Pneumococcal InfectionPhase 2NCT03467984
A Study to Evaluate the Safety and Immunogenecity of LBVE(Multivalent Pneumococcal Conjugate Vaccine) in Healthy Infants
A Phase 2 study testing LBVE and Prevnar13 in people with Pneumococcal Infection, run by LG Chem at 1 site in South Korea.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Pneumococcal Infection
- What is being tested?
- LBVE and Prevnar13
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 May 2018to 27 Mar 2019
- 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 6 to 8 weeks
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment.
- The parents or LAR(Legally authorized representative) able to understand and comply with planned study procedures.
- Signed informed consent by subject's parents or LAR(Legally authorized representative)
Who cannot join
- Previously received any pneumococcal vaccine
- Receipt of immunoglobulin or blood-derived product before the study
- Known or suspected immune disorder, or received immunosuppressive therapy
- Known major congenital malformation or serious chronic disorder
- Participation in another interventional trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-blind, Multi-center, Randomized, Active-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Immunogenicity of Intramuscular Three Injections With LBVE(Multivalent Pneumococcal Conjugate Vaccine) Compared to Prevnar13 in Healthy Infants
The purpose of this study is to evaluate the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.
- Conditions
- Pneumococcal Infection
- Being tested
- LBVE, Prevnar13
- Medical subject headings
- Pneumococcal Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LBVEBiological
Multivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
Prevnar13Biological
13-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh
| Study group | Role | What they receive |
|---|---|---|
| LBVE | Experimental | Infants will receive a 0.5mL intramuscular injection of LBVE at 6,10 and 14 weeks of age Receives: Biological: LBVE |
| Prevnar13 | Active comparator | Infants will receive a 0.5mL intramuscular injection of Prevnar13 at 6,10 and 14 weeks of age Receives: Biological: Prevnar13 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml
Measured: 4 weeks after 3rd(last) vaccination
Pneumococcal serotype-specific IgG geometic mean concentration (GMC) ratios
Measured: 4 weeks after 3rd(last) vaccination
Secondary outcomes (4)
Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer
Measured: 4 weeks after 3rd(last) vaccination
Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios
Measured: 4 weeks after 3rd(last) vaccination
Solicited adverse events
Measured: Baseline(pre-vaccination) up to 7 days after each vaccination
Unsolicited adverse events
Measured: Baseline(pre-vaccination) up to 4 weeks after 3rd(last) vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2018
- Study start25 May 2018
- Primary completion5 Oct 2018
- Study completion27 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pneumococcal InfectionStudies 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- LG Chem
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03467984
- Sponsor's protocol ID
- LG-VECL002
- Status last verified
- Aug 2019
- First submitted
- 12 Mar 2018
- Last updated
- 22 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blind, Multi-center, Randomized, Active-controlled, Parallel Group, Phase II Study to Evaluate the Safety and Immunogenicity of Intramuscular Three Injections With LBVE(Multivalent Pneumococcal Conjugate Vaccine) Compared to Prevnar13 in Healthy Infants
- ClinicalTrials.gov ID
- NCT03467984
- Acronym / sponsor ID
- LG-VECL002
- Conditions
- Pneumococcal Infection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 25 May 2018 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 27 Mar 2019 (actual)
- First posted
- 16 Mar 2018 (actual)
- 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 the safety and immunogenicity of LBVE (Multivalent Pneumococcal Conjugate Vaccine) in healthy infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LBVE | Experimental | Biological: LBVEInfants will receive a 0.5mL intramuscular injection of LBVE at 6,10 and 14 weeks of age |
| Prevnar13 | Active comparator | Biological: Prevnar13Infants will receive a 0.5mL intramuscular injection of Prevnar13 at 6,10 and 14 weeks of age |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy infants of either sex who have reached at least 42 days (6 weeks) of age and not more than 56 days (8 weeks) of age at the time of enrollment.
- The parents or LAR(Legally authorized representative) able to understand and comply with planned study procedures.
- Signed informed consent by subject's parents or LAR(Legally authorized representative)
Key exclusion criteria (5 listed)
- Previously received any pneumococcal vaccine
- Receipt of immunoglobulin or blood-derived product before the study
- Known or suspected immune disorder, or received immunosuppressive therapy
- Known major congenital malformation or serious chronic disorder
- Participation in another interventional trial
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 |
|---|---|---|
| LBVEMultivalent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh | Biological | LBVE |
| Prevnar1313-valent pneumococcal conjugate vaccine be administered by Intramuscular injection into the thigh | Biological | Prevnar13 |
Primary outcome
Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml
Time frame: 4 weeks after 3rd(last) vaccination
Pneumococcal serotype-specific IgG geometic mean concentration (GMC) ratios
Time frame: 4 weeks after 3rd(last) vaccination
4 secondary outcomes
Proportion of subjects achieving targeted pneumococcal serotype-specific opsonophagocytic assay (OPA) titer
Time frame: 4 weeks after 3rd(last) vaccination
Pneumococcal serotype-specific OPA geometic mean titer (GMT) ratios
Time frame: 4 weeks after 3rd(last) vaccination
Solicited adverse events
Time frame: Baseline(pre-vaccination) up to 7 days after each vaccination
Unsolicited adverse events
Time frame: Baseline(pre-vaccination) up to 4 weeks after 3rd(last) 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 22 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Pneumococcal Infection
RecruitingObservational study
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Trial to Evaluate Safety and Immune Response of an Investigational Pneumococcal Vaccine in Adults Aged 50 To 64 Years
Pneumonia, Bacterial
Active, not recruitingObservational study
A Study to Learn How Effective is PCV20 to Help Stop Adults Who Have a Higher Chance of Getting Pneumonia
Community-Acquired Pneumonia (CAP)
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Pneumonia and Pleuropneumonia in Hospitalized Children
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Study to Learn About Safety, Tolerability, and Immune Response of a Catch-up Pneumococcal Vaccine in Children and Adolescents
Pneumococcal Disease
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 2 study testing LBVE and Prevnar13 in people with Pneumococcal Infection, run by LG Chem 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 3 inclusion and 5 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 22 Aug 2019. 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 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?
Proportion of subjects achieving pneumococcal serotype-specific IgG >= 0.35 ug/ml (time frame: 4 weeks after 3rd(last) vaccination). 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?
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 22 Aug 2019.