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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01823536
Other study ID # V59P20E1
Secondary ID
Status Completed
Phase Phase 4
First received March 28, 2013
Last updated July 23, 2014
Start date May 2013
Est. completion date June 2014

Study information

Verified date July 2014
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

In this extension study, V59P20E1, the sponsor was planning to assess 5-year antibody persistence in subjects who received one or two doses of MenACWY conjugate vaccine at 2 to 10 years of age, and to evaluate response to a booster dose administered 5 years after primary vaccination in the parent study V59P20 (NCT00616421).


Recruitment information / eligibility

Status Completed
Enrollment 465
Est. completion date June 2014
Est. primary completion date October 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 7 Years to 15 Years
Eligibility Inclusion Criteria:

In order to participate in this study, all subjects must meet ALL of the inclusion criteria described.

1. Subject has (a) parent(s) or legal guardian(s) who has/have given written consent after the nature of the study has been explained according to local regulatory requirements.

2. If the subject is of an age where, according to local regulations, informed assent is required, that subject has provided assent to participate in the study.

3. Subject is in good health as determined by the outcome of medical history, physical examination, and clinical judgment of the investigator.

4. A negative urine pregnancy test is required before female subjects of childbearing potential will be enrolled. Of childbearing potential is defined as status post onset of menarche and not meeting any of the following conditions: menopausal for at least 2 years, status after bilateral tubal ligation for at least 1 year, status after bilateral oophorectomy, or status after hysterectomy.

5. For subjects who participated in study V59P20 (Groups MenACWYCRM_ 2 (=7-=10 Years), MenACWYCRM_1 (=7-=10 Years) and MenACWYCRM_ 1 (=11-=15 Years) only):

- subject who enrolled in Groups MenACWYCRM_2 (=7-=10 Years), MenACWYCRM_1 (=7-=10 Years) and MenACWYCRM_1 (=11-=15 Years) of study V59P20, has completed this study and included in per protocol immunogenicity analysis;

- the date of first vaccination in study V59P20 occurred 54 to 66 months prior to the collection of the blood sample at Visit 1.

6. For vaccine-naive subjects (Groups Vaccine Naive(=7-=10Years) and Vaccine Naive (=11-=15 Years) only):

- Individual is a male or female 7 to 10 years of age (group Vaccine Naive(=7-=10Years)) or 11 to 15 years of age (Group Vaccine Naive (=11-=15 Years)).

Exclusion Criteria:

In order to participate in this study, all subjects must meet NONE of the exclusion criteria described.

1. If the subject is female of childbearing potential, sexually active, and has not used any of the acceptable contraceptive methods for at least 2 months prior to study entry and for the duration of the trial.

2. Subject is a pregnant or breast-feeding female.

3. Subjects' parents or legal guardians or subjects who are not able to comprehend and to follow all required study procedures for the whole period of the study.

4. History of documented or suspected invasive meningococcal disease.

5. Previous household contact with and/or intimate exposure to an individual with laboratory proven N. meningitidis infection within 60 days prior to enrollment and for the duration of the study.

6. Have received any other meningococcal vaccine since participation in V59P20 or, if vaccine-naive subjects, have not received any meningococcal vaccine since birth.

7. Suspected or known hypersensitivity reaction after a previous dose of Menveo, any component of this vaccine, including any other CRM197 and diphtheria toxoid.

8. Any contraindication or precaution against vaccination with Novartis Menveo™ vaccine as highlighted in the package insert.

9. Serious, chronic, or acute illnesses or diseases (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system).

10. Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).

11. Administration of any cancer chemotherapy, immune-modified or immunosuppressive agents or systemic corticosteroids for at least seven days at any dose in the past 12 weeks or planned use throughout the study period (nasal or inhaled steroids are permitted, as are steroids applied to the skin).

12. Administration of blood, blood products and/or plasma derivatives or any immunoglobulin preparation in the past 12 weeks or planned use throughout the study period.

13. Administration of any vaccine within 28 days prior to the study enrollment or planned administration during the study period.

14. Subjects participating in any clinical trial with another investigational product 28 days prior to first study visit or intent to participate in another clinical study at any time during the study period.

15. Subjects who have experienced a significant acute infection requiring systemic antibiotic treatment within the 5 days prior to enrolment or have experienced a body temperature =38°C (=100.4°F) within the 3 days before the intended study vaccination.

16. Any condition which, in the opinion of the investigator, would pose a health risk to the participant.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Biological:
Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine
Subjects received at day 1 a single dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.

