Infectious Disease by Haemophilus Influenzae Type bPhase 3NCT01251133
Immunogenicity and Safety Study of 4th LBVH0101 After the Primary Vaccination in LG-VHCL002 Study
A Phase 3 study testing LBVH0101 (Hib vaccine) and Hiberix™ Vaccine in people with Infectious Disease by Haemophilus Influenzae Type b, run by LG Life Sciences at 1 site in South Korea.
Trial summary
This is a multi-center, comparative, two-arm, parallel-group, single-blind, phase III study to assess immunogenicity and safety of 4th LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) vaccination compared with 4th Hiberix™ vaccination after the same vaccination with primary one in healthy… Read more about this study
- Who is it for?
- Ages 12 to 15 months
- Conditions the study is for
- Infectious Disease by Haemophilus Influenzae Type b
- What is being tested?
- LBVH0101 (Hib vaccine) and Hiberix™ Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2008to Mar 2009
- Phase
- Phase 3
- 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 12 to 15 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Were vaccinated with LBVH0101 or Hiberix™ three times in LG-VHCL002 study
- Healthy male and female infants at the age of 12 to 15 months from birth
- The infants and their parents/legally acceptable representative could comply with all of the scheduled visits in the study
- The parents/legally acceptable representative signed the written consent form.
Who cannot join
- Subject had been vaccinated with 4th shot of Haemophilus influenzae type b
- Subject is scheduled to be administered with any vaccine other than those specified in the protocol as allowed according to the Standard Immunization Schedule, between the 4th vaccination and Completion Visit
- Subject had suffered from any infectious disease caused by Haemophilus influenzae type b
- Subject has fever of ≥ 37.5°C (axillary temperature) at the day of vaccination
- There is a clear or suspected immune function disorder
- Systemic corticosteroid (prednisolone or equivalent > 0.5 mg/kg/day) was administered for more than 14 days within 30 days prior to administration of the test vaccine or any systemic immunosuppressant was used
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III Study to Assess Immunogenicity and Safety of 4th LBVH0101 Vaccination Compared With 4th Hiberix™ Vaccination in Healthy Toddlers Who Completed Primary Vaccination in LG-VHCL002 Study
This is a multi-center, comparative, two-arm, parallel-group, single-blind, phase III study to assess immunogenicity and safety of 4th LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) vaccination compared with 4th Hiberix™ vaccination after the same vaccination with primary one in healthy toddlers who completed the primary vaccination with LBVH0101 or Hiberix™ in LG-VHCL002 study.
Read the detailed description
Primary objective: This study was purposed to compare and assess immunogenicity of 4th LBVH0101 or Hiberix™ vaccination in toddlers who completed the primary vaccination with LBVH0101 or Hiberix™, respectively, in LG-VHCL002 study.
Secondary objective: This study was purposed to compare and assess safety of 4th LBVH0101 or Hiberix™ vaccination in toddlers who completed primary vaccination with LBVH0101 or Hiberix™ in LG-VHCL002 study. It was also purposed to assess persistence of immunogenicity prior to 4th vaccination in toddlers who completed the primary vaccination with LBVH0101 or Hiberix™, respectively, in LG-VHCL002 study.
- Being tested
- LBVH0101 (Hib vaccine), Hiberix™ Vaccine
- Keywords
- Communicable Diseases, Infection, Influenza, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
- Medical subject headings
- Communicable Diseases, Infections, Influenza, Human, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBVH0101 (Hib vaccine)Biological
0.5mL
Hiberix™ VaccineBiological
0.5mL
| Study group | Role | What they receive |
|---|---|---|
| LBVH0101 | Experimental | Not described Receives: Biological: LBVH0101 (Hib vaccine) |
| Hiberix | Active comparator | Not described Receives: Biological: Hiberix™ Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of the subjects who obtained protective Ab response with anti-PRP Ab titer ≥ 1 ㎍/mL after 4th vaccination
Measured: at 4 weeks after 4th vaccination
Secondary outcomes (3)
Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 1㎍/mL prior to 4th vaccination
Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL prior to 4th vaccination
Percentage of the subjects who obtained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL after 4th vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2010 (estimated)
- Study startJul 2008
- Primary completionMar 2009
- Study completionMar 2009
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 Infectious Disease by Haemophilus Influenzae Type bStudies of the same condition, open and under way.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01251133
- Sponsor's protocol ID
- LG-VHCL004
- Status last verified
- Nov 2010
- First submitted
- 30 Nov 2010
- Last updated
- 1 Dec 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kim KH, Kim YK, Kim NH, Chang SH, Lee J, Park EA, Park SE, Eun BW, Lee H, Lee HJ. Immunogenicity and safety of LBVH0101, a new Haemophilus influenzae type b tetanus toxoid conjugate vaccine, compared with Hiberix in Korean infants and children: a randomized trial. Vaccine. 2012 Feb 27;30(10):1886-94. doi: 10.1016/j.vaccine.2011.12.122. Epub 2012 Jan 13.
