TetanusPhase 2NCT01248884

Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744)

A Phase 2 study testing Infanrix hexa™, Prevenar 13® and GSK217744 in people with Tetanus and Poliomyelitis, run by GlaxoSmithKline at 16 sites in 2 countries.

Completed

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

Official record

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Trial summary

This study is designed to evaluate the safety and immunogenicity of new formulations of GSK Biologicals' DTPa-HBV-IPV/Hib vaccine (GSK217744) when administered as a primary vaccination course to healthy infants at 2, 3 and 4 months of age. Read more about this study

Who is it for?: Ages 60 to 90 daysHealthy volunteers can take part
Conditions the study is for: Tetanus, Poliomyelitis, Hepatitis B
What is being tested?: Infanrix hexa™, Prevenar 13® and GSK217744
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 721 participants
Where: 16 sitesin 2 countries
Study dates: 9 Dec 2010to 5 Jan 2012
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 60 to 90 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

A male or female between, and including, 60 and 90 days of age at the time of the first vaccination.
Born after a gestation period of 37 to 42 weeks inclusive.
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

Child in care.
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study.
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.
Evidence of previous or intercurrent diphtheria, tetanus, pertussis, polio, hepatitis B, Hib and/or pneumococcal vaccination or disease, with the exception of hepatitis B vaccination at birth.

Show all 13Show fewer

Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination.
Family history of congenital or hereditary immunodeficiency.
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccine(s).
Major congenital defects or serious chronic illness.
History of any neurological disorders or seizures.
Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Acute disease and/or fever at the time of enrolment.

Trial locations and contacts

16 sites in 2 countries.

Country

City, postcode or hospital

16 sites in 2 countries

Finland14 sites

GSK Investigational Site
Espoo, 02100
GSK Investigational Site
Helsinki, 00100
GSK Investigational Site
Helsinki, 00930
GSK Investigational Site
Jarvenpaa, 04400
GSK Investigational Site
Kokkola, 67100
GSK Investigational Site
Kuopio, 70210
GSK Investigational Site
Lahti, 15140
GSK Investigational Site
Oulu, 90220
GSK Investigational Site
Pori, 28100
GSK Investigational Site
Seinäjoki, 60100
GSK Investigational Site
Tampere, 33100
GSK Investigational Site
Turku, 20520
GSK Investigational Site
Vantaa, 01300
GSK Investigational Site
Vantaa, 01600

Other trials in Finland

Dominican Republic2 sites

GSK Investigational Site
Santo Domingo
GSK Investigational Site
Santo Domingo, Distrito Nacional

Other trials in Dominican Republic

About this study

Official title: Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744) in Primary Infant Vaccination

Read the detailed description

This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the exclusion criteria.

Conditions: Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria
Being tested: Infanrix hexa™, Prevenar 13®, GSK217744
Keywords: combination vaccine, Primary vaccination
Medical subject headings: Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Infections, Diphtheria

What participants receive

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

Infanrix hexa™Biological
Also called DTPa-HBV-IPV/Hib
3 doses, intramuscular into left thigh
Prevenar 13®Biological
Also called Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine
3 co-administered doses, intramuscular into right thigh
GSK217744Biological
3 doses, intramuscular into left thigh

Study groups in NCT01248884
Study group	Role	What they receive
GSK217744 Group 1	Experimental	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively. Receives: Biological: Prevenar 13®; Biological: GSK217744
GSK217744 Group 2	Experimental	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively. Receives: Biological: Prevenar 13®; Biological: GSK217744
Infanrix hexa Group	Active comparator	Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively. Receives: Biological: Infanrix hexa™; Biological: Prevenar 13®

What is being measured

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

Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Measured: At Month 0
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Measured: At Month 3
Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Measured: At Month 0
Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Measured: At Month 3
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Measured: At Month 3
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)
A seroprotected subject was defined as a vaccinated subject who had anti-HBs antibody concentrations ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
Measured: At Month 3
Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL
A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/mL).
Measured: At Month 3

Secondary outcomes (10)

Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was 0.1 IU/mL.
Measured: At Months 0 and 3
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
A seropositive subject was defined as a vaccinated subject who had anti-PT and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
Measured: At Months 0 and 3
Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 0.15 µg/mL.
Measured: At Month 3
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
A seropositive subject was defined as a vaccinated subject who had anti- pneumococcal antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL). The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Measured: At Month 3
Concentrations for Anti-PNE Antibodies.
Concentrations were expressed as geometric mean concentrations (GMCs). The seropositivity cut-off of the assay was 0.15 µg /mL. The anti-PNE serotypes assessed were 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F.
Measured: At Month 3
Number of Subjects With a Vaccine Response to PT and PRN.
Vaccine response defined as: for initially seronegative subjects, antibody concentration ≥ 5 EL.U/mL at 1 month post primary vaccination (Month 3); for initially seropositive subjects, antibody concentration at 1 month post primary vaccination (Month 3) ≥ 1 fold the pre-vaccination antibody concentration.
Measured: At Month 3
Number of Subjects Reporting Any Solicited Local Symptoms.
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of any local symptom regardless of intensity grade.
Measured: During the 8-day (Days 0-7)
Number of Subjects Reporting Any Solicited General Symptoms.
Solicited local symptoms assessed were drowsiness, irritability, loss of appetite and fever [axillary temperature above (≥) 37.5 degrees Celsius (°C)]. Any = occurrence of any local symptom regardless of intensity grade.
Measured: During the 8-day (Days 0-7)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
An unsolicited AE is any AE (i.e. any untoward medical occurrence in a patient or clinical investigation subject, temporally associated with use of a medicinal product, whether or not considered related to the medicinal product) 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 = occurrence of an AE regardless of intensity grade or relationship to study vaccination.
Measured: Within the 31-day (Days 0-30) follow up period after vaccination.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects. Any SAE = any SAE regardless of assessment of relationship to study vaccination.
Measured: During the entire study period (Month 0 to Month 3)

Timeline

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

9 Dec 20105 Jan 2012

First posted25 Nov 2010 (estimated)
Study start9 Dec 2010
Primary completion5 Jan 2012
Study completion5 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.
Publications (1)Papers the sponsor has linked to this study.
Other trials for TetanusStudies 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: 721 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01248884
Sponsor's protocol ID: 113948
Status last verified: Jul 2014
First submitted: 24 Nov 2010
Last updated: 20 Aug 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

Vesikari T, Rivera L, Korhonen T, Ahonen A, Cheuvart B, Hezareh M, Janssens W, Mesaros N. Immunogenicity and safety of primary and booster vaccination with 2 investigational formulations of diphtheria, tetanus and Haemophilus influenzae type b antigens in a hexavalent DTPa-HBV-IPV/Hib combination vaccine in comparison with the licensed Infanrix hexa. Hum Vaccin Immunother. 2017 Jul 3;13(7):1505-1515. doi: 10.1080/21645515.2017.1294294. Epub 2017 Mar 24.
PubMed 28340322

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 at a glance

From the registry record, last updated by the sponsor on 20 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Immunogenicity of New Formulations of GlaxoSmithKline Biologicals' DTPa-HBV-IPV/Hib Vaccine (GSK217744) in Primary Infant Vaccination
ClinicalTrials.gov ID: NCT01248884
Acronym / sponsor ID: 113948
Conditions: Tetanus, Poliomyelitis, Hepatitis B, Haemophilus Influenzae Type b, Acellular Pertussis, Diphtheria
Keywords: combination vaccine, Primary vaccination
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 721 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 9 Dec 2010
Primary completion: 5 Jan 2012 (actual)
Study completion: 5 Jan 2012 (actual)
First posted: 25 Nov 2010 (estimated)
Results: Posted 6 Jun 2014

Clinical summary

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

Detailed description

This Protocol Posting has been updated following Protocol Amendment 1, February 2011, leading to the update of the exclusion criteria.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 3

Arm	Type	Receives
GSK217744 Group 1	Experimental	Biological: Prevenar 13®, Biological: GSK217744Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation A vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
GSK217744 Group 2	Experimental	Biological: Prevenar 13®, Biological: GSK217744Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of GSK217744 formulation B vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The GSK217744 and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.
Infanrix hexa Group	Active comparator	Biological: Infanrix hexa™, Biological: Prevenar 13®Subjects aged between and including 60 and 90 days of age at the time of first vaccination received 3 doses of Infanrix hexa™ vaccine, co-administered with Prevenar 13® at 2, 3 and 4 months of age. The Infanrix hexa™ and Prevenar 13® vaccines were administered intramuscularly into the left and right sides of the thigh, respectively.

