Hepatitis BPhase 3NCT00332566
Assess Immunogenicity, Reactogenicity, Safety of a Booster of GSK Biologicals DTPw-HBV/Hib Kft Compared to DTPw-HBV/Hib
A Phase 3 study testing DTPw-HBV/Hib Kft vaccine GSK323527A and Tritanrix™-HepB/Hiberix™ in people with Hepatitis B and Whole Cell Pertussis, run by GlaxoSmithKline at 2 sites in 2 countries.
Trial summary
This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Read more about this study
- Who is it for?
- Ages 18 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Whole Cell Pertussis, Tetanus
- What is being tested?
- DTPw-HBV/Hib Kft vaccine GSK323527A and Tritanrix™-HepB/Hiberix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 148 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Jun 2006to Oct 2006
- Phase
- Phase 3
- 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 18 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female toddler, 18 to 24 months of age at the time of booster vaccination, who completed the three-dose primary vaccination course in the 101223 study.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of the booster vaccine dose, with the exception of oral polio vaccine (OPV).
- Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study.
- History of diphtheria, tetanus, pertussis, hepatitis B and Hib disease.
- Known exposure to diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study.
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- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s).
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products during the study period.
- Other conditions which in the opinion of the investigator may potentially interfere with interpretation of study outcomes.
- One of the following adverse events that constitute absolute contraindications to further administration of DTP vaccine, having occurred after previous administration of DTPw vaccine.
- Known hypersensitivity to any component of the vaccine, or having shown signs of hypersensitivity after previous administration of diphtheria, tetanus, pertussis or HB vaccines.
- Encephalopathy
- Axillary temperature of >= 40 °C/ rectal temperature >= 40.5 °C within 48 hours of vaccination.
- Collapse or shock-like state within 48 hours of vaccination.
- Persistent, inconsolable crying lasting >= 3 hours occurring within 48 hours of vaccination.
- Seizures with or without fever occurring within 3 days of vaccination.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Argentina1 site
GSK Investigational Site
Capital Federal, Buenos Aires, 1425
Nicaragua1 site
GSK Investigational Site
León
About this study
Official title: Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals' DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals' DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.
This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
- Being tested
- DTPw-HBV/Hib Kft vaccine GSK323527A, Tritanrix™-HepB/Hiberix™
- Medical subject headings
- Hepatitis B, Tetanus, Haemophilus Infections, Diphtheria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTPw-HBV/Hib Kft vaccine GSK323527ABiological
Intramuscular injection, 1 dose
Tritanrix™-HepB/Hiberix™Biological
Intramuscular injection, 1 dose
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Not described Receives: Biological: DTPw-HBV/Hib Kft vaccine GSK323527A |
| Group B | Active comparator | Not described Receives: Biological: Tritanrix™-HepB/Hiberix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration
Measured: One month after the booster dose
Anti-hepatitis B surface antigen (HBs) antibody concentration
Measured: One month after the booster dose
Anti-diphtheria antibody concentration
Measured: One month after the booster dose
Anti-tetanus antibody concentration
Measured: One month after the booster dose
Secondary outcomes (9)
Anti-Bordetella pertussis (BPT) antibody concentration
Measured: One month after the booster dose
Anti-PRP antibody concentration
Measured: Prior to the booster dose
Anti-HBs antibody concentration
Measured: Prior to the booster dose
Anti-diphtheria antibody concentration
Measured: Prior to the booster dose
Anti-tetanus antibody concentration
Measured: Prior to the booster dose
Anti-BPT antibody concentration
Measured: Prior to the booster dose
Occurrence of solicited symptoms
Measured: During the 4-day follow-up period after the booster dose
Occurrence of unsolicited symptoms
Measured: During the 31-day follow-up period after the booster dose
Occurrence of serious adverse events
Measured: During the entire study period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2006 (estimated)
- Study startJun 2006
- Primary completionOct 2006
- Study completionOct 2006
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 GlaxoSmithKlineThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 148 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00332566
- Sponsor's protocol ID
- 106602
- Status last verified
- Sep 2016
- First submitted
- 31 May 2006
- Last updated
- 28 Sep 2016
- Results posted
- No
- Individual data sharing
- Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
Publications
Espinoza F, Tregnaghi M, Gentile A, Abarca K, Casellas J, Collard A, Lefevre I, Jacquet JM. Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial. BMC Infect Dis. 2010 Oct 15;10:297. doi: 10.1186/1471-2334-10-297.
