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

NCT01823536 | Completed Phase 4 Results

• 1 other identifier: V59P20E1
• Study Type: interventional
• Target: 465
• Locations: 2 countries
• Sites: 16

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

Keywords

Meningitis

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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.

  5 years post-vaccination

• 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

  5 years post-vaccination; baseline for naive

• 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.

  Day 28 post-vaccination

• Geometric Mean Titers Against N.Meningitidis Serogroups A, C, W and Y, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.

  Day 28 post-vaccination

• Number of Subjects Reporting Solicited Adverse Events, After Receiving One Injection of MenACWY-CRM Vaccine in the Present Study.

  Day 1 to day 7 post-vaccination

Study Arms (5)

MenACWY-CRM (≥7-≤10 years of age)

EXPERIMENTAL

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.

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

MenACWY-CRM_1 (≥7-≤10 years of age)

EXPERIMENTAL

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.

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

Vaccine naive (≥7-≤10 years of age)

EXPERIMENTAL

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.

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

MenACWY-CRM_1 (≥11-≤15 years of age)

EXPERIMENTAL

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.

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

Vaccine naive (≥11-≤15 years of age)

EXPERIMENTAL

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.

Biological: 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 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 (≥7-≤10 years of age); MenACWY-CRM_1 (≥11-≤15 years of age); MenACWY-CRM_1 (≥7-≤10 years of age); Vaccine naive (≥11-≤15 years of age); Vaccine naive (≥7-≤10 years of age)

Eligibility Criteria

• Age: 7 Years - 15 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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.
• Subject is a pregnant or breast-feeding female.
• 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.
• History of documented or suspected invasive meningococcal disease.
• 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.
• Have received any other meningococcal vaccine since participation in V59P20 or, if vaccine-naive subjects, have not received any meningococcal vaccine since birth.
• Suspected or known hypersensitivity reaction after a previous dose of Menveo, any component of this vaccine, including any other CRM197 and diphtheria toxoid.
• Any contraindication or precaution against vaccination with Novartis Menveo™ vaccine as highlighted in the package insert.
• Serious, chronic, or acute illnesses or diseases (i.e., cardiac, renal, neurologic, rheumatologic, metabolic, gastrointestinal, psychiatric, or other organ system).
• Any confirmed or suspected condition with impaired/altered function of immune system (immunodeficient or autoimmune conditions).
• 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).
• 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.
• Administration of any vaccine within 28 days prior to the study enrollment or planned administration during the study period.
• 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.
• 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.

Sponsors & Collaborators

• Novartis Vaccines: lead

Study Sites (16)

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

Bentonville, Arkansas, 72712, United States

Location

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

Little Rock, Arkansas, 72205, United States

Location

32 Prem Health Research Center 9317 Firestone Blvd.

Downey, California, 90241, United States

Location

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

Bardstown, Kentucky, 40004, United States

Location

36 Meridian Clinical Research 3319 N. 107th Street

Omaha, Nebraska, 68134, United States

Location

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

Cleveland, Ohio, 44121, United States

Location

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

Fort Worth, Texas, 76135, United States

Location

25 Benchmark Research, San Angelo 3555 Knickerbocker Rd.

San Angelo, Texas, 76904, United States

Location

65 Westside Medical 1477 N 2000 W, Suite C

Clinton, Utah, 84015, United States

Location

29 J. Lewis Research, Inc. 6360 South 3000 East, Ste. 100

Salt Lake City, Utah, 84121, United States

Location

30 J. Lewis Research, Inc. 6360 South 3000 East, Ste. 100

Salt Lake City, Utah, 84121, United States

Location

37 Copperview Medical Associates 3556 West 9800 South

South Jordan, Utah, 84095, United States

Location

47 Wee Care Pediatrics 1792 W. 1700 S.

Syracuse, Utah, 84075, United States

Location

34 Rockwood Clinic P S 400 East Fifth Avenue

Spokane, Washington, 99202, United States

Location

35 Rockwood Clinic-North Pediatrics 9001 N Country Homes Blvd

Spokane, Washington, 99218, United States

Location

26 Benchmark Research 3800 Houma Blvd., Suite 345

Metairie, LA, 70006, Ukraine

Location

Related 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.

  PMID: 20943209 BACKGROUND

MeSH Terms

Conditions

Meningococcal Infections; Meningitis

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Neuroinflammatory Diseases; Nervous System Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines and Diagnostics

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines and Diagnostics

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2013
• First Posted: April 4, 2013
• Study Start: May 1, 2013
• Primary Completion: October 1, 2013
• Study Completion: June 1, 2014
• Last Updated: August 15, 2014
• Results First Posted: August 15, 2014

Record last verified: 2014-07

Locations

US (15); UA (1)