CholeraPhase 2NCT02742558
Safety and Immunogenicity of Locally Manufactured Oral Cholera Vaccine
A Phase 2 study testing Cholvax and Shanchol in people with Cholera, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
Trial summary
To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM, Investigators will conduct a clinical trial study Bangladeshi healthy adults and children. Cholvax is locally produced orally administered whole cell inactivated bivalent cholera vaccine. Read more about this study
- Who is it for?
- Ages 1 year to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Cholera
- What is being tested?
- Cholvax and Shanchol
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,052 participants
- Where
- 1 siteBangladesh
- Study dates
- Apr 2016to Jun 2017
- 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 1 year to 45 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Age: 1-45 Years.
- Informed consent from study participants and guardian in case of children (1-17 years) and assent from children aged 11-17 years.
- Participation in the study at least for next 6 months
- Considered healthy as per medical judgment of the investigator
Who cannot join
- Suffering from diarrhea or abdominal pain or vomiting in the past 24 hours or diarrhea lasting for more than 2 weeks in the past 6 months
- History of taking oral cholera vaccine and history of confirmed cholera.
- History of taking any other live or killed enteric vaccine in the last 8 weeks.
- History of anaphylaxis or serious vaccine reaction.
- Currently use of any immunosuppressive or immune-modifying drugs. 6.100.4 0 F (38℃) or higher body temperature measured prior to investigational product dosing.
- 7.Receipt of blood or blood products or parenteral immunoglobulin preparation in the past 3 months.
- 8.Currently on antimicrobial therapy. 9.Severe malnutrition or chornic disease based on the jugement of the investigator.
- 10.Stool sample at screening positive for V. cholerae. 11.Pregnant women or plans to become pregnant during the study period .
Trial locations and contacts
1 site in 1 country.
Bangladesh1 site
International Centre for Diarrhoeal Disease Research, Bangladesh
Dhaka, 1212
About this study
Official title: A Randomized Observer Blinded Controlled Non Inferiority Trial to Evaluate the Safety and Immunogenicity of Locally Manufactured Inactivated Bivalent Whole Cell-oral Cholera Vaccine (WC-OCV) 'Cholvax' in Bangladeshi Healthy Adults and Children
To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM, Investigators will conduct a clinical trial study Bangladeshi healthy adults and children. Cholvax is locally produced orally administered whole cell inactivated bivalent cholera vaccine. Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the oral cholera vaccine, Cholvax with technological support from International Vaccine Institute (IVI). Cholvax meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation. By this transfer of technology, it expected that the vaccine will become available for use in public health programs in Bangladesh and in the future in other cholera-affected countries in Asia and Africa to control endemic cholera, as well as to help control large-scale epidemics and outbreaks.
Investigators will also evaluate and compare the safety and immunogenicity of 3 Cholvax lots (lot-to-lot consistency).
Read the detailed description
Background : Cholera continues to be a major cause of morbidity and mortality in low-income countries including Bangladesh. It is estimated that there are at least 300,000 severe cases and over 4,500 deaths in Bangladesh each year1. The overall morbidity for cholera remains high. A global stockpile of OCV has been created by WHO in 2013 for epidemic and outbreak settings2. However, the global demand for the vaccine far exceeds the present supply for both epidemic and also endemic settings3. It can be envisioned that local production of an affordable OCV for high risk population in endemic settings will improve the present scenario in Bangladesh and other countries.
Knowledge gap: The WHO recommends OCV for use in both endemic and epidemic cholera settings4. At present there are two vaccines that are WHO prequalified. These include Dukoral which is registered in Bangladesh and in over 50 countries. However, the disadvantage of use of Dukoral is that its current price it is expensive for Bangladesh and other developing countries. In addition, the need for buffer to formulate the vaccine makes it less fieldable for mass vaccination programs. Another whole cell killed OCV, ShancholTM, which is WHO prequalified, is based on similar bacterial components as Dukoral and licensed in India but not in Bangladesh. Although this vaccine is relatively affordable it may not be sufficiently cost effective for the Government of Bangladesh to implement it in our poor endemic settings. At present, the vaccine is in short supply and will not be able to meet the global demands. In order to increase supply of OCV and make the vaccine more affordable, a locally manufactured killed bivalent whole cell-oral cholera vaccine Cholvax is now available. The present study will evaluate the safety and immunogenicity of Cholvax as a test vaccine using Shanchol TM as the comparator vaccine in a non inferiority trial design.
