Phase 3
N=341
Immunogenicity and Safety of Meningococcal ACWY Conjugate Vaccine in Healthy Subjects From 2 to 18 Years in Taiwan
Bacterial Meningitis
Bottom Line
View on ClinicalTrials.gov: NCT01410474 ↗Enrolled (actual)
341
Serious AEs
0.3%
Results posted
Sep 2014
Primary outcome: Primary: Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination — 83; 93; 50; 65 Percentages of Subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Meningococcal ACWY conjugate vaccine (Biological)
- Age
- Pediatric, Adult · 2+ yrs
- Sex
- All
- Sponsor
- Novartis
- Primary completion
- Jan 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Overall Subjects With Seroresponse, Directed Against Neisseria Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination |
83; 93; 50; 65 | — |
| SECONDARY Percentage of Subjects With Seroresponse, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination, by Age Group |
77; 89; 92; 95; 54; 46 | — |
| SECONDARY Geometric Mean Titers (GMTs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination |
2.05; 2.2; 2.12; 32; 88; 53 | — |
| SECONDARY Geometric Mean Ratios (GMRs) of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination |
16; 40; 25; 44; 75; 57 | — |
| SECONDARY Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y After MenACWY-CRM Vaccination |
1; 4; 3; 77; 90; 83 | — |
| SECONDARY Number of Subjects Who Reported Solicited Local and Systemic Adverse Events After MenACWY-CRM Vaccination, Age 2 to 5 Years |
27; 7; 6; 2; 3; 5 | — |
| SECONDARY Number of Subjects Who Reported Solicited Local and Systemic AEs After MenACWY-CRM Vaccination, Age 6 to 18 Years |
37; 62; 99; 17; 17; 34 | — |
Summary
This study will evaluate the immunogenicity and safety of a single injection of Novartis Meningococcal ACWY conjugate vaccine in healthy subjects from 2 to 18 years in Taiwan.
Eligibility Criteria
Inclusion Criteria
- Healthy subjects from 2 up to and including 18 years of age
- Who are in good health as determined by : medical history, physical exam,clinical judgment of the investigator, who have a negative urine pregnancy test for female subjects ≥11 years of age
Exclusion Criteria
Individuals not eligible to be enrolled in the study were those:
- Who had a previous confirmed or suspected disease caused by N. meningitidis.
- Who had household contact with and/or intimate exposure to an individual with culture-proven N. meningitidis infection within 60 days prior to enrolment.
- Who have previously been immunized with a meningococcal vaccine or vaccine containing meningococcal antigen(s) (licensed or investigational).
- Who have received any vaccines within 14 days (for inactivated vaccines) or 28 days (for live vaccines) prior to enrolment in this study or who are planning to receive any vaccine within 30 days from the study vaccines.
- Who have experienced within the 7 days prior to enrolment significant acute infection or have experienced fever within 3 days prior to enrolment.
- Who have any serious acute, chronic or progressive who have epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
- Who have a history of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components.
- Who have a known or suspected impairment/alteration of immune function, either congenital or acquired
- Who are known to have a bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
- Who have Down's syndrome or other known cytogenic disorders.
Data sourced from ClinicalTrials.gov (NCT01410474). 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.