Clinical trial NCT01148017: Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
Official title: A Phase IIIb, Open-Label, Controlled, Multi-Center Study to Evaluate the Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Meningococcal Meningitis
Keywords: Meningococcal
ACWY
Conjugate Vaccine
Meningitis
Children
Persistence
Booster dose
Lead sponsor: Novartis
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2010-06-22
Enrollment: 433
Sex: ALL
Minimum age (years): 37
Maximum age (years): 63
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Serious, acute, or chronic illnesses are reasons for exclusion.
* 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).

Primary outcomes:
measure: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
timeFrame: Visit 9 (continuation from the parent study), 40-month visit.
measure: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y
timeFrame: Visit 10, 60 months of age
Secondary outcomes:
measure: 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
timeFrame: Visit 9, 40 months of age.
measure: Percentages of Subjects With hSBA Titers ≥ 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age
timeFrame: Visit 10, 60 months of age.
measure: hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age
timeFrame: Visit 9 (continuation from the parent study), 40-months of age.
measure: hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age
timeFrame: Visit 10, 60 months of age.
measure: 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
timeFrame: Visit 11, 1 month after vaccination.
measure: Percentage of Subjects With Seroresponse at 1 Month Post-vaccination
timeFrame: Visit 11, 1 month after vaccination.
measure: Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity
timeFrame: From day 1 to 7 after vaccination.
measure: Number of Subjects Reporting Unsolicited AEs and SAEs
timeFrame: Day 1 to 7 after vaccination for any unsolicited AEs, day 1 to study termination for SAEs and medically attended AEs (for the naive-40 group), day 8 to study termination for SAEs and medically attended AEs (for the other groups).
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615
state: Alabama
city: Downey
country: United States
facility: Premier Health Research 9317 Firestone Blvd.
state: California
city: Oakland
country: United States
facility: Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308
state: California
city: Paramount
country: United States
facility: Center for Clinical Trials, LLC 16660 Paramount Blvd., Suite 301
state: California
city: Pleasanton
country: United States
facility: Kaiser Permanente Pleasanton 7601 Stoneridge Drive, Second Floor
state: California
city: San Francisco
country: United States
facility: Kaiser Permanente San Francisco 2200 O'Farrell St., Sixth Floor
state: California
city: Santa Clara
country: United States
facility: Kaiser Permanente Santa Clara 710 Lawrence Expressway, Pediatric Clinic Department
state: California
city: Chicago
country: United States
facility: Children's Memorial Hospital 2300 Children's Plaza, Box 155
state: Illinois
city: Bardstown
country: United States
facility: Kentucky Pediatric/Adult Research 201 South Fifth Street, Suite 102
state: Kentucky
city: Annapolis
country: United States
facility: 28 Annapolis Pediatrics, 200 Forbes Street, Suite 200
state: Maryland
city: Cleveland
country: United States
facility: Senders Pediatrics 2054 South Green Road
state: Ohio
city: East Norriton
country: United States
facility: Pediatric Medical Associates 160 West Germantown Pike Suite D2
state: Pennsylvania
city: Erie
country: United States
facility: Children's Health Care 2501 West 12th Street
state: Pennsylvania
city: Harleysville
country: United States
facility: Pennridge Pediatric Associates 270 Main Street
state: Pennsylvania
city: Hermitage
country: United States
facility: Kid's Way Pediatrics 3068 Innovation Way
state: Pennsylvania
city: Rydal
country: United States
facility: Pediatric Medical Associates 1077 Rydal Road Suite 300
state: Pennsylvania
city: Sellersville
country: United States
facility: Pennridge Pediatric Associates 711 Lawn Avenue
state: Pennsylvania
city: Upper Saint Clair
country: United States
facility: PEAK Research 2859 Washington Rd., Ste. 412B
state: Pennsylvania
Study officials:
affiliation: Novartis Vaccines
name: Novartis Vaccines
role: STUDY_CHAIR
References:
citation: 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.