PoliomyelitisPhase 2NCT02347423
3 Adjuvated Reduced Dose IPV-Al SSI and Non-adjuvated Full Dose IPV SSI Given as Primary Vaccinations to Infants
A Phase 2 study testing Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI and IPV Vaccine SSI in people with Poliomyelitis, run by Statens Serum Institut at 1 site in Dominican Republic.
Trial summary
The background of the present clinical trial is the overall aim of the World Health Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to be available in low resource third… Read more about this study
- Who is it for?
- Ages 42 to 49 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI and IPV Vaccine SSI
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 824 participants
- Where
- 1 siteDominican Republic
- Study dates
- Feb 2015to 26 Sep 2015
- 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 42 to 49 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Infants of 6 weeks of age (+7 days) on date of first vaccination
- Healthy assessed from medical history and physical examination
- One parent/guardian has been properly informed about the trial and has signed the informed consent form
- One parent/guardian grants access to the infant's trial related medical records
- One parent/guardian is likely to comply with trial procedures
Who cannot join
- Vaccinated with poliovirus vaccine (OPV or IPV), other than the trial vaccines, prior to inclusion or planned during the trial (e.g. on national polio immunisation days)
- OPV vaccination or known exposure to poliovirus in household (living together) within 3 month prior to inclusion or planned during the trial
- Has a sibling who is ≤5 years of age, and for whom OPV vaccination is planned during the trial
- Low birth weight (< 2,500 g)
- Known or suspected immunodeficiency (e.g. HIV, leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency
- Severe uncontrolled chronic disease (e.g. neurologic, pulmonary, gastrointestinal, hepatic, renal or endocrine)
Show all 12Show fewer
- Known or suspected allergy to vaccine constituents (e.g. hypersensitivity to formaldehyde)
- Acute severe febrile illness at day of vaccination deemed by the investigator to be a contraindication for vaccination
- 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.
Dominican Republic1 site
Hospital Maternidad Nuestra de la Altagracia
Santo Domingo
About this study
Official title: Immunogenicity and Safety of 3 Adjuvated Reduced Dose Inactivated Polio Vaccines (IPV-Al SSI) and Non-adjuvated Full Dose IPV SSI, Given as Primary Vaccinations to Infants at 6, 10 and 14 Weeks of Age
The background of the present clinical trial is the overall aim of the World Health Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to be available in low resource third world countries. The intention of the present phase II clinical trial is to determine if reduced dose(s) of IPV-Al SSI are safe in the target population and do not decrease the immunogenicity clinically significantly compared to full dose IPV Vaccine SSI. The infants will receive three doses of one of the trial vaccines according to the WHO Expanded Program on Immunization (EPI) schedule of 6, 10 and 14 weeks of age.
A total of 824 healthy infants will be included in the trial.
Read the detailed description
The trial is a phase II, dose investigation, parallel and multi-group, observer-blind, randomised, controlled, multicentre and non-inferiority trial.
Three investigational reduced dose adjuvated IPV-Al SSI vaccines and full dose IPV SSI vaccine will be investigated in four parallel groups:
- 1/3 IPV-Al SSI
- 1/5 IPV-Al SSI
- 1/10 IPV-Al SSI
- IPV Vaccine SSI (comparator)
At Visit 1 (screening and 1st vaccination visit), written informed consent is obtained and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria, including measurement of axillary temperature. If the subject is included, a pre-vaccination blood sample is taken for polio antibody determinations, and the subject is randomly allocated into one of the four groups to be vaccinated.
The subject is observed for ½ an hour after the injection of the investigational medical product (IMP) and any immediate adverse events observed are to be recorded. A diary, thermometer and ruler are handed out to the parents/guardians so that they can measure daily the injection site reactions and the axillary temperature the first 3 days and record any adverse event until the next visit.
At Visit 2 (2nd vaccination visit), 28-42 days after Visit 1, contraindications are reviewed, the 2nd vaccination is given, the diary is collected and adverse events and concomitant medications are recorded in the eCRF. A new diary is handed out.
At Visit 3 (3rd vaccination and blood sample visit), 28-42 days after Visit 2, a blood sample for immunogenicity assessment is taken, contraindications are reviewed, the 3rd vaccination is given, the diary is collected and adverse events and concomitant medications are recorded in the eCRF. A new diary is handed out.
At Visit 4 (blood sample visit), 28-42 days after Visit 3, a blood sample for immunogenicity assessment is taken, the diary is collected, and adverse events and concomitant medications are recorded in the eCRF. The trial termination form is completed.
