Acellular PertussisPhase 3NCT01449812
Immunogenicity and Safety Study of Booster Dose of GSK Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) Vaccine
A Phase 3 study testing Infanrix+Hib™ and Poliorix™ in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 2 sites in China.
Trial summary
The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. Read more about this study
- Who is it for?
- Ages 18 to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Acellular Pertussis, Tetanus, Diphtheria
- What is being tested?
- Infanrix+Hib™ and Poliorix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 831 participants
- Where
- 2 sitesChina
- Study dates
- 1 Oct 2011to 16 Jan 2012
- Phase
- Phase 3
- 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 18 to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
- Subjects who completed the full three-dose primary vaccination course in study NCT01086423.
- Subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Who cannot join
- Child in care
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of the 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 dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccination, or planned administration during the study period.
- Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
- Evidence of previous diphtheria, tetanus, pertussis, poliomyelitis and Haemophilus influenzae type b, vaccination or disease since the conclusion visit of primary study NCT01086423.
Show all 16Show fewer
- Serious chronic illness.
- Administration of immunoglobulins and/or any blood products within the 90 days preceding the booster dose of study vaccine or planned administration during the study period.
- Occurrence of any of the following adverse events after a previous administration of a DTP vaccine.
- Encephalopathy
- Temperature of ≥ 40.0°C (axillary temperature) within 48 hours of vaccination, not due to another identifiable cause.
- Collapse or shock-like state within 48 hours of vaccination.
- Persistent, inconsolable crying occurring within 48 hours of vaccination and lasting ≥ 3 hours.
- Seizures with or without fever occurring within 3 days of vaccination.
- The following condition is temporary or self-limiting, and a subject may be vaccinated once the condition has resolved if no other exclusion criteria is met:
- Acute disease and/or fever at the time of enrolment.
Trial locations and contacts
2 sites in 1 country.
China2 sites
GSK Investigational Site
Wuzhou, Guangxi, 543002
GSK Investigational Site
Wuzhou, Guangxi, 543100
About this study
Official title: Immunogenicity and Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers
The purpose of this booster study is to evaluate the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.
This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).
- Being tested
- Infanrix+Hib™, Poliorix™
- Keywords
- combination vaccine, booster vaccination
- Medical subject headings
- Tetanus, Diphtheria, Haemophilus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Infanrix+Hib™Biological
Also called DTPa /Hib
Intramuscular, one dose
Poliorix™Biological
Also called IPV
Intramuscular, one dose
| Study group | Role | What they receive |
|---|---|---|
| INFANRIX+HIB/POLIORIX 1 GROUP | Experimental | Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. Receives: Biological: Infanrix+Hib™; Biological: Poliorix™ |
| INFANRIX+HIB/POLIORIX 2 GROUP | Experimental | Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. Receives: Biological: Infanrix+Hib™; Biological: Poliorix™ |
| CONTROL GROUP | Active comparator | Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. Receives: Biological: Infanrix+Hib™; Biological: Poliorix™ |
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 vaccinated 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 vaccination (At Day 0)
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.
Measured: Before the booster vaccination (At Day 0)
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Measured: Before the booster vaccination (At Day 0)
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Measured: Before the booster vaccination (At Day 0)
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Measured: Before the booster vaccination (At Day 0)
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Measured: Before the booster vaccination (At Day 0)
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
Measured: Before the booster vaccination (At Day 0)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Measured: Before the booster vaccination (At Day 0)
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Measured: Before the booster vaccination (At Day 0)
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
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) for the seroprotection cut-off of ≥ 0.1 IU/mL.
Measured: Before the booster vaccination (At Day 0)
Anti-D and Anti-T Antibody Concentrations
Antibody concentrations were presented as GMCs for the seroprotection cut-off of ≥ 0.1 IU/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 vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.
Measured: Before the booster vaccination (At Day 0)
Number of Seroprotected Subjects Against PRP
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Measured: One month after the booster vaccination (At Month 1)
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 micrograms per milliliter (µg/mL).
Measured: Before the booster vaccination (At Day 0)
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Measured: One month after the booster vaccination (At Month 1)
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Measured: Before the booster vaccination (At Day 0)
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Measured: One month after the booster vaccination (At Month 1)
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.
Measured: Before the booster vaccination (At Day 0)
Anti-polio Type 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Measured: One month after the booster vaccination (At Month 1)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).
Measured: Before the booster vaccination (At Day 0)
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
A seropositive subject was defined as a vaccinated 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)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.
