Hepatitis BNCT02610348
Anti-Hep B Antibodies at Age 12 to 18 Months After Hep B Vaccine at Birth and DTaP-IPV-Hep B-PRP-T Hexavalent Vaccine Concomitantly With Prevnar® at 2, 4 and 6 Months of Age
A study testing DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines and DTaP-HB-IPV and Pneumococcal polysaccharide vaccines in people with Hepatitis B, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Thailand.
Trial summary
Primary Objective: To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth. Read more about this study
- Who is it for?
- Ages 12 to 18 monthsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines and DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 2 sitesThailand
- Study dates
- Nov 2015to Mar 2016
- Phase
- Interventional
- 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 12 to 18 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects having received 4 Hep B doses in A3L12 (i.e. one dose at birth + three doses during study at 2, 4 \& 6 months of age)
- Subjects having participated in PNA19
- Subject's parents having given authorization to use serum collected in PNA19 for future research
- The initials, birth date, and gender of the subject are consistent between A3L12 and PNA19 databases
- Subjects for whom retention sera are of enough volume to allow a valid determination of the HBsAg antibody level.
Who cannot join
- Not applicable.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Persistence of Anti-Hep B Antibodies at 12 to 18 Months of Age in Children Having Received Hep B Vaccine at Birth and a DTaP-IPV-HB-Hib Hexavalent Vaccine (Hexaxim® or Infanrix Hexa®) Concomitantly With Prevnar® at 2, 4 and 6 Months of Age
Primary Objective:
To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth.
Read the detailed description
Sera from subjects who have participated in study PNA19 trial (NCT00594347) and for whom parents or legal representatives had given authorization to use the sera taken from their child will be used for this study.
- Conditions
- Hepatitis B
- Being tested
- DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines, DTaP-HB-IPV and Pneumococcal polysaccharide vaccines
- Keywords
- Hepatitis B, Hexaxim®, Hexyon®, Hexacima®, Prevnar®, DTaP-IPV-HB-Hib hexavalent vaccine
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccinesBiological
Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study
DTaP-HB-IPV and Pneumococcal polysaccharide vaccinesBiological
Original Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Toddlers vaccinated with Hexaxim®/Hexyon®/Hexacima® in study A3L12 Receives: Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines |
| Group B | Experimental | Toddlers vaccinated with Infanrix hexa® in study A3L12 Receives: Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study
Levels of anti-Hepatitis B antibody concentrations will be determined at ≥ 10 mIU/mL and ≥ 100 mIU/mL
Measured: Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 Sanofi Pasteur, a Sanofi CompanyThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur SA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02610348
- Sponsor's protocol ID
- A3L47
- Other IDs
- U1111-1161-2649
- Status last verified
- Mar 2018
- First submitted
- 18 Nov 2015
- Last updated
- 20 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Kosalaraksa P, Chokephaibulkit K, Benjaponpitak S, Pancharoen C, Chuenkitmongkol S, B'Chir S, Da Costa X, Vidor E. Persistence of hepatitis B immune memory until 9-10 years of age following hepatitis B vaccination at birth and DTaP-IPV-HB-PRP approximately T vaccination at 2, 4 and 6 months. Hum Vaccin Immunother. 2018 May 4;14(5):1257-1265. doi: 10.1080/21645515.2018.1426418. Epub 2018 Feb 21.
PubMed 29333947
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Persistence of Anti-Hep B Antibodies at 12 to 18 Months of Age in Children Having Received Hep B Vaccine at Birth and a DTaP-IPV-HB-Hib Hexavalent Vaccine (Hexaxim® or Infanrix Hexa®) Concomitantly With Prevnar® at 2, 4 and 6 Months of Age
- ClinicalTrials.gov ID
- NCT02610348
- Acronym / sponsor ID
- A3L47
- Conditions
- Hepatitis B
- Keywords
- Hepatitis B, Hexaxim®, Hexyon®, Hexacima®, Prevnar®, DTaP-IPV-HB-Hib hexavalent vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Nov 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Nov 2015 (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.
Primary Objective:
To describe the persistence of Hep B antibodies (Ab) at 12 to 18 months of age following a three-dose infant primary series vaccination of either Hexaxim®/Hexyon®/Hexacima® or Infanrix® hexa at 2, 4 and 6 months of age following Hep B vaccination at birth.
Detailed description
Sera from subjects who have participated in study PNA19 trial (NCT00594347) and for whom parents or legal representatives had given authorization to use the sera taken from their child will be used for this study.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccinesToddlers vaccinated with Hexaxim®/Hexyon®/Hexacima® in study A3L12 |
| Group B | Experimental | Biological: DTaP-HB-IPV and Pneumococcal polysaccharide vaccinesToddlers vaccinated with Infanrix hexa® in study A3L12 |
Who may qualify
- Ages
- 12 to 18 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects having received 4 Hep B doses in A3L12 (i.e. one dose at birth + three doses during study at 2, 4 \& 6 months of age)
- Subjects having participated in PNA19
- Subject's parents having given authorization to use serum collected in PNA19 for future research
- The initials, birth date, and gender of the subject are consistent between A3L12 and PNA19 databases
- Subjects for whom retention sera are of enough volume to allow a valid determination of the HBsAg antibody level.
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 |
|---|---|---|
| DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccinesOriginal Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study | Biological | Group A |
| DTaP-HB-IPV and Pneumococcal polysaccharide vaccinesOriginal Vaccine in Study A3L12 (NCT00401531). No vaccination will be administered as part of this study | Biological | Group B |
Primary outcome
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study
Time frame: Day 0
Levels of anti-Hepatitis B antibody concentrations will be determined at ≥ 10 mIU/mL and ≥ 100 mIU/mL
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 20 Mar 2018.
- Results publication: PubMed 29333947Kosalaraksa P, Chokephaibulkit K, Benjaponpitak S, Pancharoen C, Chuenkitmongkol S, B'Chir S, Da Costa X, Vidor E. Persistence of hepatitis B immune memory until 9-10 years of age following hepatitis B vaccination at birth and DTaP-IPV-HB-PRP approximately T vaccination at 2, 4 and 6 months. Hum Vaccin Immunother. 2018 May 4;14(5):1257-1265. doi: 10.1080/21645515.2018.1426418. Epub 2018 Feb 21.
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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.
Medical Director study director
Sanofi Pasteur SA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DTaP-IPV-HB-PRP~T and Pneumococcal polysaccharide vaccines and DTaP-HB-IPV and Pneumococcal polysaccharide vaccines in people with Hepatitis B, run by Sanofi Pasteur, a Sanofi Company at 2 sites in Thailand.
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 5 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 20 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. 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.
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?
Levels of anti-Hepatitis B antibody concentrations in subject that received Hexaxim® or Infanrix® hexa vaccine in a previous study (time frame: Day 0). 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 NCT02610348, which also lists 1 linked publication.
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 20 Mar 2018.