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| ID | Type | Description | Link |
|---|---|---|---|
| 103860/257 ext. 278 |
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| Name | Class |
|---|---|
| Institut National en Santé Publique du Québec | OTHER |
| Centre de Recheche du Centre Hospitalier Université Laval | OTHER |
| SmithKlinBeecham Biologicals | UNKNOWN |
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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:
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
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Engerix-B | Biological | 10 mkg per dose; 3 doses according to 0, 1, 6 month schedule; booster doses 5, 10 or 15 years post-primary vaccination. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Long term persistence of anti-HBs and the effect of a booster dose given 5, 10 or 15 years post-primary vaccination. | 1995 - 2011 |
| Measure | Description | Time Frame |
|---|---|---|
| - To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert | Anti-HBs titers were measured 1 months post-primary vaccination | 1 month post primary vaccination |
| - To determine the antibody levels of one third of subjects at age 15, 5 years after primary vaccination (Group A) |
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Inclusion Criteria:
Exclusion Criteria:
- Not applicable
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| Name | Affiliation | Role |
|---|---|---|
| Bernard Duval, MD | Laval University Hospital Center, Public Health Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vladimir Gilca | Québec | Quebec | G1E 7G9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15750456 | Result | Duval B, Gilca V, Boulianne N, De Wals P, Masse R, Trudeau G, De Serres G. Comparative long term immunogenicity of two recombinant hepatitis B vaccines and the effect of a booster dose given after five years in a low endemicity country. Pediatr Infect Dis J. 2005 Mar;24(3):213-8. doi: 10.1097/01.inf.0000154329.00361.39. | |
| 10618544 |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| C075654 | Engerix-B |
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Anti-HBs titers were measured 5 years post primary vaccination. |
| 2001 |
| - To determine the effect on antibody levels of a booster injection at age 15 years given to one third of the subjects (Group A) | The effect of a booster dose was measured | 2001 |
| - 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) | Anti-HBs titers were measured 10 years post primary vaccination (Group B) and 5 years post booster dose (Group A) | 2006 |
| - To determine the effect on antibody levels of a booster injection at age 20 years given to one third of the subjects (Group B) | Anti-HBs titers were measured 1 month post booster dose given 10 years post-primary vaccination | 2006 |
| - To determine the persistence of antibody 15 years after primary vaccination (Group C) | Anti-HBs titers will be measured | 2011 |
| - To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster | anti-HBs titers will be measured 10 years post booster dose (Group A) and 5 years post booster dose (Group B) | 2011 |
| - To evaluate the effect of a booster dose given 15 years post primary vaccination (Group C) | Anti-HBs titers will be measured one month post booster dose (Group C) | 2011 |
| Duval B, Boulianne N, De Serres G, Laflamme N, De Wals P, Masse R, Trudeau G, Delage G, Desjardins L. Comparative immunogenicity under field conditions of two recombinant hepatitis B vaccines in 8-10-year-old children. Vaccine. 2000 Feb 14;18(15):1467-72. doi: 10.1016/s0264-410x(99)00422-3. |
| 19683086 | Result | Gilca V, De Serres G, Boulianne N, De Wals P, Murphy D, Trudeau G, Masse R, Duval B. Antibody kinetics among 8-10 years old respondents to hepatitis B vaccination in a low endemic country and the effect of a booster dose given 5 or 10 years later. Vaccine. 2009 Oct 9;27(43):6048-53. doi: 10.1016/j.vaccine.2009.07.100. Epub 2009 Aug 13. |
| 23206974 | Result | Gilca V, De Serres G, Boulianne N, Murphy D, De Wals P, Ouakki M, Trudeau G, Masse R, Dionne M. Antibody persistence and the effect of a booster dose given 5, 10 or 15 years after vaccinating preadolescents with a recombinant hepatitis B vaccine. Vaccine. 2013 Jan 7;31(3):448-51. doi: 10.1016/j.vaccine.2012.11.037. Epub 2012 Dec 1. |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |