children's Health Care West 4671 West Lake Road

    Erie, Pennsylvania, 16505

  • 6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway

    Fremont, California, 94538

  • 7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor

    Fresno, California, 93726

  • 47 UTMB Galveston Office of Pediatric Clinical Trials Children's Hospital 301 University Blvd., Rm 1 288H

    Galveston, Texas, 77555

  • 21 Greenville Medical Centre Inc 90 Shenango Street

    Greenville, Pennsylvania, 16125

  • 24 (seen at site 21) Family Healthcare Partners 420 Hillcrest Avenue

    Grove City, Pennsylvania, 16127

  • 8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB

    Hayward, California, 94545

  • 23 Pediatric Associates of Latrobe 210 Weldon Street

    Latrobe, Pennsylvania, 15650

  • 2 PAMPA 2155 Post Oak Tritt Road, Suite 100

    Marietta, Georgia, 30062

  • Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor

    Oakland, California, 94612

  • 14 Squirrel Hill Office 4070 Beechwood Blvd

    Pittsburgh, Pennsylvania, 15217

  • 16 Pediatric Alliance Greentree Division 969 Greentree Road Suite 100

    Pittsburgh, Pennsylvania, 15220

  • 15 South Hills Pediatrics 4411 Stilley Road

    Pittsburgh, Pennsylvania, 15227

  • 13 Pediatric Alliance Southwestern 850 Clairton Blvd.

    Pittsburgh, Pennsylvania, 15236

  • 20 Pediatric Alliance Arcadia Division 9000 Perry Highway Suite 120

    Pittsburgh, Pennsylvania, 15237

  • 12 & 18 Primary Physicians Research, Inc. 1580 McLaughlin Run Road

    Pittsburgh, Pennsylvania, 15241

  • Admin Primary Physicians Research, Inc. 1580 McLaughlin Run Road

    Pittsburgh, Pennsylvania, 15241

  • 9 Kaiser Permanente Roseville 1840 Sierra Gardens Drive, Vaccine Studies

    Roseville, California, 95661

  • 11 Kaiser Permanente Sacramento 6600 Bruceville Rd., Pediatric Station C

    Sacramento, California, 95823

  • Kaiser Permanente, 6600 Bruceville Rd.

    Sacramento, California, 95823

  • 56 J. Lewis Research, Inc/Foothill Family Clinic South 6360 South 3000 East, Suite 100

    Salt Lake City, Utah, 84121

  • 10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1

    San Jose, California, 95119

  • 45 Group Health Research Institute 1730 Minor Ave, Suite 1600

    Seattle, Washington, 98101

  • 35 Pennridge Pediatric Associates 711 Lawn Avenue

    Sellersville, Pennsylvania, 18960

  • 43 Dr. Senders and Associates 2054 South Green Road

    South Euclid, Ohio, 44121

  • 22 Laurel Pediatrics 140 Wayland Smith Drive

    Uniontown, Pennsylvania, 15401

  • 25 Family Practice Medical Associates South 2581 Washington Road Suite 211

    Upper Saint Clair, Pennsylvania, 15241

  • PEAK Research, LLC, 2589 Washington Road, Suite 412B

    Upper Saint Clair, Pennsylvania

  • 3 PAMPA 120 Stonebridge Parkway Ste. 410

    Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: An Open-Label, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Adolescents Who Previously Received Novartis MenACWY Conjugate Vaccine or Commercially Available MenACWY Conjugate Vaccine

The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercially available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.

Being tested
MenACWY-CRM conjugate vaccine, Licensed comparator
Keywords
Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Adolescents, Persistence
Medical subject headings
Meningitis, Meningococcal, Meningitis

What participants receive

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

  • MenACWY-CRM conjugate vaccineBiological

  • Licensed comparatorBiological

    Also called Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier

Study groups in NCT00856297
Study groupRoleWhat they receive
MenACWY-CRMExperimentalSubjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
Receives: Biological: MenACWY-CRM conjugate vaccine
Licensed comparatorActive comparatorSubjects received one primary dose of a quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier in the parent study and were followed for persistence in the present study at 5 years postvaccination.
Receives: Biological: Licensed comparator
NaiveOtherSubjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
Receives: Biological: MenACWY-CRM conjugate vaccine; Biological: Licensed comparator
MenACWY-CRM/MenACWY-CRMExperimentalSubjects received one primary dose of the MenACWY-CRM conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Receives: Biological: MenACWY-CRM conjugate vaccine
Licensed comparator/MenACWY-CRMExperimentalSubjects received one primary dose of quadrivalent meningococcal diphtheria toxoid conjugate vaccine in the parent study and one booster dose of MenACWY-CRM conjugate vaccine at 3 years after primary vaccination.
Receives: Biological: MenACWY-CRM conjugate vaccine; Biological: Licensed comparator

What is being measured

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

  1. Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine

    Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with human complement serum bactericidal activity (hSBA) titers≥ 1:8 directed against N meningitidis serogroups A, C, W and Y.

