HealthyPhase 2NCT03566940
A Study to Assess the Safety, Reactogenicity and Immunogenicity of a Trivalent Inactivated Poliovirus Vaccine (IPV) Based on Sabin Strains Compared to Conventional Salk IPV in a 6, 10 and 14 Weeks of Age Immunization Schedule
A Phase 2 study testing sIPV and cIPV in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 3 sites in Philippines.
Trial summary
The purpose of this study is to assess the safety and reactogenicity of 3 different dose levels of inactivated poliovirus vaccine based on Sabin strains (sIPV) in healthy participants, using conventional Salk IPV (cIPV) as an active control. Read more about this study
- Who is it for?
- Ages 39 to 59 daysHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- sIPV and cIPV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 302 participants
- Where
- 3 sitesPhilippines
- Study dates
- 31 Jul 2018to 17 Oct 2019
- 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 39 to 59 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Study participant is a boy or a girl, who is eligible for expanded programme on immunization (EPI) vaccinations (that is, inactivated poliovirus vaccine [IPV], Diphtheria, Tetanus, whole cell Pertussis [DTwP]-Haemophilus influenzae type b [Hib]-Hepatitis B virus [HBV] and 13-valent Pneumococcal conjugate vaccine [PCV13]) at Weeks 6, 10 and 14 and Rotavirus vaccination at Weeks 6 and 14
- Study participant has born after a normal term pregnancy (greater than or equal to [>=]37 weeks) and with a birth weight of >=2.5 kilogram (kg)
- Study participant must be healthy as confirmed by the investigator on the basis of physical examination, vital signs and medical history, including the course of the pregnancy and relevant medical history of the mother, such as but not limited to human immunodeficiency virus, Hepatitis B virus (HBV), hepatitis C virus status or other significant disease that might impact the participant's health. Information about the course of the pregnancy and relevant medical history of the mother is obtained from the mother in person and at the discretion of the investigator without the need for official documentation or testing
- Each study participant and his or her legally acceptable representative must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Study participant and his or her legally acceptable representative are available and reachable for all scheduled study visits and telephone contacts within the allowed window
Who cannot join
- Contraindication to intramuscular (IM) injections and blood draws (venipuncture) for example, bleeding disorders
- Known allergies, hypersensitivity, or intolerance to 1 of the excipients of IPV based on Sabin strains (sIPV) or conventional Salk IPV (cIPV) or any other vaccine component in the participant or mother
- Received polio vaccine or were previously infected with poliovirus
- Known or suspected autoimmune disease or persistent impairment/alteration of the immune function
- Known neurological disease including seizures, congenital defects, or genetic disorders (for example, Down syndrome)
Trial locations and contacts
3 sites in 1 country.
Philippines3 sites
De La Salle Health Sciences Institute- DLSUMC
Dasmariñas, 4114
De La Salle University Medical Center
Dasmariñas, 4114
Philippine General Hospital
Manila, 1000
About this study
Official title: A Phase 2, Observer-blind, Active-controlled, Randomized Dose-finding Study in Healthy Infants to Assess the Safety, Reactogenicity and Immunogenicity of 3 Dose Levels of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains Compared to Conventional Salk IPV, in a 6, 10 and 14 Weeks of Age Immunization Schedule, and Co-administered With Diphtheria, Tetanus, Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Pneumococcal Conjugate and Rotavirus Vaccines
The purpose of this study is to assess the safety and reactogenicity of 3 different dose levels of inactivated poliovirus vaccine based on Sabin strains (sIPV) in healthy participants, using conventional Salk IPV (cIPV) as an active control.
- Conditions
- Healthy
- Being tested
- sIPV, cIPV
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sIPVBiological
Also called JNJ-64152348
Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection.
cIPVBiological
Participants will receive 0.5 mL of cIPV as a suspension for IM injection.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Low Dose IPV Based on Sabin Strains (sIPV) | Experimental | Participants will receive intramuscular (IM) injection of the low dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of conventional Salk IPV (cIPV) at approximately 24 weeks after the third vaccination (38 weeks of age). Receives: Biological: sIPV; Biological: cIPV |
| Group 2: Intermediate Dose sIPV | Experimental | Participants will receive IM injection of the intermediate dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age). Receives: Biological: sIPV; Biological: cIPV |
| Group 3: High Dose sIPV | Experimental | Participants will receive IM injection of the high dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age). Receives: Biological: sIPV; Biological: cIPV |
| Group 4: Conventional Salk IPV (cIPV) | Active comparator | Participants will receive IM injection of cIPV (3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age). Receives: Biological: cIPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
Number of participants with solicited local and systemic AEs will be determined up to 7 days after first vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.
Measured: 7 days after first vaccination
Number of Participants with Solicited Local and Systemic AEs
Number of participants with solicited local and systemic AEs will be determined up to 7 days after second vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.
Measured: 7 days after second vaccination
Number of Participants with Solicited Local and Systemic AEs
Number of participants with solicited local and systemic AEs will be determined up to 7 days after third vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.
Measured: 7 days after third vaccination
Number of Participants with Unsolicited AEs
Number of participants with unsolicited AEs will be determined up to 28 days after first vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).
Measured: 28 days after first vaccination
Number of Participants with Unsolicited AEs
Number of participants with unsolicited AEs will be determined up to 28 days after second vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).
Measured: 28 days after second vaccination
Number of Participants with Unsolicited AEs
Number of participants with unsolicited AEs will be determined up to 28 days after third vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).
Measured: 28 days after third vaccination
Number of Participants with Serious Adverse Events (SAEs)
Number of participants with SAEs will be reported. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Approximately up to 36 weeks
Number of Participants Discontinued due to AEs
Number of participants discontinued from vaccinations or from the study due to AEs will be reported.
Measured: Approximately up to 36 weeks
Secondary outcomes (3)
Percentage of Participants with Seroprotection
Percentage of participants with seroprotection will be reported. Seroprotection is defined as having a poliovirus neutralizing antibody (NAb) titer greater than or equal to (>=)8 at 28 days after the third vaccination for each poliovirus strain against Salk virus neutralization assay (VNA).
Measured: 28 days after the third vaccination
Percentage of Participants with Seroconversion
Percentage of participants with seroconversion will be reported. Seroconversion is defined as: 1) Pre-vaccination poliovirus NAb titer less than (<)8 and post-vaccination NAb >=8 at 28 days after the third vaccination for each poliovirus strain against Salk VNA, or 2) Pre-vaccination poliovirus NAb titer >=8 and post vaccination >=4 fold increase in poliovirus NAb titer (with correction for maternal-antibody decline at Week 18, with a half-life of maternal antibodies of 1 month), at 28 days after the third vaccination for each poliovirus strain against Salk VNA.
Measured: 28 days after the third vaccination
Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses
Poliovirus NAb titers will be determined against the wild-type Salk strains (Type 1 [Mahoney], Type 2 [MEF-1] and Type 3 [Saukett]) as well as against the Sabin strains (Types 1, 2 and 3), in accordance with the World Health Organization (WHO) recommendations for immunogenicity assessment of inactivated poliovirus vaccine (IPV).
