Phase 3
Completed N=433
Evaluation of Meningococcal Immune Response Among Children Who Previously Received MenACWY Conjugate Vaccine
Source: ClinicalTrials.gov NCT01148017 ↗Enrolled (actual)
433
Serious AEs
0.0%
Results posted
May 2014
Primary outcomePrimary: Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y — 10; 35; 2; 34 Percentages of subjects
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Subjects With Human Serum Bactericidal Assay (hSBA) Titers ≥ 1:8 Directed Against N. Meningitidis Serogroups A, C, W-135, and Y |
6; 25; 2; 27; 43; 22 | — |
| 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 |
13; 40; 2; 43; 61; 16 | — |
| 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 |
9; 33; 2; 46; 60; 33 | — |
| SECONDARY hSBA Geometric Mean Titers (GMTs) Directed Against N. Meningitidis Serogroups A, C, W-135, and Y in Subjects of 40 Months of Age |
2.54; 4.81; 2.02; 6.14; 9.24; 2.52 | — |
| SECONDARY hSBA GMTs Directed Against N Meningitidis Serogroups A, C, W-135, and Y in Subjects of 60 Months of Age |
2.27; 3.74; 2.14; 5.17; 9.26; 3.87 | — |
| 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 |
97; 97; 87; 96; 99; 84 | — |
| SECONDARY Percentage of Subjects With Seroresponse at 1 Month Post-vaccination |
97; 96; 87; 87; 87; 73 | — |
| SECONDARY Number of Subjects Reporting Solicited Local and Systemic Adverse Events (AEs) and Other Indicators of Reactogenicity |
67; 44; 29; 54; 33; 24 | — |
| SECONDARY Number of Subjects Reporting Unsolicited AEs and SAEs |
7; 8; NA; 12; 0; 0 | — |
Eligibility 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 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).
Data sourced from ClinicalTrials.gov (NCT01148017). 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. Informational only — not medical advice.