Measured: Before the booster vaccination (At Day 0)
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Measured: One month after the booster vaccination (At Month 1)
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
Measured: One month after the booster vaccination (At Month 1)
Secondary outcomes (4)
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) post-vaccination period
Number of Subjects With Any Solicited General Symptoms
Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever [defined as axillary temperature equal to or above 37.1 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade and relationship to vaccination.
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any 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 (Days 0-30) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period (from Month 0 up to Month 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study start1 Oct 2011
- Primary completion16 Jan 2012
- Study completion16 Jan 2012
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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 831 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
- NCT01449812
- Sponsor's protocol ID
- 114386
- Status last verified
- Apr 2017
- First submitted
- 6 Oct 2011
- Last updated
- 6 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
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 Safety of a Booster Dose of GlaxoSmithKline Biologicals' IPV (Poliorix™) and DTPa/Hib (Infanrix+Hib™) in Healthy Chinese Toddlers
- ClinicalTrials.gov ID
- NCT01449812
- Acronym / sponsor ID
- 114386
- Keywords
- combination vaccine, booster vaccination
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 831 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 1 Oct 2011
- Primary completion
- 16 Jan 2012 (actual)
- Study completion
- 16 Jan 2012 (actual)
- First posted
- 10 Oct 2011 (estimated)
- Results
- Posted 13 Apr 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 the immune persistence in healthy Chinese subjects primed in study NCT01086423 with GSK Biologicals' Infanrix-IPV+Hib™ (DTPa-IPV/Hib) vaccine. The study will also evaluate the safety and immune response of these subjects to a booster dose of Infanrix-Hib™ (DTPa/Hib) and Poliorix™ (IPV) vaccine.
This protocol posting deals with objectives \& outcome measures of the booster phase. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT01086423).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| INFANRIX+HIB/POLIORIX 1 GROUP | Experimental | Biological: Infanrix+Hib™, Biological: Poliorix™Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. |
| INFANRIX+HIB/POLIORIX 2 GROUP | Experimental | Biological: Infanrix+Hib™, Biological: Poliorix™Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix-IPV/Hib™ vaccine at 3, 4 and 5 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. |
| CONTROL GROUP | Active comparator | Biological: Infanrix+Hib™, Biological: Poliorix™Healthy male or female children between, and including, 18 and 24 months of age at the time of booster vaccination, who were primed with 3 doses of the Infanrix+Hib™ and of Poliorix™ vaccines at 2, 3 and 4 months of age in the DTPA-IPV-056 (112584) primary study, additionally received 1 dose of Poliorix™ and of Infanrix+Hib™ vaccines, administered intramuscularly into the upper sides of the left and right thighs, respectively. |
Who may qualify
- Ages
- 18 to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- A male or female child between, and including, 18 and 24 months of age at the time of the booster vaccination.
- Subjects who completed the full three-dose primary vaccination course in study NCT01086423.
- Subjects who the investigator believes that their parent(s)/ Legally Acceptable Representative(s) LAR(s) can and will comply with the requirements of the protocol
- Written informed consent obtained from the parent(s)/LAR(s) of the subject.
- Healthy subjects as established by medical history and clinical examination before entering into the study.
Key exclusion criteria (16 listed)
- Child in care
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the booster dose of the 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 dose.
- Administration of a vaccine not foreseen by the study protocol within 30 days prior to the booster vaccination, or planned administration during the study period.
- Participation in another clinical study within three months prior to enrolment in the present booster study or at any time during the present booster study, in which the subject has been or will be exposed to an investigational or a non-investigational product.
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+Hib™Also: DTPa /HibIntramuscular, one dose | Biological | CONTROL GROUP, INFANRIX+HIB/POLIORIX 1 GROUP, INFANRIX+HIB/POLIORIX 2 GROUP |
| Poliorix™Also: IPVIntramuscular, one dose | Biological | CONTROL GROUP, INFANRIX+HIB/POLIORIX 1 GROUP, INFANRIX+HIB/POLIORIX 2 GROUP |
Primary outcome
Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Toxoids
Time frame: Before the booster vaccination (At Day 0)
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).
Anti-D and Anti-T Antibody Concentrations
Time frame: Before the booster vaccination (At Day 0)
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥0.1 IU/mL.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (Anti-PRP)
Time frame: Before the booster vaccination (At Day 0)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Anti-PRP Antibody Concentrations
Time frame: Before the booster vaccination (At Day 0)
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
Time frame: Before the booster vaccination (At Day 0)
A seroprotected subject was defined as a vaccinated subject with anti-polio type 1, 2 and 3 antibody concentrations ≥ the cut-off value of 8 Estimated Dose 50% (ED50). ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Anti-polio Type 1, 2 and 3 Antibody Titers
Time frame: Before the booster vaccination (At Day 0)
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT), Anti-filamentous Haemagglutinin (Anti-FHA) and Anti-pertactin (Anti-PRN)
Time frame: Before the booster vaccination (At Day 0)
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/ml).
