Infectious Disease by Haemophilus Influenzae Type bPhase 3NCT01019772
Immunogenicity and Safety Study of LBVH0101 in Healthy Infants at Two, Four and Six Months of Age
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
The purpose of this study is to evaluate and compare the immunogenicity and safety of LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) to that of Hiberix™ at vaccination in healthy infants at their 2, 4, and 6 months of age. Read more about this study
- Who is it for?
- Ages 49 to 84 daysHealthy volunteers can take part
- 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
- 217 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2007to Aug 2008
- 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 49 to 84 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy male or female infants aged from 49 days to 84 days at the time of enrollment.
- The gestation period was 37 weeks or longer, and birth weight was 2.5 kg or more.
- The infants and their parents/legally acceptable representative could comply with all of the scheduled visits in the study and the study requirements related to protocol compliance.
- The parents/legally acceptable representative (LAR) signed the written consent form.
Who cannot join
- Had previously received Haemophilus influenzae type b vaccine prior to this clinical study.
- Had a plan for vaccination with the vaccine other than those permitted in the protocol based on the standard vaccination schedule.
- Had been contacted with a patient with confirmed Hib infection within 30 days before the study start.
- Had had fever of ≥ 37.5°C within the last 3 days (If measured by tympanic thermometer, fever of 38°C or higher)
- Had or were suspected for immune function disorders; had previously received or were suspected to receive the immunosuppressive therapy; or had received the immunosuppressive therapy within 30 days prior to participating in the study (including systemic corticosteroids or inhalation corticosteroids) (However, it was not the exclusion criteria to have received corticosteroid therapy (prednisolone equivalent ≤ 0.5 mg/kg/day) not more than for 14 consecutive days at least 30 days before their participation in the study).
- Had received the treatment of parenteral immunoglobulin or blood products after birth.
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- Had allergic history to be considered due to any component of the vaccine including excipients or preservatives.
- Three preceding generations in an ancestral line were not of Korean heritage.
- Had or were suspected to have significant disorders of blood, heart, liver, kidney, nervous system, respiratory system, or digestive system, or the investigator decided that the evaluation of study objective might be interrupted.
- Had been treated with other investigational drug by participating in another clinical trial within 30 days prior to this study entry, or were participating in another clinical study at that time.
- Had plans to move away from the area of the study site before completing the study.
- Inappropriate to take part in this clinical study in the principal investigator or sub-investigator's opinion, for the reasons other than above criteria.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Children's Hospital
Seoul, Jongno-gu, 110-769
About this study
Official title: A Multicentre, Comparative, Two-arm, Parallel-group, Double-blind, Randomized Phase III Study to Assess Immunogenicity and Safety of LBVH0101 (Haemophilus Influenzae Type b Tetanus Toxoid Conjugate Vaccine) Compared With Hiberix™ Vaccine in Healthy Infants at Two, Four and Six Months of Age
The purpose of this study is to evaluate and compare the immunogenicity and safety of LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) to that of Hiberix™ at vaccination in healthy infants at their 2, 4, and 6 months of age.
- Being tested
- LBVH0101 (Hib vaccine), Hiberix™ Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBVH0101 (Hib vaccine)Biological
Hiberix™ VaccineBiological
| 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.
Proportion of subjects who have obtained protective antibody response with anti-PRP antibody titer not less than 1㎍/mL after the 3rd vaccination (at 4 weeks after the 3rd vaccination) in the test group and control group.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2009 (estimated)
- Study startJul 2007
- Study completionAug 2008
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
- 217 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Life Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01019772
- Sponsor's protocol ID
- LG-VHCL002
- Status last verified
- Nov 2009
- First submitted
- 23 Nov 2009
- Last updated
- 25 Nov 2009
- Results posted
- No
- Data monitoring committee
- No
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 25 Nov 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicentre, Comparative, Two-arm, Parallel-group, Double-blind, Randomized Phase III Study to Assess Immunogenicity and Safety of LBVH0101 (Haemophilus Influenzae Type b Tetanus Toxoid Conjugate Vaccine) Compared With Hiberix™ Vaccine in Healthy Infants at Two, Four and Six Months of Age
- ClinicalTrials.gov ID
- NCT01019772
- Acronym / sponsor ID
- LG-VHCL002
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 217 participants (actual)
- Lead sponsor
- LG Life SciencesIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Study completion
- Aug 2008 (actual)
- First posted
- 25 Nov 2009 (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.
The purpose of this study is to evaluate and compare the immunogenicity and safety of LBVH0101 (Haemophilus influenzae type b tetanus toxoid conjugate vaccine) to that of Hiberix™ at vaccination in healthy infants at their 2, 4, and 6 months of age.
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
- 49 to 84 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Healthy male or female infants aged from 49 days to 84 days at the time of enrollment.
- The gestation period was 37 weeks or longer, and birth weight was 2.5 kg or more.
- The infants and their parents/legally acceptable representative could comply with all of the scheduled visits in the study and the study requirements related to protocol compliance.
- The parents/legally acceptable representative (LAR) signed the written consent form.
Key exclusion criteria (12 listed)
- Had previously received Haemophilus influenzae type b vaccine prior to this clinical study.
- Had a plan for vaccination with the vaccine other than those permitted in the protocol based on the standard vaccination schedule.
- Had been contacted with a patient with confirmed Hib infection within 30 days before the study start.
- Had had fever of ≥ 37.5°C within the last 3 days (If measured by tympanic thermometer, fever of 38°C or higher)
- Had or were suspected for immune function disorders; had previously received or were suspected to receive the immunosuppressive therapy; or had received the immunosuppressive therapy within 30 days prior to participating in the study (including systemic corticosteroids or inhalation corticosteroids) (However, it was not the exclusion criteria to have received corticosteroid therapy (prednisolone equivalent ≤ 0.5 mg/kg/day) not more than for 14 consecutive days at least 30 days before their participation in the study).
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) | Biological | LBVH0101 |
| Hiberix™ Vaccine | Biological | Hiberix |
Primary outcome
Proportion of subjects who have obtained protective antibody response with anti-PRP antibody titer not less than 1㎍/mL after the 3rd vaccination (at 4 weeks after the 3rd vaccination) in the test group and control group.
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 25 Nov 2009.
- 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 12 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 25 Nov 2009. 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?
Proportion of subjects who have obtained protective antibody response with anti-PRP antibody titer not less than 1㎍/mL after the 3rd vaccination (at 4 weeks after the 3rd vaccination) in the test group and control group.. 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 NCT01019772, 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 25 Nov 2009.