Phase 3
N=715
Immunogenicity, Safety and 1 Year Persistence of Antibodies After Either One or Two Doses of Meningococcal ACWY Conjugate Vaccine in Healthy Children 2 Through 10 Years of Age.
Meningococcal Disease · Infections, Meningococcal
Bottom Line
View on ClinicalTrials.gov: NCT01682876 ↗Enrolled (actual)
715
Serious AEs
0.7%
Results posted
Oct 2014
Primary outcome: Primary: Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination — 94; 75; 89; 77 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- MenACWY-CRM (Biological)
- Age
- Pediatric · 2+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Jul 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Non-inferiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination |
94; 75; 89; 77; 92; 65 | — |
| PRIMARY Superiority of Two Vaccinations Versus One Vaccination of MenACWY-CRM, by Age Cohort, as Measured by the Percentage of Subjects With hSBA Seroresponse Against N. Meningitidis Serogroups A, C, W and Y, at 1 Month After Last Vaccination |
95; 77; 89; 79; 93; 65 | — |
| SECONDARY Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM |
95; 76; 91; 80; 98; 76 | — |
| SECONDARY Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Month After One or Two Vaccination(s) of MenACWY-CRM |
68; 21; 67; 36; 146; 22 | — |
| SECONDARY Percentage of Subjects With hSBA Titer ≥1:8, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM |
30; 11; 30; 20; 61; 41 | — |
| SECONDARY Geometric Mean Titers of Subjects, Directed Against N. Meningitidis Serogroups A, C, W and Y At One Year After One or Two Vaccination(s) of MenACWY-CRM |
4.72; 2.66; 4.66; 3.56; 10; 7.03 | — |
| SECONDARY Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination |
25; 11; 19; 7; 84; 79 | — |
| SECONDARY Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination |
23; 15; 24; 15; 106; 78 | — |
| SECONDARY Number of Subjects Who Reported Selected AEs After Any Vaccination |
103; 101; 95; 97; 1; 4 | — |
| SECONDARY Number of Subjects Who Reported Selected AEs After Any Vaccination |
103; 101; 95; 97; 1; 4 | — |
Summary
This study was designed to conduct a comparative trial to further evaluate the safety, immunogenicity and antibody persistence of two doses of Novartis MenACWY conjugate vaccine, given 2 months apart, versus one dose of Novartis MenACWY conjugate vaccine in children 2 through 10 years of age.
Eligibility Criteria
Inclusion Criteria
- Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations
Exclusion Criteria
- Unwilling or unable to give written informed assent or consent to participate in the study.
- Perceived to be unreliable or unavailable for the duration of the study period.
- Previous confirmed or suspected disease caused by N. meningitidis.
- Previously immunized with a meningococcal vaccine (licensed or investigational).
- Receipt of any investigational or non-registered product within 30 days prior to enrolment or who expect to receive an investigational drug or vaccine prior to the completion of the study.
- Receipt or plan to receive any vaccines within 30 days before and after administration of each dose of the study vaccine.
(certain exceptions influenza vaccines apply)
- Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment.
- Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome.
- History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components
- Impairment/alteration of immune function, either congenital or acquired or resulting from (for example):
- receipt of immunosuppressive therapy,
- receipt of immunostimulants,
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives.
- Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Data sourced from ClinicalTrials.gov (NCT01682876). 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.