Hepatitis BPhase 2NCT00289796
Assess Feasibility of an Acellular Pertussis Vaccine (Pa) Given Soon After Birth, Followed by 3-dose Primary Vaccination With the DTPa-HBV-IPV/Hib Vaccine
A Phase 2 study testing DTPa-HBV-IPV/Hib in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Germany.
Trial summary
This study will assess immunogenicity, safety and reactogenicity of primary and booster vaccination. Read more about this study
- Who is it for?
- Ages 2 to 5 daysHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- DTPa-HBV-IPV/Hib
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2004to Dec 2006
- Phase
- Phase 2
- 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 2 to 5 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy newborn male or female infant 2 to 5 days old at the time of the first vaccination \& written informed consent taken from the parents/guardians of the subject
- Born at term (gestational age 37-42 weeks) after an uncomplicated pregnancy
- Birth weight >= 2.5 kg and 5 minute Apgar >= 7
- Mother seronegative for Hepatitis B surface antigen (HBsAg) For the booster vaccination phase
- A healthy male or female between, and including, 12 and 23 months of age at the time of booster vaccination who has completed the primary vaccination course in the primary vaccination phase with written informed consent obtained from the parent or guardian of the subject
Who cannot join
- Mother known or suspected to be seropositive for HIV (testing not required for inclusion)
- Planned use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the study
- Planned administration of immuno-suppressants or other immune-modifying drugs, administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
- Administration of immunoglobulins and/or any blood products to the mother during pregnancy
- Neonatal jaundice requiring parenteral treatment (light therapy for physiological jaundice is allowed)
- At risk of pneumococcal disease or planning to receive Prevenar™ during the study period
Show all 13Show fewer
- Administration or planned administration of BCG vaccination during the study period
- Acute disease at the time of vaccination. For the booster vaccination phase
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose, or planned use during the booster phase.
- Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination since the study conclusion visit of the primary vaccination phase.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
- Administration/ planned administration of a vaccine not foreseen by the study protocol, administration/ planned administration of immunoglobulins and/or any blood products during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose."
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assess the Feasibility of an Investigational Vaccination Regimen, Compared to a 3-dose Primary Vaccination With GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib Vaccine) Following Hepatitis B Vaccination at Birth. Primary Vaccination is Followed in the 2nd Year of Life by a Booster Dose of Infanrix-hexa
This study will assess immunogenicity, safety and reactogenicity of primary and booster vaccination.
Read the detailed description
"There will be two groups in this study:
- one group will receive a birth dose of Pa vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination
- the control group will receive a birth dose of hepatitis B vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination".
- Conditions
- Hepatitis B
- Being tested
- DTPa-HBV-IPV/Hib
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DTPa-HBV-IPV/HibBiological
GSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine
| Study group | Role | What they receive |
|---|---|---|
| Infanrix hexa Group | Active comparator | Subjects received a dose of hepatitis B vaccine at birth followed by immunization with 3 doses of Infanrix hexa™ (2, 4 and 6 months of age) and one booster dose of Infanrix hexa™ between 12 and 23 months of age. All vaccines were administered by deep intramuscular injection into the left anterolateral thigh. Receives: Biological: DTPa-HBV-IPV/Hib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Measured: At Month 0
Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Measured: At Month 3
Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Measured: At Month 5
Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Measured: At Month 7
Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Measured: At Month 0
Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Measured: At Month 3
Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Measured: At Month 5
Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Measured: At Month 7
Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Measured: At Month 1 Post-Booster
Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Measured: At Month 1 Post-Booster
Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration.
Measured: At Month 7
Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration.
Measured: At Month 1 Post-Booster
Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Measured: At Month 7
Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Measured: At pre-booster vaccination (Month 0 BST)
Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Measured: At Month 1 post-booster vaccination
Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.
Measured: At Month 7
Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.
Measured: At pre-booster vaccination (Month 0 BST)
Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.
Measured: At Month 1 post-booster vaccination
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Measured: At Month 7
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Measured: At pre-booster vaccination (Month 0 BST)
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Measured: At Month 1 post-booster vaccination
Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Measured: At Month 7
Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Measured: At pre-booster vaccination (Month 0 BST)
Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Measured: At Month 1 post-booster vaccination
Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.
Measured: At Month 7
Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.
Measured: At pre-booster vaccination (Month 0 BST)
Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.
Measured: At Month 1 post-booster vaccination
Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.
Measured: At Month 7
Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.
Measured: At pre-booster vaccination (Month 0 BST)
Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.
