Hepatitis BPhase 3NCT00414050
A Study of 2 Doses of a Hepatitis B Vaccine (V232 RECOMBIVAX HB) in Healthy Infants (V232-057)
A Phase 3 study testing Modified Process Hepatitis B Vaccine (Experimental) and Hepatitis B Vaccine (Recombinant) in people with Hepatitis B, run by Merck Sharp & Dohme LLC.
Trial summary
This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared… Read more about this study
- Who is it for?
- Ages 2 to 2 monthsHealthy volunteers can take part
- Conditions the study is for
- Hepatitis B
- What is being tested?
- Modified Process Hepatitis B Vaccine (Experimental) and Hepatitis B Vaccine (Recombinant)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,718 participants
- Where
- No sites listed yet
- Study dates
- 6 Oct 2006to 24 Oct 2007
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 2 to 2 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant is a healthy infant approximately 2 months of age
Who cannot join
- Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant
- Participant's birth mother did not receive any prenatal care
- Participant has previous history of hepatitis B infection
- Participant has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of participant
- Participant has had a fever within 72 hours of study start
- Participant has received any blood-derived product or birth mother received blood-derived product within 6 months of birth of participant
About this study
Official title: A Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age
This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).
- Conditions
- Hepatitis B
- Being tested
- Modified Process Hepatitis B Vaccine (Experimental), Hepatitis B Vaccine (Recombinant)
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Modified Process Hepatitis B Vaccine (Experimental)Biological
Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm).
Hepatitis B Vaccine (Recombinant)Biological
Also called RECOMBIVAX HB™
RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months.
Hepatitis B Vaccine (Recombinant)Biological
Also called ENGERIX-B®
ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months
| Study group | Role | What they receive |
|---|---|---|
| Modified Process Hepatitis B vaccine 5 μg | Experimental | Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. Receives: Biological: Modified Process Hepatitis B Vaccine (Experimental) |
| RECOMBIVAX HB™ Hepatitis B Vaccine | Active comparator | Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age. Receives: Biological: Hepatitis B Vaccine (Recombinant) |
| Modified Process Hepatitis B vaccine 10 μg | Experimental | Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. Receives: Biological: Modified Process Hepatitis B Vaccine (Experimental) |
| ENGERIX-B® | Active comparator | Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age. Receives: Biological: Hepatitis B Vaccine (Recombinant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®
The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.
Measured: 7 months of age (1 month after 3 doses)
Secondary outcomes (1)
Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®
Geometric Mean Titer - Antibody titer is a laboratory test that measures the presence and amount of antibodies in blood.
Measured: 7 months of age (1 month after 3 doses)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2006 (estimated)
- Study start6 Oct 2006
- Primary completion22 Oct 2007
- Study completion24 Oct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,718 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Merck Sharp & Dohme LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00414050
- Sponsor's protocol ID
- V232-057
- Other IDs
- 2006_053, 2006-001638-42
- Status last verified
- Apr 2017
- First submitted
- 20 Dec 2006
- Last updated
- 23 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final\_Updated%20July\_9\_2014.pdf http://engagezone.msd.com/ds\_documentation.php
Publications
Vesikari T, Martin JC, Liss CL, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. Pediatr Infect Dis J. 2011 Jul;30(7):e109-13. doi: 10.1097/INF.0b013e31821ed1a4.
