PoliomyelitisPhase 2/3NCT03169725
A Clinical Study to Evaluate the Safety and Immunogenicity of Inactivated Poliomyelitis Vaccine in Healthy Infants
A Phase 2/3 study testing Inactivated Poliomyelitis Vaccine (Sabin strain) and Inactivated Poliomyelitis Vaccine (Salk strain) in people with Poliomyelitis, run by LG Chem at 3 sites in 2 countries.
Trial summary
The purpose of the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC. Read more about this study
- Who is it for?
- Ages 6 to 8 weeksHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Inactivated Poliomyelitis Vaccine (Sabin strain) and Inactivated Poliomyelitis Vaccine (Salk strain)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,417 participants
- Where
- 3 sitesin 2 countries
- Study dates
- 31 May 2017to 14 Jun 2019
- Phase
- Phase 2/3
- 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 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
- Born at full term of pregnancy (Gestational age ≥37 weeks)
- Body weight ≥ 3.2 kg at the time of screening
- Born to HIV negative mother
- The parents or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
- Signed informed consent by subject's parents or Legally Acceptable Representative (LAR)
Who cannot join
- Previously received any polio vaccines (OPV or IPV)
- History of previous or concurrent vaccinations other than HepB, BCG, DTP, Hib, Rotavirus vaccine and PCV
- History of bleeding disorder contraindicating intramuscular injection.
- Experienced fever ≥ 38 °C/ 100.4 °F within the past 3 days prior to the screening
- Receipt of immunoglobulin or blood-derived product since birth
- History of allergic reactions to any vaccine components, including excipients and preservatives (neomycin, streptomycin and polymyxin B, etc.)
Show all 14Show fewer
- Known or suspected immune disorder, or received immunosuppressive therapy
- History of poliomyelitis
- History of any neurological disorders or seizures
- Known or suspected febrile, acute or progressive illness
- Household contact and/or intimate exposure in the previous 30 days to an individual with poliomyelitis
- Participation in another interventional trial within 30 days before to the enrollment or simultaneous participation in another clinical study
- Infants whose families are planning to leave the area of the study site before the end of the study period
- Infants who is considered unsuitable for the clinical study by the investigator
Trial locations and contacts
3 sites in 2 countries.
3 sites in 2 countries
Thailand2 sites
Mahidol University Faculty of Medicine Siriraj Hospital
Bangkok
Chiang Mai University Maharaj Nakhon Chiang Mai Hospital
Chiang Mai
About this study
Official title: A Prospective, Multi-national, Multi-center, Double-blind, Randomized, Active Controlled, Parallel-group, Seamless Phase II/III Clinical Study to Evaluate the Safety and Immunogenicity of 'LBVC (Sabin Poliomyelitis Vaccine (Inactivated))' Compared With 'Imovax® Polio (Poliomyelitis Vaccine (Inactivated))' in Healthy Infants
The purpose of the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.
- Conditions
- Poliomyelitis
- Being tested
- Inactivated Poliomyelitis Vaccine (Sabin strain), Inactivated Poliomyelitis Vaccine (Salk strain)
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Poliomyelitis Vaccine (Sabin strain)Biological
Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.
Inactivated Poliomyelitis Vaccine (Salk strain)Biological
Commercialized IPV based on Salk strain (Imovax Polio). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age.
| Study group | Role | What they receive |
|---|---|---|
| Test group 1 | Experimental | Low dose (Stage2: Lot A) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC) Receives: Biological: Inactivated Poliomyelitis Vaccine (Sabin strain) |
| Test group 2 | Experimental | Middle dose (Stage2: Lot B) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC) Receives: Biological: Inactivated Poliomyelitis Vaccine (Sabin strain) |
| Test group 3 | Experimental | High dose (Stage2: Lot C) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC) Receives: Biological: Inactivated Poliomyelitis Vaccine (Sabin strain) |
| Comparator | Active comparator | Cormmercialized inactivated poliomyelitis vaccine based on Sabin strains (Imovax Polio) Receives: Biological: Inactivated Poliomyelitis Vaccine (Salk strain) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stage1: Seroconversion rate(%)
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Measured: 4 weeks after 3rd vaccination
Stage2: Seroconversion rate(%)
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Measured: 4 weeks after 3rd vaccination
Secondary outcomes (4)
Stage1: Seroconversion rate (%)
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Measured: 4 weeks after 2nd vaccination
Stage2: Seroprotection rate (%)
Proportion of subjects achieving seroprotection of each poliovirus serotype using microneutralization assay
Measured: 4 weeks after 3rd vaccination
Stage1: GMTs (Geometric Mean Titers)
Comparison of GMTs and GMT ratios
Measured: 4 weeks after 2nd and 3rd vaccination
Stage2: GMTs (Geometric Mean Titers)
Comparison of GMTs and GMT ratios
Measured: 4 weeks after 3rd vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2017
- Study start31 May 2017
- Primary completion18 Jan 2019
- Study completion14 Jun 2019
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 PoliomyelitisStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,417 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
- NCT03169725
- Sponsor's protocol ID
- LG-VCCL001
- Status last verified
- Jan 2019
- First submitted
- 11 May 2017
- Last updated
- 29 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Capeding MR, Gomez-Go GD, Oberdorfer P, Borja-Tabora C, Bravo L, Carlos J, Tangsathapornpong A, Uppala R, Laoprasopwattana K, Yang Y, Han S, Wittawatmongkol O. Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study. J Infect Dis. 2022 Aug 24;226(2):308-318. doi: 10.1093/infdis/jiaa770.