- Conditions
- Poliomyelitis
- Being tested
- Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI, IPV Vaccine SSI
- Keywords
- Poliomyelitis immunization, primary series
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary series of immunisation comprised by 3 vaccinations IPV-Al SSIBiological
IPV Vaccine SSIBiological
| Study group | Role | What they receive |
|---|---|---|
| 1/3 IPV-Al SSI | Experimental | 3 vaccinations of 1/3 IPV-Al SSI given at 6, 10 and 14 weeks of age Receives: Biological: Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI |
| 1/5 IPV-Al SSI | Experimental | 3 vaccinations of 1/5 IPV-Al SSI given at 6, 10 and 14 weeks of age Receives: Biological: Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI |
| 1/10 IPV-Al SSI | Experimental | 3 vaccinations of 1/10 IPV-Al SSI given at 6, 10 and 14 weeks of age Receives: Biological: Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI |
| IPV Vaccine SSI | Active comparator | 3 vaccinations of IPV Vaccine SSI given at 6, 10 and 14 weeks of age, The comparator IPV Vaccine SSI contains: Type 1: 40DU, Type 2: 8 DU and Type 3: 32 DU. Receives: Biological: IPV Vaccine SSI |
What is being measured
The primary outcome is the main question the study is designed to answer.
For each of the 3 poliovirus types 1, 2 and 3, for the IPV-Al and IPV Vaccine SSI vaccines to evaluate: Type specific seroconversion rates based on baseline and 4 weeks post 3rd vaccincation
Measured: Change from baseline to 4 weeks post 3rd vaccincation
Secondary outcomes (4)
Type-specific geometric mean titers (GMTs)
Measured: 4 weeks post 3rd vaccination for each vaccine
Type-specific seroprotection rates (titers ≥ 1/8)
Measured: 4 weeks post 3rd vaccination for each vaccine
Type-specific reverse cumulative titer distribution curves based on pre-vaccination and 4 weeks post 3rd vaccination serum titers for each vaccine
Measured: 4 weeks post 3rd vaccination for each vaccine
Adverse events following the vaccinations for each vaccine
Measured: From inclusion to 4 weeks post 3rd vaccincation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2015 (estimated)
- Study startFeb 2015
- Primary completionSep 2015
- Study completion26 Sep 2015
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 824 participants (actual)
Sponsor and investigators
- Lead sponsor
- Statens Serum Institut
- Sponsor type
- University, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Quintiles, Inc., Larix A/S
- Responsible party
- Sponsor
- Investigators
- Ingrid Kromann, Study director, Statens Serum Institut
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02347423
- Sponsor's protocol ID
- VIPV-05
- Other IDs
- 2014-003449-88, 2014
- Status last verified
- Nov 2018
- First submitted
- 15 Jan 2015
- Last updated
- 14 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Rivera L, Pedersen RS, Pena L, Olsen KJ, Andreasen LV, Kromann I, Nielsen PI, Sorensen C, Dietrich J, Bandyopadhyay AS, Thierry-Carstensen B. Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial. Lancet Infect Dis. 2017 Jul;17(7):745-753. doi: 10.1016/S1473-3099(17)30177-9. Epub 2017 Apr 25.
PubMed 28454674
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
- Immunogenicity and Safety of 3 Adjuvated Reduced Dose Inactivated Polio Vaccines (IPV-Al SSI) and Non-adjuvated Full Dose IPV SSI, Given as Primary Vaccinations to Infants at 6, 10 and 14 Weeks of Age
- ClinicalTrials.gov ID
- NCT02347423
- Acronym / sponsor ID
- VIPV-05
- Conditions
- Poliomyelitis
- Keywords
- Poliomyelitis immunization, primary series
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 824 participants (actual)
- Lead sponsor
- Statens Serum InstitutUniversity, hospital or other
- Collaborators
- Bill and Melinda Gates Foundation, Quintiles, Inc., Larix A/S
- Study start
- Feb 2015
- Primary completion
- Sep 2015 (actual)
- Study completion
- 26 Sep 2015 (actual)
- First posted
- 27 Jan 2015 (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 background of the present clinical trial is the overall aim of the World Health Organization (WHO) to obtain eradication of polio in the world. As part of this overall plan, inactivated polio vaccine (IPV) against poliovirus types 1, 2 and 3, at an affordable price, needs to be available in low resource third world countries. The intention of the present phase II clinical trial is to determine if reduced dose(s) of IPV-Al SSI are safe in the target population and do not decrease the immunogenicity clinically significantly compared to full dose IPV Vaccine SSI. The infants will receive three doses of one of the trial vaccines according to the WHO Expanded Program on Immunization (EPI) schedule of 6, 10 and 14 weeks of age.
A total of 824 healthy infants will be included in the trial.
Detailed description
The trial is a phase II, dose investigation, parallel and multi-group, observer-blind, randomised, controlled, multicentre and non-inferiority trial.
Three investigational reduced dose adjuvated IPV-Al SSI vaccines and full dose IPV SSI vaccine will be investigated in four parallel groups:
- 1/3 IPV-Al SSI
- 1/5 IPV-Al SSI
- 1/10 IPV-Al SSI
- IPV Vaccine SSI (comparator)
At Visit 1 (screening and 1st vaccination visit), written informed consent is obtained and the subject's eligibility is assessed according to the pre-specified in-/exclusion criteria, including measurement of axillary temperature. If the subject is included, a pre-vaccination blood sample is taken for polio antibody determinations, and the subject is randomly allocated into one of the four groups to be vaccinated.