PubMed 22245607
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Study to Assess Immunogenicity and Safety of 4th LBVH0101 Vaccination Compared With 4th Hiberix™ Vaccination in Healthy Toddlers Who Completed Primary Vaccination in LG-VHCL002 Study
- ClinicalTrials.gov ID
- NCT01251133
- Acronym / sponsor ID
- LG-VHCL004
- Keywords
- Communicable Diseases, Infection, Influenza, Orthomyxoviridae Infections, RNA Virus Infections, Virus Diseases, Respiratory Tract Infections, Respiratory Tract Diseases
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Mar 2009 (actual)
- First posted
- 1 Dec 2010 (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.
This is a multi-center, comparative, two-arm, parallel-group, single-blind, phase III study to assess immunogenicity and safety of 4th LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) vaccination compared with 4th Hiberix™ vaccination after the same vaccination with primary one in healthy toddlers who completed the primary vaccination with LBVH0101 or Hiberix™ in LG-VHCL002 study.
Detailed description
Primary objective: This study was purposed to compare and assess immunogenicity of 4th LBVH0101 or Hiberix™ vaccination in toddlers who completed the primary vaccination with LBVH0101 or Hiberix™, respectively, in LG-VHCL002 study.
Secondary objective: This study was purposed to compare and assess safety of 4th LBVH0101 or Hiberix™ vaccination in toddlers who completed primary vaccination with LBVH0101 or Hiberix™ in LG-VHCL002 study. It was also purposed to assess persistence of immunogenicity prior to 4th vaccination in toddlers who completed the primary vaccination with LBVH0101 or Hiberix™, respectively, in LG-VHCL002 study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBVH0101 | Experimental | Biological: LBVH0101 (Hib vaccine) |
| Hiberix | Active comparator | Biological: Hiberix™ Vaccine |
Who may qualify
- Ages
- 12 to 15 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Were vaccinated with LBVH0101 or Hiberix™ three times in LG-VHCL002 study
- Healthy male and female infants at the age of 12 to 15 months from birth
- The infants and their parents/legally acceptable representative could comply with all of the scheduled visits in the study
- The parents/legally acceptable representative signed the written consent form.
Key exclusion criteria (6 listed)
- Subject had been vaccinated with 4th shot of Haemophilus influenzae type b
- Subject is scheduled to be administered with any vaccine other than those specified in the protocol as allowed according to the Standard Immunization Schedule, between the 4th vaccination and Completion Visit
- Subject had suffered from any infectious disease caused by Haemophilus influenzae type b
- Subject has fever of ≥ 37.5°C (axillary temperature) at the day of vaccination
- There is a clear or suspected immune function disorder
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 |
|---|---|---|
| LBVH0101 (Hib vaccine)0.5mL | Biological | LBVH0101 |
| Hiberix™ Vaccine0.5mL | Biological | Hiberix |
Primary outcome
Percentage of the subjects who obtained protective Ab response with anti-PRP Ab titer ≥ 1 ㎍/mL after 4th vaccination
Time frame: at 4 weeks after 4th vaccination
3 secondary outcomes
Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 1㎍/mL prior to 4th vaccination
Percentage of the subjects who maintained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL prior to 4th vaccination
Percentage of the subjects who obtained preventive Ab response with anti-PRP Ab titer ≥ 0.15㎍/mL after 4th vaccination
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 1 Dec 2010.
- Derived from this study: PubMed 22245607Kim KH, Kim YK, Kim NH, Chang SH, Lee J, Park EA, Park SE, Eun BW, Lee H, Lee HJ. Immunogenicity and safety of LBVH0101, a new Haemophilus influenzae type b tetanus toxoid conjugate vaccine, compared with Hiberix in Korean infants and children: a randomized trial. Vaccine. 2012 Feb 27;30(10):1886-94. doi: 10.1016/j.vaccine.2011.12.122. Epub 2012 Jan 13.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing LBVH0101 (Hib vaccine) and Hiberix™ Vaccine in people with Infectious Disease by Haemophilus Influenzae Type b, run by LG Life Sciences at 1 site in South Korea.
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 4 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 1 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
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?
Percentage of the subjects who obtained protective Ab response with anti-PRP Ab titer ≥ 1 ㎍/mL after 4th vaccination (time frame: at 4 weeks after 4th vaccination). 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 NCT01251133, 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 1 Dec 2010.