Acellular PertussisPhase 2NCT00627458
Immunogenicity and Reactogenicity of a Booster Dose of GSK Bio's DTPa-HBV-IPV/Hib Vaccine
A Phase 2 study testing Infanrix Hexa in people with Acellular Pertussis and Diphtheria, run by GlaxoSmithKline at 6 sites in Finland.
Trial summary
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). Read more about this study
- Who is it for?
- Ages 16 to 20 monthsHealthy volunteers can take part
- Conditions the study is for
- Acellular Pertussis, Diphtheria, Poliomyelitis
- What is being tested?
- Infanrix Hexa
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 403 participants
- Where
- 6 sitesFinland
- Study dates
- 1 Feb 2008to 18 Aug 2008
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 16 to 20 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
- A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
- 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 vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
- Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
- Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination.
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- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
- Acute disease at the time of enrolment.
- Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Finland6 sites
GSK Investigational Site
Jarvenpaa, 04400
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Pori, 28100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520
GSK Investigational Site
Vantaa, 01300
About this study
Official title: Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).
Read the detailed description
This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.
- Conditions
- Acellular Pertussis, Diphtheria, Poliomyelitis, Haemophilus Influenzae Type b, Tetanus, Hepatitis B
- Being tested
- Infanrix Hexa
- Keywords
- Hexavalent vaccine, Booster
- Medical subject headings
- Diphtheria, Poliomyelitis, Haemophilus Infections, Tetanus, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infanrix HexaBiological
Also called GSK Biological's combined DTPa-HBV-IPV/Hib vaccine
Vaccine administered as a booster dose at 16-20 months of age
| Study group | Role | What they receive |
|---|---|---|
| INFANRIX HEXA PF GROUP | Experimental | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. Receives: Biological: Infanrix Hexa |
| INFANRIX HEXA PC GROUP | Experimental | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. Receives: Biological: Infanrix Hexa |
| CONTROL GROUP | Active comparator | Healthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. Receives: Biological: Infanrix Hexa |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Measured: Before the booster administration (At Month 0)
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Measured: One month after the booster vaccination (At Month 1)
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Measured: Before the booster vaccination (At Month 0)
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Measured: One month after the booster vaccination (At Month 1)
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Measured: Before the booster vaccination (At Month 0)
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Measured: One month after the booster vaccination (At Month 1)
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: Before the booster vaccination (At Month 0)
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Measured: One month after the booster vaccination (At Month 1)
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Measured: Before the booster vaccination (At Month 0)
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Measured: One month after the booster vaccination (At Month 1)
Number of Subjects With a Vaccine Response to PT, FHA and PR
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) [i.e. with concentrations greater than (>) the cut-off value).
Measured: One month after the booster vaccination (At Month 1)
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Measured: Before the booster vaccination (At Month 0)
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Measured: One month after the booster vaccination (At Month 1)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Measured: Before the booster vaccination (At Month 0)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Measured: One month after the booster vaccination (At Month 1)
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Measured: Before the booster vaccination (At Month 0)
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Measured: One month after the booster vaccination (At Month 1)
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Before the booster vaccination (At Month 0)
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: One month after the booster vaccination (At Month 1)
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).
Measured: Before the booster vaccination (At Month 0)
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Measured: One month after the booster vaccination (At Month 1)
Secondary outcomes (16)
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL .
Measured: Before (Month 0) and one month after (Month 1) the booster vaccination
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Measured: Before (Month 0) and one month after (Month 1) the booster vaccination
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
A seroprotected subject was defined as a subject with anti-polio 1, 2 and 3 antibody titers ≥ the value of 8.
Measured: Before (Month 0) and one month after (Month 1) the booster vaccination
Number of Seroprotected Subjects Against PT, FHA and PRN
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL .
