PoliomyelitisPhase 1/2NCT02985320
Studies of the Safety and Immunogenicity of a Sabin Inactivated Poliovirus Vaccine
A Phase 1/2 study testing Single-dose regimen of high dosage investigational sIPV, Single-dose regimen of medium dosage investigational sIPV and Three-dose regimen of high dosage investigational sIPV in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study. Read more about this study
- Who is it for?
- Ages 2 months to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- Single-dose regimen of high dosage investigational sIPV, Single-dose regimen of medium dosage investigational sIPV and Three-dose regimen of high dosage investigational sIPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 708 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Jun 2017
- Phase
- Phase 1/2
- 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 2 months to 49 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old;
- Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
- Proven legal identity;
- Participants (≥ 18 years old), or guardians of the participants (< 18 years old) should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
- Complying with the requirement of the study protocol;
- Axillary temperature ≤ 37.0 °C;
Who cannot join
- Breast feeding, pregnant, or expected to conceive in the next 60 days;
- History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
- Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- Autoimmune disease or immunodeficiency/immunosuppressive;
- serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;
- severe nervous system disease (epilepsy, seizures or convulsions) or mental illness;
Show all 19Show fewer
- History of thyroidectomy, asplenia, functional asplenia, or any condition resulting in the absence or removal the spleen;
- Bleeding disorder diagnosed by a doctor (e.g., coagulation factor deficiency, coagulation disorder, or platelet disorder) , or significant bruising or coagulopathy;
- Long term history of alcoholism or drug abuse;
- Receipt of any of the following products:
- Any subunit or inactivated vaccine within the past 7 day;
- Any live attenuated vaccine within the past 14 days;
- Any other investigational medicine(s) within the past 30 days;
- Any blood product within the past 3 months;
- Any immunosuppressant, cytotoxic medications, or inhaled corticosteroids (except corticosteroid spray for treatment of allergic rhinitis or corticosteroid treatment on surface for acute non-complicated dermatitis) within the past 6 month prior to study entry;
- Acute illness or acute exacerbation of chronic disease within the past 7 days;
- Axillary temperature > 37.0 °C;
- Infant participants with prior vaccination of poliovirus;
- Any other factor that, in the judgment of the investigator, suggesting the volunteer is unsuitable for this study;
Trial locations and contacts
1 site in 1 country.
China1 site
Pizhou City Center for Disease Control and Prevention
Xuzhou, Jiangsu, 221300
About this study
Official title: A Open-label Phase I Study to Evaluate Safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Adults, Children, and Infants, and a Blinded, Randomized and Controlled Phase II to Evaluate Safety and Immunogenicity of it in Infants
The purpose of this study is to evaluate the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.
Read the detailed description
This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.
- Conditions
- Poliomyelitis
- Being tested
- Single-dose regimen of high dosage investigational sIPV, Single-dose regimen of medium dosage investigational sIPV, Three-dose regimen of high dosage investigational sIPV, Three-dose regimen of medium dosage investigational sIPV, Three-dose regimen of low dosage investigational sIPV
- Keywords
- Sabin strain, Inactivated poliovirus vaccine, poliomyelitis, safety, immunogenicity, infant
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single-dose regimen of high dosage investigational sIPVBiological
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Single-dose regimen of medium dosage investigational sIPVBiological
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Three-dose regimen of high dosage investigational sIPVBiological
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Three-dose regimen of medium dosage investigational sIPVBiological
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Three-dose regimen of low dosage investigational sIPVBiological
The investigational vaccines were manufactured by Sinovac Biotech Co., Ltd..
Three-dose regimen of commercialized sIPVBiological
The control vaccine was manufactured by Chinese Academy of Medical Sciences.
Three-dose regimen of commercialized IPVBiological
The control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO).
| Study group | Role | What they receive |
|---|---|---|
| Phase I Adult Group - High dosage | Experimental | * Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;
* Intervention: Single-dose regimen of high dosage investigational sIPV Receives: Biological: Single-dose regimen of high dosage investigational sIPV |
| Phase I Adult Group - Medium dosage | Experimental | * Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;
* Intervention: Single-dose regimen of medium dosage investigational sIPV Receives: Biological: Single-dose regimen of medium dosage investigational sIPV |
| Phase I Child Group - High dosage | Experimental | * Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;
* Intervention: Single-dose regimen of high dosage investigational sIPV Receives: Biological: Single-dose regimen of high dosage investigational sIPV |
| Phase I Child Group - Medium dosage | Experimental | * Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0;
* Intervention: Single-dose regimen of medium dosage investigational sIPV Receives: Biological: Single-dose regimen of medium dosage investigational sIPV |
| Phase I Infant Group - High dosage | Experimental | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
* Intervention: Three-dose regimen of high dosage investigational sIPV Receives: Biological: Three-dose regimen of high dosage investigational sIPV |
| Phase I Infant Group - Medium dosage | Experimental | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
* Intervention: Three-dose regimen of medium dosage investigational sIPV Receives: Biological: Three-dose regimen of medium dosage investigational sIPV |
| Phase I Infant Group - Low dosage | Experimental | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
* Intervention: Three-dose regimen of low dosage investigational sIPV Receives: Biological: Three-dose regimen of low dosage investigational sIPV |
| PhaseⅡExperimental Group - High dosage | Experimental | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
* Intervention: Three-dose regimen of high dosage investigational sIPV Receives: Biological: Three-dose regimen of high dosage investigational sIPV |
| PhaseⅡExperimental Group - Medium dosage | Experimental | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
* Intervention: Three-dose regimen of medium dosage investigational sIPV Receives: Biological: Three-dose regimen of medium dosage investigational sIPV |
| PhaseⅡExperimental Group - Low dosage | Experimental | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
* Intervention: Three-dose regimen of low dosage investigational sIPV Receives: Biological: Three-dose regimen of low dosage investigational sIPV |
| PhaseⅡControl Group -commercialized sIPV | Active comparator | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
* Intervention:Three-dose regimen of commercialized sIPV Receives: Biological: Three-dose regimen of commercialized sIPV |
| PhaseⅡ Control Group -commercialized IPV | Active comparator | * Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively;
* Intervention: Three-dose regimen of commercialized IPV Receives: Biological: Three-dose regimen of commercialized IPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen
Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
Measured: 90 days
The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen
GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.
