PoliomyelitisPhase 3NCT05386810

Safety of Sabin Inactivated Poliovirus Vaccine in Adults, Children and Infants and Lot Consistency Immunogenicity, and Safety of the msIPV in 2 Months Old Infants

A Phase 3 study testing Experimental vaccine in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 2 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 2 months to 49 years
Conditions the study is for: Poliomyelitis
What is being tested?: Experimental vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,572 participants
Where: 2 sitesChina
Study dates: 5 Nov 2020to 20 Jul 2023
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 2 months to 49 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Healthy adults aged 18-49 days;
Proven legal identification;
The subject can understand and voluntarily sign the informed consent form.
Healthy children aged 4 years old;
Subjects who have completed primary immunization with 3 doses of sIPV vaccine;
Proven legal identification and vaccination certificate;

Show all 10Show fewer

The subject and/or guardian can understand and voluntarily sign the informed consent form.
Healthy infants aged 2 months (60~89 days)
Proven legal identification and vaccination certificate;
The subject and/or guardian can understand and voluntarily sign the informed consent form.

Who cannot join

Women aged 18 to 49 years, positive urine pregnancy test, pregnant women, breastfeeding women, or planning to become pregnant within 3 months;
Previous history of vaccination of sIPV vaccine;
Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc;
Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
Autoimmune disease or immunodeficiency/immunosuppression;
Thyroid disease or thyroidectomy history, absence of spleen, functional absence of spleen, and any conditions resulting in absence of spleen or splenectomy;

Show all 55Show fewer

Serious chronic diseases, serious cardiovascular diseases, hypertension that cannot be controlled by drugs (systolic blood pressure > 140mmHg, diastolic blood pressure > 90mmHg), diabetes, liver and kidney diseases, malignant tumors, etc;
Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Medical diagnosis of coagulation abnormalities (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or marked bruising or coagulation disorders;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
History of alcohol or drug abuse;
Receipt of blood products within in the past 3 months;
Receipt of other investigational drugs in the past 30 days;
Receipt of attenuated live vaccines in the past 14 days;
Receipt of inactivated or subunit vaccines in the past 7 days;
Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
Axillary temperature >37.0°C;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Have received 4 doses of sIPV vaccine;
History of polio;
Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc;
Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
Autoimmune disease or immunodeficiency/immunosuppression;
Thyroid disease or thyroidectomy history, absence of spleen, functional absence of spleen, and any conditions resulting in absence of spleen or splenectomy;
Suffering from serious cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc;
Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Medical diagnosis of coagulation abnormalities (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or marked bruising or coagulation disorders;
Immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy) in the past 6 months;
History of alcohol or drug abuse;
Receipt of blood products within in the past 3 months;
Receipt of other investigational drugs in the past 30 days;
Receipt of attenuated live vaccines in the past 14 days;
Receipt of inactivated or subunit vaccines in the past 7 days;
Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
Axillary temperature >37.0°C;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.
Previous history of vaccination of sIPV vaccine;
History of polio;
Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc;
Preterm birth babies (delivered before 37 weeks gestation), low birth weight (girls with birth weight <2300g, boy with birth weight<2500 g);
History of dystocia, asphyxia and nervous system damage at birth;
Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
Autoimmune disease or immunodeficiency/immunosuppression;
Thyroid disease or thyroidectomy history, absence of spleen, functional absence of spleen, and any conditions resulting in absence of spleen or splenectomy;
-Suffering from serious cardiovascular diseases, diabetes, liver and kidney diseases, malignant tumors, etc;
Severe neurological disease (epilepsy, convulsions or convulsions) or mental illness;
Medical diagnosis of coagulation abnormalities (such as coagulation factor deficiency, coagulation disorders, platelet abnormalities) or marked bruising or coagulation disorders;
Have received immunosuppressive therapy, cytotoxic therapy, inhaled corticosteroids(excluding allergic rhinitis corticosteroid spray therapy, acute noncomplicated dermatitis superficial corticosteroid therapy);
Receipt of blood products ;
Receipt of other investigational drugs in the past 30 days;
Receipt of attenuated live vaccines in the past 14 days;
Receipt of inactivated or subunit vaccines in the past 7 days;
Acute diseases or acute exacerbation of chronic diseases in the past 7 days;
Axillary temperature >37.0°C;
According to the investigator's judgment, the subject has any other factors that are not suitable for participating in the clinical trial.

Trial locations and contacts

2 sites in 1 country.

