search
Back to results

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

Primary Purpose

Meningococcal Meningitis

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
MenACWY-CRM conjugate vaccine
Licensed comparator
Sponsored by
Novartis Vaccines
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Meningococcal Meningitis focused on measuring Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Adolescents, Persistence

Eligibility Criteria

11 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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).

Exclusion Criteria:

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:

  • 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.

Sites / Locations

  • 37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615
  • 6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway
  • 7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor
  • 8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB
  • Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor
  • 9 Kaiser Permanente Roseville 1840 Sierra Gardens Drive, Vaccine Studies
  • 11 Kaiser Permanente Sacramento 6600 Bruceville Rd., Pediatric Station C
  • Kaiser Permanente, 6600 Bruceville Rd.
  • 10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1
  • 2 PAMPA 2155 Post Oak Tritt Road, Suite 100
  • 3 PAMPA 120 Stonebridge Parkway Ste. 410
  • 53 Pediatric/Adult Research Inc. 201 South Fifth Street, Suite 102
  • 38 Akron Children's Hospital One Perkins Square
  • 43 Dr. Senders and Associates 2054 South Green Road
  • 19 Children's Health Care West 4671 West Lake Road
  • 21 Greenville Medical Centre Inc 90 Shenango Street
  • 24 (seen at site 21) Family Healthcare Partners 420 Hillcrest Avenue
  • 23 Pediatric Associates of Latrobe 210 Weldon Street
  • 14 Squirrel Hill Office 4070 Beechwood Blvd
  • 16 Pediatric Alliance Greentree Division 969 Greentree Road Suite 100
  • 15 South Hills Pediatrics 4411 Stilley Road
  • 13 Pediatric Alliance Southwestern 850 Clairton Blvd.
  • 20 Pediatric Alliance Arcadia Division 9000 Perry Highway Suite 120
  • 12 & 18 Primary Physicians Research, Inc. 1580 McLaughlin Run Road
  • Admin Primary Physicians Research, Inc. 1580 McLaughlin Run Road
  • 35 Pennridge Pediatric Associates 711 Lawn Avenue
  • 22 Laurel Pediatrics 140 Wayland Smith Drive
  • 25 Family Practice Medical Associates South 2581 Washington Road Suite 211
  • PEAK Research, LLC, 2589 Washington Road, Suite 412B
  • 47 UTMB Galveston Office of Pediatric Clinical Trials Children's Hospital 301 University Blvd., Rm 1 288H
  • 56 J. Lewis Research, Inc/Foothill Family Clinic South 6360 South 3000 East, Suite 100
  • 45 Group Health Research Institute 1730 Minor Ave, Suite 1600

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Other

Experimental

Experimental

Arm Label

MenACWY-CRM

Licensed comparator

Naive

MenACWY-CRM/MenACWY-CRM

Licensed comparator/MenACWY-CRM

Arm Description

Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.

Subjects 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.

Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.

Subjects 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.

Subjects 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
March 2, 2009
Last Updated
May 17, 2017
Sponsor
Novartis Vaccines
Collaborators
GlaxoSmithKline
search

1. Study Identification

Unique Protocol Identification Number
NCT00856297
Brief Title
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novartis Vaccines
Collaborators
GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Meningococcal Meningitis
Keywords
Meningococcal, ACWY, Conjugate Vaccine, Meningitis, Adolescents, Persistence

