Phase 3
N=389
Evaluation of Persistence of Anti-meningococcal Bactericidal Antibodies Among Adolescents Who Previously Received MenACWY Conjugate Vaccine
Meningococcal Meningitis
Bottom Line
View on ClinicalTrials.gov: NCT00856297 ↗Enrolled (actual)
389
Serious AEs
0.2%
Results posted
Jan 2014
Primary outcome: Primary: Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine — 44; 27; 37; 18 percentages of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MenACWY-CRM conjugate vaccine (Biological); Licensed comparator (Biological)
- Age
- Pediatric, Adult · 11+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With Human Complement Serum Bactericidal Activity (hSBA) Titers≥ 1:8, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine |
44; 27; 37; 18; 34; 37 | — |
| SECONDARY Percentages of Subjects With hSBA Titers≥ 1:4, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine |
44; 32; 38; 22; 37; 37 | — |
| SECONDARY hSBA Geometric Mean Titers (GMTs), After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine |
6.46; 4.12; 5.51; 3.69; 4.36; 4.92 | — |
| SECONDARY Percentages of Subjects With No Previous Meningococcal Vaccination With hSBA Titers≥ 1:4 and ≥ 1:8 |
11; 8; 51; 38; 66; 66 | — |
| SECONDARY hSBA Geometric Mean Titers (GMT) in Subjects With No Previous Meningococcal Vaccination |
2.34; 4.33; 18; 5.4 | — |
| SECONDARY Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 After a Booster Dose of MenACWY-CRM Conjugate Vaccine |
100; 100; 100; 100; 100; 100 | — |
| SECONDARY Percentages of Subjects With hSBA Titers≥ 1:4 and ≥ 1:8 in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine |
77; 87; 77; 77; 95; 97 | — |
| SECONDARY Persistence of hSBA Geometric Mean Titers (GMTs) in Subjects After One Dose of MenACWY-CRM Conjugate Vaccine |
21; 19; 133; 61; 95; 114 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events |
40; 40; 37; 37; 6; 7 | — |
| SECONDARY Number of Subjects With New Medical Diagnoses of Chronic Diseases, After One Dose of Either MenACWY-CRM Conjugate Vaccine or Licensed Comparator |
1; 0; 0; 0; 0; 0 | — |
| SECONDARY Number of Subjects Who Reported Medically Attended Adverse Events, After One Dose of Either MenACWY-CRM Conjugate or Licensed Comparator Vaccine |
0; 1; 0; 1; 0; 0 | — |
Summary
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 commercially 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.
Eligibility Criteria
Inclusion Criteria
Subjects enrolled in V59P13:
- healthy subjects who have completed the V59P13 study.
Naïve subjects:
- healthy subjects aged-matched with subjects who had completed the V59P13 trial.(currently 16-23 years old).
Exclusion Criteria
Subjects who had completed the V59P13 study:
- who received any meningococcal vaccine after the V59P13 trial;
- who have had 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 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.
Data sourced from ClinicalTrials.gov (NCT00856297). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.