PoliomyelitisPhase 3VIPV-06NCT03032419
Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine Given at 6, 10, 14 Weeks and 9 Months
A Phase 3 study testing IPV-Al SSI and IPV SSI in people with Poliomyelitis, run by Statens Serum Institut at 1 site in Philippines.
Trial summary
The trial is a phase III, non-inferiority, observer-blind, randomised, controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (reference vaccine) Read more about this study
- Who is it for?
- Ages 6 weeks to 9 monthsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- IPV-Al SSI and IPV SSI
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,002 participants
- Where
- 1 sitePhilippines
- Study dates
- 6 Feb 2017to 12 Mar 2018
- 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 6 weeks to 9 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants of 6 weeks of age (-3 to +14 days) on the date of the 1st vaccination
- Healthy assessed from medical history and physical examination
- Parent(s)/guardian(s) willing to let their infant follow the national Philippine childhood vaccination programme and schedule, in addition to let their infant receive the trial vaccine
- Parent(s)/guardian(s) properly informed about the trial and has signed the informed consent form
- Parent(s)/guardian(s) granting access to the infant's trial related medical records
- Parent(s)/guardian(s) likely to comply with the trial procedures
Who cannot join
- Vaccinated with any polio vaccine other than the trial vaccines, prior to inclusion or planned during the trial
- OPV vaccination or known exposure to poliovirus (wild or vaccine derived) in household (living together) within 3 months prior to inclusion or planned during the trial
- Low birth weight (< 2,500 g)
- Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criteria
- Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
- Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde, aluminium or 2-phenoxyethanol)
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- Uncontrolled coagulopathy or blood disorder contraindicating intramuscular injections or blood sampling
- Treatment with a product which is likely to modify the immune response (e.g. blood products and immunoglobulins) prior to inclusion or planned during the trial
- Participating in another clinical trial
- Not suitable for inclusion in the opinion of the investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI, in Comparison to Non-adjuvanted Full Dose IPV SSI, in Infants Vaccinated at 6, 10, 14 Weeks and 9 Months of Age
The trial is a phase III, non-inferiority, observer-blind, randomised, controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (reference vaccine)
Read the detailed description
In addition to the trial vaccine (IPV-Al SSI or IPV SSI), the trial subjects will receive vaccinations with the Philippine national childhood vaccination programme. The trial vaccine (IPV-Al SSI or IPV SSI) is administered in the RIGHT thigh, where other injectable childhood vaccines are administered in the opposite (LEFT) thigh. There are 6 trial visits:
Visit 1 (screening, 1st vaccination and blood sampling visit): written informed consent is obtained. Information on medical history, demographics and concomitant medication is collected, a physical examination is performed and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. A pre-vaccination blood sample is taken for polio antibody measurements, and the subject is randomly allocated into one of the 2 groups and vaccinated. If it is not possible to draw a blood sample on Visit 1 the child cannot continue in the trial. The subject is observed for immediate AEs ½ an hour after all vaccinations. A diary, a ruler and a thermometer are handed out to the parents to record daily the temperature and injection site reactions, during the first 3 days after the vaccinations until resolved and to record any AEs as instructed by the trial staff. 2 days after Visit 1 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 2 (2nd vaccination visit), 28-42 days after Visit 1: contraindications are reviewed, the 2nd vaccination is given, the diary is collected and AEs and concomitant medications (CMs) are recorded. A new diary is handed out.
2 days after Visit 2 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 3 (3rd vaccination visit), 28-42 days after Visit 2: contraindications are reviewed, the 3rd vaccination is given, the diary is collected and AEs and CMs are recorded. A new diary is handed out. 2 days after Visit 3 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 4 (blood sample visit), 28-42 days after Visit 3: a blood sample for polio antibody measurements is taken, the diary is collected, and AEs and CMs are recorded.
Visit 5 (4th vaccination and blood sample visit), at 9 months of age (+14 days): a blood sample is taken for polio antibody measurements, contraindications are reviewed, the 4th vaccination is given, and AEs and CMs are recorded. A new diary is handed out. 2 days after Visit 5 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 6 (blood sample and end of trial visit), 28-42 days after Visit 5: a blood sample for polio antibody measurements is taken, the diary is collected, and AEs and CMs are recorded. The end of trial form is completed.
