Haemophilus Influenzae Type BPhase 3NCT00441012
Study of Modified Process Hib/Hep B Vaccine in Infants (V121-019)(COMPLETED)
A Phase 3 study testing Comparator: Modified Process Vaccine and Comparator: COMVAX™ in people with Haemophilus Influenzae Type B and Hepatitis B, run by Merck Sharp & Dohme LLC.
Trial summary
To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine Read more about this study
- Who is it for?
- Ages 40 to 80 daysHealthy volunteers can take part
- Conditions the study is for
- Haemophilus Influenzae Type B, Hepatitis B
- What is being tested?
- Comparator: Modified Process Vaccine and Comparator: COMVAX™
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 546 participants
- Where
- No sites listed yet
- Study dates
- Dec 2006to Jun 2008
- 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 40 to 80 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy 2-month-old full term infants born to non-HBs Ag (hepatitis B virus) carrier mothers
Who cannot join
- Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or known carriers ever living in close contact with the subject
- History of previous hepatitis B infection; history of vaccination with any hepatitis B vaccine
- Recent (<72 hours) history of febrile illness (rectal temperature >=38.1°C/>=100.5°F)
- Known or suspected hypersensitivity to any component of RECOMBIVAXHB™ or COMVAX™ (e.g., aluminum, yeast)
- Recent administration (w/i 3 months prior to study start) of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
- Receipt of investigational drugs or investigational vaccines within 3 months prior to study start or if planned within the study period;
- Known or suspected impairment of immunologic function or recent use (within 3 months prior to study start) of immunomodulatory medications (does not include topical and inhaled steroids);
- Any condition that, in the opinion of the investigator, might interfere with the evaluation of study objectives; or inability to comply with the study schedule and/or inability to attend all required study visits
About this study
Official title: A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus Influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process
To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B vaccine
- Conditions
- Haemophilus Influenzae Type B, Hepatitis B
- Being tested
- Comparator: Modified Process Vaccine, Comparator: COMVAX™
- Keywords
- Haemophilus Influenza, type b and Hepatitis B
- Medical subject headings
- Haemophilus Infections, Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparator: Modified Process VaccineBiological
Modified process vaccine HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 \& 12 months of age. Duration of treatment is 11 months.
Comparator: COMVAX™Biological
COMVAX™ HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Modified process Hib/Hep B vaccine Receives: Biological: Comparator: Modified Process Vaccine |
| 2 | Active comparator | COMVAX™ Receives: Biological: Comparator: COMVAX™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
Measured: 11 months (1 month after the third dose)
The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.
Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).
Measured: 11 months (1 month after the third dose)
Secondary outcomes (3)
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
Participants with adverse experiences considered possibly, probably, or definitely related to study vaccines and considered serious (death, persistent disability, life threatening, hospitalization, birth defects, cancer, or overdose)
Measured: 0-11 months (recorded from first dose until the participant completes or discontinues)
The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.
The number of participants as measured by the seroprotection rate (anti-polyribosylribitol phosphate antibodies greater than 1 µg/mL). Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after
the third dose)
Measured: 11 months (1 month after the third dose)
The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.
Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-PRP (Antibodies against polyribosylribitol phosphate) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
Measured: 11 months (1 month after the third dose)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2007 (estimated)
- Study startDec 2006
- Primary completionJun 2008
- Study completionJun 2008
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 Haemophilus Influenzae Type 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
- 546 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
- NCT00441012
- Sponsor's protocol ID
- V121-019
- Other IDs
- 2007_513
- Status last verified
- Mar 2015
- First submitted
- 26 Feb 2007
- Last updated
- 19 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Lee AW, Vesikari T, Gilbert CL, Klopfer SO, Schodel FP, Bhuyan PK. Immunogenicity and safety of a Haemophilus influenzae B (Hib)-hepatitis B vaccine with a modified process hepatitis B component administered with concomitant pneumococcal conjugate vaccine to infants. Vaccine. 2011 Oct 19;29(45):7942-8. doi: 10.1016/j.vaccine.2011.08.071. Epub 2011 Aug 27.
