Last updated: 06/14/2019 12:11:26
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.
GSK study ID
205238
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Phase 3b, Randomized, Observer-Blind, Placebo-Controlled Multi-Center Study Comparing Immunogenicity, Safety and 1 Year Persistence of Antibodies after either One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine, administered to Healthy Children 2 to 10 years of age.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
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
Timeframe: One Month After Last Vaccination ( day 86)
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
Timeframe: One Month After Last Vaccination (day 86)
Secondary outcomes:
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
Timeframe: One Month After Last Vaccination (day 86)
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
Timeframe: One Month After Last Vaccination (day 86)
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
Timeframe: One year after one vaccination or two vaccinations (day 422).
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
Timeframe: One year after one vaccination or two vaccinations (day 422).
Number of 2 to 5 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Timeframe: From Days 1-7 after each vaccination
Numbers of 6 to 10 Years-Old Subjects Who Reported Solicited Local and Systemic Adverse Events After Any Vaccination
Timeframe: From Days 1-7 after each vaccination
Number of Subjects who Reported Selected AEs After Any Vaccination
Timeframe: Day 1 to Day 86
Number of Subjects Who Reported Selected AEs After Any Vaccination
Timeframe: Day 1 to Day 422
Interventions:
Biological/vaccine: MenACWY-CRM
Enrollment:
715
Observational study model:
Not applicable
Primary completion date:
2013-02-07
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Meningococcal disease
Product
GSK3536820A
Collaborators
Not applicable
Study date(s)
October 2012 to May 2014
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
2 - 10 Years
Accepts healthy volunteers
Yes
- Healthy children, 2 to 10 years of age who have up to date routine childhood vaccination, according to U.S. ACIP recommendations
- 1. Unwilling or unable to give written informed assent or consent to participate in the study.
- 2. Perceived to be unreliable or unavailable for the duration of the study period.
Inclusion and exclusion 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:
- 1. Unwilling or unable to give written informed assent or consent to participate in the study. 2. Perceived to be unreliable or unavailable for the duration of the study period. 3. Previous confirmed or suspected disease caused by N. meningitidis. 4. Previously immunized with a meningococcal vaccine (licensed or investigational). 5. 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. 6. 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) 7. Significant acute infection within the 7 days prior to enrolment or body temperature of 38°C or greater within 3 days prior to enrolment. 8. Previous serious acute, chronic or progressive disease, epilepsy or any progressive neurological disease or history of Guillain-Barre syndrome. 9. History of any anaphylaxis, serious vaccine reactions, or allergy to any vaccine components 10. 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. 11. Known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time.
Trial location(s)
Location
GSK Investigational Site
Bellevue, Nebraska, United States, 68005
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35205
Status
Study Complete
Location
GSK Investigational Site
Council Bluffs, Iowa, United States, 51503
Status
Study Complete
Location
GSK Investigational Site
Fort Worth, Texas, United States, 76135
Status
Study Complete
Location
GSK Investigational Site
Fremont, Nebraska, United States, 68025
Status
Study Complete
Location
GSK Investigational Site
Johnson City, New York, United States, 13790
Status
Study Complete
Location
GSK Investigational Site
Lake Mary, Florida, United States, 32746
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40291
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30062
Status
Study Complete
Location
GSK Investigational Site
Metairie, Louisiana, United States, 70006
Status
Study Complete
Location
GSK Investigational Site
Sacramento, California, United States, 95822
Status
Study Complete
Location
GSK Investigational Site
Stevensville, Michigan, United States, 49127
Status
Study Complete
Location
GSK Investigational Site
West Jordan, Utah, United States, 84088
Status
Study Complete
Location
GSK Investigational Site
Woodstock, Georgia, United States, 30189
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2013-02-07
Actual study completion date
2014-30-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
Participate in clinical trial
Access to clinical trial data by researchers
Visit website