China2 sites

Xiangfu District Center for Disease Prevention and Control
Kaifeng, Henan, 475100
Xiangcheng County Center for Disease Control and Prevention
Xuchang, Henan, 461700

Other trials in China

About this study

Official title: A Clinical Trial With an Open-label Phase to Evaluate the Safety of Five-dose Sabin Inactivated Poliovirus Vaccine (Vero Cell)（ msIPV） in Adults, Children and Infants, and a Blinded,Randomized and Controlled Phase to Evaluate the Lot Consistency Immunogenicity, and Safety of the msIPV in 2 Months Old Infants

This study includes two parts.A clinical trial with a open-label to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml-5 doses)(hereinafter referred to as "msIPV")manufactured by Sinovac Biotech Co., Ltd. in adults, children and infants in partⅠ and a blinded,randomized and controlled clinical trial to evaluate the lot consistency immunogenicity, and safety of the msIPV in 2 months old infants in partⅡ.

Read the detailed description

This study includes two stages. A clinical trial with an open-label to evaluate the safety of Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml-5 doses) (hereinafter referred to as "msIPV") in adults, children and infants in stageⅠ and a blinded, randomized and controlled clinical trial to evaluate the lot consistency immunogenicity, and safety of the msIPV in 2 months old infants in stage Ⅱ. A total of 1572 subjects including 24 adults aged 18-49 years,24 children aged 4 years,1524 infants aged 2 months will be enrolled.

StagesⅠ:72 healthy subjects, including 24 adults,24 children and 24 infants will be enrolled. 24 adults and 24 children will receive one dose of vaccine and 24 infants will receive 4 doses of vaccine according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months.

StagesⅡ:1500 infants aged 2 months will be randomly divided into 5 groups (Experimental Vaccine-lot 1, Experimental Vaccine-lot 2, Experimental Vaccine-lot 3,IPV control group and single-dose sIPV control group) according to the ratio of 1:1:1:1:1. Subjects in 3 experimental groups will receive 5-dose sIPV produced by Sinovac for three lots, subjects in IPV control group will receive IPV produced by Pasteur, and subjects in single-dose sIPV control group will receive single-dose sIPV produced by Sinovac. All subjects will receive 4 doses of experimental or control vaccine according to the primary immunization schedule of 0,1,2 months, one dose of booster at 18 months of age.

Conditions: Poliomyelitis
Being tested: Experimental vaccine, IPV control vaccine, single-person sIPV control vaccine
Medical subject headings: Poliomyelitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Experimental vaccineBiological
Also called msIPV
Sabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml)-investigational vaccine produced by Sinovac Biotech Co., Ltd. Inactivated Sabin poliovirus antigen (per 0.5ml): type 1 (15DU), type 2 (45DU), and type 3 (45DU)in 2.5 ml mixture of medium 199,glycine,formaldehyde,sodium chloride,potassium chloride,calcium chloride,magnesium sulfate,disodium phosphate,sodium dihydrogen phosphate,2 - phenoxyethanol for per injection.
IPV control vaccineBiological
Inactivated Poliovirus Vaccine - control vaccine produced by Sanofi. Inactivated poliovirus antigens: Mahoney strain for type 1 (40DU), MEF-1 strain for type 2 (8DU), Saukett strains for type 3 (32DU) in 0.5 ml mixture of 2- phenoxyethanol,ethanol,formaldehyde,hanks199 medium (containing amino acids, mineral salts, vitamins, glucose, polysorbate 80 and water for injection),hydrochloric acid or sodium hydroxide (for pH value adjustment),trace amounts of antibiotics (neomycin, streptomycin and polymyxin B)for per injection.
single-person sIPV control vaccineBiological
Sabin Inactivated Poliovirus Vaccine (Vero cell) (0.5ml) -control vaccine produced by Sinovac Biotech Co., Ltd.
Inactivated Sabin poliovirus antigen: type 1 (15DU), type 2 (45DU), and type 3 (45DU)in 0.5 ml mixture of medium 199,glycine,formaldehyde,sodium chloride,potassium chloride,calcium chloride,magnesium sulfate,disodium phosphate,sodium dihydrogen phosphate for per injection.