Relevance: The study of this locally manufactured OCV, Cholvax among children and adults will be able to give us information regarding the safety and immunogenicity of the vaccine. Based on this information, it can be anticipated that regulatory requirements as well as licensure of the vaccine will be initiated in Bangladesh. This will pave the way forward for the future approval by WHO and for its global use. The introduction of Cholvax in endemic settings, seasonal outbreak as well as in the EPI program of the country in the future can be expected based on the study results; initiatives and plans can be made to introduce this locally produced vaccine in Bangladesh at an affordable cost and in the future globally.
Hypothesis (if any): Locally produced orally administered whole cell inactivated bivalent cholera vaccine, Cholvax is non inferior or at least as safe and immunogenic in adults and children in Bangladesh as compared to Shanchol TM.
Objectives: The objectives of this study are- i. To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM ii. To evaluate the safety and immunogenicity of Cholvax in healthy adults and children in Dhaka.
iii. To evaluate and compare the safety and immunogenicity of 3 Cholvax lots (lot-to-lot consistency) Methods: This will be a randomized, observer blinded and comparative study on a total of 2052 healthy participants, 1026 Cholvax (Test Group) and 1026 ShancholTM (Comparator Group) recipients. There will be three age cohort arms in each test and comparator group which will consist of 219 participants for age 1-5Yrs, 373 participants for age 6-17Yrs and 434 for Age 18-45Yrs, with a total of 2052 participants. Participants will receive either Cholvax or ShancholTM two doses 14 days apart.
Each age cohort of the study (Cohort I onwards) will be completed and based on the development, and progress, the next age cohort will be initiated. If the vaccine is found to be safe in the adults it will be tested in the children, 6-17 years of age and followed by the younger age group 1-5 years of age. The results will be presented to the Data Safety Monitoring Board after completing the 28-day safety surveillance part of each age cohort of the study and before proceeding to the next study age cohort.
- Conditions
- Cholera
- Being tested
- Cholvax, Shanchol
- Keywords
- cholera vaccine, randomized trial, immunogenicity
- Medical subject headings
- Cholera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholvaxBiological
Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the OCV, Cholvax with technological support from International Vaccine Institute (IVI), which meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation.
ShancholBiological
The vaccine is manufactured by Shantha Biotechnics, in Hyderabad, India and is prequalified by the WHO. Shanchol™ is available in a single dose vial.This vaccine is used as two dose regimen.
| Study group | Role | What they receive |
|---|---|---|
| cholvax | Experimental | Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the OCV, Cholvax with technological support from International Vaccine Institute (IVI), which meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation. Receives: Biological: Cholvax |
| shanchol | Active comparator | The vaccine is manufactured by Shantha Biotechnics, in Hyderabad, India and is prequalified by the WHO. Shanchol™ is available in a single dose vial.This vaccine is used as two dose regimen. Receives: Biological: Shanchol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with vaccine related reactogenicity as assessed by study personnel
Number of reactogenecity events will be compared between test group and comparator group.
Measured: Within 30 minutes after administration of vaccine
Number of participants with solicited adverse events as assessed by study personnel
Number of solicited adverse events observed after each dose of vaccination assessed by study personnel through home visit and will be compared between test group and comparator group
Measured: Within 7 days after administration of vaccine
Number of participants with unsolicited adverse event including serious adverse event as assessed by study physician
Number of unsolicited adverse events including serious adverse event observed after each dose of vaccination assessed by study personnel through home visit and will be compared between test group and comparator group
Measured: Within 6 months after administration of vaccine
Number of participants showing seroconversion against sero group V. cholerae O1
Proportion of participants showing sero-conversion against V. cholerae O1, upon vaccination Cholvax being tested in comparison with ShancholTM.
