Clinical Trial Results:
A Hepatitis B Vaccine Challenge Study to Demonstrate the Durability of Protection Against Hepatitis B Virus Infection in Healthy Children Vaccinated Approximately 9 Years Previously With a 2- or 3-Dose Infant Series and Toddler Dose of Vaxelis®
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Summary
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EudraCT number |
2020-000126-26 |
Trial protocol |
FI |
Global end of trial date |
08 Mar 2021
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Results information
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Results version number |
v2(current) |
This version publication date |
25 Sep 2021
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First version publication date |
18 Aug 2021
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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 |
V419-013
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT04490499 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.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 |
08 Mar 2021
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Dec 2020
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Global end of trial reached? |
Yes
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Global end of trial date |
08 Mar 2021
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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 |
The purpose of this study is to demonstrate the durability of protection against hepatitis B virus (HBV) infection approximately 8-9 years after vaccination with Vaxelis®. This is an estimation study, and no formal hypothesis testing will be performed.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
02 Sep 2020
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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 |
Finland: 207
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Worldwide total number of subjects |
207
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EEA total number of subjects |
207
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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) |
207
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Adolescents (12-17 years) |
0
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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 |
- | ||||||||||||
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Pre-assignment
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Screening details |
Approximately 200 planned to be enrolled and 207 were enrolled. | ||||||||||||
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Period 1
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Period 1 title |
Overall Period
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Is this the baseline period? |
Yes | ||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||
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Arms
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Arm title
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HBVAXPRO™ | ||||||||||||
Arm description |
Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). | ||||||||||||
Arm type |
Experimental | ||||||||||||
Investigational medicinal product name |
Hepatitis B virus (HBV) vaccine
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Single 0.5 mL intramuscular dose
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Baseline characteristics reporting groups
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Reporting group title |
HBVAXPRO™
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Reporting group description |
Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
HBVAXPRO™
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Reporting group description |
Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). | ||
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End point title |
Percentage of Participants with a Protective Hepatitis B Surface Antibody Level of ≥10 milli International Units/mL (mIU/mL) at 30 Days Post-Challenge with HBVAXPRO™ [1] | ||||||||
End point description |
Participant serum samples were collected for analysis with an enhanced chemiluminescence (ECi) assay to determine the concentration of antibodies to hepatitis B surface antigen (HBsAg). Response rate was the percentage of participants with a protective hepatitis B surface antibody (anti-HBs) level of ≥ 10 mIU/mL at Day 30 post-challenge. The analysis population consisted of all enrolled participants without deviations from the protocol (i.e., did not receive study vaccine, use of prohibited medicine/vaccine, or blood sample collected outside of analysis window) that may substantially affect the results of the immunogenicity endpoint.
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End point type |
Primary
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End point timeframe |
Day 30
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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: This is a single arm study, and subjects were enrolled in the same vaccination group. Also, this is an estimation study, and no formal hypothesis testing was performed. |
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| No statistical analyses for this end point | |||||||||
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End point title |
Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen | ||||||||||||
End point description |
Participant serum samples will be assessed with an ECi assay for anti-HBs geometric mean concentrations (GMCs) pre-challenge on Day 1 and 30 days post-challenge with HBVAXPRO™ in mIU/mL. The analysis population consisted of all enrolled participants without deviations from the protocol (i.e., did not receive study vaccine, use of prohibited medicine/vaccine, or blood sample collected outside of analysis window) that may substantially affect the results of the immunogenicity endpoint.
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End point type |
Secondary
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End point timeframe |
Day 1 and Day 30
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| No statistical analyses for this end point | |||||||||||||
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Adverse events information [1]
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Timeframe for reporting adverse events |
Up to Day 30
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Adverse event reporting additional description |
The analysis population included all participants who received study vaccine and had safety follow-up data after the vaccination. The all cause mortality analysis population included all enrolled participants. Per protocol, reported non-serious adverse events only include non-serious adverse events that lead to study discontinuation.
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Assessment type |
Systematic | ||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||
Dictionary version |
23.1
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Reporting groups
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Reporting group title |
HBVAXPRO™
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Reporting group description |
Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who received a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). | ||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||
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| Notes [1] - There are no non-serious adverse events recorded for these results. It is expected that there will be at least one non-serious adverse event reported. Justification: In the vaccinated participant population, no adverse events (AEs) resulting in discontinuation from study were reported. |
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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 | |||