Study groups in NCT05386810
Study group	Role	What they receive
Safety group in adults	Experimental	24 adults will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV vaccine. Receives: Biological: Experimental vaccine
Safety group in children	Experimental	24 children will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV vaccine. Receives: Biological: Experimental vaccine
Safety group in infants	Experimental	24 infants will receive 4 doses of vaccine according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months to evaluate the safety of msIPV vaccine . Receives: Biological: Experimental vaccine
Experimental Vaccine-lot 1	Experimental	300 infants will receive 4 doses of 5-person sIPV vaccine of commercial scale lot 1 according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. Receives: Biological: Experimental vaccine
Experimental Vaccine-lot 2	Experimental	300 infants will receive 4 doses of 5-person sIPV vaccine of commercial scale lot 2 according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. Receives: Biological: Experimental vaccine
Experimental Vaccine-lot 3	Experimental	300 infants will receive 4 doses of 5-person sIPV vaccine of commercial scale lot 3 according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. Receives: Biological: Experimental vaccine
IPV control group	Active comparator	300 infants will receive 4 doses of IPV vaccine produced by Pasteur according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. Receives: Biological: IPV control vaccine
single-person sIPV control group	Active comparator	300 infants will receive 4 doses of single-dose sIPV vaccine produced by Pasteur according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months. Receives: Biological: single-person sIPV control vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

Safety index-incidence of adverse reactions
Incidence of adverse reactions within 30 days after each dose
Measured: Within 30 days after each dose
Immunogenicity index-Geometric mean titers (GMT)
GMT 30 days after primary immunization in msIPV vaccination group
Measured: 30 days after primary immunization
Immunogenicity index- seroconversion rate of neutralizing antibody
Seroconversion rate of neutralizing antibody 30 days after primary immunization in combined experiment group and IPV control group
Measured: 30 days after primary immunization

Secondary outcomes (5)

Safety index-incidence of adverse reactions
Incidence of adverse reactions within 7 days after each dose
Measured: Within 7 days after each dose
Safety index-the incidence of adverse reactions
Incidence of SAE during the period of safety monitoring
Measured: During the period of safety monitoring
Immunogenicity index- Neutralizing antibody positive rate and GMI
Neutralizing antibody positive rate and GMI and percentage of subjects with antibody ≥1:64 30 days after primary immunization
Measured: 30 days after primary immunization
Immunogenicity index- Neutralizing antibody positive rate
Neutralizing antibody positive rate, percentage of subjects with antibody ≥1:64 and GMT before booster dose
Measured: Before booster dose
Immunogenicity index-Neutralizing antibody positive rate,GMT and GMI
Neutralizing antibody positive rate, percentage of subjects with antibody ≥1:64, GMT and GMI 30 days after booster dose
Measured: 30 days after booster dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Nov 202020 Jul 2023

First posted23 May 2022
Study start5 Nov 2020
Primary completion8 Oct 2022
Study completion20 Jul 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 1,572 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05386810
Sponsor's protocol ID: PRO-msIPV-3001
Status last verified: May 2022
First submitted: 18 May 2022
Last updated: 15 Apr 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 15 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial With an Open-label Phase to Evaluate the Safety of Five-dose Sabin Inactivated Poliovirus Vaccine (Vero Cell)（ msIPV） in Adults, Children and Infants, and a Blinded,Randomized and Controlled Phase to Evaluate the Lot Consistency Immunogenicity, and Safety of the msIPV in 2 Months Old Infants
ClinicalTrials.gov ID: NCT05386810
Acronym / sponsor ID: PRO-msIPV-3001
Conditions: Poliomyelitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,572 participants (actual)
Lead sponsor: Sinovac Biotech Co., LtdIndustry (pharma, biotech, devices)
Study start: 5 Nov 2020 (actual)
Primary completion: 8 Oct 2022 (actual)
Study completion: 20 Jul 2023 (actual)
First posted: 23 May 2022 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
Safety group in adults	Experimental	Biological: Experimental vaccine24 adults will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV vaccine.
Safety group in children	Experimental	Biological: Experimental vaccine24 children will receive one dose of 5-person sIPV vaccine to evaluate the safety of msIPV vaccine.
Safety group in infants	Experimental	Biological: Experimental vaccine24 infants will receive 4 doses of vaccine according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months to evaluate the safety of msIPV vaccine .
Experimental Vaccine-lot 1	Experimental	Biological: Experimental vaccine300 infants will receive 4 doses of 5-person sIPV vaccine of commercial scale lot 1 according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months.
Experimental Vaccine-lot 2	Experimental	Biological: Experimental vaccine300 infants will receive 4 doses of 5-person sIPV vaccine of commercial scale lot 2 according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months.
Experimental Vaccine-lot 3	Experimental	Biological: Experimental vaccine300 infants will receive 4 doses of 5-person sIPV vaccine of commercial scale lot 3 according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months.
IPV control group	Active comparator	Biological: IPV control vaccine300 infants will receive 4 doses of IPV vaccine produced by Pasteur according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months.
single-person sIPV control group	Active comparator	Biological: single-person sIPV control vaccine300 infants will receive 4 doses of single-dose sIPV vaccine produced by Pasteur according to the primary immunization schedule of 0,1,2 months and booster immunization schedule of 18 months.

