Haemophilus Influenzae Type bPhase 2NCT01106092

Study to Evaluate the Immunogenicity and Reactogenicity of a Booster Dose of GSK2036874A Vaccine in Healthy Toddlers

A Phase 2 study testing GSK2036874A vaccine, Zilbrix™/Hib vaccine and Poliorix™ in people with Haemophilus Influenzae Type b and Tetanus, run by GlaxoSmithKline at 1 site in Philippines.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of the study is to assess the immunogenicity and safety of three formulations of GSK Biologicals' GSK2036874A vaccine compared to Zilbrix™/Hib and Poliorix™ vaccines administered concomitantly, when administered as a single booster dose to healthy poliovirus-primed toddlers aged 12-24 months. Read more about this study

Who is it for?: Ages 12 to 24 monthsHealthy volunteers can take part
Conditions the study is for: Haemophilus Influenzae Type b, Tetanus, Hepatitis B
What is being tested?: GSK2036874A vaccine, Zilbrix™/Hib vaccine and Poliorix™
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 312 participants
Where: 1 sitePhilippines
Study dates: 13 May 2010to 2 Sep 2010
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 12 to 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s)/Legally Acceptable Representative (s) 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 other than the study vaccine(s) 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 dose.
Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2).
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.
Previous booster vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B or H. influenzae diseases.

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Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
A family history of congenital or hereditary immunodeficiency.
Major congenital defects or serious chronic illness.
History of neurologic disorders or seizures.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
Administration of immunoglobulins and/or any blood products within the three months preceding the booster dose or planned administration during the study period.
Occurrence of transient thrombocytopenia or neurological complications following an earlier immunisation against diphtheria and/or tetanus.
Child in care.
Occurrence of any of the following adverse events after a previous administration of a diphtheria-tetanus-pertussis vaccine:
encephalopathy of unknown aetiology occurring within seven days following previous vaccination with pertussis-containing vaccine,
fever >= 40 °C within 48 hours of vaccination not due to another identifiable cause,
collapse or shock-like state within 48 hours of vaccination,
convulsions with or without fever, occurring within 3 days of vaccination.
Acute disease and/or fever at the time of enrolment.
Fever is defined as temperature >= 37.5°C on oral, axillary or tympanic setting, or >= 38.0°C on rectal setting.
Subjects with a minor illness without fever may, be enrolled at the discretion of the investigator.
Other conditions which, in the opinion of the investigator, may potentially interfere with interpretation of study results.

Trial locations and contacts

1 site in 1 country.

Philippines1 site

GSK Investigational Site
City of Muntinlupa, 1781

Other trials in Philippines

About this study

Official title: Immunogenicity and Reactogenicity of a Booster Dose of GlaxoSmithKline Biologicals' GSK2036874A Vaccine in Healthy Toddlers

Read the detailed description

The study will be conducted in a partially double-blinded manner. The study will be double-blinded with respect to the three GSK2036874A formulation groups and open-label with respect to the Control Group.

Conditions: Haemophilus Influenzae Type b, Tetanus, Hepatitis B, Whole Cell Pertussis, Diphtheria, Poliomyelitis Vaccines
Being tested: GSK2036874A vaccine, Zilbrix™/Hib vaccine, Poliorix™
Medical subject headings: Haemophilus Infections, Tetanus, Hepatitis B, Diphtheria

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

GSK2036874A vaccineBiological
Intramuscular, single dose
Zilbrix™/Hib vaccineBiological
Intramuscular, single dose
Poliorix™Biological
Intramuscular, single dose

Study groups in NCT01106092
Study group	Role	What they receive
GSK2036874A GROUP 1	Experimental	Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0. Receives: Biological: GSK2036874A vaccine
GSK2036874A GROUP 2	Experimental	Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0. Receives: Biological: GSK2036874A vaccine
GSK2036874A GROUP 3	Experimental	Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0. Receives: Biological: GSK2036874A vaccine
ZILBRIX/HIB/POLIORIX GROUP	Active comparator	Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively. Receives: Biological: Zilbrix™/Hib vaccine; Biological: Poliorix™

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.
Measured: One month after booster vaccination (At Month 1)
Anti-polio Types 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: Prior to booster vaccination (At Month 0)
Anti-polio Types 1, 2 and 3 Antibody Titers
Antibody titers were presented as geometric mean titers (GMTs).
Measured: One month after booster vaccination (At Month 1)

Secondary outcomes (15)

Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3
Seroconversion was defined as: For initially seronegative subjects, antibody titer ≥ 8 ED50 one month after the booster dose. For initially seropositive subjects: antibody titer one month after the booster dose ≥ 4 fold the pre-booster antibody titer. For subjects with pre-booster antibody titer below the highest dilution tested (reciprocal < 8192 ED50): highest dilution tested one month after the booster dose (reciprocal > 8192 ED50).
Measured: One month after booster vaccination (At Month 1)
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.
Measured: Prior to booster vaccination (At Month 0)
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
Seroprotection was defined as anti-D and anti-T antibody concentration ≥ 0.1 international units per milliliter (IU/mL).
Measured: Prior to (At Month 0) and one month after 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: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)
Seropositivity was defined as anti-HBs antibody concentration ≥ 3.3 milli-international units per milliliter (mIU/mL). Seprotection was defined as anti-HBs antibody concentration ≥ 10 mIU/mL. Note that percentage of subjects with concentration ≥ 10 mIU/mL was over-estimated due to the use of in-house assay overestimating concentrations between 10-100 mIU/mL. Accordingly GMCs were also overestimated. A decrease in the specificity of the anti-HB ELISA assay had been observed in some studies for low levels of antibody (10-100 mIU/mL). The table shows updated results following partial or complete retesting/reanalysis. Some of the available blood samples initially tested with ELISA were re-tested using the new assay, CLIA.
Measured: Prior to (At Month 0) and 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: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)
Seprotection was defined as anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (μg/mL).
Measured: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Anti-PRP Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in μg/mL.
Measured: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)
Seropositivity was defined as anti-BPT antibody concentration ≥ 15 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL).
Measured: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
Anti-BPT Antibody Concentrations
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.
Measured: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Number of Subjects With a Booster Response for Anti-BPT
Booster response was defined as: For initially seronegative subjects, antibody concentration ≥ 15 EL.U/mL one month after the booster dose. For initially seropositive subjects: antibody concentration one month after the booster dose ≥ 2 fold the pre-booster antibody concentration.
Measured: One month after booster vaccination (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 8-day (Days 0-7) 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 (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of the symptom regardless of intensity grade.
Measured: During the 8-day (Days 0-7) 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 (Day 0-Day 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 to Month 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 May 20102 Sep 2010

First posted19 Apr 2010 (estimated)
Study start13 May 2010
Primary completion2 Sep 2010
Study completion2 Sep 2010

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Haemophilus Influenzae Type 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: 312 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01106092
Sponsor's protocol ID: 113264
Other IDs: 2016-000645-31, 2016
Status last verified: Sep 2019
First submitted: 1 Apr 2010
Last updated: 1 Oct 2019
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.

Publications

Quiambao B, Van Der Meeren O, Kolhe D, Gatchalian S. A randomized, dose-ranging assessment of the immunogenicity and safety of a booster dose of a combined diphtheria-tetanus-whole cell pertussis-hepatitis B-inactivated poliovirus-Hemophilus influenzae type b (DTPw-HBV-IPV/Hib) vaccine vs. co-administration of DTPw-HBV/Hib and IPV vaccines in 12 to 24 months old Filipino toddlers. Hum Vaccin Immunother. 2012 Mar;8(3):347-54. doi: 10.4161/hv.18630. Epub 2012 Feb 14.
PubMed 22330958
Quiambao B et al. The immunogenicity and safety of a new combined DTPw-HBV-IPV/HIB vaccine when administered as a booster dose in Filipino toddlers. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID), Melbourne, Australia, 16-19 November 2011.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study Interchangeability Hep-B Vaccine Administered at Birth Dose
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A Phase II/III Study to Evaluate the Immunogenicity, Safety and Lot-to-lot Consistency of LBVD, a Fully Liquid Hexavalent Diphtheria-tetanus-whole Cell Pertussis-hepatitis B-poliovirus-Haemophilus Influenzae Type b Conjugate (DTwP-HepB-IPV-Hib) Vaccine, in Healthy Infants as Primary Series
Diphtheria, Tetanus
Not yet recruitingPhase 3
Study of BK1803 in Healthy Infants
Pertussis, Diphtheria
Active, not recruitingPhase 1
Clinical Trial of Lyophilized Haemophilus Influenzae Type b Conjugate Vaccine
Haemophilus Influenzae Type B Infection

All Haemophilus Influenzae Type b trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Reactogenicity of a Booster Dose of GlaxoSmithKline Biologicals' GSK2036874A Vaccine in Healthy Toddlers
ClinicalTrials.gov ID: NCT01106092
Acronym / sponsor ID: 113264
Conditions: Haemophilus Influenzae Type b, Tetanus, Hepatitis B, Whole Cell Pertussis, Diphtheria, Poliomyelitis Vaccines
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 312 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 13 May 2010 (actual)
Primary completion: 2 Sep 2010 (actual)
Study completion: 2 Sep 2010 (actual)
First posted: 19 Apr 2010 (estimated)
Results: Posted 12 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 4