PubMed 21552183
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Assess the Safety, Tolerability, and Immunogenicity of 2 Antigen Doses of Recombinant Hepatitis B Vaccine Manufactured With a Modified Process Administered to Healthy Infants at 2, 4, and 6 Months of Age
- ClinicalTrials.gov ID
- NCT00414050
- Acronym / sponsor ID
- V232-057
- Conditions
- Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,718 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- 6 Oct 2006 (actual)
- Primary completion
- 22 Oct 2007 (actual)
- Study completion
- 24 Oct 2007 (actual)
- First posted
- 21 Dec 2006 (estimated)
- Results
- Posted 14 Apr 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was conducted in healthy infants and will provide new immunogenicity and safety data for the modified process hepatitis B vaccine. This study was conducted to address the following: to evaluate the immunogenicity and safety data of the 5 microgram dose of the modified process hepatitis B vaccine compared with a 10 microgram dose of the modified process hepatitis B vaccine, to evaluate another dosing schedule of 2, 4, and 6 months, and to provide descriptive immunogenicity data of another marketed vaccine (ENGERIX-B®).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Modified Process Hepatitis B vaccine 5 μg | Experimental | Biological: Modified Process Hepatitis B Vaccine (Experimental)Infants received a primary series of 3 doses of experimental vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
| RECOMBIVAX HB™ Hepatitis B Vaccine | Active comparator | Biological: Hepatitis B Vaccine (Recombinant)Infants received a primary series of 3 doses of currently licensed vaccine (5 μg per dose) at 2, 4 and 6 months of age. |
| Modified Process Hepatitis B vaccine 10 μg | Experimental | Biological: Modified Process Hepatitis B Vaccine (Experimental)Infants received a primary series of 3 doses of experimental vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
| ENGERIX-B® | Active comparator | Biological: Hepatitis B Vaccine (Recombinant)Infants received a primary series of 3 doses of currently licensed vaccine (10 μg per dose) at 2, 4 and 6 months of age. |
Who may qualify
- Ages
- 2 to 2 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Participant is a healthy infant approximately 2 months of age
Key exclusion criteria (6 listed)
- Birth mother is a known carrier of hepatitis B virus or another known carrier has lived in close contact with the participant
- Participant's birth mother did not receive any prenatal care
- Participant has previous history of hepatitis B infection
- Participant has been vaccinated against hepatitis B or birth mother was vaccinated within 6 months before birth of participant
- Participant has had a fever within 72 hours of study start
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 |
|---|---|---|
| Modified Process Hepatitis B Vaccine (Experimental)Modified Process Hepatitis B Vaccine given intramuscularly (IM) in 3 injections of 5 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 5 μg arm). Modified Process Hepatitis B Vaccine given IM in 3 Injections of 10 ug (micrograms)/0.5 mL each over 4 months (Modified Process Hepatitis B vaccine 10 μg arm). | Biological | Modified Process Hepatitis B vaccine 10 μg, Modified Process Hepatitis B vaccine 5 μg |
| Hepatitis B Vaccine (Recombinant)Also: RECOMBIVAX HB™RECOMBIVAX HB™ (currently licensed product) given IM in 3 Injections of 5 ug/0.5 mL each over 4 months. | Biological | RECOMBIVAX HB™ Hepatitis B Vaccine |
| Hepatitis B Vaccine (Recombinant)Also: ENGERIX-B®ENGERIX-B® (currently licensed product) given IM in 3 Injections of 10 ug/0.5 mL each over 4 months | Biological | ENGERIX-B® |
Primary outcome
The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B®
Time frame: 7 months of age (1 month after 3 doses)
The percentage of participants as measured by Seroresponse. Seroresponse was defined as anti-hepatitis B surface antibodies greater than or equal to 10 milli-International Units (mIU)/mL. Success on the primary immunogenicity hypothesis required demonstrating an adequate anti-HBs seroprotection rate response for either modified process hepatitis B 5 μg vaccine or RECOMBIVAX HB™. Specifically, the lower bound of the multiplicity adjusted 95% confidence interval (CI) on the seroprotection rate for either vaccine was required to be above 90.0%.
1 secondary outcome
Antibody to Hepatitis B Surface Antigen Geometric Mean Titer (Anti-HBs GMT) Responses for Modified Process Vaccine (5 μg and 10 μg), RECOMBIVAX™ Hepatitis B (Currently Licensed Vaccine), and ENGERIX-B®
Time frame: 7 months of age (1 month after 3 doses)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21552183Vesikari T, Martin JC, Liss CL, Liska V, Schodel FP, Bhuyan PK. Safety and immunogenicity of a modified process hepatitis B vaccine in healthy infants. Pediatr Infect Dis J. 2011 Jul;30(7):e109-13. doi: 10.1097/INF.0b013e31821ed1a4.
- Individual participant dataSharing planned: Yes. http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php
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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 Director study director
Merck Sharp & Dohme LLC
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Modified Process Hepatitis B Vaccine (Experimental) and Hepatitis B Vaccine (Recombinant) in people with Hepatitis B, 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 1 inclusion and 6 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 23 May 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Apr 2009). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Percentage of Seroresponders to the Modified Process Hepatitis B Vaccine (5 μg and 10 μg Dose), RECOMBIVAX HB™ Hepatitis B Vaccine (Currently Licensed Vaccine), and ENGERIX-B® (time frame: 7 months of age (1 month after 3 doses)). 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 NCT00414050, 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 23 May 2017.