Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00282295
Status:
COMPLETED
Last Update Posted:
2018-08-17
First Post:
2006-01-25
Brief Title:
US-licensed Combined Vaccine Against Tetanus Diphtheria Given With US-licensed Vaccine Against Meningococcal Disease
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Safety Immunogenicity of a Booster Dose of dTPa Vaccine Boostrix Co-admnd With Aventis Pasteurs Meningococcal Serogroups A C Y and W-135 Polysaccharide Vaccine Menactra vs Admn of Either Vaccine Alone in Healthy Adolescents
Status:
COMPLETED
Status Verified Date:
2018-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
New immunization recommendations in the US include vaccination of adolescents against pertussis and meningococcal disease The Advisory Committee on Immunization Practices of the Centers for Disease Control and Prevention recommends that Tdap Tetanus Toxoid Reduced Diphtheria Toxoid And Acellular Pertussis Vaccine Adsorbed and MCV4 Meningococcal conjugate vaccine against serotypes A C Y and W-135 vaccines be administered to adolescents at the same office visit if vaccination with both vaccines is indicated Therefore this study is designed to evaluate the safety and immunogenicity of a booster vaccination with Boostrix co-administered with Menactra as compared to the administration of either vaccine alone in healthy adolescents 11 - 18 years of age
Detailed Description:
A phase IV randomized partially blinded multicenter study to evaluate the safety and immunogenicity of a booster vaccination with GlaxoSmithKlines tetanus toxoid reduced diphtheria toxoid and acellular pertussis vaccine adsorbed Tdap Boostrix co-administered intramuscularly with Aventis-Pasteurs meningococcal serogroups A C Y and W-135 polysaccharide diphtheria toxoid conjugate vaccine Menactra as compared to the administration of either vaccine alone in healthy adolescents 11-18 years of age Experimental design Prospective randomized controlled multicenter study with three groups
Group 1 Boostrix Menactra on Day 0 blood samples at Month 0 and Month 1 Group 2 Boostrix on Day 0 Menactra at Month 1 blood samples at Month 0 Month 1 and Month 2 Group 3 Menactra on Day 0 Boostrix at Month 1 blood samples at Month 0 Month 1 and Month 2 Treatment allocation randomized 111 Type of study self-contained Duration of the study Approximately one month for each subject in Group 1 and approximately two months for each subject in the Group 2 and Group 3
Group 1 Boostrix Menactra on Day 0 blood samples at Month 0 and Month 1 Group 2 Boostrix on Day 0 Menactra at Month 1 blood samples at Month 0 Month 1 and Month 2 Group 3 Menactra on Day 0 Boostrix at Month 1 blood samples at Month 0 Month 1 and Month 2 Treatment allocation randomized 111 Type of study self-contained Duration of the study Approximately one month for each subject in Group 1 and approximately two months for each subject in the Group 2 and Group 3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None