- Conditions
- Poliomyelitis
- Being tested
- IPV-Al SSI, IPV SSI
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IPV-Al SSIBiological
3 primary injections of IPV-Al SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age
IPV SSIBiological
Also called IPV Vaccine SSI
3 primary injections of IPV SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age
| Study group | Role | What they receive |
|---|---|---|
| IPV-Al SSI | Experimental | IPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh. Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age Receives: Biological: IPV-Al SSI |
| IPV SSI | Active comparator | IPV SSI contains the full dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh. Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age Receives: Biological: IPV SSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI
Measured: Change from baseline to one month after 3rd vaccination
Secondary outcomes (7)
Adverse event following vaccinations (key secondary)
Measured: After primary injections at 2, 4 and 6 months of age
Subjects with seroprotection against poliovirus types 1, 2 and 3
Measured: One months after 3rd vaccination
Subjects with seroprotection against poliovirus types 1, 2 and 3
Measured: Before and one month after the 4th vaccination
Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above the estimated titre of maternal antibody
Measured: One months after 3rd vaccination
Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3
Measured: One months after 3rd vaccination
Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3
Measured: Before and one month after the 4th vaccination
Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3
Measured: From baseline, one month after 3rd vaccination, and before and one month 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 posted26 Jan 2017 (estimated)
- Study start6 Feb 2017
- Primary completion21 Sep 2017
- Study completion12 Mar 2018
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 3
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,002 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Larix A/S, Syneos Health, AJ Vaccines A/S
- Responsible party
- Sponsor
- Investigators
- Ingrid Kromann, Study director, Statens Serum Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03032419
- Sponsor's protocol ID
- VIPV-06
- Acronym
- VIPV-06
- Status last verified
- Nov 2018
- First submitted
- 16 Jan 2017
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Bravo LC, Carlos JC, Gatchalian SR, Montellano MEB, Tabora CFCB, Thierry-Carstensen B, Tingskov PN, Sorensen C, Wachmann H, Bandyopadhyay AS, Nielsen PI, Kusk MV. Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, compared to standard IPV: A phase 3 observer-blinded, randomised, controlled trial in infants vaccinated at 6, 10, 14 weeks and 9 months of age. Vaccine. 2020 Jan 16;38(3):530-538. doi: 10.1016/j.vaccine.2019.10.064. Epub 2019 Nov 5.
PubMed 31703934
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Adjuvanted Reduced Dose Inactivated Polio Vaccine, IPV-Al SSI, in Comparison to Non-adjuvanted Full Dose IPV SSI, in Infants Vaccinated at 6, 10, 14 Weeks and 9 Months of Age
- ClinicalTrials.gov ID
- NCT03032419
- Acronym / sponsor ID
- VIPV-06 / VIPV-06
- Conditions
- Poliomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,002 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Larix A/S, Syneos Health, AJ Vaccines A/S
- Study start
- 6 Feb 2017 (actual)
- Primary completion
- 21 Sep 2017 (actual)
- Study completion
- 12 Mar 2018 (actual)
- First posted
- 26 Jan 2017 (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 trial is a phase III, non-inferiority, observer-blind, randomised, controlled, multicentre clinical trial with 2 parallel groups: IPV-Al SSI (investigational vaccine) and IPV SSI (reference vaccine)
Detailed description
In addition to the trial vaccine (IPV-Al SSI or IPV SSI), the trial subjects will receive vaccinations with the Philippine national childhood vaccination programme. The trial vaccine (IPV-Al SSI or IPV SSI) is administered in the RIGHT thigh, where other injectable childhood vaccines are administered in the opposite (LEFT) thigh. There are 6 trial visits:
Visit 1 (screening, 1st vaccination and blood sampling visit): written informed consent is obtained. Information on medical history, demographics and concomitant medication is collected, a physical examination is performed and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria. A pre-vaccination blood sample is taken for polio antibody measurements, and the subject is randomly allocated into one of the 2 groups and vaccinated. If it is not possible to draw a blood sample on Visit 1 the child cannot continue in the trial. The subject is observed for immediate AEs ½ an hour after all vaccinations. A diary, a ruler and a thermometer are handed out to the parents to record daily the temperature and injection site reactions, during the first 3 days after the vaccinations until resolved and to record any AEs as instructed by the trial staff. 2 days after Visit 1 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 2 (2nd vaccination visit), 28-42 days after Visit 1: contraindications are reviewed, the 2nd vaccination is given, the diary is collected and AEs and concomitant medications (CMs) are recorded. A new diary is handed out.
2 days after Visit 2 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 3 (3rd vaccination visit), 28-42 days after Visit 2: contraindications are reviewed, the 3rd vaccination is given, the diary is collected and AEs and CMs are recorded. A new diary is handed out. 2 days after Visit 3 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 4 (blood sample visit), 28-42 days after Visit 3: a blood sample for polio antibody measurements is taken, the diary is collected, and AEs and CMs are recorded.
