Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine

NCT01148017 | Completed Phase 3 Results

• 1 other identifier: V59P14E1
• Study Type: interventional
• Target: 433
• Locations: 1 country
• Sites: 19

Brief Summary

The primary objective was to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 (NCT00474526) study who received Novartis MenACWY Conjugate Vaccine. The study also enrolled age-matched subjects who have never received any meningococcal vaccine (naïve subjects) to serve as a control group. In addition, the response of a booster dose at 60 months was evaluated.

Conditions

Meningococcal Meningitis

Keywords

Meningococcal; ACWY; Conjugate Vaccine; Meningitis; Children; Persistence; Booster dose

Outcome Measures

Primary Outcomes (2)

• Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y

  The persistence of the antibody response in subjects of 40 months of age, previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.

  Visit 9 (continuation from the parent study), 40-month visit.

• Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y

  The persistence of the antibody response in subjects of 60 months of age previously vaccinated with MenACWY-CRM in the parent study, and baseline antibody levels in age-matched naive subjects, is measured by the percentages of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against N. meningitidis serogroups A, C, W-135, and Y.

  Visit 10, 60 months of age

Secondary Outcomes (8)

• Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age

  Visit 9, 40 months of age.

• Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age

  Visit 10, 60 months of age.

• hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age

  Visit 9 (continuation from the parent study), 40-months of age.

• hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age

  Visit 10, 60 months of age.

• Percentages of Subjects With hSBA Titers ≥ 1:8, and ≥ 1:4 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y, at 1 Month Post-vaccination

  Visit 11, 1 month after vaccination.

Study Arms (4)

ACWY - 4

EXPERIMENTAL

Subjects who had previously received 4 doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in the parent study during their first year of life are administered one booster dose of the same vaccine at 60 months of age.

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

ACWY - 2

EXPERIMENTAL

Subjects who had previously received 1 or 2 doses of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine in the parent study during their second year of life, are administered one booster dose of the same vaccine at 60 months of age.

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

Naïve - 40

OTHER

Control subjects, age-matched with the intervention groups subjects (40 months of age), to receive 1 optional dose 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

Naïve - 60

ACTIVE COMPARATOR

Control subjects, age-matched with the intervention groups subjects (60 months of age), are administered one dose 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

ACWY - 2; ACWY - 4; Naïve - 40; Naïve - 60

Eligibility Criteria

• Age: 37 Months - 63 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Children eligible to be enrolled in the study are those whose parents provide written informed consent, and are in generally good health based on the clinical judgment of the investigators.
• Group 1 and 2 (Follow up) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study (NCT00474526).
• Group 3 and 4 (Naïve) subjects must be healthy, meningococcal vaccine-naïve children ages 40 +/- 3 months (Group 3) or 60 +/-3 months (Group 4) at the time of enrollment, respectively.

You may not qualify if:

• Subjects who have received any vaccine (excluding influenza vaccines) 28 days preceding enrollment visit. Influenza vaccines (including FluMist®) are excluded for the 14 days prior to the enrollment visit.
• Subjects who have received any meningococcal vaccine since birth (Groups 3 \& 4 -naive) or last study dose in V59P14 (NCT00474526) trial (Groups 1 \& 2 - follow on).

Sponsors & Collaborators

• Novartis Vaccines: lead
• GlaxoSmithKline: collaborator

Study Sites (19)

Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615

Birmingham, Alabama, 35205, United States

Location

Premier Health Research 9317 Firestone Blvd.

Downey, California, 90241, United States

Location

Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624

Oakland, California, 94611, United States

Location

Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308

Paramount, California, 90723, United States

Location

Center for Clinical Trials, LLC 16660 Paramount Blvd., Suite 301

Paramount, California, 90723, United States

Location

Kaiser Permanente Pleasanton 7601 Stoneridge Drive, Second Floor

Pleasanton, California, 94588, United States

Location

Kaiser Permanente San Francisco 2200 O'Farrell St., Sixth Floor

San Francisco, California, 94115, United States

Location

Kaiser Permanente Santa Clara 710 Lawrence Expressway, Pediatric Clinic Department

Santa Clara, California, 95051, United States

Location

Children's Memorial Hospital 2300 Children's Plaza, Box 155

Chicago, Illinois, 60614, United States

Location

Kentucky Pediatric/Adult Research 201 South Fifth Street, Suite 102

Bardstown, Kentucky, 40004, United States

Location

28 Annapolis Pediatrics, 200 Forbes Street, Suite 200

Annapolis, Maryland, 21401, United States

Location

Senders Pediatrics 2054 South Green Road

Cleveland, Ohio, 44121, United States

Location

Pediatric Medical Associates 160 West Germantown Pike Suite D2

East Norriton, Pennsylvania, 19402, United States

Location

Children's Health Care 2501 West 12th Street

Erie, Pennsylvania, 16505, United States

Location

Pennridge Pediatric Associates 270 Main Street

Harleysville, Pennsylvania, 19438, United States

Location

Kid's Way Pediatrics 3068 Innovation Way

Hermitage, Pennsylvania, 16148, United States

Location

Pediatric Medical Associates 1077 Rydal Road Suite 300

Rydal, Pennsylvania, 19046, United States

Location

Pennridge Pediatric Associates 711 Lawn Avenue

Sellersville, Pennsylvania, 18960, United States

Location

PEAK Research 2859 Washington Rd., Ste. 412B

Upper Saint Clair, Pennsylvania, 15241, United States

Location

Related Publications (1)

• Klein NP, Block SL, Essink B, Barbi S, Smolenov I, Keshavan P. Antibody persistence and booster response following MenACWY-CRM vaccination in children as assessed by two different assay methods. Vaccine. 2019 Jul 26;37(32):4460-4467. doi: 10.1016/j.vaccine.2019.06.076. Epub 2019 Jul 3.

  PMID: 31279564 DERIVED

MeSH Terms

Conditions

Meningitis, Meningococcal; Meningitis

Condition Hierarchy (Ancestors)

Meningitis, Bacterial; Central Nervous System Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Meningococcal Infections; Neisseriaceae Infections; Gram-Negative Bacterial Infections; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Neuroinflammatory Diseases

Results Point of Contact

• Title: Posting Director
• Organization: Novartis Vaccines

RegistryContactVaccinesUS@novartis.com

Study Officials

• Novartis Vaccines

  Novartis Vaccines

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 22, 2010
• Study Start: July 1, 2010
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: August 14, 2017
• Results First Posted: May 14, 2014

Record last verified: 2017-07

Locations

US (19)