Persistence of Immunogenicity of MenACWY Conjugate Vaccine 5 Years After Childhood Vaccination, and Immune Response to a Booster Dose

NCT ID: NCT01823536

Last Updated: 2014-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 465 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-05-31
• Study Completion Date: 2014-06-30

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).

Conditions

Meningococcal Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

MenACWY-CRM (≥7-≤10 years of age)

Subjects, who had previously received 2 injections of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine at 2-5 years of age, were administered 1 injection of the same vaccine at 7-10 years of age.

Group Type: EXPERIMENTAL

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Intervention Type: BIOLOGICAL

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

MenACWY-CRM_1 (≥7-≤10 years of age)

Subjects, who had previously received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine at 2-5 years of age, were administered 1 injection of the same vaccine at 7-10 years of age.

Group Type: EXPERIMENTAL

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Intervention Type: BIOLOGICAL

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

Vaccine naive (≥7-≤10 years of age)

Vaccine naive subjects, age-matched to the ≥7-≤10 years of age groups, received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.

Group Type: EXPERIMENTAL

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Intervention Type: BIOLOGICAL

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

MenACWY-CRM_1 (≥11-≤15 years of age)

Subjects, who had previously received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine at 7-10 years of age, were administered 1 injection of the same vaccine at 11-15 years of age.

Group Type: EXPERIMENTAL

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Intervention Type: BIOLOGICAL

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

Vaccine naive (≥11-≤15 years of age)

Vaccine naive subjects, age-matched to the ≥11-≤15 years of age group, received 1 injection of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.

Group Type: EXPERIMENTAL

Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine

Intervention Type: BIOLOGICAL

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

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Novartis Vaccines

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Vaccines and Diagnostics

Role: STUDY_CHAIR

Novartis Vaccines

Locations

82 Children s Inv Research Prgm (ChIRP) 2900 Medical Center Parkway, Ste. 300

Bentonville, Arkansas, United States

83 AR Pediatric Clinical Research 500 South University, Ste. 200

Little Rock, Arkansas, United States

32 Prem Health Research Center 9317 Firestone Blvd.

Downey, California, United States

27 KY Pediatric Adult Research 201 South 5th Street, Suite 102

Bardstown, Kentucky, United States

36 Meridian Clinical Research 3319 N. 107th Street

Omaha, Nebraska, United States

33 Dr. Sender's and Associates 2054 South Green Road

Cleveland, Ohio, United States

31 Benchmark Research, Fort Worth 4504 Boat Club Rd., Suite 400A

Fort Worth, Texas, United States

25 Benchmark Research, San Angelo 3555 Knickerbocker Rd.

San Angelo, Texas, United States

65 Westside Medical 1477 N 2000 W, Suite C

Clinton, Utah, 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

37 Copperview Medical Associates 3556 West 9800 South

South Jordan, Utah, United States

47 Wee Care Pediatrics 1792 W. 1700 S.

Syracuse, 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

26 Benchmark Research 3800 Houma Blvd., Suite 345

Metairie, LA, Ukraine

Countries

United States; Ukraine

References

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.

Reference Type: BACKGROUND

PMID: 20943209 (View on PubMed)

Other Identifiers

V59P20E1

Identifier Type: -

Identifier Source: org_study_id