Measured: Before (Month 0) and one month after (Month 1) the booster vaccination
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 μg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Measured: Before (Month 0) and one month after (Month 1) the booster vaccination
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Measured: Before (Month 0) and one month after (Month 1) the booster vaccination
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Measured: Before (Month 0) and one month after (Month 1) the booster vaccination
Anti-HBs Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Measured: Before (Month 0) and one month after (Month 1) the booster vaccination
Anti-poliovirus Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Before (Month 0) and one month after (Month 1) the booster vaccination
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
Measured: Before (Month 0) and one month after (Month 1) the booster vaccination
Number of Subjects With a Vaccine Response to PT, FHA and PR
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) (i.e. with concentrations < cut-off value) or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) (i.e. with concentrations > cut-off value).
Measured: One month after the booster dose (At Month 1)
Number of Subjects With Any Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) follow-up period after the booster vaccination
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, fever [defined as rectal temperature equal to or above (≥) 38.0 degrees Celsius (°C)], irritability and loss of appetite. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) follow-up period after the booster vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
An unsolicited AE covers 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 and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During the 31-day (Day 0-30) follow-up period after the booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Assessed SAEs include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: From Month 0 to Month 1, during the entire study period
Number of Subjects Reporting Concomitant Medications
Measured: During the 4-day (Days 0-3) follow-up period after the booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2008 (estimated)
- Study start1 Feb 2008
- Primary completion18 Aug 2008
- Study completion18 Aug 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acellular PertussisStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 403 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
- NCT00627458
- Sponsor's protocol ID
- 111344
- Status last verified
- Apr 2017
- First submitted
- 20 Feb 2008
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Reactogenicity of GSK Biologicals' DTPa-HBV-IPV/Hib Vaccine When Given as a Booster Dose
- ClinicalTrials.gov ID
- NCT00627458
- Acronym / sponsor ID
- 111344
- Conditions
- Acellular Pertussis, Diphtheria, Poliomyelitis, Haemophilus Influenzae Type b, Tetanus, Hepatitis B
- Keywords
- Hexavalent vaccine, Booster
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Feb 2008
- Primary completion
- 18 Aug 2008 (actual)
- Study completion
- 18 Aug 2008 (actual)
- First posted
- 3 Mar 2008 (estimated)
- Results
- Posted 26 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this booster study is to evaluate, in subjects primed in the primary study 106786, the persistence, at the time of the booster vaccination, of antibodies elicited by the different formulation of DTPa-HBV-IPV/ Hib vaccine (Infanrix Hexa TM). The study will also evaluate the immune response of these subjects to a DTPa-HBV-IPV/Hib booster. This protocol posting deals with the objectives and outcome measures of the booster phase. The objectives and outcomes measures of the primary phase are presented in a separate protocol posting (NCT = 00376779).
Detailed description
This protocol posting has been updated in order to comply with the FDA AA, Sep 2007.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INFANRIX HEXA PF GROUP | Experimental | Biological: Infanrix HexaHealthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-free (PF) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| INFANRIX HEXA PC GROUP | Experimental | Biological: Infanrix HexaHealthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the preservative-containing (PC) formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
| CONTROL GROUP | Active comparator | Biological: Infanrix HexaHealthy male and female subjects between, and including 16 and 20 months of age at the time of booster vaccination, who were given the licensed formulation of Infanrix Hexa™ in the primary vaccination study 106786, additionally received a single booster dose of Infanrix Hexa™ vaccine, administered intramuscularly into the anterolateral quadrant of the right thigh. |
Who may qualify
- Ages
- 16 to 20 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol
- Subjects must have completed the full three-dose primary vaccination course with one of the formulations of the DTPa-HBV-IPV/Hib vaccine in primary study 106786.
- A male or female between, and including, 16 and 20 months of age at the time of booster vaccination.
- 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 (9 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the booster dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the booster vaccine dose.
- Participation in another clinical study, between the primary study 106786 and the present booster study, or at any time during the study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Planned administration or administration of a vaccine not foreseen by the study protocol during the period starting 30 days before the administration of the booster dose and ending 30 days after the booster dose.
- Evidence of previous diphtheria, tetanus, pertussis, polio, hepatitis B and/or Hib booster vaccination or disease since the conclusion visit of study 106786.
