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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01148017
Other study ID # V59P14E1
Secondary ID
Status Completed
Phase Phase 3
First received June 16, 2010
Last updated October 19, 2015
Start date July 2010
Est. completion date April 2013

Study information

Verified date October 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 433
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 37 Months to 63 Months
Eligibility 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).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Intervention

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


Locations

Country Name City State
United States 28 Annapolis Pediatrics, 200 Forbes Street, Suite 200 Annapolis Maryland
United States Kentucky Pediatric/Adult Research 201 South Fifth Street, Suite 102 Bardstown Kentucky
United States Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615 Birmingham Alabama
United States Children's Memorial Hospital 2300 Children's Plaza, Box 155 Chicago Illinois
United States Senders Pediatrics 2054 South Green Road Cleveland Ohio
United States Premier Health Research 9317 Firestone Blvd. Downey California
United States Children's Health Care 2501 West 12th Street Erie Pennsylvania
United States Pennridge Pediatric Associates 270 Main Street Harleyville Pennsylvania
United States Kid's Way Pediatrics 3068 Innovation Way Hermitage Pennsylvania
United States Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624 Oakland California
United States Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308 Paramount California
United States Center for Clinical Trials, LLC 16660 Paramount Blvd., Suite 301 Paramount California
United States Kaiser Permanente Pleasanton 7601 Stoneridge Drive, Second Floor Pleasanton California
United States Kaiser Permanente San Francisco 2200 O'Farrell St., Sixth Floor San Francisco California
United States Kaiser Permanente Santa Clara 710 Lawrence Expressway, Pediatric Clinic Department Santa Clara California
United States Pennridge Pediatric Associates 711 Lawn Avenue Sellersville Pennsylvania
United States Pediatric Medical Associates 1077 Rydal Road Suite 300 Rydal Pennsylvania
United States Pediatric Medical Associates 160 West Germantown Pike Suite D2 East Norriton Pennsylvania
United States PEAK Research 2859 Washington Rd., Ste. 412B Upper St. Clair Pennsylvania

Sponsors (1)

Lead Sponsor Collaborator
Novartis Vaccines

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Primary 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 No
Secondary 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 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 = 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y. Visit 9, 40 months of age. No
Secondary Percentages of Subjects With hSBA Titers = 1:4 Against N Meningitidis Serogroups A, C, W-135, and Y Subjects of 60 Months of Age 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 percentage of subjects with human Serum Bactericidal Assay (hSBA) titers = 1:4 directed against N. meningitidis serogroups A, C, W-135, and Y. Visit 10, 60 months of age. No
Secondary hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age The persistence of the antibody response in children of 40 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects, is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y. Visit 9 (continuation from the parent study), 40-months of age. No
Secondary hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age The persistence of the antibody response in children of 60 months of age previously vaccinated with MenACWY-CRM in study V59P14 (NCT00474526), and baseline antibody levels in age-matched naive subjects is measured by the hSBA GMTs directed against N meningitidis serogroups A, C, W-135, and Y. Visit 10, 60 months of age. No
Secondary 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 The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage 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. No
Secondary Percentage of Subjects With Seroresponse at 1 Month Post-vaccination The antibody response to one booster dose of MenACWY-CRM in children of 60 months of age who had previously received at least one dose of MenACWY-CRM in the parent study, compared to the antibody response to one dose of MenACWY-CRM in meningococcal vaccine-naïve subjects, is measured by the percentage of subjects with seroresponse at 1 month post-vaccination.
Seroresponse is defined as hSBA = 1:8 for subjects with pre-vaccination hSBA titer =1:4, and as at least a four-fold rise in hSBA for subjects with pre-vaccination hSBA titer = 1:4.
Visit 11, 1 month after vaccination. No
Secondary Percentages of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity Percentages of subjects reporting solicited local and systemic Adverse Events (AEs) and other indicators of reactogenicity after receiving study vaccination.
Note: solicited AEs were not recorded for naive subjects at 40 months of age, but only SAEs and medically attended AEs.
From day 1 to 7 after vaccination. Yes
Secondary Percentages of Subjects Reporting Unsolicited AEs and SAEs Percentages of subjects reporting unsolicited AEs, serious adverse events (SAEs) and medically attended AEs after receiving study vaccination. 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). Yes
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