PoliomyelitisPhase 3NCT01309646

Immunogenicity and Safety of GlaxoSmithKline Biologicals' Infanrix™-IPV+Hib Vaccine

A Phase 3 study testing Infanrix™-IPV+Hib, Infanrix™ IPV and Hiberix™ in people with Poliomyelitis and Tetanus, run by GlaxoSmithKline at 11 sites in South Korea.

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 Infanrix™-IPV+Hib vaccine when administered as a primary vaccination course to healthy Korean infants at 2, 4 and 6 months of age. Read more about this study

Who is it for?: Ages 42 to 69 daysHealthy volunteers can take part
Conditions the study is for: Poliomyelitis, Tetanus, Acellular Pertussis
What is being tested?: Infanrix™-IPV+Hib, Infanrix™ IPV and Hiberix™
Type of treatment: Vaccines, Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 454 participants
Where: 11 sitesSouth Korea
Study dates: 4 Mar 2011to 24 Feb 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 42 to 69 days
All sexes
Healthy volunteers accepted
Child

Who may be able to join

A male or female between, and including, 42 and 69 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 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 vaccine(s) within 30 days preceding the first dose, 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, with the exception of hepatitis B and Bacillus Calmette-Guérin vaccination; or planned administration during the study period, with the exception of hepatitis B and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the DTPa vaccine.
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, poliomyelitis and Hib vaccination or disease.

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

11 sites in 1 country.

City, postcode or hospital

11 sites in 1 country

South Korea11 sites

GSK Investigational Site
Daegu, 700-712
GSK Investigational Site
Goyang
GSK Investigational Site
GyeongSangNam-do, 641-560
GSK Investigational Site
Iksan, 570-711
GSK Investigational Site
Jeonju Jeonbuk, 561-712
GSK Investigational Site
Seongnam-si, 463-712
GSK Investigational Site
Seoul, 120-752
GSK Investigational Site
Seoul, 139-706
GSK Investigational Site
Suwon City, Gyeonggi-do, 442-723
GSK Investigational Site
Uijeongbu, Gyeonggi-do, 480-717
GSK Investigational Site
Wonju-si Kangwon-do, 220-701

Other trials in South Korea

About this study

Official title: Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix™-IPV+Hib) Vaccine in Healthy Korean Infants

Conditions: Poliomyelitis, Tetanus, Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b
Being tested: Infanrix™-IPV+Hib, Infanrix™ IPV, Hiberix™, Synflorix™, Rotarix™
Keywords: Primary vaccination, combination vaccine, South Korea
Medical subject headings: Poliomyelitis, Tetanus, Diphtheria, Haemophilus Infections

What participants receive

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

Infanrix™-IPV+HibBiological
Intramuscular, 3 doses
Infanrix™ IPVBiological
Intramuscular, 3 doses
Hiberix™Biological
Intramuscular, 3 doses
Synflorix™Biological
Intramuscular, 3 doses
Rotarix™Biological
Oral, 2 doses

Study groups in NCT01309646
Study group	Role	What they receive
Infanrix-IPV+Hib Group	Experimental	Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally. Receives: Biological: Infanrix™-IPV+Hib; Biological: Synflorix™; Biological: Rotarix™
Infanrix IPV Group	Active comparator	Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally. Receives: Biological: Infanrix™ IPV; Biological: Hiberix™; Biological: Synflorix™; Biological: Rotarix™

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 an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).
Measured: At Month 5
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.
Measured: At Month 5
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Measured: At Month 5
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL).
Measured: At Month 5

Secondary outcomes (13)

Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).
A seropositive subjects was defined as a vaccinated subjects who had an anti-PRN, anti-PT and anti-FHA antibody concentration ≥ 5 ELISA units per milliliter (EL.U/mL).
Measured: At Month 0 and Month 5
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 EL.U/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 an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).
Measured: At Month 0
Concentrations for Anti-D and 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 Month 0 and Month 5
Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.
Measured: At Month 0
Titres for Anti-polio Types 1, 2 and 3.
Titres were expressed as geometric mean titres (GMTs). The seroprotection cut-off of the assay was 8.
Measured: At Month 0 and Month 5
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Measured: At Month 0
Concentrations of 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 0 and Month 5
Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.
Vaccine response was defined as antibody concentration ≥ 5 EL.U/mL at post vaccination, for initially seronegative subjects, and at least maintenance of antibody concentration from pre to post-vaccination (i.e. antibody concentration at post vaccination ≥ 1 fold the pre-vaccination antibody concentration), for initially seropositive subjects.
Measured: At Month 5
Number of Subjects With Any Solicited Local Symptoms.
Assessed solicited local symptoms were pain, redness and swelling at the injection site. Any = incidence of a particular symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Number of Subjects With Any Solicited General Symptoms.
Assessed solicited general symptoms were drowsiness, irritability/fussiness, loss of appetite and fever [defined as tympanic temperature ≥ 37.5 degrees Celsius (°C)]. Any = incidence of a particular symptom regardless of intensity grade.
Measured: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Unsolicited AE covers any AE 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 = any unsolicited AE regardless of intensity or relationship to vaccination.
Measured: During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Number of Subjects With Any 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 7)