Arm	Type	Receives
GSK2036874A GROUP 1	Experimental	Biological: GSK2036874A vaccineHealthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 1) intramuscularly into the anterolateral region of the left thigh, at Day 0.
GSK2036874A GROUP 2	Experimental	Biological: GSK2036874A vaccineHealthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 2) intramuscularly into the anterolateral region of the left thigh, at Day 0.
GSK2036874A GROUP 3	Experimental	Biological: GSK2036874A vaccineHealthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of GSK2036874A vaccine (Formulation 3) intramuscularly into the anterolateral region of the left thigh, at Day 0.
ZILBRIX/HIB/POLIORIX GROUP	Active comparator	Biological: Zilbrix™/Hib vaccine, Biological: Poliorix™Healthy male or female children between and including 12 and 24 months of age at the time of the booster vaccination, who were primed with a three-dose vaccination course of polio vaccine, additionally received 1 dose of Zilbrix/Hib™ and Poliorix™ vaccines at Day 0, administered intramuscularly into the anterolateral regions of the left and right thighs, respectively.

Who may qualify

Ages: 12 to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

A male or female subject, between and including 12 and 24 months of age at the time of booster vaccination.
Subjects who have received three doses of polio vaccine as primary vaccination along with the routine vaccinations indicated during the first year of life.
Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative (s) can and will comply with the requirements of the protocol.
Written informed consent obtained from the parent(s)/Legally Acceptable Representative (s) of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (23 listed)

Use of any investigational or non-registered product other than the study vaccine(s) 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 dose.
Administration of a vaccine not foreseen by the study protocol within 30 days prior to booster vaccination, or planned administration during the active study period (up to Visit 2).
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
History of diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis and/or Haemophilus influenza type b diseases.

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
GSK2036874A vaccineIntramuscular, single dose	Biological	GSK2036874A GROUP 1, GSK2036874A GROUP 2, GSK2036874A GROUP 3
Zilbrix™/Hib vaccineIntramuscular, single dose	Biological	ZILBRIX/HIB/POLIORIX GROUP
Poliorix™Intramuscular, single dose	Biological	ZILBRIX/HIB/POLIORIX GROUP

Primary outcome

Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Time frame: One month after booster vaccination (At Month 1)
Seroprotection was defined as anti-polio types 1, 2 and 3 antibody titres ≥ 8 effective dose (ED50), for 50% of vaccinated subjects.
Anti-polio Types 1, 2 and 3 Antibody Titers
Time frame: Prior to booster vaccination (At Month 0)
Antibody titers were presented as geometric mean titers (GMTs).
Anti-polio Types 1, 2 and 3 Antibody Titers
Time frame: One month after booster vaccination (At Month 1)
Antibody titers were presented as geometric mean titers (GMTs).

15 secondary outcomes

Number of Seroconverted Subjects for Anti-polio Types 1, 2 and 3
Time frame: One month after booster vaccination (At Month 1)
Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3
Time frame: Prior to booster vaccination (At Month 0)
Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T)
Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Anti-D and Anti-T Antibody Concentrations
Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Number of Seroprotected and Seropositive Subjects for Anti-hepatitis B (Anti-HBs)
Time frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
Anti-HBs Antibody Concentrations
Time frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
Number of Seroprotected Subjects Against Polyribosil-ribitol-phosphate (PRP)
Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Anti-PRP Antibody Concentrations
Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Number of Seropositive Subjects for Anti-Bordetella Pertussis (Anti-BPT)
Time frame: Prior to (At Month 0) and one month after the booster vaccination (At Month 1)
Anti-BPT Antibody Concentrations
Time frame: Prior to (At Month 0) and one month after booster vaccination (At Month 1)
Number of Subjects With a Booster Response for Anti-BPT
Time frame: One month after booster vaccination (At Month 1)
Number of Subjects With Any Solicited Local Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period
Number of Subjects With Any Solicited General Symptoms
Time frame: During the 8-day (Days 0-7) post-vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: During the 31-day (Day 0-Day 30) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Month 0 to Month 1)

Results and safety

Results posted to the registry on 12 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK2036874A Group 1	78	78
GSK2036874A Group 2	78	78
GSK2036874A Group 3	78	78
Zilbrix/Hib/Poliorix Group	78	77

Primary outcome: Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3

Time frame: One month after booster vaccination (At Month 1). Count of participants. Unit: Participants

Measure	GSK2036874A Group 1 n = 78	GSK2036874A Group 2 n = 78	GSK2036874A Group 3 n = 78	Zilbrix/Hib/Poliorix Group n = 77
Anti-polio 1	78	77	78	77
Anti-polio 2	77	78	78	77
Anti-polio 3	77	77	78	77

