Ignite Creation Date:
2025-12-25 @ 12:11 AM
Ignite Modification Date:
2025-12-25 @ 10:11 PM
Study NCT ID:
NCT00169858
Status:
COMPLETED
Last Update Posted:
2013-05-29
First Post:
2005-09-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
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:
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:
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| 103860/257 ext. 278 | None | None | View |