Measured: At Month 1 post-booster vaccination
Number of subjects with solicited general symptoms
The solicited local symptoms assessed were Drowsiness, Temperature (Fever), Irritability and Loss of appetite. Temperature = Fever ≥ 38.0 °C. Grade 3 drowsiness = drowsiness that prevented normal activity; Grade 3 irritability = crying that could not be comforted/prevented normal activity; Grade 3 loss of appetite = not eating at all; Grade 3 Temperature = > 39.5 °C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Measured: During the 8-day (Day 0-Day 7) follow-up period after the any dose and booster vaccination
Number of subjects with unsolicited adverse events (AES)
An AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
Measured: Occurring within Day 0-30 following primary and booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2006 (estimated)
- Study startJul 2004
- Primary completionApr 2006
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 121 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
- NCT00289796
- Sponsor's protocol ID
- 210602-002
- Other IDs
- 105752
- Status last verified
- Feb 2017
- First submitted
- 9 Feb 2006
- Last updated
- 8 Feb 2017
- 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
Knuf M, Schmitt HJ, Wolter J, Schuerman L, Jacquet JM, Kieninger D, Siegrist CA, Zepp F. Neonatal vaccination with an acellular pertussis vaccine accelerates the acquisition of pertussis antibodies in infants. J Pediatr. 2008 May;152(5):655-60, 660.e1. doi: 10.1016/j.jpeds.2007.09.034. Epub 2007 Nov 19.
PubMed 18410769Knuf M, Schmitt HJ, Jacquet JM, Collard A, Kieninger D, Meyer CU, Siegrist CA, Zepp F. Booster vaccination after neonatal priming with acellular pertussis vaccine. J Pediatr. 2010 Apr;156(4):675-8. doi: 10.1016/j.jpeds.2009.12.019.
PubMed 20303444
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assess the Feasibility of an Investigational Vaccination Regimen, Compared to a 3-dose Primary Vaccination With GSK Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib Vaccine) Following Hepatitis B Vaccination at Birth. Primary Vaccination is Followed in the 2nd Year of Life by a Booster Dose of Infanrix-hexa
- ClinicalTrials.gov ID
- NCT00289796
- Acronym / sponsor ID
- 210602-002
- Conditions
- Hepatitis B
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 10 Feb 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 study will assess immunogenicity, safety and reactogenicity of primary and booster vaccination.
Detailed description
"There will be two groups in this study:
- one group will receive a birth dose of Pa vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination
- the control group will receive a birth dose of hepatitis B vaccine and 3 doses of DTPa-HBV-IPV/Hib vaccine as primary vaccination and a dose of DTPa-HBV-IPV/Hib vaccine as booster vaccination".
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Infanrix hexa Group | Active comparator | Biological: DTPa-HBV-IPV/HibSubjects received a dose of hepatitis B vaccine at birth followed by immunization with 3 doses of Infanrix hexa™ (2, 4 and 6 months of age) and one booster dose of Infanrix hexa™ between 12 and 23 months of age. All vaccines were administered by deep intramuscular injection into the left anterolateral thigh. |
Who may qualify
- Ages
- 2 to 5 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Healthy newborn male or female infant 2 to 5 days old at the time of the first vaccination \& written informed consent taken from the parents/guardians of the subject
- Born at term (gestational age 37-42 weeks) after an uncomplicated pregnancy
- Birth weight >= 2.5 kg and 5 minute Apgar >= 7
- Mother seronegative for Hepatitis B surface antigen (HBsAg) For the booster vaccination phase
- A healthy male or female between, and including, 12 and 23 months of age at the time of booster vaccination who has completed the primary vaccination course in the primary vaccination phase with written informed consent obtained from the parent or guardian of the subject
Key exclusion criteria (13 listed)
- Mother known or suspected to be seropositive for HIV (testing not required for inclusion)
- Planned use of any investigational or non-registered product (drug or vaccine) other than the study vaccines during the study
- Planned administration of immuno-suppressants or other immune-modifying drugs, administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
- Administration of immunoglobulins and/or any blood products to the mother during pregnancy
- Neonatal jaundice requiring parenteral treatment (light therapy for physiological jaundice is allowed)
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 |
|---|---|---|
| DTPa-HBV-IPV/HibGSK Biologicals' combined diphtheria, tetanus, acellular pertussis, hepatitis B, inactivated poliovirus and Haemophilus influenzae type b conjugate vaccine | Biological | Infanrix hexa Group |
Primary outcome
Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Time frame: At Month 0
A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Time frame: At Month 3
A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Time frame: At Month 5
A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Time frame: At Month 7
A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Time frame: At Month 0
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Time frame: At Month 3
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Time frame: At Month 5
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Time frame: At Month 7
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Time frame: At Month 1 Post-Booster
A seropositive subject was defined a subject with antibody concentrations ≥ 5 EL.U/mL.
