Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.

NCT01682876 | Completed Phase 3 Results

• 3 other identifiers: 205238V59_572011-004421-27
• Study Type: interventional
• Target: 715
• Locations: 1 country
• Sites: 19

Brief Summary

This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.

Conditions

Meningococcal Disease; Infections, Meningococcal

Keywords

Prevention of meningococcal disease, children, vaccine

Outcome Measures

Primary Outcomes (2)

• Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination

  Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 97.5% Clopper-Pearson confidence interval (CI), directed against N. meningitidis serogroups A, C, W and Y, by serum bactericidal assay using human complement (hSBA) at 1 month after one vaccination or two vaccinations of MenACWY-CRM given two months apart. Seroresponse is defined as: a. postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4; b. for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.

  One Month After Last Vaccination ( day 86)

• Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination

  Immunogenicity was measured as the percentage of subjects with overall seroresponse and associated 2-sided 95% CI, directed against N. meningitidis serogroups A, C, W and Y, by hSBA at 1 month after one vaccination or two vaccinations of MenACWY-CRM. Seroresponse -postvaccination hSBA titer ≥1:8 for subjects with a prevaccination hSBA titer \<1:4 and for subjects with a prevaccination hSBA ≥1:4, an increase of at least four times of the prevaccination hSBA titer.

  One Month After Last Vaccination (day 86)

Secondary Outcomes (8)

• Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM

  One Month After Last Vaccination (day 86)

• Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM

  One Month After Last Vaccination (day 86)

• Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM

  One year after one vaccination or two vaccinations (day 422).

• Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM

  One year after one vaccination or two vaccinations (day 422).

• Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination

  From Days 1-7 after each vaccination

Study Arms (4)

2 through 5 years (1 Vac) MenACWY-CRM 1

PLACEBO COMPARATOR

Subjects 2 through 5 years received one vaccination of MenACWY-CRM

Biological: MenACWY-CRM

2 through 5 years (2 Vac) MenACWY-CRM 2

ACTIVE COMPARATOR

Subjects 2 through 5 years received two vaccinations of MenACWY-CRM

Biological: MenACWY-CRM

6 through 10 years (1 Vac) MenACWY-CRM 3

PLACEBO COMPARATOR

Subjects 6 through 10 years received one vaccination of MenACWY-CRM

Biological: MenACWY-CRM

6 through 10 years (2 Vac) MenACWY-CRM 4

ACTIVE COMPARATOR

Subjects 6 through 10 years received two vaccinations of MenACWY-CRM

Biological: MenACWY-CRM

Interventions

MenACWY-CRM BIOLOGICAL

The investigational meningococcal (groups A, C, Y, and W-135 vaccine) oligosaccharide diphtheria CRM197 conjugate vaccine (MenACWY-CRM) was administered intramuscularly in the nondominant arm

2 through 5 years (1 Vac) MenACWY-CRM 1; 2 through 5 years (2 Vac) MenACWY-CRM 2; 6 through 10 years (1 Vac) MenACWY-CRM 3; 6 through 10 years (2 Vac) MenACWY-CRM 4

Eligibility Criteria

• Age: 2 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations

You may not qualify if:

• Unwilling or unable to give written informed assent or consent to participate in the study.
• Perceived to be unreliable or unavailable for the duration of the study period.
• Previous confirmed or suspected disease caused by N. meningitidis.
• Previously immunized with a meningococcal vaccine (licensed or investigational).
• Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
• Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine.
• (certain exceptions influenza vaccines apply)
• Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment.
• Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
• History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components
• Impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
• receipt of immunosuppressive therapy,
• receipt of immunostimulants,
• receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.
• Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (19)

GSK Investigational Site

Birmingham, Alabama, 35205, United States

Location

GSK Investigational Site

Sacramento, California, 95822, United States

Location

GSK Investigational Site

Lake Mary, Florida, 32746, United States

Location

GSK Investigational Site

Marietta, Georgia, 30062, United States

Location

GSK Investigational Site

Woodstock, Georgia, 30189, United States

Location

GSK Investigational Site

Council Bluffs, Iowa, 51503, United States

Location

GSK Investigational Site

Louisville, Kentucky, 40291, United States

Location

GSK Investigational Site

Metairie, Louisiana, 70006, United States

Location

GSK Investigational Site

Niles, Michigan, 49120, United States

Location

GSK Investigational Site

Stevensville, Michigan, 49127, United States

Location

GSK Investigational Site

Bellevue, Nebraska, 68005, United States

Location

GSK Investigational Site

Fremont, Nebraska, 68025, United States

Location

GSK Investigational Site

Omaha, Nebraska, 68134, United States

Location

GSK Investigational Site

Johnson City, New York, 13790, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44121, United States

Location

GSK Investigational Site

Cleveland, Ohio, 44122, United States

Location

GSK Investigational Site

Austin, Texas, 78705, United States

Location

GSK Investigational Site

Fort Worth, Texas, 76135, United States

Location

GSK Investigational Site

West Jordan, Utah, 84088, United States

Location

Related Publications (1)

• Johnston W, Essink B, Kirstein J, Forleo-Neto E, Percell S, Han L, Keshavan P, Smolenov I. Comparative Assessment of a Single Dose and a 2-dose Vaccination Series of a Quadrivalent Meningococcal CRM-conjugate Vaccine (MenACWY-CRM) in Children 2-10 Years of Age. Pediatr Infect Dis J. 2016 Jan;35(1):e19-27. doi: 10.1097/INF.0000000000000931.

  PMID: 26398741 DERIVED

MeSH Terms

Conditions

Meningococcal Infections

Interventions

MenACWY-CRM vaccine

Condition Hierarchy (Ancestors)

Neisseriaceae Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

877-379-3718

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2012
• First Posted: September 11, 2012
• Study Start: October 7, 2012
• Primary Completion: July 2, 2013
• Study Completion: May 30, 2014
• Last Updated: June 14, 2019
• Results First Posted: October 6, 2014

Record last verified: 2019-06

Locations

US (19)