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).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
465
Subjects received at day 1 a single dose of Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine.
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
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).
Time frame: 5 years post-vaccination
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.
Time frame: 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
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.
Time frame: 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.
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.
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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
...and 6 more locations
Time frame: 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.
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.
Time frame: Day 28 post-vaccination
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, 1. Subjects, who had 5 years earlier received either one or two doses of MenACWY-CRM vaccine 2. Vaccine-naive subjects.
Time frame: Day 1 to day 7 post-vaccination
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.
Time frame: Day 1 to day 28