Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
This study has been completed.
Sponsor:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00856297
First received: March 2, 2009
Last updated: December 17, 2012
Last verified: December 2012
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Purpose
The primary objective is to evaluate the persistence of bactericidal antibodies in adolescents previously enrolled in the V59P13 study who received either Novartis MenACWY Conjugate Vaccine or commercial available MenACWY conjugate vaccine. The study will also enroll age-matched subjects who have never received any other meningococcal vaccine (naïve subjects) to serve as an additional control group.
| Condition | Intervention | Phase |
|---|---|---|
|
Meningococcal Meningitis |
Other: Blood draw Biological: Group IV Biological: Group V |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | An Open-Label, Multi-Center Study to Evaluate the Persistence Of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received Novartis MenACWY Conjugate Vaccine or Commercial Available MenACWY Conjugate Vaccine |
Resource links provided by NLM:
Further study details as provided by Novartis:
Primary Outcome Measures:
- Persistence of bactericidal antibodies [ Time Frame: 21 months, 3 years and 5 years post vaccination ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Immunity against meningococcal serogroups A, C, W-135 and Y with either Novartis MenACWY Conjugate Vaccine or Menactra® in study V59P13. [ Time Frame: 21 months, 3 years and 5 years post vaccination ] [ Designated as safety issue: No ]In terms of percentage of subjects with hSBA titers ≥ 1:4 and hSBA geometric mean titers (GMTs) directed against N meningitidis serogroups A, C, W-135, and Y.
- Immunity against meningococcal serogroups A, C, W-135, Y of age-matched adolescents with no previous meningococcal vaccination. [ Time Frame: 21 months, 3 years and 5 years post vaccination ] [ Designated as safety issue: No ]In terms of percentage of subjects with hSBA titer ≥ 1:4, percentage of subjects with hSBA titer ≥ 1:8 and hSBA GMTs directed against N. meningitidis serogroups A, C, W-135, and Y.
- Antibody response after one dose of MenACWY in subjects who had previously received one dose of Menactra or MenACWY vaccine. [ Time Frame: 1 month ] [ Designated as safety issue: No ]
- Persistence of the antibody response after one dose of MenACWY in subjects who had previously received one dose of Menactra or MenACWY vaccine. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Number of new medical diagnoses of chronic diseases in subjects who previously received Novartis MenACWY Conjugate Vaccine or Menactra® in study V59P13. [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
- Safety and tolerability of one dose of MenACWY in all study subjects (Group IV and V only). [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]
- Safety of one dose of meningococcal conjugate vaccine [ Time Frame: 28 days following administration to Group I, II and III subjects enrolled at the time of Visit 6 (Visit1 for subjects in Group III) ] [ Designated as safety issue: Yes ]Data will be summarized per treatment group
| Enrollment: | 866 |
| Study Start Date: | February 2009 |
| Study Completion Date: | November 2012 |
| Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: 1
Subjects who previously received the Novartis MenACWY vaccine.
|
Other: Blood draw
Blood draw at 21 months, 3, and 5 years after study vaccine in V59P13. Booster dose of Novartis MenACWY offered to eligible subjects in Group 1
|
|
No Intervention: 2
Subjects who previously received commercially available MenACWY.
|
Other: Blood draw
Blood draw at 21 months, 3 and 5 years after study vaccine in V59P13.Booster dose of Novartis MenACWY offered to eligible subjects in Group 2.
|
|
No Intervention: 3
Subjects, age-matched with Group I and Group II, who will be enrolled at each of the three study visits.
|
Other: Blood draw
One dose of commercially available meningococcal conjugate vaccine.
|
|
Experimental: 4
Subjects who previously received Novartis MenACWY vaccine.
|
Biological: Group IV
Blood draw at 3 years post injection in V59P13 trial, followed by Novartis MenACWY booster dose. Blood draw 1 month post boost and at 5 years post injection in V59P13 trial.
|
|
Experimental: 5
Subjects who previously received commercially available MenACWY vaccine.
|
Biological: Group V
Blood draw at 3 years post injection in V59P13 trial, followed by Novartis MenACWY booster dose. Blood draw 1 month post boost and at 5 years post injection in V59P13 trial.
|
Eligibility| Ages Eligible for Study: | 11 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
Subjects enrolled in V59P13:
- healthy, who have completed the V59P13 study and are in good health.
Naïve subjects:
- healthy children aged-matched with subjects enrolled in V59P13 trial.
- aged matched with subjects enrolled in V59P13 (currently 16-23 years old).
Exclusion Criteria:
Subjects enrolled in V59P13:
- who received any meningococcal vaccine after V59P13 trial;
- who have had a previous confirmed or suspected disease caused by N. meningitidis;
- who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
- subjects with any serious, acute or chronic progressive disease.