Timeline

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

4 Mar 201124 Feb 2012

First posted7 Mar 2011 (estimated)
Study start4 Mar 2011
Primary completion24 Feb 2012
Study completion24 Feb 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 PoliomyelitisStudies 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: 454 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01309646
Sponsor's protocol ID: 114260
Other IDs: 2012-004137-16
Status last verified: Nov 2019
First submitted: 24 Feb 2011
Last updated: 27 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)

Publications

Kim KH, Kim CS, Kim HM, Kim JD, Ma SH, Kim DH, Hwang PH, Han JW, Lee TJ, Kim JH, Karkada N, Mesaros N, Sohn WY, Kim JH. Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course in healthy Korean infants: phase III, randomized study. Hum Vaccin Immunother. 2019;15(2):317-326. doi: 10.1080/21645515.2018.1536588. Epub 2018 Nov 15.
PubMed 30431387

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?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of GlaxoSmithKline Biologicals' DTPa-IPV/Hib (Infanrix™-IPV+Hib) Vaccine in Healthy Korean Infants
ClinicalTrials.gov ID: NCT01309646
Acronym / sponsor ID: 114260
Conditions: Poliomyelitis, Tetanus, Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b
Keywords: Primary vaccination, combination vaccine, South Korea
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 454 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 4 Mar 2011 (actual)
Primary completion: 24 Feb 2012 (actual)
Study completion: 24 Feb 2012 (actual)
First posted: 7 Mar 2011 (estimated)
Results: Posted 2 Apr 2013

Clinical summary

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

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Infanrix-IPV+Hib Group	Experimental	Biological: Infanrix™-IPV+Hib, Biological: Synflorix™, Biological: Rotarix™Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™-IPV+Hib at 2, 4 and 6 months of age, 3 doses of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™-IPV+Hib was administered intramuscularly in the right thigh, the Synflorix™ vaccine was administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.
Infanrix IPV Group	Active comparator	Biological: Infanrix™ IPV, Biological: Hiberix™, Biological: Synflorix™, Biological: Rotarix™Subjects aged between, and including, 42 and 69 days at the time of first vaccination received 3 doses of Infanrix™ IPV and Hiberix™ co-administered at separate injection sites at 2, 4 and 6 months of age, 3 dose of Synflorix™ at 6 weeks, 3.5 and 5.5 months of age and 2 doses of Rotarix™ at 6 weeks and 3.5 months of age. The Infanrix™ IPV was administered intramuscularly in the right thigh, the Synflorix™ and Hiberix™ vaccines were administered intramuscularly in the left thigh and the Rotarix™ vaccine was administered orally.

Who may qualify

Ages: 42 to 69 days
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

A male or female between, and including, 42 and 69 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 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 vaccine(s) within 30 days preceding the first dose, 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, with the exception of hepatitis B and Bacillus Calmette-Guérin vaccination; or planned administration during the study period, with the exception of hepatitis B and influenza vaccines, which will be allowed at least 7 days before or 30 days after the administration of the DTPa vaccine.
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™-IPV+HibIntramuscular, 3 doses	Biological	Infanrix-IPV+Hib Group
Infanrix™ IPVIntramuscular, 3 doses	Biological	Infanrix IPV Group
Hiberix™Intramuscular, 3 doses	Biological	Infanrix IPV Group
Synflorix™Intramuscular, 3 doses	Biological	Infanrix IPV Group, Infanrix-IPV+Hib Group
Rotarix™Oral, 2 doses	Biological	Infanrix IPV Group, Infanrix-IPV+Hib Group

Primary outcome

Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Time frame: At Month 5
A seroprotected subject was defined as a vaccinated subject who had an anti-D and anti-T antibody concentration equal to or above (≥) 0.1 international units per milliliter (IU/mL).
Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Time frame: At Month 5
A seroprotected subject was defined as a vaccinated subject who had an anti-polio types 1, 2 and 3 antibody titres equal to or above (≥) 8, cut off corresponding to the effective dose for 50% of the vaccinated subjects.
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
Time frame: At Month 5
A seroprotected subject was defined as a vaccinated subject who had an anti-PRP antibody concentration ≥ 0.15 micrograms per milliliter (µg/mL).
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.
Time frame: At Month 5
Concentrations were expressed as geometric mean concentrations (GMCs) for the seropositivity cut-off of 5 ELISA units per milliliter (EL.U/mL).