PubMed 33351072
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-national, Multi-center, Double-blind, Randomized, Active Controlled, Parallel-group, Seamless Phase II/III Clinical Study to Evaluate the Safety and Immunogenicity of 'LBVC (Sabin Poliomyelitis Vaccine (Inactivated))' Compared With 'Imovax® Polio (Poliomyelitis Vaccine (Inactivated))' in Healthy Infants
- ClinicalTrials.gov ID
- NCT03169725
- Acronym / sponsor ID
- LG-VCCL001
- Conditions
- Poliomyelitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,417 participants (actual)
- Lead sponsor
- LG ChemIndustry (pharma, biotech, devices)
- Study start
- 31 May 2017 (actual)
- Primary completion
- 18 Jan 2019 (actual)
- Study completion
- 14 Jun 2019 (actual)
- First posted
- 30 May 2017 (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 the study is to evaluate safety and immunogenicity of inactivated poliomyelitis vaccine based on Sabin strain (LBVC) in healthy infants to select optimal dose of LBVC as well as to demonstrate the lot-to-lot consistency and non-inferiority of LBVC.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Test group 1 | Experimental | Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)Low dose (Stage2: Lot A) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC) |
| Test group 2 | Experimental | Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)Middle dose (Stage2: Lot B) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC) |
| Test group 3 | Experimental | Biological: Inactivated Poliomyelitis Vaccine (Sabin strain)High dose (Stage2: Lot C) of investigational inactivated poliomyelitis vaccine based on Sabin strains (LBVC) |
| Comparator | Active comparator | Biological: Inactivated Poliomyelitis Vaccine (Salk strain)Cormmercialized inactivated poliomyelitis vaccine based on Sabin strains (Imovax Polio) |
Who may qualify
- Ages
- 6 to 8 weeks
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 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
- Born at full term of pregnancy (Gestational age ≥37 weeks)
- Body weight ≥ 3.2 kg at the time of screening
- Born to HIV negative mother
- The parents or Legally Acceptable Representative (LAR) able to understand and comply with planned study procedures
Key exclusion criteria (14 listed)
- Previously received any polio vaccines (OPV or IPV)
- History of previous or concurrent vaccinations other than HepB, BCG, DTP, Hib, Rotavirus vaccine and PCV
- History of bleeding disorder contraindicating intramuscular injection.
- Experienced fever ≥ 38 °C/ 100.4 °F within the past 3 days prior to the screening
- Receipt of immunoglobulin or blood-derived product since birth
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 |
|---|---|---|
| Inactivated Poliomyelitis Vaccine (Sabin strain)Investigational IPV based on Sabin strain (LBVC). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age. | Biological | Test group 1, Test group 2, Test group 3 |
| Inactivated Poliomyelitis Vaccine (Salk strain)Commercialized IPV based on Salk strain (Imovax Polio). Should be injected by intramuscular three injections in the anterolateral aspect of thigh at 6, 10 and 14 weeks of age. | Biological | Comparator |
Primary outcome
Stage1: Seroconversion rate(%)
Time frame: 4 weeks after 3rd vaccination
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
Stage2: Seroconversion rate(%)
Time frame: 4 weeks after 3rd vaccination
Proportion of subjects achieving seroconversion of each poliovirus serotype using microneutralization assay
4 secondary outcomes
Stage1: Seroconversion rate (%)
Time frame: 4 weeks after 2nd vaccination
Stage2: Seroprotection rate (%)
Time frame: 4 weeks after 3rd vaccination
Stage1: GMTs (Geometric Mean Titers)
Time frame: 4 weeks after 2nd and 3rd vaccination
Stage2: GMTs (Geometric Mean Titers)
Time frame: 4 weeks after 3rd 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 29 Aug 2019.
- Derived from this study: PubMed 33351072Capeding MR, Gomez-Go GD, Oberdorfer P, Borja-Tabora C, Bravo L, Carlos J, Tangsathapornpong A, Uppala R, Laoprasopwattana K, Yang Y, Han S, Wittawatmongkol O. Safety and Immunogenicity of a New Inactivated Polio Vaccine Made From Sabin Strains: A Randomized, Double-Blind, Active-Controlled, Phase 2/3 Seamless Study. J Infect Dis. 2022 Aug 24;226(2):308-318. doi: 10.1093/infdis/jiaa770.
- Individual participant dataSharing planned: No
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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.
3 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Inactivated Poliomyelitis Vaccine (Sabin strain) and Inactivated Poliomyelitis Vaccine (Salk strain) in people with Poliomyelitis, run by LG Chem at 3 sites in 2 countries.
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 6 inclusion and 14 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 29 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 3 sites in Thailand, Philippines. 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 combined 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.
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?
Stage1: Seroconversion rate(%) (time frame: 4 weeks after 3rd 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?
On the ClinicalTrials.gov record for NCT03169725, 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 29 Aug 2019.