Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00169858
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2005-09-13
Brief Title:
Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections
Sponsor:
Laval University
Organization:
Laval University
Study Overview
Official Title:
Open Randomised Clinical Study of the Long Term Immunogenicity of Engerix-B in 10 Year Old Children and of the Effect of Booster Injections Given 5 10 or 15 Years After Primary Vaccination
Status:
COMPLETED
Status Verified Date:
2013-05
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:
Hepatitis B immunization has been offered to all grade 4 students age 9-10 in the province of Quebec using Engerix-B at a dose of 10 mkg The peak incidence of hepatitis B occurs between age 15 and 35 the proportion of vaccinated children who will still be protected at this age is currently unknown This study is designed to determine
persistence of immunity until age 25
persistence of immunological memory as demonstrated by an anamnestic response following a booster dose
the effect of a booster dose on immunogenicity at either 5 10 or 15 years after the primary vaccination course at age 15 20 or 25
persistence of immunity until age 25
persistence of immunological memory as demonstrated by an anamnestic response following a booster dose
the effect of a booster dose on immunogenicity at either 5 10 or 15 years after the primary vaccination course at age 15 20 or 25
Detailed Description:
Three doses of Engerix-B vaccine 10 mkg were administered according to 0 1 6 month schedule to 1126 9-10 year-old children
The primary objective of the study is to evaluate the persistence of antibodies to Engerix-B in all subjects at age 25 and to compare the levels obtained in those given a booster injection at age 15 or 20 with those receiving no booster injection
Secondary objectives
To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert
To determine the antibody levels of one third of subjects at age 15 5 years after primary vaccination Group A
To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects Group A
To determine the antibody levels of subjects in groups A and B at age 20 5 years after booster Group A 10 years after primary vaccination Group B
To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects Group B
To determine the effect on antibody levels of a booster injection at age 25 years given to one third of the subjects Group C
To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster
To evaluate safety
The primary objective of the study is to evaluate the persistence of antibodies to Engerix-B in all subjects at age 25 and to compare the levels obtained in those given a booster injection at age 15 or 20 with those receiving no booster injection
Secondary objectives
To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert
To determine the antibody levels of one third of subjects at age 15 5 years after primary vaccination Group A
To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects Group A
To determine the antibody levels of subjects in groups A and B at age 20 5 years after booster Group A 10 years after primary vaccination Group B
To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects Group B
To determine the effect on antibody levels of a booster injection at age 25 years given to one third of the subjects Group C
To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster
To evaluate safety
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 |
|---|---|---|---|
| 103860257 ext 278 | None | None | None |