Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
This study is currently recruiting participants.
Verified December 2012 by Novartis
Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01148017
First received: June 16, 2010
Last updated: December 3, 2012
Last verified: December 2012
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Purpose
The primary objective is to evaluate the persistence of bactericidal antibodies in children 40 and 60 months of age previously enrolled in the V59P14 study who received Novartis MenACWY Conjugate Vaccine. The study will also enroll 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 the 60 months will be evaluated.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Meningitis |
Biological: Meningococcal ACWY conjugate vaccine |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| 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 |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- 40 months of age persistence of bactericidal antibodies antibody response in children who previously received at least one dose of MenACWY [ Time Frame: 40 months of age ] [ Designated as safety issue: No ]
- 60 months of age persistence of bactericidal antibodies antibody response in children who previously received at least one dose of MenACWY [ Time Frame: 60 months of age ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Evaluation of the antibody response and safety and tolerability of one MenACWY dose administered at 60 months of age [ Time Frame: 60 months of age (perisistance) and 28 days post vaccination at 60 months of age (bost analysis) ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 409 |
| Study Start Date: | July 2010 |
| Estimated Study Completion Date: | July 2013 |
| Estimated Primary Completion Date: | July 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Group 1
Subjects who previously received the Novartis MenACWY vaccine with a 2,4,6,12 or 2,4,6,13 months of age schedule in V59P14 trial. Blood draw at 40 and 60 months of age, MenACWY injection at 60 months of age and a blood draw 28 days after the injection.
|
Biological: Meningococcal ACWY conjugate vaccine
Detailed safety will be collected for 7 days post injection and medically attended Adverse Events and SAEs for 28 days post injection.
|
|
Experimental: Group 2
Subjects who previously received the Novartis MenACWY vaccine in the second year of life in V59P14 trial. Blood draw at 40 and 60 months of age, MenACWY injection at 60 months of age and a blood draw 28 days after the injection.
|
Biological: Meningococcal ACWY conjugate vaccine
Detailed safety will be collected for 7 days post injection and medically attended Adverse Events and SAEs for 28 days post injection.
|
|
Experimental: Group 3
Naïve subjects, age-matched with Group 1 and Group 2, enrolled at the 40 months of age. Blood draw at 40 months of age and an optional dose of MenACWY.
|
Biological: Meningococcal ACWY conjugate vaccine
Medically attended Adverse Events and SAEs will be collected for 28 days post injection.
|
|
Experimental: Group 4
Naïve subjects, age-matched with Group 1 and Group 2, enrolled at the 60 months of age. Blood draw at 60 months of age and dose of MenACWY. Blood draw 28 days after the injection.
|
Biological: Meningococcal ACWY conjugate vaccine
Detailed safety will be collected for 7 days post injection and medically attended Adverse Events and SAEs for 28 days post injection.
|
Eligibility| Ages Eligible for Study: | 37 Months to 63 Months |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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 on) subjects must be 40 +/- 3 months of age at the time of enrollment and participated in the original V59P14 study.
- 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 trial (Groups 1 & 2 - follow on).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01148017
Contacts
| Contact: Novartis Drug Information Services | +1 800 244 7668 |
Locations
| United States, Alabama | |
| Alabama Clinical Therapeutics 806 St. Vincent's Drive, Suite 615 | Recruiting |
| Birmingham, Alabama, United States, 35205 | |
| United States, California | |
| Premier Health Research 9317 Firestone Blvd. | Recruiting |
| Downey, California, United States, 90241 | |
| Kaiser Permanente Oakland 3505 Broadway, 6th Floor, Room 624 | Recruiting |
| Oakland, California, United States, 94611 | |
| Center for Clinical Trials, LLC 16660 Paramount Blvd., Suite 301 | Recruiting |
| Paramount, California, United States, 90723 | |
| Center for Clinical Trials, LLC 16415 S. Colorado Ave., Suite 308 | Recruiting |
| Paramount, California, United States, 90723 | |
| Kaiser Permanente Pleasanton 7601 Stoneridge Drive, Second Floor | Recruiting |
| Pleasanton, California, United States, 94588 | |
| Kaiser Permanente San Francisco 2200 O'Farrell St., Sixth Floor | Recruiting |
| San Francisco, California, United States, 94115 | |
| Kaiser Permanente Santa Clara 710 Lawrence Expressway, Pediatric Clinic Department | Recruiting |
| Santa Clara, California, United States, 95051 | |
| United States, Illinois | |
| Children's Memorial Hospital 2300 Children's Plaza, Box 155 | Recruiting |
| Chicago, Illinois, United States, 60614 | |
| United States, Kentucky | |
| Kentucky Pediatric/Adult Research 201 South Fifth Street, Suite 102 | Recruiting |
| Bardstown, Kentucky, United States, 40004 | |
| United States, Maryland | |
| 28 Annapolis Pediatrics, 200 Forbes Street, Suite 200 | Recruiting |
| Annapolis, Maryland, United States, 21401 | |
| United States, Ohio | |
| Senders Pediatrics 2054 South Green Road | Recruiting |
| Cleveland, Ohio, United States, 44121 | |
| United States, Pennsylvania | |
| Children's Health Care 2501 West 12th Street | Recruiting |
| Erie, Pennsylvania, United States, 16505 | |
| Pennridge Pediatric Associates 270 Main Street | Recruiting |
| Harleyville, Pennsylvania, United States, 19438 | |
| Kid's Way Pediatrics 3068 Innovation Way | Recruiting |
| Hermitage, Pennsylvania, United States, 16148 | |
| Pennridge Pediatric Associates 711 Lawn Avenue | Recruiting |
| Sellersville, Pennsylvania, United States, 18960 | |
| Pediatric Medical Associates 1077 Rydal Road | Recruiting |
| Suite 300 Rydal, Pennsylvania, United States, 19046 | |
| Pediatric Medical Associates 160 West Germantown Pike | Recruiting |
| Suite D2 East Norriton, Pennsylvania, United States, 19402 | |
| PEAK Research 2859 Washington Rd., Ste. 412B | Recruiting |
| Upper St. Clair, Pennsylvania, United States, 15241 | |
Sponsors and Collaborators
Novartis Vaccines
Investigators
| Study Chair: | Novartis Vaccines | Novartis Vaccines |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT01148017 History of Changes |
| Other Study ID Numbers: | V59P14E1 |
| Study First Received: | June 16, 2010 |
| Last Updated: | December 3, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Meningococcal ACWY Conjugate Vaccine Meningitis |
Children Persistence Booster dose |
Additional relevant MeSH terms:
|
Meningitis Meningitis, Meningococcal Central Nervous System Infections Central Nervous System Diseases Nervous System Diseases Meningitis, Bacterial |
Central Nervous System Bacterial Infections Bacterial Infections Meningococcal Infections Neisseriaceae Infections Gram-Negative Bacterial Infections |
ClinicalTrials.gov processed this record on May 23, 2013