Measured: 7 days after administration of vaccine
Secondary outcomes (1)
Number of participants showing seroconversion against sero group V. cholerae O139
Proportion of participants showing sero-conversion against serogroup V. cholerae O139 upon vaccination with Cholvax in comparison with ShancholTM will be measured and compared between test and comparator group Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by anti-V. cholerae O1 antibody titer at day 7 and day 21 after the first dose of investigational product dose as compared to baseline (day0).
Geometric Mean Titer (GMT) and Geometric Mean Ratio (GMR) as measured by anti-V. cholerae O139 antibody titer at day 7 and day 21 after the first dose of investigational product dose as compared to baseline (day 0).
Measured: 7 days after administration of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startApr 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 (3)Papers the sponsor has linked to this study.
- Other trials for CholeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 2,052 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- International Vaccine Institute
- Responsible party
- Sponsor
- Investigators
- Firdausi Qadri, Dr., Study director, International Centre for Diiarrhoeal Disease Research, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742558
- Sponsor's protocol ID
- PR-15076
- Status last verified
- Oct 2016
- First submitted
- 7 Apr 2016
- Last updated
- 16 Jun 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: Data will be shared with International Vaccine Institute
Publications
Ali M, Lopez AL, You YA, Kim YE, Sah B, Maskery B, Clemens J. The global burden of cholera. Bull World Health Organ. 2012 Mar 1;90(3):209-218A. doi: 10.2471/BLT.11.093427. Epub 2012 Jan 24.
PubMed 22461716Maskery B, DeRoeck D, Levin A, Kim YE, Wierzba TF, Clemens JD. Strategy, demand, management, and costs of an international cholera vaccine stockpile. J Infect Dis. 2013 Nov 1;208 Suppl 1:S15-22. doi: 10.1093/infdis/jit233.
PubMed 24101640Saha A, Chowdhury MI, Khanam F, Bhuiyan MS, Chowdhury F, Khan AI, Khan IA, Clemens J, Ali M, Cravioto A, Qadri F. Safety and immunogenicity study of a killed bivalent (O1 and O139) whole-cell oral cholera vaccine Shanchol, in Bangladeshi adults and children as young as 1 year of age. Vaccine. 2011 Oct 26;29(46):8285-92. doi: 10.1016/j.vaccine.2011.08.108. Epub 2011 Sep 9.
PubMed 21907255
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Observer Blinded Controlled Non Inferiority Trial to Evaluate the Safety and Immunogenicity of Locally Manufactured Inactivated Bivalent Whole Cell-oral Cholera Vaccine (WC-OCV) 'Cholvax' in Bangladeshi Healthy Adults and Children
- ClinicalTrials.gov ID
- NCT02742558
- Acronym / sponsor ID
- PR-15076
- Conditions
- Cholera
- Keywords
- cholera vaccine, randomized trial, immunogenicity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,052 participants (actual)
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, BangladeshUniversity, hospital or other
- Collaborators
- International Vaccine Institute
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 19 Apr 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.
To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM, Investigators will conduct a clinical trial study Bangladeshi healthy adults and children. Cholvax is locally produced orally administered whole cell inactivated bivalent cholera vaccine. Incepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the oral cholera vaccine, Cholvax with technological support from International Vaccine Institute (IVI). Cholvax meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation. By this transfer of technology, it expected that the vaccine will become available for use in public health programs in Bangladesh and in the future in other cholera-affected countries in Asia and Africa to control endemic cholera, as well as to help control large-scale epidemics and outbreaks.
Investigators will also evaluate and compare the safety and immunogenicity of 3 Cholvax lots (lot-to-lot consistency).
