NCT01086423 is a Phase 3 clinical trial of Infanrix-IPV/Hib™ in Tetanus, sponsored by GlaxoSmithKline.

Who is sponsoring NCT01086423?

NCT01086423 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01086423?

Interventions in NCT01086423: Infanrix-IPV/Hib™, Infanrix Hib™, Poliorix™.

What condition does NCT01086423 study?

NCT01086423 studies Tetanus, Poliomyelitis, Acellular Pertussis, Diphtheria, Haemophilus Influenzae Type b.

Is NCT01086423 still recruiting?

NCT01086423 is currently completed. Last updated 6 June 2018.

Are results published for NCT01086423?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-06-06 · How we verify

NCT01086423

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 3 Results posted Last updated 6 June 2018

What this trial tests

Phase 3 trial testing Infanrix-IPV/Hib™ in Tetanus in 985 participants. Completed in 19 November 2010.

Timeline

1 March 2010

Primary endpoint
19 November 2010

19 November 2010

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	985
Start date	1 March 2010
Primary completion	19 November 2010
Estimated completion	19 November 2010
Sites	2 locations across China

Drugs / interventions tested

Infanrix-IPV/Hib™
Infanrix Hib™ — full drug profile →
Poliorix™

Conditions studied

Tetanus — all drugs for Tetanus →
Poliomyelitis — all drugs for Poliomyelitis →
Acellular Pertussis — all drugs for Acellular Pertussis →
Diphtheria — all drugs for Diphtheria →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 60 Days to 90 Days, any sex, with Tetanus or Poliomyelitis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Seroprotected Subjects Against Diphtheria (D) and Tetanus (T) Antigens Primary · One month after the third vaccine dose (Month 3 or Month 4)

A seroprotected subject was defined as a subject with anti-D and anti-T antibody concentrations greater than or equal to (≥) 0.1 international units per milliliter (IU/mL).

Anti-D

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	146
Infanrix-IPV+Hib 2 Group	156
Infanrix-Hib+Poliorix Group	147

Anti-T

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	147
Infanrix-IPV+Hib 2 Group	156
Infanrix-Hib+Poliorix Group	147

Number of Seroprotected Subjects Against Polyribosyl-ribitol-phosphate (PRP) Antigen Primary · One month after the third vaccine dose (Month 3 or Month 4)

A seroprotected subject was defined as a subject with anti-PRP antibody concentrations ≥ 0.15 micrograms per milliliter (μg/mL).

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	142
Infanrix-IPV+Hib 2 Group	155
Infanrix-Hib+Poliorix Group	133

Number of Seroprotected Subjects Against Poliovirus Types 1, 2 and 3 Antigens Primary · One month after the third vaccine dose (Month 3 or Month 4)

A seroprotected subject was defined as a subject with anti-poliovirus (anti-polio) types 1, 2 and 3 antibody titres ≥ the value of 8.

Anti-polio 1

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	147
Infanrix-IPV+Hib 2 Group	157
Infanrix-Hib+Poliorix Group	150

Anti-polio 2

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	147
Infanrix-IPV+Hib 2 Group	157
Infanrix-Hib+Poliorix Group	150

Anti-polio 3

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	147
Infanrix-IPV+Hib 2 Group	157
Infanrix-Hib+Poliorix Group	150

Number of Subjects With a Vaccine Response to Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Antigens Primary · One month after the third vaccine dose (Month 3 or Month 4)

Vaccine response was defined as: For PT and FHA response, antibody concentration ≥ 20 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at post-vaccination. For PRN response: for initially seronegative subjects \[antibody concentration lower than (\<) 5 EL.U/mL\], post-vaccination antibody concentration ≥ 20 EL.U/mL; for initially seropositive subjects (antibody concentration ≥ 5 EL.U/mL), at least a 4-fold increase in antibody concentration from pre to post-vaccination.

Anti-PT

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	147
Infanrix-IPV+Hib 2 Group	155
Infanrix-Hib+Poliorix Group	147

Anti-FHA

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	147
Infanrix-IPV+Hib 2 Group	155
Infanrix-Hib+Poliorix Group	144

Anti-PRN

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	145
Infanrix-IPV+Hib 2 Group	156
Infanrix-Hib+Poliorix Group	145

Anti-D and Anti-T Antibody Concentrations Secondary · Before the first dose (Month 0) and one month after the third dose of vaccination (Month 3 or Month 4)

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in IU/mL.

Anti-D, M0

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	0.052	0.05 – 0.053
Infanrix-IPV+Hib 2 Group	0.051	0.05 – 0.052
Infanrix-Hib+Poliorix Group	0.051	0.049 – 0.052

Anti-D, M3/M4

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	0.719	0.661 – 0.782
Infanrix-IPV+Hib 2 Group	0.753	0.699 – 0.812
Infanrix-Hib+Poliorix Group	0.613	0.565 – 0.666

Anti-T, M0

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	0.051	0.05 – 0.052
Infanrix-IPV+Hib 2 Group	0.052	0.05 – 0.054
Infanrix-Hib+Poliorix Group	0.05	0.05 – 0.05

Anti-T, M3/M4

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	4.118	3.779 – 4.488
Infanrix-IPV+Hib 2 Group	4.124	3.796 – 4.479
Infanrix-Hib+Poliorix Group	3.618	3.339 – 3.921

Anti-PRP Antibody Concentrations Secondary · Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in µg/mL.

Anti-PRP, M0

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	0.127	0.104 – 0.154
Infanrix-IPV+Hib 2 Group	0.135	0.112 – 0.163
Infanrix-Hib+Poliorix Group	0.15	0.122 – 0.185

Anti-PRP, M3/M4

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	5.601	4.676 – 6.709
Infanrix-IPV+Hib 2 Group	9.396	8.032 – 10.992
Infanrix-Hib+Poliorix Group	2.826	2.235 – 3.572

Anti-polio Types 1, 2 and 3 Antibody Titers Secondary · Before the first dose (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)

Antibody titers were presented as geometric mean titers (GMTs).

Anti-polio 1, M0

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	9.4	7.7 – 11.5
Infanrix-IPV+Hib 2 Group	7.1	6.2 – 8.2
Infanrix-Hib+Poliorix Group	9.2	7.7 – 11

Anti-polio 1, M3/M4

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	1143.7	952.7 – 1372.9
Infanrix-IPV+Hib 2 Group	1328.9	1137.6 – 1552.4
Infanrix-Hib+Poliorix Group	533.6	469.5 – 606.4

Anti-polio 2, M0

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	6.3	5.5 – 7.2
Infanrix-IPV+Hib 2 Group	5	4.6 – 5.5
Infanrix-Hib+Poliorix Group	6.9	6 – 8

Anti-polio 2, M3/M4

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	416.2	344.5 – 502.8
Infanrix-IPV+Hib 2 Group	458.6	385.6 – 545.5
Infanrix-Hib+Poliorix Group	186.4	160.4 – 216.5

Anti-polio 3, M0

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	5.8	5 – 6.8
Infanrix-IPV+Hib 2 Group	4.9	4.3 – 5.6
Infanrix-Hib+Poliorix Group	5.7	5.1 – 6.4

Anti-polio 3, M3/M4

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	1478.8	1210.6 – 1806.5
Infanrix-IPV+Hib 2 Group	1411.6	1175.3 – 1695.3
Infanrix-Hib+Poliorix Group	820.7	820.7 – 964.4

Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Secondary · Before (Month 0) and one month after the third dose of study vaccine (Month 3 or Month 4)

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in EL.U/mL.

Anti-PT, M0

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	2.9	2.8 – 3.1
Infanrix-IPV+Hib 2 Group	2.7	2.6 – 2.8
Infanrix-Hib+Poliorix Group	2.8	2.6 – 2.9

Anti-PT, M3/M4

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	108.7	99.2 – 119.1
Infanrix-IPV+Hib 2 Group	114.7	105.4 – 124.8
Infanrix-Hib+Poliorix Group	97.1	88.3 – 106.8

Anti-FHA, M0

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	2.9	2.7 – 3.1
Infanrix-IPV+Hib 2 Group	2.6	2.5 – 2.7
Infanrix-Hib+Poliorix Group	2.9	2.7 – 3.1

Anti-FHA, M3/M4

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	87.7	79.9 – 96.3
Infanrix-IPV+Hib 2 Group	87.6	79.6 – 96.4
Infanrix-Hib+Poliorix Group	76.3	68.5 – 85

Anti-PRN, M0

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	2.6	2.5 – 2.7
Infanrix-IPV+Hib 2 Group	2.6	2.5 – 2.6
Infanrix-Hib+Poliorix Group	2.5	2.5 – 2.6

Anti-PRN, M3/M4

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	44.8	42 – 47.9
Infanrix-IPV+Hib 2 Group	43.7	41.3 – 46.3
Infanrix-Hib+Poliorix Group	43.2	39.8 – 47

Number of Subjects With Any Solicited Local Symptoms Secondary · During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Any Pain, Dose 1

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	65
Infanrix-IPV+Hib 2 Group	64
Infanrix-Hib+Poliorix Group	83

Any Redness, Dose 1

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	16
Infanrix-IPV+Hib 2 Group	19
Infanrix-Hib+Poliorix Group	15

Any Swelling, Dose 1

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	8
Infanrix-IPV+Hib 2 Group	9
Infanrix-Hib+Poliorix Group	9

Any Pain, Dose 2

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	43
Infanrix-IPV+Hib 2 Group	50
Infanrix-Hib+Poliorix Group	58

Any Redness, Dose 2

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	14
Infanrix-IPV+Hib 2 Group	19
Infanrix-Hib+Poliorix Group	13

Any Swelling, Dose 2

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	6
Infanrix-IPV+Hib 2 Group	8
Infanrix-Hib+Poliorix Group	8

Any Pain, Dose 3

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	39
Infanrix-IPV+Hib 2 Group	41
Infanrix-Hib+Poliorix Group	39

Any Redness, Dose 3

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	10
Infanrix-IPV+Hib 2 Group	11
Infanrix-Hib+Poliorix Group	8

Number of Subjects With Any Solicited General Symptoms Secondary · During the 4-day (Days 0-3) post-vaccination period after each vaccine dose and across doses

Assessed solicited general symptoms were drowsiness, irritability, loss of appetite and fever \[defined as axillary temperature equal to or above 37.0 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade or relationship to study vaccination.

Any Drowsiness, Dose 1

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	95
Infanrix-IPV+Hib 2 Group	80
Infanrix-Hib+Poliorix Group	69

Any Irritability, Dose 1

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	123
Infanrix-IPV+Hib 2 Group	120
Infanrix-Hib+Poliorix Group	116

Any Loss of appetite, Dose 1

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	77
Infanrix-IPV+Hib 2 Group	86
Infanrix-Hib+Poliorix Group	76

Any Fever/Axillary, Dose 1

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	137
Infanrix-IPV+Hib 2 Group	152
Infanrix-Hib+Poliorix Group	103

Any Drowsiness, Dose 2

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	53
Infanrix-IPV+Hib 2 Group	47
Infanrix-Hib+Poliorix Group	53

Any Irritability, Dose 2

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	96
Infanrix-IPV+Hib 2 Group	100
Infanrix-Hib+Poliorix Group	103

Any Loss of appetite, Dose 2

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	69
Infanrix-IPV+Hib 2 Group	72
Infanrix-Hib+Poliorix Group	59

Any Fever/Axillary, Dose 2

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	131
Infanrix-IPV+Hib 2 Group	144
Infanrix-Hib+Poliorix Group	102

Number of Subjects With Unsolicited Adverse Events (AEs) Secondary · During the 31-day (Days 0-30) post-vaccination period after any dose

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.

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	98
Infanrix-IPV+Hib 2 Group	114
Infanrix-Hib+Poliorix Group	110

Number of Subjects With Serious Adverse Events (SAEs) Secondary · During the entire study period (from Month 0 to Month 4/5)

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.

Group	Value	95% CI
Infanrix-IPV+Hib 1 Group	6
Infanrix-IPV+Hib 2 Group	3
Infanrix-Hib+Poliorix Group	4

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited local and general symptoms: during the 4-day (Days 0-3) post-vaccination period. Unsolicited AEs: during the 31-day (Days 0-30) post-vaccination period. SAEs: during the entire study period (from Month 0 up to Month 4/5).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Infanrix-IPV+Hib 1 Group

Serious: 6/330 (2%)

Deaths: 1/330

Infanrix-IPV+Hib 2 Group

Serious: 3/324 (1%)

Deaths: 0/324

Infanrix-Hib+Poliorix Group

Serious: 4/330 (1%)

Deaths: 0/330

Serious adverse events (10 terms)

Reaction	System	Infanrix-IPV+Hib 1 Group	Infanrix-IPV+Hib 2 Group	Infanrix-Hib+Poliorix Group
Bronchopneumonia	Infections and infestations	—	—	—
Bronchitis	Infections and infestations	—	—	—
Enteritis	Gastrointestinal disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Hepatitis neonatal	Hepatobiliary disorders	—	—	—
Hypokalaemia	Metabolism and nutrition disorders	—	—	—
Malnutrition	Metabolism and nutrition disorders	—	—	—
Pharyngitis	Infections and infestations	—	—	—
Pneumonia	Infections and infestations	—	—	—
Septic shock	Infections and infestations	—	—	—

Other adverse events (10 terms — click to expand)

Reaction	System	Infanrix-IPV+Hib 1 Group	Infanrix-IPV+Hib 2 Group	Infanrix-Hib+Poliorix Group
Fever (Axillary)	General disorders	—	—	—
Irritability	General disorders	—	—	—
Loss of appetite	General disorders	—	—	—
Drowsiness	General disorders	—	—	—
Pain	General disorders	—	—	—
Nasopharyngitis	General disorders	—	—	—
Redness	General disorders	—	—	—
Diarrhoea	Gastrointestinal disorders	—	—	—
Pyrexia	General disorders	—	—	—
Swelling	General disorders	—	—	—

Most-reported serious reactions: Bronchopneumonia, Bronchitis, Enteritis, Diarrhoea, Hepatitis neonatal, Hypokalaemia, Malnutrition, Pharyngitis.

Data from ClinicalTrials.gov NCT01086423 adverse events section.

Sponsor's own description

The purpose of the study is to evaluate the immunogenicity and reactogenicity of Infanrix-IPV/Hib™ vaccine when administered to healthy Chinese infants at 2, 3 and 4 or 3, 4 and 5 months of age.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Safety, immunogenicity and persistence of immune response to the combined diphtheria, tetanus, acellular pertussis, poliovirus and Haemophilus influenzae type b conjugate vaccine (DTPa-IPV/Hib) administered in Chinese infants.
Li Y, Li RC, Ye Q, Li C, et al · · 2017 · cited 12× · PMID 27768515 · DOI 10.1080/21645515.2016.1239670

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01086423 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 6 June 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01086423.

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