Naïve subjects:
- who previously received any meningococcal vaccine;
- who have had a previous confirmed or suspected disease caused by N. meningitidis;
- who have had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis (serogroups A, C, W135, or Y);
- subjects with any serious, acute or chronic progressive disease.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00856297
Locations
| United States, Alabama | |
| 37, 50 Birmingham Pediatric Associates 806 Saint Vincent's Drive, Suite 615 | |
| Birmingham, Alabama, United States, 35205 | |
| United States, California | |
| 6 Kaiser Permanente Fremont 39400 Paseo Padre Parkway | |
| Fremont, California, United States, 94538 | |
| 7 Kaiser Permanente Fresno 4785 North First Street, 3rd Floor | |
| Fresno, California, United States, 93726 | |
| 8 Kaiser Permanente Hayward 27303 Sleepy Hollow Ave., 1st Floor, MOB | |
| Hayward, California, United States, 94545 | |
| Admin Kaiser Permanente Vaccine Study Center One Kaiser Plaza, Ordway Building - 16th Floor | |
| Oakland, California, United States, 94612 | |
| 9 Kaiser Permanente Roseville 1840 Sierra Gardens Drive, Vaccine Studies | |
| Roseville, California, United States, 95661 | |
| 11 Kaiser Permanente Sacramento 6600 Bruceville Rd., Pediatric Station C | |
| Sacramento, California, United States, 95823 | |
| 10 Kaiser Permanente San Jose 276 International Circle, Family Health Center, Unit B1 | |
| San Jose, California, United States, 95119 | |
| United States, Georgia | |
| 2 PAMPA 2155 Post Oak Tritt Road, Suite 100 | |
| Marietta, Georgia, United States, 30062 | |
| 3 PAMPA 120 Stonebridge Parkway Ste. 410 | |
| Woodstock, Georgia, United States, 30189 | |
| United States, Kentucky | |
| 53 Pediatric/Adult Research Inc. 201 South Fifth Street, Suite 102 | |
| Bardstown, Kentucky, United States, 40004 | |
| United States, Ohio | |
| 38 Akron Children's Hospital One Perkins Square | |
| Akron, Ohio, United States, 44308 | |
| 43 Dr. Senders and Associates 2054 South Green Road | |
| South Euclid, Ohio, United States, 44121 | |
| United States, Pennsylvania | |
| 19 Children's Health Care West 4671 West Lake Road | |
| Erie, Pennsylvania, United States, 16505 | |
| 21 Greenville Medical Centre Inc 90 Shenango Street | |
| Greenville, Pennsylvania, United States, 16125 | |
| 24 (seen at site 21) Family Healthcare Partners 420 Hillcrest Avenue | |
| Grove City, Pennsylvania, United States, 16127 | |
| 23 Pediatric Associates of Latrobe 210 Weldon Street | |
| Latrobe, Pennsylvania, United States, 15650 | |
| 12 & 18 Primary Physicians Research, Inc. 1580 McLaughlin Run Road | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| 16 Pediatric Alliance Greentree Division 969 Greentree Road Suite 100 | |
| Pittsburgh, Pennsylvania, United States, 15220 | |
| 15 South Hills Pediatrics 4411 Stilley Road | |
| Pittsburgh, Pennsylvania, United States, 15227 | |
| 20 Pediatric Alliance Arcadia Division 9000 Perry Highway Suite 120 | |
| Pittsburgh, Pennsylvania, United States, 15237 | |
| 14 Squirrel Hill Office 4070 Beechwood Blvd | |
| Pittsburgh, Pennsylvania, United States, 15217 | |
| Admin Primary Physicians Research, Inc. 1580 McLaughlin Run Road | |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| 13 Pediatric Alliance Southwestern 850 Clairton Blvd. | |
| Pittsburgh, Pennsylvania, United States, 15236 | |
| 35 Pennridge Pediatric Associates 711 Lawn Avenue | |
| Sellersville, Pennsylvania, United States, 18960 | |
| 22 Laurel Pediatrics 140 Wayland Smith Drive | |
| Uniontown, Pennsylvania, United States, 15401 | |
| 25 Family Practice Medical Associates South 2581 Washington Road Suite 211 | |
| Upper St. Clair, Pennsylvania, United States, 15241 | |
| United States, Texas | |
| 47 UTMB Galveston Office of Pediatric Clinical Trials Children's Hospital 301 University Blvd., Rm 1 288H | |
| Galveston, Texas, United States, 77555 | |
| United States, Utah | |
| 56 J. Lewis Research, Inc/Foothill Family Clinic South 6360 South 3000 East, Suite 100 | |
| Salt Lake City, Utah, United States, 84121 | |
| United States, Washington | |
| 45 Group Health Research Institute 1730 Minor Ave, Suite 1600 | |
| Seattle, Washington, United States, 98101 | |
Sponsors and Collaborators
Novartis Vaccines
More Information
Publications:
| Responsible Party: | Novartis ( Novartis Vaccines ) |
| ClinicalTrials.gov Identifier: | NCT00856297 History of Changes |
| Other Study ID Numbers: | V59P13E1 |
| Study First Received: | March 2, 2009 |
| Last Updated: | December 17, 2012 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Meningococcal ACWY Conjugate Vaccine |
Meningitis Adolescents Persistence |
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 16, 2013