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: Before the booster vaccination (At Day 0)
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
Time frame: Before the booster vaccination (At Day 0)
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 IU/mL.
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoids
Time frame: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a vaccinated subject with anti-D and anti-T antibody concentrations ≥ 0.1 IU/mL.
Anti-D and Anti-T Antibody Concentrations
Time frame: Before the booster vaccination (At Day 0)
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.1 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 GMCs for the seroprotection cut-off of ≥ 0.1 IU/mL.
Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP)
Time frame: Before the booster vaccination (At Day 0)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentration ≥ 0.15 µg/mL.
Number of Seroprotected Subjects Against PRP
Time frame: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a vaccinated subject with anti-PRP antibody concentrations ≥ 0.15 µg/mL.
Anti-PRP Antibody Concentrations
Time frame: Before the booster vaccination (At Day 0)
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seroprotection cut-off of ≥ 0.15 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) for the seroprotection cut-off of ≥ 0.15 µg/mL.
Number of Seroprotected Subjects for Anti-polio Type 1, 2 and 3
Time frame: Before the booster vaccination (At Day 0)
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentration ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Number of Seroprotected Subjects Against Polio Type 1, 2 and 3
Time frame: One month after the booster vaccination (At Month 1)
A seroprotected subject was defined as a vaccinated subject with anti-polivirus antibody concentrations ≥ 8 ED50. ED50 is the estimated serum dilution reducing the signal generated by viral infection with 50%.
Anti-polio Type 1, 2 and 3 Antibody Titers
Time frame: Before the booster vaccination (At Day 0)
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ the value of 8.
Anti-polio Type 1, 2 and 3 Antibody Titers
Time frame: One month after the booster vaccination (At Month 1)
Antibody titers were presented as geometric mean titers (GMTs) for the seroprotection cut-off of ≥ 8.
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Time frame: Before the booster vaccination (At Day 0)
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 ELISA units per milliliter (EL.U/mL).
Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN
Time frame: One month after the booster vaccination (At Month 1)
A seropositive subject was defined as a vaccinated subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations
Time frame: Before the booster vaccination (At Day 0)
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off value of ≥ 5 EL.U/mL.
Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrattions
Time frame: One month after the booster vaccination (At Month 1)
Antibody concentrations were presented as geometric mean concentrations (GMCs) for the seropositivity cut-off of ≥ 5 EL.U/mL.
Number of Subjects With a Booster Response to Anti-PT, Anti-FHA and Anti-PRN
Time frame: One month after the booster vaccination (At Month 1)
Booster response was defined as the appearance of antibodies in subjects who were initially seronegative (i.e. with concentrations < cut-off value) or at least maintenance of pre-vaccination antibody concentrations in subjects who were initially seropositive (i.e. with concentrations ≥ cut-off value), taking into consideration the decreasing maternal antibodies.
4 secondary outcomes
Number of Subjects With Any Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any Solicited General Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Days 0-30) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Month 0 up to Month 1)
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.
Related trials for Acellular Pertussis
RecruitingPhase 2
A Phase II Clinical Trial of Absorbed Acellular Pertussis (Two-Component) Diphtheria-Tetanus Combined Vaccine (For Adults and Adolescents)
Pertussis (Whooping Cough), Diphtheria
RecruitingPhase 1/2
A Phase I/II Clinical Trial of the Diphtheria, Tetanus, Acellular Component Pertussis and Sabin Inactivated Poliomyelitis Vaccine Adsorbed
Diphtheria, Pertussis
RecruitingPhase 4
Concurrent Versus Sequential Administration of Tdap and RSV Vaccines in Pregnancy
RSV, Tdap - Tetanus, Diphtheria and Acellular Pertussis Vaccination
Active, not recruitingPhase 3
A Study on the Immune Response and Safety of a Combined Vaccine Against Diphtheria, Tetanus and Acellular Pertussis (dTpa) in Japanese Healthy Pregnant Women
Diphtheria-Tetanus-acellular Pertussis Vaccines
Not yet recruitingObservational study
A Clinical Study on Immunogenicity Persistence of Adsorbed 5-component Acellular Pertussis, Diphtheria and Tetanus Combined Vaccine
Diphtheria, Tetanus
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 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Infanrix+Hib™ and Poliorix™ in people with Acellular Pertussis and Tetanus, run by GlaxoSmithKline at 2 sites in China.
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 16 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 2 sites in China. 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?
Yes. Results are posted in the registry (first posted 13 Apr 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 vaccination (At Day 0)). The study lists 25 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.