PoliomyelitisPhase 3NCT02434770
Immunogenicity and Safety of Liquid Bivalent Oral Poliomyelitis Vaccine
A Phase 3 study testing BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1, BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2 and BioFarma Bivalent Oral Poliomyelitis Vaccine in people with Poliomyelitis, run by PATH at 2 sites in Kenya.
Trial summary
The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV) manufactured by Beijing Bio-Institute Biological Products Co., Ltd (BBIBP) has a similar immunogenicity profile to a WHO prequalified bOPV. Read more about this study
- Who is it for?
- Ages 1 day to 14 daysHealthy volunteers can take part
- Conditions the study is for
- Poliomyelitis
- What is being tested?
- BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1, BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2 and BioFarma Bivalent Oral Poliomyelitis Vaccine
- Type of treatment
- Vaccines, Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 2 sitesKenya
- Study dates
- Aug 2015to 17 Jun 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 1 day to 14 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy, full-term infants, as established by medical history and clinical examination before entering into the study.
- Parents willing to provide written informed consent.
- Age: infants less than 2 weeks of age at the time of enrollment (from the 1st through the 14th day of life, inclusive)
Who cannot join
- Birth weight (as documented at first medical contact) less than 2.5 kg
- Presence of diarrhea or vomiting in the previous 24 hours or on the day of enrollment (temporary exclusion)
- Presence of fever (> 37.5°C) on the day of enrollment (temporary exclusion)
- Acute disease at the time of enrollment (temporary exclusion)
- Significant malnutrition as per Investigator's judgment
- Concurrent participation in another clinical study at any time during the study period in which the infant will be exposed to an investigational or a non-investigational product
Show all 14Show fewer
- Presence of any significant systemic disorder (cardiovascular, pulmonary, hepatic, renal, gastrointestinal, hematological, endocrine, immunological, dermatological, neurological, cancer or autoimmune disease) as determined by medical history and/or physical examination which would compromise the child's health or is likely to result in non-conformance to the protocol
- Known or suspected impairment of immunological function (including human immunodeficiency virus [HIV] exposure) based on medical history and physical examination
- Previous receipt of polio virus vaccine
- Household contact with a known immunosuppressed individual
- Unwillingness or inability of parents for active follow-up by the study staff
- History of any neurological disorders or seizures
- Any medical condition that, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence or a participant's ability to give informed consent
- Maternal HIV infection
Trial locations and contacts
2 sites in 1 country.
Kenya2 sites
Kenya Medical Research Institute (KEMRI)/Walter Reed Project
Kericho
Kenya Medical Research Institute/Walter Reed Project
Kisumu, Nyanza, PO Box 54-40100
About this study
Official title: A Phase III Single-blind, Randomized, Controlled Study in Healthy Kenyan Infants to Assess the Immunogenicity and Safety of Beijing TiantanBio Liquid Bivalent Oral Poliomyelitis Vaccine (bOPV) in Comparison to a WHO Prequalified Comparator bOPV
The purpose of this study will be to evaluate whether a bivalent oral polio vaccine (bOPV) manufactured by Beijing Bio-Institute Biological Products Co., Ltd (BBIBP) has a similar immunogenicity profile to a WHO prequalified bOPV.
Read the detailed description
BBIBP has been one of the two suppliers of trivalent oral polio vaccine (tOPV) in China since 1985, with control of polio in China evidence of the effectiveness of its vaccine. The company plans to introduce a liquid formulation of bOPV (types 1 and 3) to meet increasing global demand with the phasing-out of tOPV. The proposed study is intended to provide data sufficient to obtain World Heath Organization (WHO) prequalification for the BBIBP bOPV, thus making the vaccine available to help meet global demand.
Infants were enrolled and randomized prior to the birth dose of bOPV. The first dose of study vaccine was administered during the first two weeks of life and then co-administered with the primary Expanded Programme on Immunization (EPI) series vaccines in Kenya at 6, 10 and 14 weeks of age. The Kenya EPI schedule includes the following additional vaccines:
- Bacille Calmette-Guérin Vaccine (BCG) at birth
- Diphtheria and Tetanus Toxoid with Whole Cell Pertussis, Haemophilus influenzae Type V vaccine (Hib), and Hepatitis B Vaccine (DTwPHibHep) at 6, 10, 14 weeks;
- Pneumococcal Conjugate vaccine (PCV) at 6, 10, 14 weeks
- Rotavirus vaccine (Rotarix) at 6, 10 weeks
- Conditions
- Poliomyelitis
- Being tested
- BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1, BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2, BioFarma Bivalent Oral Poliomyelitis Vaccine
- Medical subject headings
- Poliomyelitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1Biological
Also called Poliomyelitis (Live) Vaccine Type I Type III (Human Diploid Cell), Oral
Each dose of bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10^6 cell culture infectious dose 50% (CCID50)/dose and 10^5.8 CCID50/dose, respectively.
BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2Biological
Also called Poliomyelitis (Live) Vaccine Type I Type III (Human Diploid Cell), Oral
Each dose of bOPV (2 drops, 0.1 ml) contains types 1 and 3 attenuated polioviruses (Sabin), with at least 10^6 CCID50/dose and 10^5.8 CCID50/dose, respectively.
BioFarma Bivalent Oral Poliomyelitis VaccineBiological
Each dose of the WHO prequalified Bio Farma bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10^6 and 10^5.8 infective units per dose, respectively.
| Study group | Role | What they receive |
|---|---|---|
| BBIBP bOPV Lot 1 | Experimental | Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 1, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age. Receives: Biological: BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1 |
| BBIBP bOPV Lot 2 | Experimental | Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 2, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age. Receives: Biological: BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2 |
| BioFarma bOPV | Active comparator | Infants received 2 drops of WHO prequalified liquid bivalent oral polio vaccine manufactured by BioFarma, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age. Receives: Biological: BioFarma Bivalent Oral Poliomyelitis Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity
Solicited systemic reactogenicity events evaluated during the week after each vaccination included fever, vomiting, diarrhea, decreased appetite/ poor feeding, irritability, and decreased activity. Reactions were recorded by participant's parents via memory aid. Each event was graded as:
Mild (Grade 1): No or minimal interference with usual activities; no medical intervention/therapy required, Moderate (Grade 2): Greater than minimal interference with usual activities; no or minimal medical intervention/therapy required, Severe (Grade 3): Marked limitation in ability to perform usual activities; medical intervention/therapy required, or Potentially life-threatening (Grade 4): Inability to perform basic functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death.
The overall number of participants who experienced any systemic reaction is reported. Grades are based on maximum severity per participant.
Measured: 7 days after each vaccination (Weeks 0, 6, 10, and 14)
Number of Participants Experiencing Adverse Events
Adverse events were graded as mild (Grade 1 = No or minimal interference with usual activities; no medical intervention/therapy required), moderate (Grade 2 = Greater than minimal interference with usual activities; no or minimal medical intervention/therapy required), severe (Grade 3 = Marked limitation in ability to perform usual activities; medical intervention/therapy required), or potentially life-threatening (Grade 4 = Inability to perform basic functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death).
The overall number of participants who experienced any adverse event is reported. Grades are based on maximum severity per participant.
Measured: From the time of the first vaccination through 28 days after each vaccination (up to Day 126).
Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1
The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated.
Anti-polio antibody titer four weeks after the fourth vaccination was adjusted for the decrease in maternal antibodies based on a half-life of 28 days.
Measured: Screening and 4 weeks post vaccination 4 (Week 18)
Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3
The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated.
Anti-polio antibody titer four weeks after the fourth vaccination was adjusted for the decrease in maternal antibodies based on a half-life of 28 days.
Measured: Screening and 4 weeks post vaccination 4 (Week 18)
Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose
The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated.
Seroconversion was defined as a titer ≥ 1:8 if seronegative at screening, otherwise a ≥ 4-fold increase in adjusted titers (i.e., adjusted for the decay in maternal antibodies, based on a half life of 28 days).
Measured: 4 weeks post vaccination 4 (Week 18)
Secondary outcomes (3)
Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers
Anti-HBsAg titers were measured to assess the impact of concomitant administration of BBIBP liquid bOPV on immune responses to other Expanded Programme on Immunization (EPI) vaccines in comparison to that of the WHO pre-qualified bOPV, 4 weeks after the fourth vaccination.
The enzyme-linked immunosorbent assay (ELISA) assays for serum antibodies to HBsAg were performed at the Children's Hospital Medical Center (CCHMC). The HBsAb assay was a qualified assay using a kit from BioRad.
Measured: 4 weeks post vaccination 4 (Week 18)
Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection
Seroprotection was defined as a HBsAg titer ≥ 1:10 The ELISA assays for serum antibodies to HBsAg were performed at the Children's Hospital Medical Center (CCHMC). The HBsAb assay was a qualified assay using a kit from BioRad.
Measured: 28 days after vaccination 4
Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers
Anti-rotavirus immunoglobulin A titers were measured to assess the impact of concomitant administration of BBIBP liquid bOPV on immune responses to other Expanded Programme on Immunization (EPI) vaccines in comparison to that of the WHO pre-qualified bOPV, 4 weeks after the fourth vaccination.
The ELISA assay for antibodies to rotavirus was performed at the Children's Hospital Medical Center (CCHMC) using a validated in-house assay.
Measured: 4 weeks post vaccination 4 (Week 18)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2015 (estimated)
- Study startAug 2015
- Primary completion17 Jun 2016
- Study completion17 Jun 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PoliomyelitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- PATH
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing Bio-Institute Biological Products Co., Ltd., formerly Beijing TiantanBio
- Responsible party
- Sponsor
- Investigators
- Jessica Cowden, MD, MSPH, Study chair, US Army Medical Research Unit-Kenya
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02434770
- Sponsor's protocol ID
- VAC-015
- Status last verified
- Feb 2020
- First submitted
- 30 Apr 2015
- Last updated
- 10 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Single-blind, Randomized, Controlled Study in Healthy Kenyan Infants to Assess the Immunogenicity and Safety of Beijing TiantanBio Liquid Bivalent Oral Poliomyelitis Vaccine (bOPV) in Comparison to a WHO Prequalified Comparator bOPV
- ClinicalTrials.gov ID
- NCT02434770
- Acronym / sponsor ID
- VAC-015
- Conditions
- Poliomyelitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- PATHUniversity, hospital or other
- Collaborators
- Beijing Bio-Institute Biological Products Co., Ltd., formerly Beijing TiantanBio
- Study start
- Aug 2015
- Primary completion
- 17 Jun 2016 (actual)
- Study completion
- 17 Jun 2016 (actual)
- First posted
- 5 May 2015 (estimated)
- Results
- Posted 10 Mar 2020
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 will be to evaluate whether a bivalent oral polio vaccine (bOPV) manufactured by Beijing Bio-Institute Biological Products Co., Ltd (BBIBP) has a similar immunogenicity profile to a WHO prequalified bOPV.
Detailed description
BBIBP has been one of the two suppliers of trivalent oral polio vaccine (tOPV) in China since 1985, with control of polio in China evidence of the effectiveness of its vaccine. The company plans to introduce a liquid formulation of bOPV (types 1 and 3) to meet increasing global demand with the phasing-out of tOPV. The proposed study is intended to provide data sufficient to obtain World Heath Organization (WHO) prequalification for the BBIBP bOPV, thus making the vaccine available to help meet global demand.
Infants were enrolled and randomized prior to the birth dose of bOPV. The first dose of study vaccine was administered during the first two weeks of life and then co-administered with the primary Expanded Programme on Immunization (EPI) series vaccines in Kenya at 6, 10 and 14 weeks of age. The Kenya EPI schedule includes the following additional vaccines:
- Bacille Calmette-Guérin Vaccine (BCG) at birth
- Diphtheria and Tetanus Toxoid with Whole Cell Pertussis, Haemophilus influenzae Type V vaccine (Hib), and Hepatitis B Vaccine (DTwPHibHep) at 6, 10, 14 weeks;
- Pneumococcal Conjugate vaccine (PCV) at 6, 10, 14 weeks
- Rotavirus vaccine (Rotarix) at 6, 10 weeks
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BBIBP bOPV Lot 1 | Experimental | Biological: BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 1, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age. |
| BBIBP bOPV Lot 2 | Experimental | Biological: BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2Infants received 2 drops of liquid bivalent oral polio vaccine (bOPV) manufactured by BBIBP, Lot 2, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age. |
| BioFarma bOPV | Active comparator | Biological: BioFarma Bivalent Oral Poliomyelitis VaccineInfants received 2 drops of WHO prequalified liquid bivalent oral polio vaccine manufactured by BioFarma, administered directly into the mouth in the first two weeks of life, and at 6, 10, and 14 weeks of age. |
Who may qualify
- Ages
- 1 day to 14 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy, full-term infants, as established by medical history and clinical examination before entering into the study.
- Parents willing to provide written informed consent.
