Hepatitis BPhase 2NCT00322361
Modified Process Hepatitis B Vaccine in Healthy Neonates (V232-056)
A Phase 2 study testing Comparator: RECOMBIVAX HB™ and Comparator: Modified process Hepatitis B Vaccine in people with Hepatitis B and Hepatocellular Carcinoma, run by Merck Sharp & Dohme LLC.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 1 day to 10 daysHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B, Hepatocellular Carcinoma
- What is being tested?
- Comparator: RECOMBIVAX HB™ and Comparator: Modified process Hepatitis B Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 566 participants
- Where
- No sites listed yet
- Study dates
- May 2006to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 10 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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
About this study
Official title: A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process
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
- Hepatitis B, Hepatocellular Carcinoma
- Being tested
- Comparator: RECOMBIVAX HB™, Comparator: Modified process Hepatitis B Vaccine
- Medical subject headings
- Hepatitis B, Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: RECOMBIVAX HB™Biological
RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection.
Comparator: Modified process Hepatitis B VaccineBiological
Modified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Modified Process Hepatitis B Vaccine Receives: Biological: Comparator: Modified process Hepatitis B Vaccine |
| 2 | Active comparator | Recombivax HB™ Receives: Biological: Comparator: RECOMBIVAX HB™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Geometric mean titer to hepatitis B surface antigen at Month 7
Measured: 4 weeks Post Dose 3
Secondary outcomes (1)
Safety and tolerability including use of Vaccination Report Card
Measured: Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2006 (estimated)
- Study startMay 2006
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis BStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 566 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Monitor, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00322361
- Sponsor's protocol ID
- V232-056
- Other IDs
- 2006_007
- Status last verified
- Mar 2017
- First submitted
- 2 May 2006
- Last updated
- 16 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Minervini 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.
PubMed 22227229
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Healthy Neonates of Safety, Tolerability, and Immunogenicity of Recombinant Hepatitis B Vaccine Manufactured Using a Modified Process
- ClinicalTrials.gov ID
- NCT00322361
- Acronym / sponsor ID
- V232-056
- Conditions
- Hepatitis B, Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 566 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- May 2006
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 5 May 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Comparator: Modified process Hepatitis B VaccineModified Process Hepatitis B Vaccine |
| 2 | Active comparator | Biological: Comparator: RECOMBIVAX HB™Recombivax HB™ |
Who may qualify
- Ages
- 1 day to 10 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparator: RECOMBIVAX HB™RECOMBIVAX HB™ 3 x 5-mcg regimen administered via intramuscular injection. | Biological | 2 |
| Comparator: Modified process Hepatitis B VaccineModified Process Hepatitis B 3 x 5-mcg regimen administered via intramuscular injection. | Biological | 1 |
Primary outcome
Geometric mean titer to hepatitis B surface antigen at Month 7
Time frame: 4 weeks Post Dose 3
1 secondary outcome
Safety and tolerability including use of Vaccination Report Card
Time frame: Follow-up 14 days Post Vaccination 1, 2, & 3 (Via Vaccination Report Card)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2017.
- Derived from this study: PubMed 22227229Minervini 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.
- Click here to access a synopsis of the study results.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Monitor study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Comparator: RECOMBIVAX HB™ and Comparator: Modified process Hepatitis B Vaccine in people with Hepatitis B and Hepatocellular Carcinoma, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Geometric mean titer to hepatitis B surface antigen at Month 7 (time frame: 4 weeks Post Dose 3). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00322361, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2017.