Who may qualify

Ages: 60 to 90 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

A male or female between, and including, 60 and 90 days of age at the time of the first vaccination.
Born after a gestation period of 37 to 42 weeks inclusive.
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 (13 listed)

Child in care.
Use of any investigational or non-registered product other than the study vaccines within 30 days preceding the first dose of study vaccine, or planned use during the study period.
Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
Administration of a vaccine not foreseen by the study protocol, within 30 days prior to the first study visit, or planned administration during the study period, with the exception of oral rotavirus vaccination which is allowed at any time during the study.
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.

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 hexa™Also: DTPa-HBV-IPV/Hib3 doses, intramuscular into left thigh	Biological	Infanrix hexa Group
Prevenar 13®Also: Pfizer's 13-valent pneumococcal polysaccharide conjugate vaccine3 co-administered doses, intramuscular into right thigh	Biological	GSK217744 Group 1, GSK217744 Group 2, Infanrix hexa Group
GSK2177443 doses, intramuscular into left thigh	Biological	GSK217744 Group 1, GSK217744 Group 2

Primary outcome

Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Time frame: At Month 0
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Time frame: At Month 3
A seroprotected subject was defined as a vaccinated subject who had anti-D and anti-T antibody concentrations ≥ 0.1 international units per milliliter (IU/mL).
Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Time frame: At Month 0
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Time frame: At Month 3
Concentrations were expressed as geometric mean concentrations (GMCs). The seroprotection cut-off of the assay was ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliters (EL.U/mL).
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
Time frame: At Month 3
A seroprotected subject was defined as a vaccinated subject who had anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL).
Number of Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentration Equal to or Above (≥) 10 and 100 Milli-International Units Per Milliliter (mIU/mL)
Time frame: At Month 3
A seroprotected subject was defined as a vaccinated subject who had anti-HBs antibody concentrations ≥ 10 mIU/mL. A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis.
Concentrations for Anti-HBs Antibodies ≥ 10 and 100 mIU/mL
Time frame: At Month 3
A decrease in the specificity of the anti-HB enzyme-linked immunosorbent assay (ELISA) had been observed in some studies for low levels of antibody (10-100 mIU/mL). All the available blood samples initially tested with ELISA were re-tested using the Chemi Luminescence Immuno Assay (CLIA) approved by the US Food and Drug Administration (FDA). The table shows updated results following partial or complete retesting/reanalysis. Concentrations were expressed as geometric mean concentrations (GMCs) in milli-International units per milliliter (mIU/mL).

10 secondary outcomes

Concentrations for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Time frame: At Months 0 and 3
Number of Seropositive Subjects for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.
Time frame: At Months 0 and 3
Concentrations for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
Time frame: At Month 3
Number of Seropositive Subjects for Anti-pneumococcal (Anti-PNE) Serotypes.
Time frame: At Month 3
Concentrations for Anti-PNE Antibodies.
Time frame: At Month 3
Number of Subjects With a Vaccine Response to PT and PRN.
Time frame: At Month 3
Number of Subjects Reporting Any Solicited Local Symptoms.
Time frame: During the 8-day (Days 0-7)
Number of Subjects Reporting Any Solicited General Symptoms.
Time frame: During the 8-day (Days 0-7)
Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).
Time frame: Within the 31-day (Days 0-30) follow up period after vaccination.
Number of Subjects Reporting Any Serious Adverse Events (SAEs).
Time frame: During the entire study period (Month 0 to Month 3)

Results and safety

Results posted to the registry on 6 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
GSK217744 Group 1	240	238
GSK217744 Group 2	242	239
Infanrix Hexa Group	239	238

Primary outcome: Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

Time frame: At Month 0. Count of participants. Unit: Participants

Measure	GSK217744 Group 1 n = 200	GSK217744 Group 2 n = 210	Infanrix Hexa Group n = 211
Anti-D	154	165	160
Anti-T	197	206	209

Population analysed: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects, who complied with the protocol, for whom immunogenicity data were available and for whom assay results were available for antibodies against at least one study vaccine antigen component after at least one vaccination.

