Clinical trial · Interventional
Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)
A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Hepatitis B Vaccine \[Recombinant\] is a well-established vaccine which has been used extensively, worldwide since its initial licensure in 1986. Hepatitis B vaccines: \[1\] induce protection against the morbidity and mortality of acute hepatitis B virus infection, \[2\] reduce the incidence of chronic infection in vaccinated populations, and \[3\] thereby, reduce the incidence of hepatocellular carcinoma. The purpose of the trial is to assess if the new manufacturing process of the Hepatitis B Vaccine \[Recombinant\] vaccine shows the same level of hepatitis B antibody response or better as the currently licensed Hepatitis B Vaccine \[Recombinant\] vaccine. This study will also confirm that the new process vaccine is as well tolerated as the current vaccine.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatitis B | — | UNRESOLVED | — |
| Hepatocellular Carcinoma | Hepatocellular Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparator: Modified process Hepatitis B Vaccine | Biological | — | UNRESOLVED |
| Comparator: RECOMBIVAX HB™ | Biological | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- Modified Process Hepatitis B Vaccine
- interventionNames
- Biological: Comparator: Modified process Hepatitis B Vaccine
- type
- ACTIVE_COMPARATOR
- label
- 2
- description
- Recombivax HB™
- interventionNames
- Biological: Comparator: RECOMBIVAX HB™
Primary outcomes (1)
- measure
- Geometric mean titer to hepatitis B surface antigen at Month 7
- timeFrame
- 4 weeks Post Dose 3
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 1 Day
- Maximum age
- 10 Days
Show eligibility criteria text
Inclusion Criteria: * Healthy male and female full-term (37-42 weeks gestation) neonates (birth to 10 days of age) * Born to mothers with documented negative test for HBsAg within 9 months prior to delivery Exclusion Criteria: * Infant born to mother with no prenatal care * Known or suspected impairment of immunologic function * Prior vaccination with any hepatitis B vaccine for infant or mother(within 6 months prior to the birth of infant.) * Recent(\<72 hours) history of febrile illness \>/= 99.5 degrees F (\>/= 37.5 degrees C) axillary or \>/= 100.5 degrees F (\>/= 38.1 degrees C) rectal * Any prior administration of hepatitis B immune globulin (HBIG), serum immune globulin, or any other blood-derived product, or the receipt by the mother of either immunoglobulin or HBIG within 6 months prior to birth of the infant * Receipt of investigational vaccines by mother or infant within 3 months prior to first injection with study vaccine or if scheduled to be given to the infant during the study * Known or suspected hypersensitivity to any component of study vaccine (e.g., aluminum, yeast) * Any infant who cannot be adequately followed for study visits during the course of the clinical study * Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives
References
Publications (1)
- DERIVEDMinervini G, McCarson BJ, Reisinger KS, Martin JC, Stek JE, Atkins BM, Nadig KB, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy neonates. Vaccine. 2012 Feb 14;30(8):1476-80. doi: 10.1016/j.vaccine.2011.12.095. Epub 2012 Jan 5. PMID 22227229