Antibody concentrations for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Time frame: At Month 1 Post-Booster
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Time frame: At Month 7
Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration.
Modified vaccine response for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies
Time frame: At Month 1 Post-Booster
Modified vaccine response was defined as: For initially seronegative subjects, antibody concentration 5 EL.U/mL at one month after the third dose of Infanrix hexa™. For initially seropositive subjects: antibody concentration at one month post vaccination 0.25 fold the pre-vaccination antibody concentration.
Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies
Time frame: At Month 7
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies
Time frame: At pre-booster vaccination (Month 0 BST)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Number of seroprotected subjects for anti-Hepatitis B surface antigen (anti-HBs) antibodies
Time frame: At Month 1 post-booster vaccination
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL.
Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies
Time frame: At Month 7
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.
Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies
Time frame: At pre-booster vaccination (Month 0 BST)
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.
Antibody concentrations for anti-Hepatitis B surface antigen (anti-HBs) antibodies
Time frame: At Month 1 post-booster vaccination
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 10 mIU/mL.
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
Time frame: At Month 7
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
Time frame: At pre-booster vaccination (Month 0 BST)
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Number of seroprotected subjects for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
Time frame: At Month 1 post-booster vaccination
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
Time frame: At Month 7
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
Time frame: At pre-booster vaccination (Month 0 BST)
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Antibody concentrations for anti-diphtheria (anti-D) and anti-tetanus (anti-T) antibodies
Time frame: At Month 1 post-booster vaccination
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)
Time frame: At Month 7
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.
Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)
Time frame: At pre-booster vaccination (Month 0 BST)
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.
Number of seroprotected subjects for anti-polyribosyl ribitol phosphate (anti-PRP)
Time frame: At Month 1 post-booster vaccination
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.15 g/mL.
Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)
Time frame: At Month 7
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.
Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)
Time frame: At pre-booster vaccination (Month 0 BST)
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.
Antibody concentrations for anti-polyribosyl ribitol phosphate (anti-PRP)
Time frame: At Month 1 post-booster vaccination
Concentrations were expressed as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 g/mL.
Number of subjects with solicited general symptoms
Time frame: During the 8-day (Day 0-Day 7) follow-up period after the any dose and booster vaccination
The solicited local symptoms assessed were Drowsiness, Temperature (Fever), Irritability and Loss of appetite. Temperature = Fever ≥ 38.0 °C. Grade 3 drowsiness = drowsiness that prevented normal activity; Grade 3 irritability = crying that could not be comforted/prevented normal activity; Grade 3 loss of appetite = not eating at all; Grade 3 Temperature = > 39.5 °C. Related = symptoms considered by the investigator to have a causal relationship to vaccination.
Number of subjects with unsolicited adverse events (AES)
Time frame: Occurring within Day 0-30 following primary and booster vaccination
An AE was defined as any untoward medical occurrence in a clinical investigation subject, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product.
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 8 Feb 2017.
- Background: PubMed 18410769Knuf M, Schmitt HJ, Wolter J, Schuerman L, Jacquet JM, Kieninger D, Siegrist CA, Zepp F. Neonatal vaccination with an acellular pertussis vaccine accelerates the acquisition of pertussis antibodies in infants. J Pediatr. 2008 May;152(5):655-60, 660.e1. doi: 10.1016/j.jpeds.2007.09.034. Epub 2007 Nov 19.
- Background: PubMed 20303444Knuf M, Schmitt HJ, Jacquet JM, Collard A, Kieninger D, Meyer CU, Siegrist CA, Zepp F. Booster vaccination after neonatal priming with acellular pertussis vaccine. J Pediatr. 2010 Apr;156(4):675-8. doi: 10.1016/j.jpeds.2009.12.019.
- 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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DTPa-HBV-IPV/Hib in people with Hepatitis B, run by GlaxoSmithKline at 1 site in Germany.
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 13 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 8 Feb 2017. 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 Germany. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Number of seropositive subjects for anti-pertussis toxoids (PT), anti-filamentous hemagglutinin (FHA) and anti-pertactin (PRN) antibodies (time frame: At Month 0). The study lists 32 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 NCT00289796, which also lists 2 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 8 Feb 2017.