Detailed description
Background : Cholera continues to be a major cause of morbidity and mortality in low-income countries including Bangladesh. It is estimated that there are at least 300,000 severe cases and over 4,500 deaths in Bangladesh each year1. The overall morbidity for cholera remains high. A global stockpile of OCV has been created by WHO in 2013 for epidemic and outbreak settings2. However, the global demand for the vaccine far exceeds the present supply for both epidemic and also endemic settings3. It can be envisioned that local production of an affordable OCV for high risk population in endemic settings will improve the present scenario in Bangladesh and other countries.
Knowledge gap: The WHO recommends OCV for use in both endemic and epidemic cholera settings4. At present there are two vaccines that are WHO prequalified. These include Dukoral which is registered in Bangladesh and in over 50 countries. However, the disadvantage of use of Dukoral is that its current price it is expensive for Bangladesh and other developing countries. In addition, the need for buffer to formulate the vaccine makes it less fieldable for mass vaccination programs. Another whole cell killed OCV, ShancholTM, which is WHO prequalified, is based on similar bacterial components as Dukoral and licensed in India but not in Bangladesh. Although this vaccine is relatively affordable it may not be sufficiently cost effective for the Government of Bangladesh to implement it in our poor endemic settings. At present, the vaccine is in short supply and will not be able to meet the global demands. In order to increase supply of OCV and make the vaccine more affordable, a locally manufactured killed bivalent whole cell-oral cholera vaccine Cholvax is now available. The present study will evaluate the safety and immunogenicity of Cholvax as a test vaccine using Shanchol TM as the comparator vaccine in a non inferiority trial design.
Relevance: The study of this locally manufactured OCV, Cholvax among children and adults will be able to give us information regarding the safety and immunogenicity of the vaccine. Based on this information, it can be anticipated that regulatory requirements as well as licensure of the vaccine will be initiated in Bangladesh. This will pave the way forward for the future approval by WHO and for its global use. The introduction of Cholvax in endemic settings, seasonal outbreak as well as in the EPI program of the country in the future can be expected based on the study results; initiatives and plans can be made to introduce this locally produced vaccine in Bangladesh at an affordable cost and in the future globally.
Hypothesis (if any): Locally produced orally administered whole cell inactivated bivalent cholera vaccine, Cholvax is non inferior or at least as safe and immunogenic in adults and children in Bangladesh as compared to Shanchol TM.
Objectives: The objectives of this study are- i. To evaluate and compare the safety and immunogenicity of the Cholvax with ShancholTM ii. To evaluate the safety and immunogenicity of Cholvax in healthy adults and children in Dhaka.
iii. To evaluate and compare the safety and immunogenicity of 3 Cholvax lots (lot-to-lot consistency) Methods: This will be a randomized, observer blinded and comparative study on a total of 2052 healthy participants, 1026 Cholvax (Test Group) and 1026 ShancholTM (Comparator Group) recipients. There will be three age cohort arms in each test and comparator group which will consist of 219 participants for age 1-5Yrs, 373 participants for age 6-17Yrs and 434 for Age 18-45Yrs, with a total of 2052 participants. Participants will receive either Cholvax or ShancholTM two doses 14 days apart.
Each age cohort of the study (Cohort I onwards) will be completed and based on the development, and progress, the next age cohort will be initiated. If the vaccine is found to be safe in the adults it will be tested in the children, 6-17 years of age and followed by the younger age group 1-5 years of age. The results will be presented to the Data Safety Monitoring Board after completing the 28-day safety surveillance part of each age cohort of the study and before proceeding to the next study age cohort.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cholvax | Experimental | Biological: CholvaxIncepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the OCV, Cholvax with technological support from International Vaccine Institute (IVI), which meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation. |
| shanchol | Active comparator | Biological: ShancholThe vaccine is manufactured by Shantha Biotechnics, in Hyderabad, India and is prequalified by the WHO. Shanchol™ is available in a single dose vial.This vaccine is used as two dose regimen. |
Who may qualify
- Ages
- 1 year to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age: 1-45 Years.
- Informed consent from study participants and guardian in case of children (1-17 years) and assent from children aged 11-17 years.