Measured: 90 days
The geometric mean fold increase (GMI) of each group after three-dose regimen
The GMI is the increase of post-immune GMT from pre-immune GMT.
Measured: 90 days
Secondary outcomes (3)
The incidences of solicited adverse events (AEs) of each group in both phase I and II trials
Solicited AEs occurred within 7 days after each injection will be collected.
Measured: 7 days
The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials
Unsolicited AEs occurred within 30 days after each injection will be collected.
Measured: 30 days
The incidences of serious adverse events (SAEs) of each group in both phase I and II trials
SAEs occurred within 30 days after each injection will be collected.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017
- Study completionJun 2017
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.
- More trials run by Sinovac Biotech Co., LtdThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 708 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sinovac Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yuemei Hu, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02985320
- Sponsor's protocol ID
- PRO-sIPV-1001
- Status last verified
- Jul 2017
- First submitted
- 5 Dec 2016
- Last updated
- 26 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Chu K, Ying Z, Wang L, Hu Y, Xia J, Chen L, Wang J, Li C, Zhang Q, Gao Q, Hu Y. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: A phase II, randomized, dose-finding trial. Vaccine. 2018 Oct 29;36(45):6782-6789. doi: 10.1016/j.vaccine.2018.09.023. Epub 2018 Sep 21.
PubMed 30249424
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Open-label Phase I Study to Evaluate Safety of a Sabin Inactivated Poliovirus Vaccine (sIPV) in Adults, Children, and Infants, and a Blinded, Randomized and Controlled Phase II to Evaluate Safety and Immunogenicity of it in Infants
- ClinicalTrials.gov ID
- NCT02985320
- Acronym / sponsor ID
- PRO-sIPV-1001
- Conditions
- Poliomyelitis
- Keywords
- Sabin strain, Inactivated poliovirus vaccine, poliomyelitis, safety, immunogenicity, infant
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 708 participants (actual)
- Lead sponsor
- Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 7 Dec 2016 (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 the safety of sIPVs of different dosages in adults, children and infants in a phase I open-label study, and then assess its immunogenicity and safety in healthy infants between 60 and 90 days old in a phase II blind, randomized, and controlled study.
Detailed description
This study is a combination of phases I and II. Phase I study is open-label, and only collect safety information of the investigational sIPVs in adults, children and infants. Phase II study is double-blind, randomized, controlled study of the immunogenicity and safety of the investigational vaccines and two other commercialized inactivated poliovirus vaccines in healthy infants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Phase I Adult Group - High dosage | Experimental | Biological: Single-dose regimen of high dosage investigational sIPV* Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of high dosage investigational sIPV |
| Phase I Adult Group - Medium dosage | Experimental | Biological: Single-dose regimen of medium dosage investigational sIPV* Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of medium dosage investigational sIPV |
| Phase I Child Group - High dosage | Experimental | Biological: Single-dose regimen of high dosage investigational sIPV* Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of high dosage investigational sIPV |
| Phase I Child Group - Medium dosage | Experimental | Biological: Single-dose regimen of medium dosage investigational sIPV* Single intramuscular injection of the investigational vaccine(0.5 ml) on Day 0; * Intervention: Single-dose regimen of medium dosage investigational sIPV |
| Phase I Infant Group - High dosage | Experimental | Biological: Three-dose regimen of high dosage investigational sIPV* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of high dosage investigational sIPV |
| Phase I Infant Group - Medium dosage | Experimental | Biological: Three-dose regimen of medium dosage investigational sIPV* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of medium dosage investigational sIPV |
| Phase I Infant Group - Low dosage | Experimental | Biological: Three-dose regimen of low dosage investigational sIPV* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of low dosage investigational sIPV |
| PhaseⅡExperimental Group - High dosage | Experimental | Biological: Three-dose regimen of high dosage investigational sIPV* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of high dosage investigational sIPV |
| PhaseⅡExperimental Group - Medium dosage | Experimental | Biological: Three-dose regimen of medium dosage investigational sIPV* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of medium dosage investigational sIPV |
| PhaseⅡExperimental Group - Low dosage | Experimental | Biological: Three-dose regimen of low dosage investigational sIPV* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of low dosage investigational sIPV |
| PhaseⅡControl Group -commercialized sIPV | Active comparator | Biological: Three-dose regimen of commercialized sIPV* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention:Three-dose regimen of commercialized sIPV |
