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

Meningococcal Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01823536
• Other study ID #: V59P20E1
• 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

• Meningococcal Disease
• Meningococcal Infections

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