Measured: 28 days after the third vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2018
- Study start31 Jul 2018
- Primary completion7 Aug 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 302 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Vaccines & Prevention B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Vaccines & Prevention B.V. Clinical Trial, Study director, Janssen Vaccines & Prevention B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03566940
- Sponsor's protocol ID
- CR108472
- Other IDs
- GV000051POL2001
- Status last verified
- Jan 2025
- First submitted
- 12 Jun 2018
- Last updated
- 3 Feb 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Observer-blind, Active-controlled, Randomized Dose-finding Study in Healthy Infants to Assess the Safety, Reactogenicity and Immunogenicity of 3 Dose Levels of a Trivalent Inactivated Poliovirus Vaccine Based on Sabin Strains Compared to Conventional Salk IPV, in a 6, 10 and 14 Weeks of Age Immunization Schedule, and Co-administered With Diphtheria, Tetanus, Whole Cell Pertussis, Haemophilus Influenzae Type b, Hepatitis B, Pneumococcal Conjugate and Rotavirus Vaccines
- ClinicalTrials.gov ID
- NCT03566940
- Acronym / sponsor ID
- CR108472
- Conditions
- Healthy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 302 participants (actual)
- Lead sponsor
- Janssen Vaccines & Prevention B.V.Industry (pharma, biotech, devices)
- Study start
- 31 Jul 2018 (actual)
- Primary completion
- 7 Aug 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 25 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and reactogenicity of 3 different dose levels of inactivated poliovirus vaccine based on Sabin strains (sIPV) in healthy participants, using conventional Salk IPV (cIPV) as an active control.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Low Dose IPV Based on Sabin Strains (sIPV) | Experimental | Biological: sIPV, Biological: cIPVParticipants will receive intramuscular (IM) injection of the low dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of conventional Salk IPV (cIPV) at approximately 24 weeks after the third vaccination (38 weeks of age). |
| Group 2: Intermediate Dose sIPV | Experimental | Biological: sIPV, Biological: cIPVParticipants will receive IM injection of the intermediate dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age). |
| Group 3: High Dose sIPV | Experimental | Biological: sIPV, Biological: cIPVParticipants will receive IM injection of the high dose trivalent inactivated poliovirus vaccine (sIPV - 3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age). |
| Group 4: Conventional Salk IPV (cIPV) | Active comparator | Biological: cIPVParticipants will receive IM injection of cIPV (3 doses) at 6, 10 and 14 weeks of age. Participants will also be given a single booster vaccine of cIPV at approximately 24 weeks after the third vaccination (38 weeks of age). |
Who may qualify
- Ages
- 39 to 59 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Study participant is a boy or a girl, who is eligible for expanded programme on immunization (EPI) vaccinations (that is, inactivated poliovirus vaccine [IPV], Diphtheria, Tetanus, whole cell Pertussis [DTwP]-Haemophilus influenzae type b [Hib]-Hepatitis B virus [HBV] and 13-valent Pneumococcal conjugate vaccine [PCV13]) at Weeks 6, 10 and 14 and Rotavirus vaccination at Weeks 6 and 14
- Study participant has born after a normal term pregnancy (greater than or equal to [>=]37 weeks) and with a birth weight of >=2.5 kilogram (kg)
- Study participant must be healthy as confirmed by the investigator on the basis of physical examination, vital signs and medical history, including the course of the pregnancy and relevant medical history of the mother, such as but not limited to human immunodeficiency virus, Hepatitis B virus (HBV), hepatitis C virus status or other significant disease that might impact the participant's health. Information about the course of the pregnancy and relevant medical history of the mother is obtained from the mother in person and at the discretion of the investigator without the need for official documentation or testing
- Each study participant and his or her legally acceptable representative must be willing and able to adhere to the prohibitions and restrictions specified in this protocol
- Study participant and his or her legally acceptable representative are available and reachable for all scheduled study visits and telephone contacts within the allowed window
Key exclusion criteria (5 listed)
- Contraindication to intramuscular (IM) injections and blood draws (venipuncture) for example, bleeding disorders
- Known allergies, hypersensitivity, or intolerance to 1 of the excipients of IPV based on Sabin strains (sIPV) or conventional Salk IPV (cIPV) or any other vaccine component in the participant or mother
- Received polio vaccine or were previously infected with poliovirus
- Known or suspected autoimmune disease or persistent impairment/alteration of the immune function
- Known neurological disease including seizures, congenital defects, or genetic disorders (for example, Down syndrome)
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 |
|---|---|---|
| sIPVAlso: JNJ-64152348Participants will receive 0.5 milliliter (mL) of sIPV as a solution for IM injection. | Biological | Group 1: Low Dose IPV Based on Sabin Strains (sIPV), Group 2: Intermediate Dose sIPV, Group 3: High Dose sIPV |
| cIPVParticipants will receive 0.5 mL of cIPV as a suspension for IM injection. | Biological | Group 1: Low Dose IPV Based on Sabin Strains (sIPV), Group 2: Intermediate Dose sIPV, Group 3: High Dose sIPV, Group 4: Conventional Salk IPV (cIPV) |
Primary outcome
Number of Participants with Solicited Local and Systemic Adverse Events (AEs)
Time frame: 7 days after first vaccination
Number of participants with solicited local and systemic AEs will be determined up to 7 days after first vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.