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 |
|---|---|---|
| Infanrix HexaAlso: GSK Biological's combined DTPa-HBV-IPV/Hib vaccineVaccine administered as a booster dose at 16-20 months of age | Biological | CONTROL GROUP, INFANRIX HEXA PC GROUP, INFANRIX HEXA PF GROUP |
Primary outcome
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Time frame: Before the booster administration (At Month 0)
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Time frame: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Time frame: Before the booster vaccination (At Month 0)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL). Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Time frame: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a subject with anti-HBs antibody concentrations ≥ 10 mIU/mL. Also reported are the number of participants with anti-HBs antibody concentrations ≥ 100 mIU/mL.
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Time frame: Before the booster vaccination (At Month 0)
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Time frame: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a subject with anti-Polio 1, 2 and 3 antibody titers ≥ the value of 8.
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Time frame: Before the booster vaccination (At Month 0)
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Number of Seroprotected Subjects Against Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN)
Time frame: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Time frame: Before the booster vaccination (At Month 0)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations greater than or equal to (≥) 0.15 micrograms per milliliter (µg/mL). Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Time frame: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL. Also reported are the number of participants with anti-PRP antibody concentrations ≥ 1.0 µg/mL.
Number of Subjects With a Vaccine Response to PT, FHA and PR
Time frame: One month after the booster vaccination (At Month 1)
Vaccine response was defined as the appearance of antibodies in subjects who were initially seronegative (S-) [i.e. with concentrations lower than (<) the cut-off value] or at least doubling of pre-vaccination antibody concentrations in subjects who were initially seropositive (S+) [i.e. with concentrations greater than (>) the cut-off value).
Anti-D and Anti-T Antibody Concentrations
Time frame: Before the booster vaccination (At Month 0)
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Anti-D and Anti-T Antibody Concentrations
Time frame: One month after the booster vaccination (At Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: Before the booster vaccination (At Month 0)
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: One month after the booster vaccination (At Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Anti-HBs Antibody Concentrations
Time frame: Before the booster vaccination (At Month 0)
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Anti-HBs Antibody Concentrations
Time frame: One month after the booster vaccination (At Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in mIU/mL.
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Time frame: Before the booster vaccination (At Month 0)
Antibody titers were presented as geometric mean titers (GMTs).
Anti-poliovirus Type 1, Type 2 and Type 3 Antibody Titers
Time frame: One month after the booster vaccination (At Month 1)
Antibody titers were presented as geometric mean titers (GMTs).
Anti-PRP Antibody Concentrations
Time frame: Before the booster vaccination (At Month 0)
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in micrograms per milliliter (µg/mL).
Anti-PRP Antibody Concentrations
Time frame: One month after the booster vaccination (At Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.
16 secondary outcomes
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs)
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Number of Seroprotected Subjects Against Poliovirus Type 1, Type 2 and Type 3
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Number of Seroprotected Subjects Against PT, FHA and PRN
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Anti-D and Anti-T Antibody Concentrations
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Anti-PT, Anti-FHA, Anti-PRN Antibody Concentrations
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Anti-HBs Antibody Concentrations
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Anti-poliovirus Type 1, 2 and 3 Antibody Titers
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Anti-PRP Antibody Concentrations
Time frame: Before (Month 0) and one month after (Month 1) the booster vaccination
Number of Subjects With a Vaccine Response to PT, FHA and PR
Time frame: One month after the booster dose (At Month 1)
Number of Subjects With Any Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) follow-up period after the booster vaccination
Number of Subjects With Any Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) follow-up period after the booster vaccination
Number of Subjects With Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Day 0-30) follow-up period after the booster vaccination
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: From Month 0 to Month 1, during the entire study period
Number of Subjects Reporting Concomitant Medications
Time frame: During the 4-day (Days 0-3) follow-up period after the booster vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Infanrix Hexa in people with Acellular Pertussis and Diphtheria, run by GlaxoSmithKline at 6 sites in Finland.
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 9 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 6 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Finland. 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?
Yes. Results are posted in the registry (first posted 26 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids (time frame: Before the booster administration (At Month 0)). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jun 2018.