Phase 3
Completed N=207
A Hepatitis B Vaccine Challenge Study After Previous Vaxelis® Vaccination (V419-013)
Source: ClinicalTrials.gov NCT04490499 ↗Enrolled (actual)
207
Serious AEs
0.0%
Results posted
Sep 2021
Primary outcomePrimary: 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™ — 99.5 Percentage of Participants
◆ Published Evidence
Emerging
3citations · ~1 / year
Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously.
Summary
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.
Linked Publications
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Demonstration of durable hepatitis B immune memory in children vaccinated with a DTaP5-IPV-HepB-Hib infant-toddler series 7 to 8 years previously.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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™ |
99.5 | — |
| SECONDARY Geometric Mean Concentration of Antibodies to Hepatitis B Surface Antigen |
9.63; 685.84 | — |
Eligibility Criteria
Inclusion Criteria
- Is healthy (based on a review of medical history and targeted physical examination) based on the clinical judgment of the investigator.
- Has participated in Protocol V419-007 and received a 3 + 1 Vaxelis® schedule or participated in Protocol V419-008 and received a 2 + 1 Vaxelis® schedule.
- The participant (or legally acceptable representative if applicable) provides written informed consent/assent for the study.
Exclusion Criteria
- Has a history of diagnosis (clinical, serological, or microbiological) of HBV infection.
- Has a known or suspected impairment of immunological function (e.g., human immunodeficiency virus (HIV), splenectomy).
- Has a known hypersensitivity to any component of the study vaccine.
- Has a known or suspected blood dyscrasias, leukemia, lymphomas of any type or other malignant neoplasms affecting the haematopoietic and lymphatic system.
- Has a bleeding disorder contraindicating intramuscular vaccinations.
- Has received any hepatitis B vaccine after participation in Protocol V419-007 or V419-008.
- Is or has an immediate family member (e.g., spouse, parent/legal guardian, sibling, or child) who is investigational site or Sponsor staff directly involved with this study.
Data sourced from ClinicalTrials.gov (NCT04490499) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.