13 secondary outcomes

Number of Seropositive Subjects for Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN).
Time frame: At Month 0 and Month 5
Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations
Time frame: At Month 0
Number of Seroprotected Subjects for Anti-diphtheria (Anti-D) and Anti-tetanus (Anti-T) Antibodies.
Time frame: At Month 0
Concentrations for Anti-D and Anti-T Antibodies.
Time frame: At Month 0 and Month 5
Number of Seroprotected Subjects Anti-poliovirus (Anti-polio) Types 1, 2 and 3.
Time frame: At Month 0
Titres for Anti-polio Types 1, 2 and 3.
Time frame: At Month 0 and Month 5
Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.
Time frame: At Month 0
Concentrations of Anti-PRP Antibodies.
Time frame: At Month 0 and Month 5
Number of Subjects With a Vaccine Response to Anti-PT, Anti-FHA and Anti-PRN.
Time frame: At Month 5
Number of Subjects With Any Solicited Local Symptoms.
Time frame: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Number of Subjects With Any Solicited General Symptoms.
Time frame: During the 4-day (Days 0-3) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Number of Subjects With Any Unsolicited Adverse Events (AEs).
Time frame: During the 31-day (Days 0-30) follow-up period after any vaccination with Infanrix™-IPV+Hib or Infanrix™ IPV + Hiberix™
Number of Subjects With Any Serious Adverse Events (SAEs).
Time frame: During the entire study period (from Month 0 to Month 7)

Results and safety

Results posted to the registry on 2 Apr 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Infanrix-IPV+Hib Group	224	224
Infanrix IPV Group	227	227

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

Time frame: At Month 5. Count of participants. Unit: Participants

Measure	Infanrix-IPV+Hib Group n = 213	Infanrix IPV Group n = 217
Anti-D	213	217
Anti-T	213	217

Population analysed: The analysis was performed on the According-To-Protocol cohort for immunogenicity, which included all evaluable subjects who received one dose of either study vaccine according to their random assignment, for whom administration site of study vaccine was known and for whom immunogenicity data were available.

Primary outcome: Number of Seroprotected Subjects for Anti-poliovirus (Anti-polio) Types 1, 2 and 3.

Time frame: At Month 5. Count of participants. Unit: Participants

Measure	Infanrix-IPV+Hib Group n = 212	Infanrix IPV Group n = 216
Anti-Polio 1	212	216
Anti-Polio 2	204	211
Anti-polio 3	197	197

Primary outcome: Number of Seroprotected Subjects for Anti-polyribosyl-ribitol-phosphate (Anti-PRP) Antibodies.

Time frame: At Month 5. Count of participants. Unit: Participants

Measure	Infanrix-IPV+Hib Group n = 213	Infanrix IPV Group n = 217
Value	213	217

Primary outcome: Anti-pertussis Toxoid (PT), Anti-filamentous Haemagglutinin (FHA) and Anti-pertactin (PRN) Antibody Concentrations.

Time frame: At Month 5. Geometric mean (95% Confidence Interval). Unit: EL.U/mL

Measure	Infanrix-IPV+Hib Group n = 213	Infanrix IPV Group n = 217
Anti-PT	54.2 (50.4 to 58.3)	56 (51.8 to 60.5)
Anti-FHA	125 (115.4 to 135.4)	134.2 (124.2 to 145)
Anti-PRN	125.8 (116 to 136.5)	133.4 (123 to 144.6)

13 secondary outcomes are reported in the full results.

Adverse events

Time frame: SAE(s): during the entire study period (Month 0 to Month 7); Solicited local/general symptoms: during the 4-day (Days 0-3) follow-up period after any vaccination; Unsolicited AE(s): during the 31-day (Days 0-30) follow-up period after any vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Infanrix-IPV+Hib Group	25 of 224 (11.2%)	218 of 224 (97.3%)	0 of 224
Infanrix IPV Group	21 of 227 (9.3%)	220 of 227 (96.9%)	0 of 227

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 30431387Kim KH, Kim CS, Kim HM, Kim JD, Ma SH, Kim DH, Hwang PH, Han JW, Lee TJ, Kim JH, Karkada N, Mesaros N, Sohn WY, Kim JH. Immunogenicity and safety of a combined DTPa-IPV/Hib vaccine administered as a three-dose primary vaccination course in healthy Korean infants: phase III, randomized study. Hum Vaccin Immunother. 2019;15(2):317-326. doi: 10.1080/21645515.2018.1536588. Epub 2018 Nov 15.
Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)

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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

11 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™-IPV+Hib, Infanrix™ IPV and Hiberix™ in people with Poliomyelitis and Tetanus, run by GlaxoSmithKline at 11 sites in South Korea.

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 27 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in South Korea. 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 2 Apr 2013). 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 5). The study lists 4 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 NCT01309646, 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 27 Nov 2019.