Locations

Country Name City State
Ukraine 26 Benchmark Research 3800 Houma Blvd., Suite 345 Metairie LA
United States 27 KY Pediatric Adult Research 201 South 5th Street, Suite 102 Bardstown Kentucky
United States 82 Children s Inv Research Prgm (ChIRP) 2900 Medical Center Parkway, Ste. 300 Bentonville Arkansas
United States 33 Dr. Sender's and Associates 2054 South Green Road Cleveland Ohio
United States 65 Westside Medical 1477 N 2000 W, Suite C Clinton Utah
United States 32 Prem Health Research Center 9317 Firestone Blvd. Downey California
United States 31 Benchmark Research, Fort Worth 4504 Boat Club Rd., Suite 400A Ft. Worth Texas
United States 83 AR Pediatric Clinical Research 500 South University, Ste. 200 Little Rock Arkansas
United States 36 Meridian Clinical Research 3319 N. 107th Street Omaha Nebraska
United States 29 J. Lewis Research, Inc. 6360 South 3000 East, Ste. 100 Salt Lake City Utah
United States 30 J. Lewis Research, Inc. 6360 South 3000 East, Ste. 100 Salt Lake City Utah
United States 25 Benchmark Research, San Angelo 3555 Knickerbocker Rd. San Angelo Texas
United States 37 Copperview Medical Associates 3556 West 9800 South South Jordan Utah
United States 34 Rockwood Clinic P S 400 East Fifth Avenue Spokane Washington
United States 35 Rockwood Clinic-North Pediatrics 9001 N Country Homes Blvd Spokane Washington
United States 47 Wee Care Pediatrics 1792 W. 1700 S. Syracuse Utah

Sponsors (1)

Lead Sponsor Collaborator
Novartis Vaccines

Countries where clinical trial is conducted

United States,  Ukraine, 

References & Publications (1)

Halperin SA, Gupta A, Jeanfreau R, Klein NP, Reisinger K, Walter E, Bedell L, Gill C, Dull PM. Comparison of the safety and immunogenicity of an investigational and a licensed quadrivalent meningococcal conjugate vaccine in children 2-10 years of age. Vaccine. 2010 Nov 23;28(50):7865-72. doi: 10.1016/j.vaccine.2010.09.092. Epub 2010 Oct 29. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Percentages of Subjects With Persisting hSBA Titers =1:8 Against Neisseria Meningitidis (N. Meningitidis) Serogroups A, C, W and Y, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine The percentages of subjects with persisting serum bactericidal antibody =1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported.
The serum bactericidal antibodies directed against N.meningitidis serogroups, are measured by human complement Serum Bactericidal Assay (hSBA).
5 years post-vaccination No
Secondary Persisting Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y in Subjects, Five Years After Having Received One or Two Doses of MenACWY-CRM Vaccine. The persistence of geometric mean titers (GMTs) against N.meningitidis serogroups A, C, W and Y in subjects who had received one or two doses of MenACWY-CRM vaccine, five years earlier in the parent study, are reported. 5 years post-vaccination No
Secondary Percentages of Subjects With Persisting hSBA Titers =1:8 Against N.Meningitidis Serogroups A, C, W and Y as Compared to Age Matched Vaccine-naive Subjects The percentages of subjects with persisting serum bactericidal antibody =1: 8, against N.meningitidis serogroups A, C, W and Y, after having received one or two doses of MenACWY-CRM vaccine five years earlier in the parent study, are compared with the hSBA response in age matched vaccine-naive subjects. 5 years post-vaccination; baseline for naive No
Secondary Percentages of Subjects With hSBA Titers =1:8 Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of the percentages of subjects with hSBA titers =1:8. Day 28 post-vaccination No
Secondary Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. The antibody response against N.meningitidis serogroups A, C, W and Y, at one month after one injection of Men ACWY-CRM vaccine was administered in the present study to subjects who had received either one or two doses of MenACWY-CRM vaccine 5 years earlier and to age matched naive subjects, is evaluated in terms of GMTs. Day 28 post-vaccination No
Secondary Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. The number of subjects reporting solicited local and systemic adverse events after one injection of MenACWY-CRM vaccine was administered in the present study to,
Subjects, who had 5 years earlier received either one or two doses of MenACWY-CRM vaccine
Vaccine-naive subjects.
Day 1 to day 7 post-vaccination No
Secondary Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study. The safety and tolerability of one injection of MenACWY-CRM vaccine, administered in the present study, was evaluated in terms of the number of subjects reporting unsolicited adverse events, serious adverse events and adverse events leading to premature withdrawal. Day 1 to day 28 No
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