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
389 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MenACWY-CRM
Arm Type
Experimental
Arm Description
Subjects received one primary dose of MenACWY-CRM conjugate vaccine in the parent study and were followed for persistence in the present study.
Arm Title
Licensed comparator
Arm Type
Active Comparator
Arm Description
Subjects 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.
Arm Title
Naive
Arm Type
Other
Arm Description
Subjects who were age-matched to the other study groups and had not received any previous meningococcal vaccinations.
Arm Title
MenACWY-CRM/MenACWY-CRM
Arm Type
Experimental
Arm Description
Subjects 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.
Arm Title
Licensed comparator/MenACWY-CRM
Arm Type
Experimental
Arm Description
Subjects 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.
Intervention Type
Biological
Intervention Name(s)
MenACWY-CRM conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
Licensed comparator
Other Intervention Name(s)
Quadrivalent meningococcal conjugate vaccine with diphtheria toxoid as the protein carrier
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
21 months, 3 years and 5 years postvaccination
Secondary Outcome Measure Information:
Title
Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine
Description
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.
Time Frame
21 months, 3 years and 5 years postvaccination
Title
hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine
Description
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.
Time Frame
21 months, 3 years and 5 years postvaccination
Title
Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8
Description
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.
Time Frame
day 1
Title
hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination
Description
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.
Time Frame
day 1
Title
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine
Description
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.
Time Frame
1 month post booster vaccination
Title
Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine
Description
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.
Time Frame
2 years postvaccination
Title
Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine
Description
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.
Time Frame
2 years postvaccination
Title
Number of Subjects Reporting Solicited Local and Systemic Adverse Events
Description
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.
Time Frame
Day 1 to Day 7
Title
Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator
Description
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.
Time Frame
Day 1 to 5 years
Title
Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine
Description
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.
Time Frame
28 days postvaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: 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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis Vaccines
Organizational Affiliation
Novartis
Official's Role
Study Chair
Facility Information:
Facility Name
37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor
City
Fresno
State/Province
California
ZIP/Postal Code
93726
Country
United States
Facility Name
8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB
City
Hayward
State/Province
California
ZIP/Postal Code
94545
Country
United States
Facility Name
Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor
City
Oakland
State/Province
California
ZIP/Postal Code
94612
Country
United States
Facility Name
9 Kaiser Permanente Roseville 1840 Sierra Gardens Drive, Vaccine Studies
City
Roseville
State/Province
California
ZIP/Postal Code
95661
Country
United States
Facility Name
11 Kaiser Permanente Sacramento 6600 Bruceville Rd., Pediatric Station C
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
Kaiser Permanente, 6600 Bruceville Rd.
City
Sacramento
State/Province
California
ZIP/Postal Code
95823
Country
United States
Facility Name
10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1
City
San Jose
State/Province
California
ZIP/Postal Code
95119
Country
United States
Facility Name
2 PAMPA 2155 Post Oak Tritt Road, Suite 100
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30062
Country
United States
Facility Name
3 PAMPA 120 Stonebridge Parkway Ste. 410
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
53 Pediatric/Adult Research Inc. 201 South Fifth Street, Suite 102
City
Bardstown
State/Province
Kentucky
ZIP/Postal Code
40004
Country
United States
Facility Name
38 Akron Children's Hospital One Perkins Square
City
Akron
State/Province
Ohio
ZIP/Postal Code
44308
Country
United States
Facility Name
43 Dr. Senders and Associates 2054 South Green Road
City
South Euclid
State/Province
Ohio
ZIP/Postal Code
44121
Country
United States
Facility Name
19 Children's Health Care West 4671 West Lake Road
City
Erie
State/Province
Pennsylvania
ZIP/Postal Code
16505
Country
United States
Facility Name
21 Greenville Medical Centre Inc 90 Shenango Street
City
Greenville
State/Province
Pennsylvania
ZIP/Postal Code
16125
Country
United States
Facility Name
24 (seen at site 21) Family Healthcare Partners 420 Hillcrest Avenue
City
Grove City
State/Province
Pennsylvania
ZIP/Postal Code
16127
Country
United States
Facility Name
23 Pediatric Associates of Latrobe 210 Weldon Street
City
Latrobe
State/Province
Pennsylvania
ZIP/Postal Code
15650
Country
United States
Facility Name
14 Squirrel Hill Office 4070 Beechwood Blvd
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15217
Country
United States
Facility Name
16 Pediatric Alliance Greentree Division 969 Greentree Road Suite 100
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15220
Country
United States
Facility Name
15 South Hills Pediatrics 4411 Stilley Road
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15227
Country
United States
Facility Name
13 Pediatric Alliance Southwestern 850 Clairton Blvd.
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15236
Country
United States
Facility Name
20 Pediatric Alliance Arcadia Division 9000 Perry Highway Suite 120
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15237
Country
United States
Facility Name
12 & 18 Primary Physicians Research, Inc. 1580 McLaughlin Run Road
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
Admin Primary Physicians Research, Inc. 1580 McLaughlin Run Road
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
35 Pennridge Pediatric Associates 711 Lawn Avenue
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
22 Laurel Pediatrics 140 Wayland Smith Drive
City
Uniontown
State/Province
Pennsylvania
ZIP/Postal Code
15401
Country
United States
Facility Name
25 Family Practice Medical Associates South 2581 Washington Road Suite 211
City
Upper Saint Clair
State/Province
Pennsylvania
ZIP/Postal Code
15241
Country
United States
Facility Name
PEAK Research, LLC, 2589 Washington Road, Suite 412B
City
Upper Saint Clair
State/Province
Pennsylvania
Country
United States
Facility Name
47 UTMB Galveston Office of Pediatric Clinical Trials Children's Hospital 301 University Blvd., Rm 1 288H
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Facility Name
56 J. Lewis Research, Inc/Foothill Family Clinic South 6360 South 3000 East, Suite 100
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
45 Group Health Research Institute 1730 Minor Ave, Suite 1600
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21339701
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs