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| ID | Type | Description | Link |
|---|---|---|---|
| V419-013 | Other Identifier | Merck | |
| 2020-000126-26 | EudraCT Number |
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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 was performed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HBVAXPRO™ | Experimental | Healthy children vaccinated approximately 8-9 years previously with a 2- or 3-dose infant series and toddler dose of Vaxelis® who will receive a single dose of Hepatitis B vaccine challenge (HBVAXPRO™). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HBVAXPRO™ | Biological | Single 0.5 mL intramuscular dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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™ | 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. | Day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen | 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. | Day 1 and Day 30 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tampereen yliopisto Kokkolan rokotetutkimusklinikka ( Site 0009) | Kokkola | Keski-Pohjanmaa | 67100 | Finland | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35653552 | Result | Ahonen A, Zhang Y, Marcek T, Lumley J, Johnson DR, Guris D, Wilck MB. Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously. Hum Vaccin Immunother. 2022 Nov 30;18(5):2073747. doi: 10.1080/21645515.2022.2073747. Epub 2022 Jun 2. |
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Approximately 200 planned to be enrolled and 207 were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | HBVAXPRO™ | 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™). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | HBVAXPRO™ | 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™). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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™ | 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. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Day 30 |
|
Up to Day 30
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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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | HBVAXPRO™ | 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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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp. | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2020 | Aug 10, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
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| ID | Term |
|---|---|
| D017325 | Hepatitis B Vaccines |
| D014612 | Vaccines |
| ID | Term |
|---|---|
| D014761 | Viral Hepatitis Vaccines |
| D014765 | Viral Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| Tampereen yliopisto Oulun rokotetutkimusklinikka ( Site 0004) |
| Oulu |
| North Ostrobothnia |
| 90220 |
| Finland |
| Tampereen yliopisto - Tampereen rokotetutkimusklinikka ( Site 0001) | Tampere | Pirkanmaa | 33100 | Finland |
| Seinajoki Vaccine Research Center ( Site 0010) | Seinajoki | Pohjanmaa | 60100 | Finland |
| Porin rokotetutkimusklinikka ( Site 0008) | Pori | Satakunta | 28100 | Finland |
| Tampereen yliopisto Turun rokotetutkimusklinikka ( Site 0002) | Turku | Southwest Finland | 20520 | Finland |
| Tampereen yliopisto Espoon rokotetutkimusklinikka ( Site 0007) | Espoo | Uusimaa | 02230 | Finland |
| Tampereen yliopisto Etelä-Helsingin rokotetutkimusklinikka ( Site 0005) | Helsinki | Uusimaa | 00100 | Finland |
| Ita-Helsingin Rokotetutkimuskeskus ( Site 0006) | Helsinki | Uusimaa | 00930 | Finland |
| Tampereen yliopisto Järvenpään rokotetutkimusklinikka ( Site 0003) | Jarvenpaa | Uusimaa | 04400 | Finland |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
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™).
|
|
| Secondary | Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen | 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. | Posted | Geometric Mean | 95% Confidence Interval | mIU/mL | Day 1 and Day 30 |
|
|
|
| 0 |
| 207 |
| 0 |
| 205 |
| 0 |
| 205 |
If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission. This allows the Sponsor to protect proprietary information and to provide comments.
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
|