NCT01353703

Immunogenicity and Safety Study in Infants of GlaxoSmithKline Biologicals' Infanrix Hexa™ (DTPa-HBV-IPV/Hib) Vaccine

Completed Phase 3 Results posted Last updated 2 January 2020

What this trial tests

Phase 3 trial testing Infanrix hexa™ in Poliomyelitis in 224 participants. Completed in 25 February 2013.

Timeline

16 April 2012

Primary endpoint
25 February 2013

25 February 2013

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	224
Start date	16 April 2012
Primary completion	25 February 2013
Estimated completion	25 February 2013
Sites	4 locations across India

Drugs / interventions tested

• Infanrix hexa™

Conditions studied

• Poliomyelitis — all drugs for Poliomyelitis →
• Tetanus — all drugs for Tetanus →
• Acellular Pertussis — all drugs for Acellular Pertussis →
• Haemophilus Influenzae Type b — all drugs for Haemophilus Influenzae Type b →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

Adults 6 Weeks to 10 Weeks, any sex, with Poliomyelitis or Tetanus. 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 Diphteria (D) and Tetanus (T) Antigens Primary · One month post Dose 3 (Month 3 or Month 5)

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

Anti-D

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	105
Infanrix Hexa 2-4-6 Group	106

Anti-T

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	105
Infanrix Hexa 2-4-6 Group	106

Number of Seroprotected Subjects Against Hepatitis B (HBs) Primary · One month post Dose 3 (Month 3 or Month 5)

A seroprotected subject was defined as a vaccinated subject with anti-HBS antibody concentration ≥ 10 milli-international units per milliliter (mIU/mL).

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	101
Infanrix Hexa 2-4-6 Group	104

Number of Seroprotected Subjects Against Poliovirus (Polio) Types 1,2,3 Antigens Primary · One month post Dose 3 (Month 3 or Month 5)

A seroprotected subject was defined as a subject with anti-Poliovirus 1,2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).

Anti-Polio 1

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	99
Infanrix Hexa 2-4-6 Group	99

Anti-Polio 2

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	77
Infanrix Hexa 2-4-6 Group	88

Anti-Polio 3

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	73
Infanrix Hexa 2-4-6 Group	79

Number of Seroprotected Subjects Against Polyribosyl-ribitol Phosphate (PRP) Antigens Primary · One month post Dose 3 (Month 3 or Month 5)

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

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	104
Infanrix Hexa 2-4-6 Group	105

Number of Subjects With Vaccine Response for Pertussis Toxoid (PT), Filamentous Haemagglutinin (FHA) and Pertactin (PRN) Primary · One month post Dose 3 (Month 3 or Month 5)

Vaccine response was defined as : For initially seronegative subjects (S-), antibody concentration ≥ 5 enzyme-linked immunosorbent assay (ELISA) units per milliliter (EL.U/mL) at 1 month after the third dose; For initially seropositive subjects (S+): antibody concentration at 1 month after the third dose ≥ 1 fold increase in the pre-vaccination antibody concentration.

Anti-PT, S-

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	61
Infanrix Hexa 2-4-6 Group	67

Anti-PT, S+

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	44
Infanrix Hexa 2-4-6 Group	36

Anti-FHA, S-

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	12
Infanrix Hexa 2-4-6 Group	12

Anti-FHA, S+

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	86
Infanrix Hexa 2-4-6 Group	88

Anti-PRN, S-

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	86
Infanrix Hexa 2-4-6 Group	89

Anti-PRN, S+

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	18
Infanrix Hexa 2-4-6 Group	14

Anti-D and Anti-T Antibody Concentrations Secondary · One month post Dose 3 (Month 3 or Month 5)

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

Anti-D

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	2.334	2.049 – 2.659
Infanrix Hexa 2-4-6 Group	3.726	3.26 – 4.258

Anti-T

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	3.307	2.925 – 3.739
Infanrix Hexa 2-4-6 Group	4.904	4.378 – 5.493

Anti-HBs Antibody Concentrations Secondary · One month post Dose 3 (Month 3 or Month 5)

Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	1695.7	1395.2 – 2060.9
Infanrix Hexa 2-4-6 Group	3314.5	2645.2 – 4153.1

Anti-Polio Types 1, 2, 3 Antibody Titers Secondary · One month post Dose 3 (Month 3 or Month 5)

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

Anti-Polio 1

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	884.3	666.6 – 1173.1
Infanrix Hexa 2-4-6 Group	1799.2	1429 – 2265.5

Anti-Polio 2

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	840.2	616.9 – 1144.2
Infanrix Hexa 2-4-6 Group	2138.7	1658.1 – 2758.7

Anti-Polio 3

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	923.7	691.9 – 1233.2
Infanrix Hexa 2-4-6 Group	2245.5	1866.1 – 2702.1

Anti-PRP Antibody Concentrations Secondary · One month post Dose 3 (Month 3 or Month 5)

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

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	2.697	2.176 – 3.343
Infanrix Hexa 2-4-6 Group	5.404	4.168 – 7.006

Anti-PT, Anti-FHA and Anti-PRN Antibody Concentrations Secondary · One month post Dose 3 (Month 3 or Month 5)

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

Anti-PT

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	107.3	96.6 – 119.1
Infanrix Hexa 2-4-6 Group	108.2	97.4 – 120.2

Anti-FHA

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	293.7	259.4 – 332.6
Infanrix Hexa 2-4-6 Group	369.3	335.5 – 406.5

Anti-PRN

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	224.4	194.2 – 259.3
Infanrix Hexa 2-4-6 Group	243.6	213.2 – 278.4

Number of Seropositive Subjects for Anti-PT, Anti-FHA and Anti-PRN Secondary · One month post Dose 3 (Month 3 or Month 5)

A seropositive subject was defined as a subject with anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.

Anti-PT

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	105
Infanrix Hexa 2-4-6 Group	106

Anti-FHA

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	105
Infanrix Hexa 2-4-6 Group	106

Anti-PRN

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	105
Infanrix Hexa 2-4-6 Group	106

Number of Seroprotected Subjects Against Polio Type 1, 2 and 3 Antigens Secondary · At Month 0

A seroprotected subject was defined as a subject with anti-Polio type 1, 2 and 3 antibody titers ≥ 8 effective dose, for 50% of people receiving the vaccine (ED50).

Anti-Polio 1

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	71
Infanrix Hexa 2-4-6 Group	70

Anti-Polio 2

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	38
Infanrix Hexa 2-4-6 Group	42

Anti-Polio 3

Group	Value	95% CI
Infanrix Hexa 6-10-14 Group	23
Infanrix Hexa 2-4-6 Group	30

Adverse events — posted to ClinicalTrials.gov

Time frame: Solicited 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 to Month 3 or Month 5).. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Infanrix Hexa 6-10-14 Group

Serious: 2/112 (2%)

Deaths: 0/112

Infanrix Hexa 2-4-6 Group

Serious: 3/112 (3%)

Deaths: 0/112

Serious adverse events (3 terms)

Reaction	System	Infanrix Hexa 6-10-14 Group	Infanrix Hexa 2-4-6 Group
Lower respiratory tract infection	Infections and infestations	—	—
Bronchiolitis	Infections and infestations	—	—
Pneumonia	Infections and infestations	—	—

Other adverse events (7 terms — click to expand)

Reaction	System	Infanrix Hexa 6-10-14 Group	Infanrix Hexa 2-4-6 Group
Pain	General disorders	—	—
Pyrexia	General disorders	—	—
Upper respiratory tract infection	Infections and infestations	—	—
Irritability	Psychiatric disorders	—	—
Swelling	General disorders	—	—
Erythema	Skin and subcutaneous tissue disorders	—	—
Rhinitis	Infections and infestations	—	—

Most-reported serious reactions: Lower respiratory tract infection, Bronchiolitis, Pneumonia.

Data from ClinicalTrials.gov NCT01353703 adverse events section.

Sponsor's own description

This study evaluates the immunogenicity and safety of Infanrix hexa™ (DTPa-HBV-IPV/Hib) when administered as a primary vaccination course to Indian infants according to a 6-10-14 weeks or a 2-4-6 months schedule.

Publications & conference data

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

1. Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib in Indian infants.
   Lalwani SK, Agarkhedkar S, Sundaram B, Mahantashetti NS, et al · · 2017 · cited 6× · PMID 27629913 · DOI 10.1080/21645515.2016.1225639