Phase 3
N=205
Persistence Of Antibody Responses Among Children Who Previously Received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine
Meningococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01345721 ↗Enrolled (actual)
205
Serious AEs
0.0%
Results posted
Oct 2013
Primary outcome: Primary: Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine — 13; 7; 0; 27 Percentages of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MenACWY-CRM (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Sep 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Persisting Serum Bactericidal Antibody Titers ≥1:8, Upto 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine |
13; 7; 0; 27; 25; 36 | — |
| PRIMARY Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:8, One Month After MenACWY-CRM Booster Vaccination |
13; 7; 96; 98; 27; 25 | — |
| PRIMARY Geometric Mean Titers in Children,One Month After MenACWY-CRM Booster Vaccination |
2.82; 2.52; 182; 214; 3.92; 3.91 | — |
| PRIMARY Percentage of Subjects (Who Had Previously Received MenC Vaccine) With Serum Bactericidal Antibody Titers ≥ 1:8, After One Dose of MenACWY-CRM Vaccination |
0; 61; 36; 100; 12; 95 | — |
| PRIMARY Geometric Mean Titers in Children (Who Previously Received MenC Vaccine) One Month After One Dose of MenACWY-CRM Vaccine |
2; 20; 4.83; 1530; 2.82; 54 | — |
| SECONDARY Persisting Geometric Mean Titers in Children, 13-33 Months After Primary Vaccination With Either MenACWY-CRM or MenC Vaccine |
2.82; 2.52; 2; 3.94; 3.93; 4.94 | — |
| SECONDARY Percentage of Subjects With Serum Bactericidal Titers ≥1:8, Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine |
98; 61; 100; 100; 100; 95 | — |
| SECONDARY Geometric Mean Titers Following One Dose of MenACWY-CRM Vaccine in Children Who Previously Received 1 Primary Dose of Either MenACWY-CRM or Men C Vaccine |
214; 20; 968; 1530; 1267; 54 | — |
| SECONDARY Number of Children Reporting Solicited Local and Systemic Adverse Events (AEs) After MenACWY-CRM Vaccination |
33; 30; 30; 10; 15; 13 | — |
| SECONDARY Number of Children Reporting Unsolicited Adverse Events After MenACWY-CRM Vaccination |
11; 10; 9; 0; 2; 1 | — |
Summary
The primary purpose of this study is to evaluate the persistence of bactericidal antibodies in children of approximately 22 to 45 months of age previously enrolled in the V59P22 study (NCT00667602) who received Novartis MenACWY Conjugate Vaccine or Meningococcal C Conjugate Vaccine. This is measured by percentage of subjects with human Serum Bactericidal Assay (hSBA) titers ≥ 1:8 directed against Neisseria meningitidis serogroups A, C, W-135, and Y. In addition the response one month post an additional dose of Novartis MenACWY will be measured by percentage of subjects with hSBA titers ≥ 1:8 and GMTs.
Eligibility Criteria
Inclusion Criteria
Children eligible to be enrolled in the study were those
- whose parents provide written informed consent;
- were in generally good health based on the clinical judgment of the investigators;
- subjects were 22-45 months of age at the time of enrollment into V59P22E1;
- subject who had participated in the parent V59P22 study.
Exclusion Criteria
Main exclusion criteria:
- Subjects with serious, acute, or chronic illnesses
- Subjects who had received any other licensed vaccines within 28 days (Exception: Influenza vaccine was allowed up to 14 days prior to and no less than 14 days after the study immunization) prior to enrolment and any study visit
- Subjects who had received any Meningococcal vaccine since the study dose of MenACWY or Men C at 12 months of age in V59P22 trial.
Data sourced from ClinicalTrials.gov (NCT01345721). 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.