    Measured: 21 months, 3 years and 5 years postvaccination

Secondary outcomes (10)

  1. Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine

    Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4 against N meningitidis serogroups A, C, W and Y.

    Measured: 21 months, 3 years and 5 years postvaccination

  2. hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine

    Immune response of one dose of MenACWY-CRM conjugate vaccine compared to that of one dose of licensed comparator vaccine at 21 months, 3 years and 5 years after vaccination, as measured by the hSBA Geometric Mean Titers (GMTs) against N meningitidis serogroups A, C, W and Y.

    Measured: 21 months, 3 years and 5 years postvaccination

  3. Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8

    Immune response of age-matched naive subjects with no previous meningococcal vaccination, as measured by the percentages of subjects with hSBA titers≥ 1:4, and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

    Measured: day 1

  4. hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination

    Immune response of age-matched subjects with no previous meningococcal vaccination, as measured by hSBA geometric mean titers (GMTs) against N meningitidis serogroups A, C, W and Y.

    Measured: day 1

  5. Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine

    Immune response at one month after one dose of MenACWY-CRM conjugate vaccine in subjects who had previously received one dose of MenACWY-CRM conjugate vaccine or licensed comparator vaccine, as measured by percentages of subjects with hSBA Titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

    Measured: 1 month post booster vaccination

  6. Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine

    Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA titers≥ 1:4 and ≥ 1:8 against N meningitidis serogroups A, C, W and Y.

    Measured: 2 years postvaccination

  7. Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine

    Persistence of immune response at two years following administration of one dose of MenACWY-CRM conjugate vaccine in subjects who previously received one dose of either MenACWY-CRM conjugate or licensed comparator vaccine, as measured by hSBA GMTs against N meningitidis serogroups A, C, W and Y.

    Measured: 2 years postvaccination

  8. Number of Subjects Reporting Solicited Local and Systemic Adverse Events

    Safety was assessed as the number of subjects who had previously been vaccinated in the parent study with MenACWY-CRM or licensed comparator who reported solicited local and systemic adverse events within 7 days after the administration of a booster dose of MenACWY-CRM conjugate vaccine at 3 year time point.

    Measured: Day 1 to Day 7

  9. Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator

    Safety was assessed in terms of number of subjects with new diagnoses of chronic diseases, among subjects who had previously received one dose of either MenACWY-CRM conjugate vaccine or licensed comparator vaccine.

    Measured: Day 1 to 5 years

  10. Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine

    Safety was assessed in terms of number of subjects with medically attended AEs within 28 days after vaccination with one dose of either MenACWY-CRM conjugate or licensed comparator vaccine.

    Measured: 28 days postvaccination

Timeline

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

  1. First posted5 Mar 2009 (estimated)
  2. Study startFeb 2009
  3. Primary completionNov 2012
  4. Study completionNov 2012

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
389 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00856297
Sponsor's protocol ID
V59P13E1
Status last verified
May 2017
First submitted
2 Mar 2009
Last updated
14 Jun 2017

Publications

  • Gill CJ, Baxter R, Anemona A, Ciavarro G, Dull P. Persistence of immune responses after a single dose of Novartis meningococcal serogroup A, C, W-135 and Y CRM-197 conjugate vaccine (Menveo(R)) or Menactra(R) among healthy adolescents. Hum Vaccin. 2010 Nov;6(11):881-7. doi: 10.4161/hv.6.11.12849. Epub 2010 Nov 1.

    PubMed 21339701

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing MenACWY-CRM conjugate vaccine and Licensed comparator in people with Meningococcal Meningitis, run by Novartis Vaccines at 32 sites in United States.

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 10 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 14 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 32 sites in United States. 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 22 Jan 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 Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine (time frame: 21 months, 3 years and 5 years postvaccination). 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 NCT00856297, 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 14 Jun 2017.

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