Ignite Creation Date:
2025-12-25 @ 12:53 AM
Ignite Modification Date:
2025-12-26 @ 1:21 PM
Study NCT ID:
NCT01412567
Status:
COMPLETED
Last Update Posted:
2011-08-09
First Post:
2011-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Vaccine+HBIG Versus Vaccine+Placebo for Newborns of HBsAg+ Mothers
Sponsor:
Govind Ballabh Pant Hospital
Organization:
Study Overview
Official Title:
Comparison of Recombinant Hepatitis B Vaccine Plus Hepatitis B Immune Globulin (HBIG) Versus Vaccine Plus Placebo for Prophylaxis of Hepatitis B Infection in Newborns of Hepatitis B Surface Antigen (HBsAg) Positive Mothers
Status:
COMPLETED
Status Verified Date:
2011-08
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:
Prevention of perinatal transmission is essential to decrease the global burden of chronic HBV. Recombinant HBV vaccine and hepatitis B immunoglobulin (HBIG) given after delivery to the newborns of HBsAg positive mothers is the standard of care for prevention of HBV in babies. Some studies have however, shown that vaccine alone may be equally effective. Hence, immunoprophylaxis with hepatitis B vaccine with or without HBIG is effective in prevention of transmission of overt HBV infection to the babies. The primary outcome measure of most of the trials on immunoprophylaxis was the occurrence of hepatitis B, defined as a blood specimen positive for hepatitis B surface antigen (HBsAg). However, whether this immunoprophylaxis also prevents HBsAg negative HBV infection (occult HBV infection) in babies is not known. In the present study the investigators evaluated the efficacy of the two regimens; vaccination alone and compared it with vaccination plus HBIG administration at birth in preventing transmission of both overt and occult HBV infection to the newborn babies.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: