Clinical Trial Results:
An open-label, controlled, multi-centre study of the immunogenicity and safety of a challenge dose of HBVAXPRO® to explore the anamnestic immune response in healthy children vaccinated 10 years ago with a primary series (3 doses) of either HEXAVAC® or INFANRIX®-HEXA
Summary
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EudraCT number |
2013-001602-28 |
Trial protocol |
IT |
Global end of trial date |
04 Feb 2015
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Results information
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Results version number |
v2(current) |
This version publication date |
02 Jul 2016
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First version publication date |
23 Apr 2016
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Other versions |
v1 |
Version creation reason |
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Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
HXV02C
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT02012998 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Sanofi Pasteur MSD S.N.C.
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Sponsor organisation address |
162 avenue Jean Jaurès - CS 50712, Lyon Cedex 07, France, 69367
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Public contact |
Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C., ClinicalTrialsDisclosure@spmsd.com
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Scientific contact |
Clinical Trials Disclosure, Sanofi Pasteur MSD S.N.C., ClinicalTrialsDisclosure@spmsd.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
04 Feb 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
04 Feb 2015
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Global end of trial reached? |
Yes
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Global end of trial date |
04 Feb 2015
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
# To describe, in subjects vaccinated with 3 doses of HEXAVAC® as infants, the percentage of subjects with an anti-HBs concentration ≥10 mIU/mL 1 month after a challenge dose of HBVAXPRO® 5 µg given at least 10 years later
# To describe, in subjects vaccinated with 3 doses of INFANRIX®-HEXA as infants, the percentage of subjects with an anti-HBs concentration ≥10 mIU/mL 1 month after a challenge dose of HBVAXPRO® 5 µg given at least 10 years later
Note: "HBVAXPRO® 5 µg" was referred to "HBVAXPRO" to facilitate reading.
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Protection of trial subjects |
Healthy subjects with sensitivity and/or allergy to any component of HBVAXPRO were excluded.
Vaccine was administered by qualified study personnel.
After each vaccination, subjects were kept under observation for at least 20 minutes to ensure their safety.
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Background therapy |
Subjects were previously vaccinated with a 3-doses primary series of HEXAVAC or a 3-doses primary series of INFANRIX-HEXA as infants (at about 3, 5, and 12 months of life). They received the 3rd dose of HEXAVAC or INFANRIX-HEXA at least 10 years before the challenge dose of HBVAXPRO. | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
22 Jan 2014
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Italy: 751
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Worldwide total number of subjects |
751
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EEA total number of subjects |
751
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
451
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Adolescents (12-17 years) |
300
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
Study subjects were enrolled in 8 active centres in Italy. | ||||||||||||||||||
Pre-assignment
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Screening details |
753 subjects were screened. 751 subjects were enrolled and vaccinated. 749 subjects completed the study. | ||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
Blinding implementation details |
This study was open-label as all the subjects received 1 dose of HBVAXPRO.
Nevertheless, subjects were recruited from 2 different cohorts based on their vaccination history: vaccination with a 3-doses primary series of HEXAVAC or INFANRIX-HEXA during infancy.
Immunogenicity assays were performed by laboratory staff (personnel and the analysts) who were blinded for the vaccine each subject had received as primo-vaccination.
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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HEXAVAC / HBVAXPRO | ||||||||||||||||||
Arm description |
# Subjects previously vaccinated with a 3-doses primary series of HEXAVAC (at 3, 5, and 12 months of life) received 1 challenge dose of HBVAXPRO (Hepatitis B virus surface antigen, recombinant (HBsAg) 5 μg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by intramuscular (IM) route at least 10 years after the 3rd dose of the primary series. # Blood samples were collected on Day 0 (D0) before challenge dose (pre-challenge dose) and 1 month (D21 to D35) after the challenge dose (post-challenge dose). | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
HBVAXPRO®
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Investigational medicinal product code |
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Other name |
HBVAXPRO
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, IM route (deltoid region), 1 dose at least 10 years after the 3rd dose of the primary series.
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Arm title
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INFANRIX-HEXA / HBVAXPRO | ||||||||||||||||||
Arm description |
# Subjects previously vaccinated with a 3-doses primary series of INFANRIX-HEXA (at 3, 5, and 12 months of life) received 1 challenge dose of HBVAXPRO (Hepatitis B virus surface antigen, recombinant (HBsAg) 5 μg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by IM route at least 10 years after the 3rd dose of the primary series. # Blood samples were collected on Day 0 (D0) before challenge dose (pre-challenge dose) and 1 month (D21 to D35) after the challenge dose (post-challenge dose). | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
HBVAXPRO®
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Investigational medicinal product code |
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Other name |
HBVAXPRO
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Pharmaceutical forms |
Suspension for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
0.5 mL, IM route (deltoid region), 1 dose at least 10 years after the 3rd dose of the primary series.
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Baseline characteristics reporting groups
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Reporting group title |
HEXAVAC / HBVAXPRO
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Reporting group description |
# Subjects previously vaccinated with a 3-doses primary series of HEXAVAC (at 3, 5, and 12 months of life) received 1 challenge dose of HBVAXPRO (Hepatitis B virus surface antigen, recombinant (HBsAg) 5 μg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by intramuscular (IM) route at least 10 years after the 3rd dose of the primary series. # Blood samples were collected on Day 0 (D0) before challenge dose (pre-challenge dose) and 1 month (D21 to D35) after the challenge dose (post-challenge dose). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
INFANRIX-HEXA / HBVAXPRO
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Reporting group description |
# Subjects previously vaccinated with a 3-doses primary series of INFANRIX-HEXA (at 3, 5, and 12 months of life) received 1 challenge dose of HBVAXPRO (Hepatitis B virus surface antigen, recombinant (HBsAg) 5 μg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by IM route at least 10 years after the 3rd dose of the primary series. # Blood samples were collected on Day 0 (D0) before challenge dose (pre-challenge dose) and 1 month (D21 to D35) after the challenge dose (post-challenge dose). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
HEXAVAC / HBVAXPRO
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Reporting group description |
# Subjects previously vaccinated with a 3-doses primary series of HEXAVAC (at 3, 5, and 12 months of life) received 1 challenge dose of HBVAXPRO (Hepatitis B virus surface antigen, recombinant (HBsAg) 5 μg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by intramuscular (IM) route at least 10 years after the 3rd dose of the primary series. # Blood samples were collected on Day 0 (D0) before challenge dose (pre-challenge dose) and 1 month (D21 to D35) after the challenge dose (post-challenge dose). | ||
Reporting group title |
INFANRIX-HEXA / HBVAXPRO
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Reporting group description |
# Subjects previously vaccinated with a 3-doses primary series of INFANRIX-HEXA (at 3, 5, and 12 months of life) received 1 challenge dose of HBVAXPRO (Hepatitis B virus surface antigen, recombinant (HBsAg) 5 μg, adsorbed on amorphous aluminium hydroxyphosphate sulphate 0.25 mg) by IM route at least 10 years after the 3rd dose of the primary series. # Blood samples were collected on Day 0 (D0) before challenge dose (pre-challenge dose) and 1 month (D21 to D35) after the challenge dose (post-challenge dose). | ||
Subject analysis set title |
HEXAVAC / HBVAXPRO anti-HBs <10 mIU/mL at baseline
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects previously vaccinated with a 3-doses primary series of HEXAVAC (at 3, 5, and 12 months of life) with anti-HBs antibody (Ab) concentration <10 mIU/mL at baseline, i.e., at D0 before HBVAXPRO challenge dose.
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Subject analysis set title |
HEXAVAC / HBVAXPRO anti-HBs ≥10 mIU/mL at baseline
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects previously vaccinated with a 3-doses primary series of HEXAVAC (at 3, 5, and 12 months of life) with anti-HBs Ab concentration ≥10 mIU/mL at baseline, i.e., at D0 before HBVAXPRO challenge dose.
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Subject analysis set title |
INFANRIX-HEXA / HBVAXPRO anti-HBs <10 mIU/mL at baseline
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects previously vaccinated with a 3-doses primary series of INFANRIX-HEXA (at 3, 5, and 12 months of life) with anti-HBs Ab concentration <10 mIU/mL at baseline, i.e., at D0 before HBVAXPRO challenge dose.
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Subject analysis set title |
INFANRIX-HEXA / HBVAXPRO anti-HBs ≥10 mIU/mL at baseline
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects previously vaccinated with a 3-doses primary series of INFANRIX-HEXA (at 3, 5, and 12 months of life) with anti-HBs Ab concentration ≥10 mIU/mL at baseline, i.e., at D0 before HBVAXPRO challenge dose.
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Subject analysis set title |
All subjects
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who received at least 1 dose of HBVAXPRO and who had any safety follow-up data.
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End point title |
Percentage of subjects with anti-HBs Ab concentration ≥10 mIU/mL 1 month after HBVAXPRO challenge dose (POST-CHALLENGE) [1] | |||||||||||||||
End point description |
Percentage of subjects with an anti-HBs Ab concentration ≥10 mIU/mL measured by Microparticle Enzyme Immunoassay (MEIA) - AxSYM® AUSAB 1 month after HBVAXPRO challenge dose, given at least 10 years after the 3rd dose of either HEXAVAC or INFANRIX-HEXA.
Analysis was done on the Per Protocol Set (PPS), i.e. all the vaccinated subjects excluding those with a serology-confirmed diagnosis of Hepatitis B infection or with important protocol deviations which may have interfered with the immunogenicity evaluation.
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End point type |
Primary
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End point timeframe |
1 month after HBVAXPRO challenge dose (post-challenge).
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Objectives were only descriptive. Thus no formal statistical hypothesis was tested in this study. |
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No statistical analyses for this end point |
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End point title |
Percentage of subjects with anti-HBs Ab concentration ≥10 mIU/mL before HBVAXPRO challenge dose (PRE-CHALLENGE) | |||||||||||||||
End point description |
Percentage of subjects with an anti-HBs Ab concentration ≥10 mIU/mL measured by MEIA - AxSYM® AUSAB at Day 0 (D0) before HBVAXPRO challenge dose (pre-challenge), at least 10 years after the 3rd dose of either HEXAVAC or INFANRIX-HEXA.
Analysis was done on the Per Protocol Set (PPS), i.e. all the vaccinated subjects excluding those with a serology-confirmed diagnosis of Hepatitis B infection or with important protocol deviations which may have interfered with the immunogenicity evaluation.
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End point type |
Secondary
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End point timeframe |
Before HBVAXPRO challenge dose (pre-challenge).
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Notes [2] - Pre-challenge blood samples of 2 subjects were considered as missing due to suspected inversion. |
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No statistical analyses for this end point |
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End point title |
Geometric Mean Concentrations (GMCs) of anti-HBs Abs before (PRE-CHALLENGE) and 1 month after HBVAXPRO challenge dose (POST-CHALLENGE) | ||||||||||||||||||
End point description |
Anti-HBs Ab concentrations were measured by MEIA - AxSYM® AUSAB before (pre-challenge) and 1 month after HBVAXPRO challenge dose (post-challenge), given at least 10 years after the 3rd dose of either HEXAVAC or INFANRIX-HEXA.
Ab concentrations are expressed in mIU/mL.
Analysis was done on the Per Protocol Set (PPS), i.e. all the vaccinated subjects excluding those with a serology-confirmed diagnosis of Hepatitis B infection or with important protocol deviations which may have interfered with the immunogenicity evaluation.
Note: (N=***, ***) represents the number of assessed subjects in the "HEXAVAC / HBVAXPRO" and "INFANRIX-HEXA / HBVAXPRO" groups, respectively.
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End point type |
Secondary
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End point timeframe |
Before (pre-challenge) and 1 month after HBVAXPRO challenge dose (post-challenge).
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No statistical analyses for this end point |
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End point title |
GMCs of anti-HBs Abs before (PRE-CHALLENGE) and 1 month after HBVAXPRO challenge dose (POST-CHALLENGE) by subset of subjects defined according to pre-challenge anti-HBs Ab concentrations (<10 or ≥10 mIU/mL) | ||||||||||||||||||||||||||||||
End point description |
Anti-HBs Ab concentrations were measured by MEIA - AxSYM® AUSAB before (pre-challenge) and 1 month after HBVAXPRO challenge dose (post-challenge), given at least 10 years after the 3rd dose of either HEXAVAC or INFANRIX-HEXA.
Ab concentrations are expressed in mIU/mL.
Analysis was done on the Per Protocol Set (PPS), i.e. all the vaccinated subjects excluding those with a serology-confirmed diagnosis of Hepatitis B infection or with important protocol deviations which may have interfered with the immunogenicity evaluation.
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End point type |
Secondary
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End point timeframe |
Before (pre-challenge) and 1 month after HBVAXPRO challenge dose (post-challenge).
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No statistical analyses for this end point |
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End point title |
Geometric Mean of individual anti-HBs Ab Concentration post-/pre-challenge Ratios (GMCRs) 1 month after HBVAXPRO challenge dose (POST-CHALLENGE) | |||||||||||||||
End point description |
Anti-HBs Ab concentrations were measured by MEIA - AxSYM® AUSAB before (pre-challenge) and 1 month after HBVAXPRO challenge dose (post-challenge), given at least 10 years after the 3rd dose of either HEXAVAC or INFANRIX-HEXA.
Individual post- (1 month)/pre-challenge (D0) anti-HBs Ab concentration ratios were calculated.
Analysis was done on the Per Protocol Set (PPS), i.e. all the vaccinated subjects excluding those with a serology-confirmed diagnosis of Hepatitis B infection or with important protocol deviations which may have interfered with the immunogenicity evaluation.
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End point type |
Secondary
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End point timeframe |
1 month after HBVAXPRO challenge dose (post-challenge).
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No statistical analyses for this end point |
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End point title |
Geometric Mean of individual anti-HBs Ab Concentration post-/pre-challenge Ratios (GMCRs) 1 month after HBVAXPRO challenge dose (POST-CHALLENGE) by subset of subjects defined according to pre-challenge anti-HBs Ab concentrations (<10 or ≥10 mIU/mL) | |||||||||||||||||||||||||
End point description |
Anti-HBs Ab concentrations were measured by MEIA - AxSYM® AUSAB before (pre-challenge) and 1 month after HBVAXPRO challenge dose (post-challenge), given at least 10 years after the 3rd dose of either HEXAVAC or INFANRIX-HEXA.
Individual post- (1 month)/pre-challenge (D0) anti-HBs Ab concentration ratios were calculated.
Analysis was done on the Per Protocol Set (PPS), i.e. all the vaccinated subjects excluding those with a serology-confirmed diagnosis of Hepatitis B infection or with important protocol deviations which may have interfered with the immunogenicity evaluation.
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End point type |
Secondary
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End point timeframe |
1 month after HBVAXPRO challenge dose (post-challenge).
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No statistical analyses for this end point |
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End point title |
Percentage of subjects with anti-HBs Ab concentration ≥10 mIU/mL 1 month after HBVAXPRO challenge dose (POST-CHALLENGE) in subjects with pre-challenge anti-HBs concentration <10 mIU/mL | |||||||||||||||
End point description |
Percentage of subjects with an anti-HBs concentration ≥10 mIU/mL measured by MEIA - AxSYM® AUSAB 1 month after HBVAXPRO challenge dose (post-challenge) in subjects with pre-challenge anti-HBs concentration <10 mIU/mL.
Analysis was done on the Per Protocol Set (PPS), i.e. all the vaccinated subjects excluding those with a serology-confirmed diagnosis of Hepatitis B infection or with important protocol deviations which may have interfered with the immunogenicity evaluation.
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End point type |
Secondary
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End point timeframe |
1 month after HBVAXPRO challenge dose (post-challenge).
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No statistical analyses for this end point |
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End point title |
Global summary of safety from D0 to D14 after HBVAXPRO challenge dose | ||||||||||||||||||||||||||||||
End point description |
Adverse events (AEs) were recorded as follows.
1/ From D0 to D4 after vaccination: # solicited injection-site adverse reactions (ISRs: injection-site erythema, injection-site swelling, and injection-site pain), and # solicited systemic AE pyrexia (defined as body temperature ≥38.0°C).
2/ From D0 to D14 after vaccination: unsolicited ISRs (including erythema, swelling, and pain from D5 to D14), and # unsolicited systemic AEs.
AEs at injection sites were always considered as vaccine-related (ISRs). The investigator had to assess whether systemic AEs were vaccine-related systemic AEs or not to HBVAXPRO.
The percentage of subjects presenting at least once the considered events is reported hereafter.
Analysis was done on the Safety Analysis Set, i.e., all subjects who received at least 1 dose of HBVAXPRO and who had any safety follow-up data.
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End point type |
Secondary
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End point timeframe |
From Day 0 (D0) to D14 after HBVAXPRO challenge dose.
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No statistical analyses for this end point |
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End point title |
Percentage of subjects reporting ISRs from D0 to D14 after HBVAXPRO challenge dose | ||||||||||||||||||
End point description |
ISRs occurring after HBVAXPRO challenge dose were recorded as follows:
# From D0 to D4 after vaccination: solicited ISRs, i.e., injection-site erythema, injection-site swelling, and injection-site pain.
# From D0 to D14 after vaccination: unsolicited ISRs (including erythema, swelling, and pain from D5 to D14).
AEs at injection-site were always considered as related to vaccine (ISRs).
The percentage of subjects presenting at least once the considered events is reported hereafter.
Analysis was done on the Safety Analysis Set, i.e., all subjects who received at least 1 dose of HBVAXPRO and who had any safety follow-up data.
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End point type |
Secondary
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End point timeframe |
From Day 0 (D0) to D14 after HBVAXPRO challenge dose.
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Systemic adverse events (AEs) were collected from D0 to D14 after HBVAXPRO challenge dose.
Serious AEs (SAEs) and deaths were collected throughout the study.
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Adverse event reporting additional description |
Analysis was done on the Safety Analysis Set, i.e., all subjects who received at least 1 dose of HBVAXPRO and who had any safety follow-up data.
Unsolicited non-serious systemic AEs (vaccine-related or not) with incidence ≥1% are presented
hereafter.
2 subjects reported 1 SAE each; none of them was assessed as related to HBVAXPRO challenge dose.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||
Dictionary version |
16.0
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Reporting groups
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Reporting group title |
All subjects
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Reporting group description |
# Subjects previously vaccinated with a 3-doses primary series of HEXAVAC or INFANRIX-HEXA (at 3, 5, and 12 months of life) received 1 challenge dose of HBVAXPRO by IM route at least 10 years after the 3rd dose of the primary series. # Respectively, 87 (11.6%) subjects reported at least 1 unsolicited systemic AE, and 13 (1.7%) subjects reported at least 1 vaccine-related unsolicited systemic AE within 14 days after vaccination. Note: Unsolicited non-serious systemic AEs with incidence ≥1% are presented hereafter. If each non-serious systemic AE with incidence ≥1% had been reported by a different subject, the number of subjects reporting at least 1 non-serious systemic AE with incidence ≥1% would have been 51. | ||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 1% | |||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |