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

Meningococcal Meningitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01148017
• Other study ID #: V59P14E1
• 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

Related Conditions & MeSH terms

• Meningitis
• Meningitis, Meningococcal
• Meningococcal Meningitis

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