PubMed 21875633
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study in Healthy Infants of the Safety, Tolerability, and Immunogenicity of Haemophilus Influenzae, Type b/Hepatitis B Vaccine Manufactured With a Modified Process
- ClinicalTrials.gov ID
- NCT00441012
- Acronym / sponsor ID
- V121-019
- Conditions
- Haemophilus Influenzae Type B, Hepatitis B
- Keywords
- Haemophilus Influenza, type b and Hepatitis B
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 546 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2006
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 27 Feb 2007 (estimated)
- Results
- Posted 10 Jul 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To determine if there is an improvement in the immune response to HBsAg (hepatitis B virus) in healthy infants using a modified process in a combination Haemophilus Influenzae, type b/Hepatitis B vaccine and a currently licensed Haemophilus Influenzae, type b/Hepatitis B 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 VaccineModified process Hib/Hep B vaccine |
| 2 | Active comparator | Biological: Comparator: COMVAX™COMVAX™ |
Who may qualify
- Ages
- 40 to 80 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Healthy 2-month-old full term infants born to non-HBs Ag (hepatitis B virus) carrier mothers
Key exclusion criteria (8 listed)
- Birth mother known to be a carrier of hepatitis B virus (HBsAg+) or known carriers ever living in close contact with the subject
- History of previous hepatitis B infection; history of vaccination with any hepatitis B vaccine
- Recent (<72 hours) history of febrile illness (rectal temperature >=38.1°C/>=100.5°F)
- Known or suspected hypersensitivity to any component of RECOMBIVAXHB™ or COMVAX™ (e.g., aluminum, yeast)
- Recent administration (w/i 3 months prior to study start) of hepatitis B immune globulin (HBIg), serum immune globulin, or any other blood-derived product
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: Modified Process VaccineModified process vaccine HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4 \& 12 months of age. Duration of treatment is 11 months. | Biological | 1 |
| Comparator: COMVAX™COMVAX™ HBsAg 5 ug/0.5 mL and PRP [OMPC] 7.5 ug/0.5 mL in a 3-dose regimen at 2, 4, and 12 months of age. Duration of treatment is 11 months. | Biological | 2 |
Primary outcome
The Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose.
Time frame: 11 months (1 month after the third dose)
The number of participants as measured by the seroprotection rate (anti-hepatitis B surface antibodies greater than or equal to 10 mIU/mL). Anti-HBs (Antibodies against hepatitis B surface antigen) titers were measured from blood samples taken at Month 11 (1 month after the third dose)
The Anti-HBs GMT (Geometric Mean Titer) 1 Month After the Third Dose.
Time frame: 11 months (1 month after the third dose)
Geometric Mean Titer (GMT) - This is an Antibody titer that is measured using a laboratory test to detect the presence and amount of antibodies in a person's blood. Anti-HBs (Antibodies against hepatitis B surface antigen) and Geometric Mean Titers were measured from blood samples taken at Month 11 (1 month after the third dose).
3 secondary outcomes
The Total Number of Participants With Serious Vaccine-Related Clinical Adverse Experiences
Time frame: 0-11 months (recorded from first dose until the participant completes or discontinues)
The Number of Anti-PRP Seroprotected Participants 1 Month After the Third Dose.
Time frame: 11 months (1 month after the third dose)
The Anti-PRP GMT (Geometric Mean Titer) 1 Month After the Third Dose.
Time frame: 11 months (1 month after the third dose)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 21875633Lee AW, Vesikari T, Gilbert CL, Klopfer SO, Schodel FP, Bhuyan PK. Immunogenicity and safety of a Haemophilus influenzae B (Hib)-hepatitis B vaccine with a modified process hepatitis B component administered with concomitant pneumococcal conjugate vaccine to infants. Vaccine. 2011 Oct 19;29(45):7942-8. doi: 10.1016/j.vaccine.2011.08.071. Epub 2011 Aug 27.
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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 3 study testing Comparator: Modified Process Vaccine and Comparator: COMVAX™ in people with Haemophilus Influenzae Type B and 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 8 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 19 Mar 2015. 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 10 Jul 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 Number of Anti-HBs Seroprotected Participants 1 Month After the Third Dose. (time frame: 11 months (1 month after the third dose)). The study lists 2 primary outcomes in all. 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 NCT00441012, 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 19 Mar 2015.