Number of Participants with Solicited Local and Systemic AEs
Time frame: 7 days after second vaccination
Number of participants with solicited local and systemic AEs will be determined up to 7 days after second vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.
Number of Participants with Solicited Local and Systemic AEs
Time frame: 7 days after third vaccination
Number of participants with solicited local and systemic AEs will be determined up to 7 days after third vaccination. Solicited local AEs (including erythema, swelling/induration, and pain/tenderness at the study vaccine injection site) and systemic AEs (loss of appetite/change in eating habits, vomiting, diarrhea, decreased activity/lethargy, increased or decreased sleep, irritability, persistent crying and fever) will be assessed.
Number of Participants with Unsolicited AEs
Time frame: 28 days after first vaccination
Number of participants with unsolicited AEs will be determined up to 28 days after first vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).
Number of Participants with Unsolicited AEs
Time frame: 28 days after second vaccination
Number of participants with unsolicited AEs will be determined up to 28 days after second vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).
Number of Participants with Unsolicited AEs
Time frame: 28 days after third vaccination
Number of participants with unsolicited AEs will be determined up to 28 days after third vaccination. Unsolicited AEs will include all AEs for which the participant's legally acceptable representative(s) is not specifically questioned in the participant diary. Unsolicited AEs will be graded according to severity as mild (Grade 1), moderate (Grade 2), severe (Grade 3), potentially life threatening (Grade 4), and death (Grade 5).
Number of Participants with Serious Adverse Events (SAEs)
Time frame: Approximately up to 36 weeks
Number of participants with SAEs will be reported. An SAE is any AE that results in: death, persistent or significant disability/incapacity, requires inpatient hospitalization or prolongation of existing hospitalization, is life threatening experience, is a congenital anomaly/birth defect, is suspected transmission of any infectious agent via a medicinal product, is medically important, and may jeopardize participant or may require medical or surgical intervention to prevent one of the outcomes listed above.
Number of Participants Discontinued due to AEs
Time frame: Approximately up to 36 weeks
Number of participants discontinued from vaccinations or from the study due to AEs will be reported.
3 secondary outcomes
Percentage of Participants with Seroprotection
Time frame: 28 days after the third vaccination
Percentage of Participants with Seroconversion
Time frame: 28 days after the third vaccination
Poliovirus Type- and Strain-specific Neutralizing Antibody (NAb) Responses
Time frame: 28 days after the third 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 3 Feb 2025.
Related trials for Healthy
Not yet recruitingPhase 1
Dynamic Magnetic Resonance Imaging of Human Subarachnoid Space Using Intrathecal Gadolinium Contrast
Healthy Volunteers
RecruitingObservational study
Survey to Determine Incarcerated Persons' Views on Surrogate Decision Making
Healthy Volunteers
Active, not recruitingPhase 1
A Study to Learn How Different Amounts of the Study Medicine Called PF-07985631 Are Tolerated and Act in the Body of Healthy Adults
Healthy
Not yet recruitingObservational study
Collection and Distribution of Blood Components From Healthy Donors for In Vitro Research Use
Blood Donors, Apheresis
Recruiting
Metabolic Impact of VLCPUFA-Rich Fish Oil: A Clinical Study on Omega-3 Index Enhancement in Healthy Individuals
Fatty Acids, Omega-3, Fish Oils
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.
Janssen Vaccines & Prevention B.V. Clinical Trial study director
Janssen Vaccines & Prevention B.V.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing sIPV and cIPV in people with Healthy, run by Janssen Vaccines & Prevention B.V. at 3 sites 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 5 inclusion and 5 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 3 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in 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 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?
Number of Participants with Solicited Local and Systemic Adverse Events (AEs) (time frame: 7 days after first vaccination). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Feb 2025.