PubMed 20950456
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity, Reactogenicity & Safety of a Booster Dose of GSK Biologicals' DTPw-HBV/Hib Kft Vaccine Vs GSK Biologicals' DTPw-HBV/Hib Vaccine, in Infants Who Received a 3-Dose Primary Vaccination Course With the Same Vaccines.
- ClinicalTrials.gov ID
- NCT00332566
- Acronym / sponsor ID
- 106602
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 148 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jun 2006
- Primary completion
- Oct 2006 (actual)
- Study completion
- Oct 2006 (actual)
- First posted
- 1 Jun 2006 (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.
This booster study will assess the immunogenicity, reactogenicity and safety of a booster dose of GSK Biologicals' DTPw-HBV/Hib Kft. vaccine versus DTPw-HBV/Hib vaccine, in healthy children, 18 to 24 months of age, who received the same vaccine for primary vaccination. Prior to the booster dose, this study will also assess the persistence of antibodies to the vaccine antigen components administered in the primary vaccination course. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Biological: DTPw-HBV/Hib Kft vaccine GSK323527A |
| Group B | Active comparator | Biological: Tritanrix™-HepB/Hiberix™ |
Who may qualify
- Ages
- 18 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- A male or female toddler, 18 to 24 months of age at the time of booster vaccination, who completed the three-dose primary vaccination course in the 101223 study.
- Written informed consent obtained from the parent or guardian of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (20 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
- Planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from 30 days before and ending 30 days after administration of the booster vaccine dose, with the exception of oral polio vaccine (OPV).
- Previous booster vaccination against diphtheria, tetanus, pertussis, hepatitis B and Hib disease since the conclusion visit of the 101223 study.
- History of diphtheria, tetanus, pertussis, hepatitis B and Hib disease.
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 |
|---|---|---|
| DTPw-HBV/Hib Kft vaccine GSK323527AIntramuscular injection, 1 dose | Biological | Group A |
| Tritanrix™-HepB/Hiberix™Intramuscular injection, 1 dose | Biological | Group B |
Primary outcome
Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration
Time frame: One month after the booster dose
Anti-hepatitis B surface antigen (HBs) antibody concentration
Time frame: One month after the booster dose
Anti-diphtheria antibody concentration
Time frame: One month after the booster dose
Anti-tetanus antibody concentration
Time frame: One month after the booster dose
9 secondary outcomes
Anti-Bordetella pertussis (BPT) antibody concentration
Time frame: One month after the booster dose
Anti-PRP antibody concentration
Time frame: Prior to the booster dose
Anti-HBs antibody concentration
Time frame: Prior to the booster dose
Anti-diphtheria antibody concentration
Time frame: Prior to the booster dose
Anti-tetanus antibody concentration
Time frame: Prior to the booster dose
Anti-BPT antibody concentration
Time frame: Prior to the booster dose
Occurrence of solicited symptoms
Time frame: During the 4-day follow-up period after the booster dose
Occurrence of unsolicited symptoms
Time frame: During the 31-day follow-up period after the booster dose
Occurrence of serious adverse events
Time frame: During the entire study period.
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 28 Sep 2016.
- Derived from this study: PubMed 20950456Espinoza F, Tregnaghi M, Gentile A, Abarca K, Casellas J, Collard A, Lefevre I, Jacquet JM. Primary and booster vaccination in Latin American children with a DTPw-HBV/Hib combination: a randomized controlled trial. BMC Infect Dis. 2010 Oct 15;10:297. doi: 10.1186/1471-2334-10-297.
- Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.
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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.
GSK Clinical Trials study director
GlaxoSmithKline
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DTPw-HBV/Hib Kft vaccine GSK323527A and Tritanrix™-HepB/Hiberix™ in people with Hepatitis B and Whole Cell Pertussis, run by GlaxoSmithKline at 2 sites in 2 countries.
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 4 inclusion and 20 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 28 Sep 2016. 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 Argentina, Nicaragua. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Anti-polyribosyl-ribitol-phosphate (PRP) antibody concentration (time frame: One month after the booster dose). The study lists 4 primary outcomes in all. 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 NCT00332566, 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 28 Sep 2016.