- Age: infants less than 2 weeks of age at the time of enrollment (from the 1st through the 14th day of life, inclusive)
Key exclusion criteria (14 listed)
- Birth weight (as documented at first medical contact) less than 2.5 kg
- Presence of diarrhea or vomiting in the previous 24 hours or on the day of enrollment (temporary exclusion)
- Presence of fever (> 37.5°C) on the day of enrollment (temporary exclusion)
- Acute disease at the time of enrollment (temporary exclusion)
- Significant malnutrition as per Investigator's judgment
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 |
|---|---|---|
| BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1Also: Poliomyelitis (Live) Vaccine Type I Type III (Human Diploid Cell), OralEach dose of bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10^6 cell culture infectious dose 50% (CCID50)/dose and 10^5.8 CCID50/dose, respectively. | Biological | BBIBP bOPV Lot 1 |
| BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2Also: Poliomyelitis (Live) Vaccine Type I Type III (Human Diploid Cell), OralEach dose of bOPV (2 drops, 0.1 ml) contains types 1 and 3 attenuated polioviruses (Sabin), with at least 10^6 CCID50/dose and 10^5.8 CCID50/dose, respectively. | Biological | BBIBP bOPV Lot 2 |
| BioFarma Bivalent Oral Poliomyelitis VaccineEach dose of the WHO prequalified Bio Farma bOPV (2 drops, 0.1 ml) contains attenuated Sabin strains of poliovirus serotypes 1 and 3, with at least 10^6 and 10^5.8 infective units per dose, respectively. | Biological | BioFarma bOPV |
Primary outcome
Number of Participants Experiencing Any Systemic Reactogenicity, by Maximum Severity
Time frame: 7 days after each vaccination (Weeks 0, 6, 10, and 14)
Solicited systemic reactogenicity events evaluated during the week after each vaccination included fever, vomiting, diarrhea, decreased appetite/ poor feeding, irritability, and decreased activity. Reactions were recorded by participant's parents via memory aid. Each event was graded as: Mild (Grade 1): No or minimal interference with usual activities; no medical intervention/therapy required, Moderate (Grade 2): Greater than minimal interference with usual activities; no or minimal medical intervention/therapy required, Severe (Grade 3): Marked limitation in ability to perform usual activities; medical intervention/therapy required, or Potentially life-threatening (Grade 4): Inability to perform basic functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death. The overall number of participants who experienced any systemic reaction is reported. Grades are based on maximum severity per participant.
Number of Participants Experiencing Adverse Events
Time frame: From the time of the first vaccination through 28 days after each vaccination (up to Day 126).
Adverse events were graded as mild (Grade 1 = No or minimal interference with usual activities; no medical intervention/therapy required), moderate (Grade 2 = Greater than minimal interference with usual activities; no or minimal medical intervention/therapy required), severe (Grade 3 = Marked limitation in ability to perform usual activities; medical intervention/therapy required), or potentially life-threatening (Grade 4 = Inability to perform basic functions OR Medical or operative intervention indicated to prevent permanent impairment, persistent disability, or death). The overall number of participants who experienced any adverse event is reported. Grades are based on maximum severity per participant.
Anti-polio Neutralizing Antibody Geometric Mean Titers (GMT): Serotype 1
Time frame: Screening and 4 weeks post vaccination 4 (Week 18)
The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated. Anti-polio antibody titer four weeks after the fourth vaccination was adjusted for the decrease in maternal antibodies based on a half-life of 28 days.
Anti-polio Neutralizing Antibody Geometric Mean Titers: Serotype 3
Time frame: Screening and 4 weeks post vaccination 4 (Week 18)
The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated. Anti-polio antibody titer four weeks after the fourth vaccination was adjusted for the decrease in maternal antibodies based on a half-life of 28 days.
Number of Infants With Serotype-specific Anti-polio Neutralizing Antibody Seroconversion 4 Weeks After Last Dose
Time frame: 4 weeks post vaccination 4 (Week 18)
The assays for determination of anti-poliovirus neutralizing antibodies at the National Institutes for Food and Drug Control (NIFDC) were validated. Seroconversion was defined as a titer ≥ 1:8 if seronegative at screening, otherwise a ≥ 4-fold increase in adjusted titers (i.e., adjusted for the decay in maternal antibodies, based on a half life of 28 days).
3 secondary outcomes
Anti-hepatitis B Surface Antigen (HBsAg) Geometric Mean Titers
Time frame: 4 weeks post vaccination 4 (Week 18)
Number of Infants With Anti-hepatitis B Surface Antigen (HBsAg) Seroprotection
Time frame: 28 days after vaccination 4
Anti-Rotavirus Immunoglobulin A (IgA) Geometric Mean Titers
Time frame: 4 weeks post vaccination 4 (Week 18)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Jessica Cowden, MD, MSPH study chair
US Army Medical Research Unit-Kenya
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 BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 1, BBIBP Bivalent Oral Poliomyelitis Vaccine Lot 2 and BioFarma Bivalent Oral Poliomyelitis Vaccine in people with Poliomyelitis, run by PATH at 2 sites in Kenya.
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 3 inclusion and 14 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 10 Mar 2020. 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 Kenya. 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?
Yes. Results are posted in the registry (first posted 10 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Experiencing Any Systemic Reactogenicity, by Maximum Severity (time frame: 7 days after each vaccination (Weeks 0, 6, 10, and 14)). The study lists 5 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 10 Mar 2020.