Hepatitis BPhase 4NCT00169858
Long Term Immunogenicity Study of Engerix-B Vaccine in 10 Year Old Children and the Effect of Booster Injections
A Phase 4 study testing Engerix-B in people with Hepatitis B and Vaccination, run by Laval University at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Vaccination
- What is being tested?
- Engerix-B
- Type of treatment
- Vaccines
- How many people
- 1,129 participants
- Where
- 1 siteCanada
- Study dates
- Sep 1995to May 2012
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Previously completed the 1995 to 1996 Hepatitis B vaccination program vaccinations (Primary study) to the best of his/her knowledge and already enrolled and followed in the long term study
- Must be HBc negative
- Required standard interval between last dose of primary immunization and booster vaccination
- Written informed consent obtained from the subject
- Free of obvious health problems as established by medical history and clinical examination before entering into the study
- Previously completed routine childhood vaccination to the best of his/her knowledge
- If the subject is female, and the potential of pregnancy exists, it must be asked prior to immunization by the study nurse. According to the protocol d'immunisation du Québec, Engerix-B is not contra-indicated during pregnancy. However, if a participant thinks she could be pregnant (sexually active and no oral contraception or intra uterine device), a pregnancy test will be carried out. In case of pregnancy, the booster vaccination will be performed after delivery.
Who cannot join
- Not applicable
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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
- Conditions
- Hepatitis B, Vaccination
- Being tested
- Engerix-B
- Keywords
- Hepatitis B, Vaccination, Engerix-B, Immunogenicity, Long-term immunity, Booster dose, Safety
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Engerix-BBiological
10 mkg per dose; 3 doses according to 0, 1, 6 month schedule; booster doses 5, 10 or 15 years post-primary vaccination.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1995 - 2011
Secondary outcomes (8)
- 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
Measured: 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)
Anti-HBs titers were measured 5 years post primary vaccination.
Measured: 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
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)
Measured: 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
Measured: 2006
- To determine the persistence of antibody 15 years after primary vaccination (Group C)
Anti-HBs titers will be measured
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)
Measured: 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)
Measured: 2011
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2005 (estimated)
- Study startSep 1995
- Primary completionOct 2011
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Collaborators
- Institut National en Santé Publique du Québec, Centre de Recheche du Centre Hospitalier Université Laval, SmithKlinBeecham Biologicals
- Responsible party
- Principal investigator, Vladimir Gilca, Laval University
- Investigators
- Bernard Duval, MD, Principal investigator, Laval University Hospital Center, Public Health Research Unit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00169858
- Sponsor's protocol ID
- HBV-257 ext. HBV-278
- Other IDs
- 103860/257 ext. 278
- Status last verified
- May 2013
- First submitted
- 13 Sep 2005
- Last updated
- 29 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 15750456Duval 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.
PubMed 10618544Gilca 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.
PubMed 19683086Gilca 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.
PubMed 23206974
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00169858
- Acronym / sponsor ID
- HBV-257 ext. HBV-278
- Conditions
- Hepatitis B, Vaccination
- Keywords
- Hepatitis B, Vaccination, Engerix-B, Immunogenicity, Long-term immunity, Booster dose, Safety
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,129 participants (actual)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Collaborators
- Institut National en Santé Publique du Québec, Centre de Recheche du Centre Hospitalier Université Laval, SmithKlinBeecham Biologicals
- Study start
- Sep 1995
- Primary completion
- Oct 2011 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 15 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 8 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Previously completed the 1995 to 1996 Hepatitis B vaccination program vaccinations (Primary study) to the best of his/her knowledge and already enrolled and followed in the long term study
- Must be HBc negative
- Required standard interval between last dose of primary immunization and booster vaccination
- Written informed consent obtained from the subject
- Free of obvious health problems as established by medical history and clinical examination before entering into the study
Key exclusion criteria (1 listed)
- Not applicable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Engerix-B10 mkg per dose; 3 doses according to 0, 1, 6 month schedule; booster doses 5, 10 or 15 years post-primary vaccination. | Biological | – |
Primary outcome
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.
Time frame: 1995 - 2011
Long term persistence of anti-HBs and the effect of a booster dose given 5, 10 or 15 years post-primary vaccination.
8 secondary outcomes
- To determine the antibody levels obtained following primary vaccination and the proportion of children who seroconvert
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 2006
- To determine the persistence of antibody 15 years after primary vaccination (Group C)
Time frame: 2011
- To determine the antibody levels of subjects in Group A and Group B one year after their 5 or 10 year booster
Time frame: 2011
- To evaluate the effect of a booster dose given 15 years post primary vaccination (Group C)
Time frame: 2011
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2013.
- Results publication: PubMed 15750456Duval 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.
- Results publication: PubMed 10618544Duval 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.
- Results publication: PubMed 19683086Gilca 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.
- Results publication: PubMed 23206974Gilca 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bernard Duval, MD principal investigator
Laval University Hospital Center, Public Health Research Unit
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Engerix-B in people with Hepatitis B and Vaccination, run by Laval University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 1995 - 2011). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00169858, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2013; AzTrials last refreshed its copy on 7 Nov 2026.