GSK2036874A Group 1 vs Zilbrix/Hib/Poliorix Group: Difference in seroprotection rate: 0 (95% CI -4.78 to 4.72)
GSK2036874A Group 2 vs Zilbrix/Hib/Poliorix Group: Difference in seroprotection rate: 1.28 (95% CI -3.53 to 6.94)
GSK2036874A Group 3 vs Zilbrix/Hib/Poliorix Group: Difference in seroprotection rate: 0 (95% CI -4.78 to 4.72)

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Primary outcome: Anti-polio Types 1, 2 and 3 Antibody Titers

Time frame: Prior to booster vaccination (At Month 0). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	GSK2036874A Group 1 n = 78	GSK2036874A Group 2 n = 78	GSK2036874A Group 3 n = 78	Zilbrix/Hib/Poliorix Group n = 77
Anti-polio 1	321.1 (231.2 to 446.0)	219.1 (144.0 to 333.6)	296.6 (205.1 to 428.8)	296.9 (213.9 to 412.1)
Anti-polio 2	186.8 (140.1 to 249.2)	152.2 (111.8 to 207.3)	183.4 (146.4 to 229.7)	148.0 (112.4 to 194.9)
Anti-polio 3	74.5 (56.0 to 99.0)	82.1 (62.1 to 108.6)	102.1 (77.6 to 134.4)	79.1 (57.9 to 108.1)

Population analysed: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

Primary outcome: Anti-polio Types 1, 2 and 3 Antibody Titers

Time frame: One month after booster vaccination (At Month 1). Geometric mean (95% Confidence Interval). Unit: Titers

Measure	GSK2036874A Group 1 n = 78	GSK2036874A Group 2 n = 78	GSK2036874A Group 3 n = 78	Zilbrix/Hib/Poliorix Group n = 77
Anti-polio 1	2218.4 (1786.3 to 2755.1)	1486.7 (1065.9 to 2073.5)	1245.1 (1007.2 to 1539.2)	3760.2 (2973.7 to 4754.7)
Anti-polio 2	1598.8 (1293.5 to 1976.3)	1056.4 (841.5 to 1326.1)	966.5 (779.5 to 1198.3)	2883.2 (2275.2 to 3653.8)
Anti-polio 3	2820 (2129.9 to 3733.9)	2217.7 (1654 to 2973.4)	1915.8 (1498.1 to 2449.8)	3626.4 (2618.2 to 5022.9)

Population analysed: The analysis was performed on the ATP cohort for immunogenicity, which included all evaluable subjects for whom immunogenicity data were available.

15 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local/general symptoms: During the 8-day (Days 0-7) follow-up period after vaccination. Unsolicited AE(s): During the 31-day (Days 0-30) follow-up period after vaccination. SAE(s): During the entire study period (from Month 0 to Month 1).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK2036874A Group 1	1 of 78 (1.3%)	75 of 78 (96.2%)	0 of 78
GSK2036874A Group 2	3 of 78 (3.8%)	74 of 78 (94.9%)	0 of 78
GSK2036874A Group 3	2 of 78 (2.6%)	76 of 78 (97.4%)	0 of 78
Zilbrix/Hib/Poliorix Group	1 of 78 (1.3%)	77 of 78 (98.7%)	0 of 78

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 22330958Quiambao B, Van Der Meeren O, Kolhe D, Gatchalian S. A randomized, dose-ranging assessment of the immunogenicity and safety of a booster dose of a combined diphtheria-tetanus-whole cell pertussis-hepatitis B-inactivated poliovirus-Hemophilus influenzae type b (DTPw-HBV-IPV/Hib) vaccine vs. co-administration of DTPw-HBV/Hib and IPV vaccines in 12 to 24 months old Filipino toddlers. Hum Vaccin Immunother. 2012 Mar;8(3):347-54. doi: 10.4161/hv.18630. Epub 2012 Feb 14.
BackgroundQuiambao B et al. The immunogenicity and safety of a new combined DTPw-HBV-IPV/HIB vaccine when administered as a booster dose in Filipino toddlers. Abstract presented at the 7th World Congress for World Society for Pediatric Infectious Diseases (WSPID), Melbourne, Australia, 16-19 November 2011.
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 GSK2036874A vaccine, Zilbrix™/Hib vaccine and Poliorix™ in people with Haemophilus Influenzae Type b and Tetanus, run by GlaxoSmithKline at 1 site in Philippines.

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 23 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 1 Oct 2019. 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 Philippines. 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 12 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 Poliovirus Types 1, 2 and 3 (time frame: One month after booster vaccination (At Month 1)). The study lists 3 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 NCT01106092, 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 1 Oct 2019.