The subject is observed for ½ an hour after the injection of the investigational medical product (IMP) and any immediate adverse events observed are to be recorded. A diary, thermometer and ruler are handed out to the parents/guardians so that they can measure daily the injection site reactions and the axillary temperature the first 3 days and record any adverse event until the next visit.
At Visit 2 (2nd vaccination visit), 28-42 days after Visit 1, contraindications are reviewed, the 2nd vaccination is given, the diary is collected and adverse events and concomitant medications are recorded in the eCRF. A new diary is handed out.
At Visit 3 (3rd vaccination and blood sample visit), 28-42 days after Visit 2, a blood sample for immunogenicity assessment is taken, contraindications are reviewed, the 3rd vaccination is given, the diary is collected and adverse events and concomitant medications are recorded in the eCRF. A new diary is handed out.
At Visit 4 (blood sample visit), 28-42 days after Visit 3, a blood sample for immunogenicity assessment is taken, the diary is collected, and adverse events and concomitant medications are recorded in the eCRF. The trial termination form is completed.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1/3 IPV-Al SSI | Experimental | Biological: Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI3 vaccinations of 1/3 IPV-Al SSI given at 6, 10 and 14 weeks of age |
| 1/5 IPV-Al SSI | Experimental | Biological: Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI3 vaccinations of 1/5 IPV-Al SSI given at 6, 10 and 14 weeks of age |
| 1/10 IPV-Al SSI | Experimental | Biological: Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI3 vaccinations of 1/10 IPV-Al SSI given at 6, 10 and 14 weeks of age |
| IPV Vaccine SSI | Active comparator | Biological: IPV Vaccine SSI3 vaccinations of IPV Vaccine SSI given at 6, 10 and 14 weeks of age, The comparator IPV Vaccine SSI contains: Type 1: 40DU, Type 2: 8 DU and Type 3: 32 DU. |
Who may qualify
- Ages
- 42 to 49 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Infants of 6 weeks of age (+7 days) on date of first vaccination
- Healthy assessed from medical history and physical examination
- One parent/guardian has been properly informed about the trial and has signed the informed consent form
- One parent/guardian grants access to the infant's trial related medical records
- One parent/guardian is likely to comply with trial procedures
Key exclusion criteria (12 listed)
- Vaccinated with poliovirus vaccine (OPV or IPV), other than the trial vaccines, prior to inclusion or planned during the trial (e.g. on national polio immunisation days)
- OPV vaccination or known exposure to poliovirus in household (living together) within 3 month prior to inclusion or planned during the trial
- Has a sibling who is ≤5 years of age, and for whom OPV vaccination is planned during the trial
- Low birth weight (< 2,500 g)
- Known or suspected immunodeficiency (e.g. HIV, leukaemia, lymphoma) or family history of congenital or hereditary immunodeficiency
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 |
|---|---|---|
| Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI | Biological | 1/10 IPV-Al SSI, 1/3 IPV-Al SSI, 1/5 IPV-Al SSI |
| IPV Vaccine SSI | Biological | IPV Vaccine SSI |
Primary outcome
For each of the 3 poliovirus types 1, 2 and 3, for the IPV-Al and IPV Vaccine SSI vaccines to evaluate: Type specific seroconversion rates based on baseline and 4 weeks post 3rd vaccincation
Time frame: Change from baseline to 4 weeks post 3rd vaccincation
4 secondary outcomes
Type-specific geometric mean titers (GMTs)
Time frame: 4 weeks post 3rd vaccination for each vaccine
Type-specific seroprotection rates (titers ≥ 1/8)
Time frame: 4 weeks post 3rd vaccination for each vaccine
Type-specific reverse cumulative titer distribution curves based on pre-vaccination and 4 weeks post 3rd vaccination serum titers for each vaccine
Time frame: 4 weeks post 3rd vaccination for each vaccine
Adverse events following the vaccinations for each vaccine
Time frame: From inclusion to 4 weeks post 3rd vaccincation
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 28454674Rivera L, Pedersen RS, Pena L, Olsen KJ, Andreasen LV, Kromann I, Nielsen PI, Sorensen C, Dietrich J, Bandyopadhyay AS, Thierry-Carstensen B. Immunogenicity and safety of three aluminium hydroxide adjuvanted vaccines with reduced doses of inactivated polio vaccine (IPV-Al) compared with standard IPV in young infants in the Dominican Republic: a phase 2, non-inferiority, observer-blinded, randomised, and controlled dose investigation trial. Lancet Infect Dis. 2017 Jul;17(7):745-753. doi: 10.1016/S1473-3099(17)30177-9. Epub 2017 Apr 25.
- 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.
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 2 study testing Primary series of immunisation comprised by 3 vaccinations IPV-Al SSI and IPV Vaccine SSI in people with Poliomyelitis, run by Statens Serum Institut at 1 site in Dominican Republic.
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 5 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 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 Dominican Republic. 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?
For each of the 3 poliovirus types 1, 2 and 3, for the IPV-Al and IPV Vaccine SSI vaccines to evaluate: Type specific seroconversion rates based on baseline and 4 weeks post 3rd vaccincation (time frame: Change from baseline to 4 weeks post 3rd vaccincation). 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 NCT02347423, 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.