Primary outcome: Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.

Time frame: At Month 3. Count of participants. Unit: Participants

Measure	GSK217744 Group 1 n = 214	GSK217744 Group 2 n = 217	Infanrix Hexa Group n = 219
Anti-D	214	217	219
Anti-T	214	217	219

GSK217744 Group 1 vs Infanrix Hexa Group: Difference in percentage: 0 (97.5% CI -2.25 to 2.3)
GSK217744 Group 1 vs Infanrix Hexa Group: Difference in percentage: 0 (97.5% CI -2.25 to 2.3)
GSK217744 Group 2 vs Infanrix Hexa Group: Difference in percentage: 0 (97.5% CI -2.25 to 2.27)

Primary outcome: Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.

Time frame: At Month 0. Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	GSK217744 Group 1 n = 200	GSK217744 Group 2 n = 210	Infanrix Hexa Group n = 210
Anti-PT	3.3 (3.0 to 3.6)	3.4 (3.1 to 3.7)	3.1 (2.9 to 3.4)
Anti-PRN	5.1 (4.5 to 5.9)	4.9 (4.3 to 5.5)	4.9 (4.3 to 5.7)

Primary outcome: Concentrations for Anti-pertussis Toxoid (Anti-PT) and Anti-pertactin (Anti-PRN) Antibodies.

Time frame: At Month 3. Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	GSK217744 Group 1 n = 215	GSK217744 Group 2 n = 217	Infanrix Hexa Group n = 219
Anti-PT	57.7 (52.9 to 62.9)	57.5 (53.1 to 62.4)	73.2 (67.7 to 79.2)
Anti-PRN	76.6 (68.1 to 86.3)	65.7 (58.9 to 73.3)	106.6 (96.6 to 117.8)

GSK217744 Group 1 vs Infanrix Hexa Group: GMC ratio: 1.26 (97.5% CI 1.11 to 1.44)
GSK217744 Group 1 vs Infanrix Hexa Group: GMC ratio: 1.33 (97.5% CI 1.14 to 1.54)
GSK217744 Group 2 vs Infanrix Hexa Group: GMC ratio: 1.25 (97.5% CI 1.1 to 1.43)

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited symptoms: 8-day follow-up period after vaccination; unsolicited AEs: 31-day follow-up period after vaccination; SAEs: during the entire study period (Months 0-3).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
GSK217744 Group 1	9 of 240 (3.8%)	240 of 240 (100%)	Not reported
GSK217744 Group 2	5 of 242 (2.1%)	239 of 242 (98.8%)	Not reported
Infanrix Hexa Group	4 of 239 (1.7%)	235 of 239 (98.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 28340322Vesikari T, Rivera L, Korhonen T, Ahonen A, Cheuvart B, Hezareh M, Janssens W, Mesaros N. Immunogenicity and safety of primary and booster vaccination with 2 investigational formulations of diphtheria, tetanus and Haemophilus influenzae type b antigens in a hexavalent DTPa-HBV-IPV/Hib combination vaccine in comparison with the licensed Infanrix hexa. Hum Vaccin Immunother. 2017 Jul 3;13(7):1505-1515. doi: 10.1080/21645515.2017.1294294. Epub 2017 Mar 24.

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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
Not yet recruitingPhase 1/2
Safety and Immunogenicity of a Combined Diphtheria, Tetanus, Whole Cell Pertussis, Hepatitis B, Recombinant Poliomyelitis and Haemophilus Influenzae Type b (Hib) Vaccine (SIIPL DTwP-HepB-rPV-Hib)
Diptheria Immunization, Tetanus Immunization

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

16 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Infanrix hexa™, Prevenar 13® and GSK217744 in people with Tetanus and Poliomyelitis, run by GlaxoSmithKline at 16 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in Finland, Dominican Republic. 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 6 Jun 2014). 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 for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies. (time frame: At Month 0). The study lists 7 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 NCT01248884, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2018.