Phase 3
N=198
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Children, Adolescents and Adults in Russia
Meningococcal Disease
Bottom Line
View on ClinicalTrials.gov: NCT01725217 ↗Enrolled (actual)
198
Serious AEs
0.0%
Results posted
Mar 2014
Primary outcome: Primary: Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination — 85; 74; 60; 83 Percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MenACWY-CRM (Biological)
- Age
- Pediatric, Adult, Older Adult · 2+ yrs
- Sex
- All
- Sponsor
- Novartis Vaccines
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentages of Overall Subjects With Seroresponse After MenACWY-CRM Vaccination |
85; 74; 60; 83 | — |
| SECONDARY Percentages of Subjects With Seroresponse After MenACWY-CRM Vaccination, by Age Group |
89; 89; 77; 69; 82; 71 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Subjects at Baseline and After MenACWY-CRM Vaccination |
2.35; 2.17; 2.43; 2.61; 93; 67 | — |
| SECONDARY Percentages of Subjects With hSBA Titer ≥1:8 at Baseline and After MenACWY-CRM Vaccination |
6; 2; 5; 11; 89; 89 | — |
| SECONDARY Percentages of Subjects Aged 2 Through 5 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination |
41; 39; 26; 28; 19; 17 | — |
| SECONDARY Percentages of Subjects Aged ≥6 Years With Solicited Local and Systemic AEs After MenACWY-CRM Vaccination |
48; 42; 50; 50; 18; 18 | — |
| SECONDARY Percentages of Subjects Reporting Unsolicited Adverse Events (AEs) After MenACWY-CRM Vaccination |
17; 20; 12; 18; 10; 3 | — |
Summary
To evaluate the immune response and safety following a single dose of Novartis Meningococcal ACWY conjugate vaccine (MenACWY-CRM) in healthy children, adolescents and adults in Russia.
Eligibility Criteria
Inclusion Criteria
Individuals eligible for enrollment in this study were those:
- Who were of any gender, from the age of 2 years and above at the time of visit 1, and to whom the nature of the study had been described and:
- the parent/legal representative had provided written informed consent (≥2 to 1 mg/kg/day prednisone or equivalent during any of 30 days prior to enrollment, or cancer chemotherapy)
- receipt of immunostimulants
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 90 days prior to enrollment and for the full length of the study
- Who were known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Data sourced from ClinicalTrials.gov (NCT01725217). 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.