Visit 5 (4th vaccination and blood sample visit), at 9 months of age (+14 days): a blood sample is taken for polio antibody measurements, contraindications are reviewed, the 4th vaccination is given, and AEs and CMs are recorded. A new diary is handed out. 2 days after Visit 5 the trial staff will make a telephone call to the parent(s)/guardian(s) to clarify any questions regarding the AE recording in the diary.
Visit 6 (blood sample and end of trial visit), 28-42 days after Visit 5: a blood sample for polio antibody measurements is taken, the diary is collected, and AEs and CMs are recorded. The end of trial form is completed.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IPV-Al SSI | Experimental | Biological: IPV-Al SSIIPV-Al contains the reduced dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh. Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age |
| IPV SSI | Active comparator | Biological: IPV SSIIPV SSI contains the full dose of IPV to be administered intramuscularly to the anterolateral aspect of the right thigh. Each subject randomised to this group will receive three primary injection at 6, 10, and 14 weeks of age and one booster injection at 9 months of age |
Who may qualify
- Ages
- 6 weeks to 9 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Infants of 6 weeks of age (-3 to +14 days) on the date of the 1st vaccination
- Healthy assessed from medical history and physical examination
- Parent(s)/guardian(s) willing to let their infant follow the national Philippine childhood vaccination programme and schedule, in addition to let their infant receive the trial vaccine
- Parent(s)/guardian(s) properly informed about the trial and has signed the informed consent form
- Parent(s)/guardian(s) granting access to the infant's trial related medical records
Key exclusion criteria (10 listed)
- Vaccinated with any polio vaccine other than the trial vaccines, prior to inclusion or planned during the trial
- OPV vaccination or known exposure to poliovirus (wild or vaccine derived) in household (living together) within 3 months prior to inclusion or planned during the trial
- Low birth weight (< 2,500 g)
- Known or suspected immunodeficiency (e.g. leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency. HIV infection is not an exclusion criteria
- Severe uncontrolled chronic (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine) disease
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 |
|---|---|---|
| IPV-Al SSI3 primary injections of IPV-Al SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age | Biological | IPV-Al SSI |
| IPV SSIAlso: IPV Vaccine SSI3 primary injections of IPV SSI at 6, 10, and 14 weeks of age and 1 booster at 9 months of age | Biological | IPV SSI |
Primary outcome
Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI
Time frame: Change from baseline to one month after 3rd vaccination
7 secondary outcomes
Adverse event following vaccinations (key secondary)
Time frame: After primary injections at 2, 4 and 6 months of age
Subjects with seroprotection against poliovirus types 1, 2 and 3
Time frame: One months after 3rd vaccination
Subjects with seroprotection against poliovirus types 1, 2 and 3
Time frame: Before and one month after the 4th vaccination
Subjects with poliovirus types 1, 2 and 3 post-vaccination titres ≥ 4-fold above the estimated titre of maternal antibody
Time frame: One months after 3rd vaccination
Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3
Time frame: One months after 3rd vaccination
Geometric mean titres (GMTs) and medians for poliovirus types 1, 2 and 3
Time frame: Before and one month after the 4th vaccination
Reverse cumulative titre distribution curves for poliovirus types 1, 2 and 3
Time frame: From baseline, one month after 3rd vaccination, and before and one month 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 14 Nov 2018.
- Derived from this study: PubMed 31703934Bravo LC, Carlos JC, Gatchalian SR, Montellano MEB, Tabora CFCB, Thierry-Carstensen B, Tingskov PN, Sorensen C, Wachmann H, Bandyopadhyay AS, Nielsen PI, Kusk MV. Immunogenicity and safety of an adjuvanted inactivated polio vaccine, IPV-Al, compared to standard IPV: A phase 3 observer-blinded, randomised, controlled trial in infants vaccinated at 6, 10, 14 weeks and 9 months of age. Vaccine. 2020 Jan 16;38(3):530-538. doi: 10.1016/j.vaccine.2019.10.064. Epub 2019 Nov 5.
- Individual participant dataSharing planned: Yes
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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.
Ingrid Kromann study director
Statens Serum Institut
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 IPV-Al SSI and IPV SSI in people with Poliomyelitis, run by Statens Serum Institut at 1 site in Philippines.
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 10 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 14 Nov 2018. 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 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 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?
Seroconversion for poliovirus type 1, 2 and 3 for IPV-Al compared to IPV SSI (time frame: Change from baseline to one month after 3rd 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 NCT03032419, 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 14 Nov 2018.