Who may qualify

Ages: 2 months to 49 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (10 listed)

Healthy adults aged 18-49 days;
Proven legal identification;
The subject can understand and voluntarily sign the informed consent form.
Healthy children aged 4 years old;
Subjects who have completed primary immunization with 3 doses of sIPV vaccine;

Key exclusion criteria (55 listed)

Women aged 18 to 49 years, positive urine pregnancy test, pregnant women, breastfeeding women, or planning to become pregnant within 3 months;
Previous history of vaccination of sIPV vaccine;
Allergy history, history of asthma, including allergy history to vaccine or vaccine components, serious adverse reactions to the vaccine, such as urticaria, dyspnea, angioneurotic edema or stomachache, etc;
Congenital malformation or developmental disorder, genetic defect, serious malnutrition, etc.;
Autoimmune disease or immunodeficiency/immunosuppression;

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
Experimental vaccineAlso: msIPVSabin Inactivated Poliovirus Vaccine (Vero cell) (2.5ml)-investigational vaccine produced by Sinovac Biotech Co., Ltd. Inactivated Sabin poliovirus antigen (per 0.5ml): type 1 (15DU), type 2 (45DU), and type 3 (45DU)in 2.5 ml mixture of medium 199,glycine,formaldehyde,sodium chloride,potassium chloride,calcium chloride,magnesium sulfate,disodium phosphate,sodium dihydrogen phosphate,2 - phenoxyethanol for per injection.	Biological	Experimental Vaccine-lot 1, Experimental Vaccine-lot 2, Experimental Vaccine-lot 3, Safety group in adults, Safety group in children, Safety group in infants
IPV control vaccineInactivated Poliovirus Vaccine - control vaccine produced by Sanofi. Inactivated poliovirus antigens: Mahoney strain for type 1 (40DU), MEF-1 strain for type 2 (8DU), Saukett strains for type 3 (32DU) in 0.5 ml mixture of 2- phenoxyethanol,ethanol,formaldehyde,hanks199 medium (containing amino acids, mineral salts, vitamins, glucose, polysorbate 80 and water for injection),hydrochloric acid or sodium hydroxide (for pH value adjustment),trace amounts of antibiotics (neomycin, streptomycin and polymyxin B)for per injection.	Biological	IPV control group
single-person sIPV control vaccineSabin Inactivated Poliovirus Vaccine (Vero cell) (0.5ml) -control vaccine produced by Sinovac Biotech Co., Ltd. Inactivated Sabin poliovirus antigen: type 1 (15DU), type 2 (45DU), and type 3 (45DU)in 0.5 ml mixture of medium 199,glycine,formaldehyde,sodium chloride,potassium chloride,calcium chloride,magnesium sulfate,disodium phosphate,sodium dihydrogen phosphate for per injection.	Biological	single-person sIPV control group

Primary outcome

Safety index-incidence of adverse reactions
Time frame: Within 30 days after each dose
Incidence of adverse reactions within 30 days after each dose
Immunogenicity index-Geometric mean titers (GMT)
Time frame: 30 days after primary immunization
GMT 30 days after primary immunization in msIPV vaccination group
Immunogenicity index- seroconversion rate of neutralizing antibody
Time frame: 30 days after primary immunization
Seroconversion rate of neutralizing antibody 30 days after primary immunization in combined experiment group and IPV control group

5 secondary outcomes

Safety index-incidence of adverse reactions
Time frame: Within 7 days after each dose
Safety index-the incidence of adverse reactions
Time frame: During the period of safety monitoring
Immunogenicity index- Neutralizing antibody positive rate and GMI
Time frame: 30 days after primary immunization
Immunogenicity index- Neutralizing antibody positive rate
Time frame: Before booster dose
Immunogenicity index-Neutralizing antibody positive rate,GMT and GMI
Time frame: 30 days after booster dose

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 15 Apr 2024.

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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.

Yanxia Wang, Master principal investigator

Henan Provincial Center for Disease Prevention and Control

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Experimental vaccine in people with Poliomyelitis, run by Sinovac Biotech Co., Ltd at 2 sites 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 10 inclusion and 55 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 15 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 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?

Safety index-incidence of adverse reactions (time frame: Within 30 days after each dose). 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 NCT05386810.

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 15 Apr 2024.