Viewing Study NCT00393523



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Last Modification Date: 2024-10-26 @ 9:28 AM
Study NCT ID: NCT00393523
Status: COMPLETED
Last Update Posted: 2017-04-12
First Post: 2006-10-25

Brief Title: Hepatitis B Vaccine Booster Study V232-058COMPLETED
Sponsor: Merck Sharp Dohme LLC
Organization: Merck Sharp Dohme LLC

Study Overview

Official Title: A Study to Assess the Anamnestic Immune Response 4 to 8 Years After a Primary Vaccination Series With HBVAXPRO
Status: COMPLETED
Status Verified Date: 2017-03
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: To assess the safety and immunogenicity of a booster dose of hepatitis B vaccine in children who have received a 3-dose primary series of either RECOMBIVAX HB or ENGERIX-B The primary vaccination series was given 4 to 8 years prior to study entry and consisted of a licensed hepatitis B vaccine product either RECOMBIVAX HB or ENGERIX-B The booster dose given in this study will be either an investigational Merck product Modified Process Hepatitis B Vaccine or licensed ENGERIX-B vaccine
Detailed Description: None

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
2006_040 None None None