Ignite Creation Date:
2024-05-05 @ 4:55 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00345683
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2006-06-26
Brief Title:
Safety of Hib-MenCY-TT Vaccine Versus Licensed Hib Conjugate Vaccine Given at 12 to 15 Months of Age
Sponsor:
GlaxoSmithKline
Organization:
GlaxoSmithKline
Study Overview
Official Title:
Single-blind Randomized Controlled Multinational Study for the Evaluation of Safety of GSK Biologicals Hib-MenCY-TT Vaccine Compared to Monovalent Hib Control Vaccine in Healthy Infants at 2 4 6 and 12 to 15 Months of Age
Status:
COMPLETED
Status Verified Date:
2016-10
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 booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age
This protocol posting deals with objectives outcome measures of the booster phase The objectives outcome measures of the primary phase are presented in a separate protocol posting NCT number NCT00345579
No new recruitment will take place during this booster phase of the study The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
This protocol posting deals with objectives outcome measures of the booster phase The objectives outcome measures of the primary phase are presented in a separate protocol posting NCT number NCT00345579
No new recruitment will take place during this booster phase of the study The Protocol Posting has been updated in order to comply with the FDA Amendment Act Sep 2007
Detailed Description:
Hib-MenCY-TT GSK Biologicals Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine
The study will be conducted in a single blind manner up to 30 days after administration of the booster dose the extended safety follow-up after the booster dose will be conducted in an unblinded manner
All subjects will receive Prevnar M-M-R II and Varivax as study vaccines preferencially co-administered with the booster dose of Hib-MenCY-TTPedvaxHIB
Note This protocol posting deals with the objectives outcome measures for the booster phase of the study The objectives outcome measures for the primary phase are presented in a separate protocol posting NCT00345579
The study will be conducted in a single blind manner up to 30 days after administration of the booster dose the extended safety follow-up after the booster dose will be conducted in an unblinded manner
All subjects will receive Prevnar M-M-R II and Varivax as study vaccines preferencially co-administered with the booster dose of Hib-MenCY-TTPedvaxHIB
Note This protocol posting deals with the objectives outcome measures for the booster phase of the study The objectives outcome measures for the primary phase are presented in a separate protocol posting NCT00345579
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