| PhaseⅡ Control Group -commercialized IPV | Active comparator | Biological: Three-dose regimen of commercialized IPV* Three intramuscular injections of the investigational vaccine(0.5 ml) on Day 0, Day 30 and Day 60 respectively; * Intervention: Three-dose regimen of commercialized IPV |
Who may qualify
- Ages
- 2 months to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Healthy volunteer between 60-90 days old, 6-12 years old, or 18-49 years old;
- Healthy volunteers who fulfill all the required conditions for receiving the investigational vaccine as established by medical history and clinical examination and determined by investigators;
- Proven legal identity;
- Participants (≥ 18 years old), or guardians of the participants (< 18 years old) should be capable of understanding the written consent form, and such form should be signed prior to enrolment;
- Complying with the requirement of the study protocol;
Key exclusion criteria (19 listed)
- Breast feeding, pregnant, or expected to conceive in the next 60 days;
- History of allergy to any vaccine, or any ingredient of the vaccine, or serious adverse reaction(s) to vaccination, such as urticaria, dyspnea, angioneurotic edema, abdominal pain, etc;
- Congenital malformation, developmental disorders, genetic defects, or severe malnutrition;
- Autoimmune disease or immunodeficiency/immunosuppressive;
- serious chronic diseases, serious cardiovascular disease, hypertension or diabetes that cannot be stabilized by medication, liver or kidney disease, malignancy, etc;
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 |
|---|---|---|
| Single-dose regimen of high dosage investigational sIPVThe investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. | Biological | Phase I Adult Group - High dosage, Phase I Child Group - High dosage |
| Single-dose regimen of medium dosage investigational sIPVThe investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. | Biological | Phase I Adult Group - Medium dosage, Phase I Child Group - Medium dosage |
| Three-dose regimen of high dosage investigational sIPVThe investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. | Biological | Phase I Infant Group - High dosage, PhaseⅡExperimental Group - High dosage |
| Three-dose regimen of medium dosage investigational sIPVThe investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. | Biological | Phase I Infant Group - Medium dosage, PhaseⅡExperimental Group - Medium dosage |
| Three-dose regimen of low dosage investigational sIPVThe investigational vaccines were manufactured by Sinovac Biotech Co., Ltd.. | Biological | Phase I Infant Group - Low dosage, PhaseⅡExperimental Group - Low dosage |
| Three-dose regimen of commercialized sIPVThe control vaccine was manufactured by Chinese Academy of Medical Sciences. | Biological | PhaseⅡControl Group -commercialized sIPV |
| Three-dose regimen of commercialized IPVThe control vaccine was manufactured by Sanofi Pasteur S.A (IMOVAX POLIO). | Biological | PhaseⅡ Control Group -commercialized IPV |
Primary outcome
The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen
Time frame: 90 days
Subjects whose pre-immune antibody level < 1:8 and post-immune antibody level ≥ 1:8, or those whose pre-immune antibody level ≥ 1:8 and the increase of post-immune antibody level ≥ 4 folds are considered seroconverted.
The post-immune geometric mean titer (GMT) of each group of the phase II trial after three-dose regimen
Time frame: 90 days
GMT of each group of the phase II trial 30 days after three-dose regimen which lasts 60 days.
The geometric mean fold increase (GMI) of each group after three-dose regimen
Time frame: 90 days
The GMI is the increase of post-immune GMT from pre-immune GMT.
3 secondary outcomes
The incidences of solicited adverse events (AEs) of each group in both phase I and II trials
Time frame: 7 days
The incidences of unsolicited adverse events (AEs) of each group in both phase I and II trials
Time frame: 30 days
The incidences of serious adverse events (SAEs) of each group in both phase I and II trials
Time frame: 30 days
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 26 Jul 2017.
- Derived from this study: PubMed 30249424Chu K, Ying Z, Wang L, Hu Y, Xia J, Chen L, Wang J, Li C, Zhang Q, Gao Q, Hu Y. Safety and immunogenicity of inactivated poliovirus vaccine made from Sabin strains: A phase II, randomized, dose-finding trial. Vaccine. 2018 Oct 29;36(45):6782-6789. doi: 10.1016/j.vaccine.2018.09.023. Epub 2018 Sep 21.
- 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.
Yuemei Hu principal investigator
Jiangsu Province Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Single-dose regimen of high dosage investigational sIPV, Single-dose regimen of medium dosage investigational sIPV and Three-dose regimen of high dosage investigational sIPV in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 1 site in China.
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 19 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 26 Jul 2017. 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 China. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The seroconversion rates (SCRs) of each group of the phase II trial after three-dose regimen (time frame: 90 days). The study lists 3 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 NCT02985320, 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 26 Jul 2017.