Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196976
Status:
COMPLETED
Last Update Posted:
2018-06-08
First Post:
2005-09-13
Brief Title:
Safety Immunogenicity of 1 Dose of GSK134612 in Children 12-14 Months and 3-5 Years Old
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Evaluate the Immunogenicity Reactogenicity Safety of 4 Different Formulations of GSK Biologicals Conjugate Vaccine MenACWY vs 1 Dose of MenC-CRM197 or Mencevax ACWY in Children Aged 12-14 Months 3-5 Years
Status:
COMPLETED
Status Verified Date:
2017-04
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:
The purpose of this study is to evaluate the immunogenicity safety and reactogenicity of one dose of four different formulations of the MenACWY conjugate vaccine when given to healthy children aged 12-14 months and 3-5 years The selection of the best formulation will be based on data obtained up to one month after the vaccine dose
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
The study will enrol subjects of 12 to 14 months of age and subjects of 3 to 5 years of age 3 formulations of GSKs MenACWY conjugate vaccine will be administered in a double-blind manner while the 4th one will be single-blinded Administration of the candidate vaccine or the active controls MenC-CRM197 or Mencevax ACWY will be done in an open manner The study will be conducted in two stages The primary vaccination phase Study Stage 1 of the study will include all subjects the second boosterpersistence phase of the study Study Stage 2 will include subjects in the active control groups and in the group which was primed with the selected MenACWY formulation
The study will be conducted in a double-blind manner for groups receiving formulations A B C and in single blind manner with respect to the group receiving formulation D The control vaccines will be administered in an open manner with respect to the investigational vaccination regimens
Each group will have one blood sample prior to and one blood sample one month after the first vaccine dose
The study will be conducted in a double-blind manner for groups receiving formulations A B C and in single blind manner with respect to the group receiving formulation D The control vaccines will be administered in an open manner with respect to the investigational vaccination regimens
Each group will have one blood sample prior to and one blood sample one month after the first vaccine dose
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 103534 | OTHER | GSK | None |