Clinical trial NCT01823536: Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose
Official title: A Phase IV, Open-label, Controlled, Multi-center Study to Evaluate the 5-year Antibody Persistence Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine at 2 to 10 Years of Age and to Assess the Immune Response to a Single Dose of Novartis MenACWY Conjugate Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Meningococcal Disease
Keywords: Meningitis
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2013-04-04
Enrollment: 465
Sex: ALL
Minimum age (years): 7
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 5 years post-vaccination
Secondary outcomes:
measure: 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.
timeFrame: 5 years post-vaccination
measure: 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
timeFrame: 5 years post-vaccination; baseline for naive
measure: 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.
timeFrame: Day 28 post-vaccination
measure: Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
timeFrame: Day 28 post-vaccination
measure: Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
timeFrame: Day 1 to day 7 post-vaccination
measure: Number of Subjects Reporting Unsolicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.
timeFrame: Day 1 to day 28
Other outcomes:
Locations:
city: Bentonville
country: United States
facility: 82 Children s Inv Research Prgm (ChIRP) 2900 Medical Center Parkway, Ste. 300
state: Arkansas
city: Little Rock
country: United States
facility: 83 AR Pediatric Clinical Research 500 South University, Ste. 200
state: Arkansas
city: Downey
country: United States
facility: 32 Prem Health Research Center 9317 Firestone Blvd.
state: California
city: Bardstown
country: United States
facility: 27 KY Pediatric Adult Research 201 South 5th Street, Suite 102
state: Kentucky
city: Omaha
country: United States
facility: 36 Meridian Clinical Research 3319 N. 107th Street
state: Nebraska
city: Cleveland
country: United States
facility: 33 Dr. Sender's and Associates 2054 South Green Road
state: Ohio
city: Ft. Worth
country: United States
facility: 31 Benchmark Research, Fort Worth 4504 Boat Club Rd., Suite 400A
state: Texas
city: San Angelo
country: United States
facility: 25 Benchmark Research, San Angelo 3555 Knickerbocker Rd.
state: Texas
city: Clinton
country: United States
facility: 65 Westside Medical 1477 N 2000 W, Suite C
state: Utah
city: Salt Lake City
country: United States
facility: 29 J. Lewis Research, Inc. 6360 South 3000 East, Ste. 100
state: Utah
city: Salt Lake City
country: United States
facility: 30 J. Lewis Research, Inc. 6360 South 3000 East, Ste. 100
state: Utah
city: South Jordan
country: United States
facility: 37 Copperview Medical Associates 3556 West 9800 South
state: Utah
city: Syracuse
country: United States
facility: 47 Wee Care Pediatrics 1792 W. 1700 S.
state: Utah
city: Spokane
country: United States
facility: 34 Rockwood Clinic P S 400 East Fifth Avenue
state: Washington
city: Spokane
country: United States
facility: 35 Rockwood Clinic-North Pediatrics 9001 N Country Homes Blvd
state: Washington
city: Metairie
country: Ukraine
facility: 26 Benchmark Research 3800 Houma Blvd., Suite 345
state: LA
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines and Diagnostics
role: STUDY_CHAIR
References:
citation: 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.