- Participation in the study at least for next 6 months
- Considered healthy as per medical judgment of the investigator
Key exclusion criteria (8 listed)
- Suffering from diarrhea or abdominal pain or vomiting in the past 24 hours or diarrhea lasting for more than 2 weeks in the past 6 months
- History of taking oral cholera vaccine and history of confirmed cholera.
- History of taking any other live or killed enteric vaccine in the last 8 weeks.
- History of anaphylaxis or serious vaccine reaction.
- Currently use of any immunosuppressive or immune-modifying drugs. 6.100.4 0 F (38℃) or higher body temperature measured prior to investigational product dosing.
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 |
|---|---|---|
| CholvaxIncepta vaccine Limited, a leading pharmaceutical company in Bangladesh is now producing the OCV, Cholvax with technological support from International Vaccine Institute (IVI), which meets international Good Manufacturing Practice (GMP) standards and WHO production guidelines. Cholvax has the same formulation as ShancholTM in terms of strains and formulation. | Biological | cholvax |
| ShancholThe vaccine is manufactured by Shantha Biotechnics, in Hyderabad, India and is prequalified by the WHO. Shanchol™ is available in a single dose vial.This vaccine is used as two dose regimen. | Biological | shanchol |
Primary outcome
Number of participants with vaccine related reactogenicity as assessed by study personnel
Time frame: Within 30 minutes after administration of vaccine
Number of reactogenecity events will be compared between test group and comparator group.
Number of participants with solicited adverse events as assessed by study personnel
Time frame: Within 7 days after administration of vaccine
Number of solicited adverse events observed after each dose of vaccination assessed by study personnel through home visit and will be compared between test group and comparator group
Number of participants with unsolicited adverse event including serious adverse event as assessed by study physician
Time frame: Within 6 months after administration of vaccine
Number of unsolicited adverse events including serious adverse event observed after each dose of vaccination assessed by study personnel through home visit and will be compared between test group and comparator group
Number of participants showing seroconversion against sero group V. cholerae O1
Time frame: 7 days after administration of vaccine
Proportion of participants showing sero-conversion against V. cholerae O1, upon vaccination Cholvax being tested in comparison with ShancholTM.
1 secondary outcome
Number of participants showing seroconversion against sero group V. cholerae O139
Time frame: 7 days after administration of vaccine
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 16 Jun 2017.
- Results publication: PubMed 22461716Ali M, Lopez AL, You YA, Kim YE, Sah B, Maskery B, Clemens J. The global burden of cholera. Bull World Health Organ. 2012 Mar 1;90(3):209-218A. doi: 10.2471/BLT.11.093427. Epub 2012 Jan 24.
- Results publication: PubMed 24101640Maskery B, DeRoeck D, Levin A, Kim YE, Wierzba TF, Clemens JD. Strategy, demand, management, and costs of an international cholera vaccine stockpile. J Infect Dis. 2013 Nov 1;208 Suppl 1:S15-22. doi: 10.1093/infdis/jit233.
- Results publication: PubMed 21907255Saha A, Chowdhury MI, Khanam F, Bhuiyan MS, Chowdhury F, Khan AI, Khan IA, Clemens J, Ali M, Cravioto A, Qadri F. Safety and immunogenicity study of a killed bivalent (O1 and O139) whole-cell oral cholera vaccine Shanchol, in Bangladeshi adults and children as young as 1 year of age. Vaccine. 2011 Oct 26;29(46):8285-92. doi: 10.1016/j.vaccine.2011.08.108. Epub 2011 Sep 9.
- Individual participant dataSharing planned: Yes. Data will be shared with International Vaccine Institute
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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.
Firdausi Qadri, Dr. study director
International Centre for Diiarrhoeal Disease Research, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholvax and Shanchol in people with Cholera, run by International Centre for Diarrhoeal Disease Research, Bangladesh at 1 site in Bangladesh.
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 4 inclusion and 8 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 16 Jun 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 Bangladesh. 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 vaccine related reactogenicity as assessed by study personnel (time frame: Within 30 minutes after administration of vaccine). The study lists 4 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 NCT02742558, which also lists 3 linked publications.
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 16 Jun 2017.