Infections, RotavirusPhase 3NCT03954743

Safety Study of 2 Formulations of GSK's Human Rotavirus (HRV) Vaccine (444563), in Healthy Infants Starting at Age 6-12 Weeks

A Phase 3 study testing PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine and Lyophilized formulation of GSK's oral live attenuated HRV vaccine in people with Infections, Rotavirus, run by GlaxoSmithKline at 37 sites in 5 countries.

Completed

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

Official record

Search all trials

Trial summary

The purpose of this study is to complete the total safety database size for GlaxoSmithKline Biologicals' (GSK's) human rotavirus (HRV) vaccine across the Porcine circovirus (PCV)-free development plan. Read more about this study

Who is it for?: Ages 6 to 12 weeksHealthy volunteers can take part
Conditions the study is for: Infections, Rotavirus
What is being tested?: PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine and Lyophilized formulation of GSK's oral live attenuated HRV vaccine
Type of treatment: Vaccines, Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,351 participants
Where: 37 sitesin 5 countries
Study dates: 19 Jul 2019to 30 Nov 2020
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 6 to 12 weeks
All sexes
Healthy volunteers accepted
Child

Who may be able to join

All subjects must satisfy all the following criteria at study entry:
Subjects' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
Healthy subjects as established by medical history and clinical examination before entering into the study.
A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.

Who cannot join

Medical conditions
Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
Very prematurely born infants (born ≤28 weeks of gestation).
History of IS.
Family history of congenital or hereditary immunodeficiency.
Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).

Show all 20Show fewer

Hypersensitivity to latex.
Major congenital defects or serious chronic illness, as assessed by the investigator.
Previous confirmed occurrence of Rotavirus Gastroenteritis (RV GE).
History of any reaction or hypersensitivity likely to be exacerbated by any component of the vaccines.
History of Severe combined immunodeficiency (SCID). Prior/Concomitant therapy
Use of any investigational or non-registered product (drug, vaccine or medical device) other than the study vaccines during the period starting 30 days before the first dose of study vaccines (Day -29 to Day 1), or planned use during the study period.
Planned administration/administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the first dose and ending 30 days after the last dose of study vaccine administration, with the exception of the inactivated influenza vaccine, which is allowed at any time during the study, and other licensed routine childhood vaccinations.
Administration of long-acting immune-modifying drugs at any time during the study period (e.g. infliximab).
Administration of immunoglobulins and/or any blood products from birth or planned administration during the study period.
Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs since birth. For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day, or equivalent. Inhaled and topical steroids are allowed.
Previous vaccination against RV. Prior/Concurrent clinical study experience
Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product (drug or medical device).
Other exclusions
Child in care.

Trial locations and contacts

37 sites in 5 countries.

Country

City, postcode or hospital

37 sites in 5 countries

United States19 sites

GSK Investigational Site
Bingham Farms, Michigan, 48025
GSK Investigational Site
Birmingham, Alabama, 35235
GSK Investigational Site
Charlottesville, Virginia, 22902
GSK Investigational Site
Cincinnati, Ohio, 45245
GSK Investigational Site
Colorado Springs, Colorado, 80922
GSK Investigational Site
Corvallis, Oregon, 97330
GSK Investigational Site
Draper, Utah, 84020
GSK Investigational Site
East Orange, New Jersey, 07108
GSK Investigational Site
Fairfield, Ohio, 45014
GSK Investigational Site
Fall River, Massachusetts, 02721-1735
GSK Investigational Site
Frederick, Maryland, 21702
GSK Investigational Site
Lincoln, Nebraska, 68504
GSK Investigational Site
Lincoln, Nebraska, 68516
GSK Investigational Site
Lincoln, Nebraska, 68522
GSK Investigational Site
Louisville, Kentucky, 40291
GSK Investigational Site
Murray, Utah, 84107
GSK Investigational Site
Orem, Utah, 84057
GSK Investigational Site
South Jordan, Utah, 84095
GSK Investigational Site
Syracuse, New York, 13210

Other trials in United States

Canada9 sites

GSK Investigational Site
Brampton, Ontario, L6T 0G1
GSK Investigational Site
Calgary, Alberta, T3B 6A8
GSK Investigational Site
Halifax, Nova Scotia, B3K 6R8
GSK Investigational Site
London, Ontario, N5W 6A2
GSK Investigational Site
Montreal, Quebec, H3T 1C5
GSK Investigational Site
Québec, G1V 4G2
GSK Investigational Site
Sarnia, Ontario, N7T 4X3
GSK Investigational Site
Surrey, British Columbia, V3S 2N6
GSK Investigational Site
Truro, Nova Scotia, B2N 1L2

Other trials in Canada

Taiwan4 sites

GSK Investigational Site
Changhua, 500
GSK Investigational Site
Kaohsiung City, 83301
GSK Investigational Site
Taipei, 100
GSK Investigational Site
Taipei, 104

Other trials in Taiwan

Turkey (Türkiye)3 sites

GSK Investigational Site
Eskişehir, 26040
GSK Investigational Site
Izmir, 35340
GSK Investigational Site
Kayseri, 38030

Other trials in Turkey (Türkiye)

Hong Kong2 sites

GSK Investigational Site
Pokfulam
GSK Investigational Site
Shatin

Other trials in Hong Kong

About this study

Official title: A Phase III, Observer-blind, Randomized, Multi-country Study to Assess the Reactogenicity and Safety of the Porcine Circovirus (PCV) Free Liquid Formulation of GSK's Oral Live Attenuated Human Rotavirus (HRV) Vaccine as Compared to the Lyophilized Formulation of the GSK's HRV Vaccine, When Administered as a 2-dose Vaccination in Infants Starting at Age 6-12 Weeks

This study used a purposely selected lot for PCV-free liquid HRV vaccine that is in the upper range of the usual release potencies. The PCV-free liquid HRV vaccine lots used were stored frozen in order to keep the titer stable until administration during the study.

As the liquid formulation of GSK's HRV vaccine is not licensed in the US, the lyophilized formulation of the vaccine was used as a control in all phase III studies as part of the PCV-free development plan.

Conditions: Infections, Rotavirus
Being tested: PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine, Lyophilized formulation of GSK's oral live attenuated HRV vaccine
Keywords: HRV, Lyophilized formulation, Liquid formulation, Human rotavirus vaccine, Rotarix, Healthy infants, PCV-free, Porcine circovirus-free
Medical subject headings: Rotavirus Infections

What participants receive

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

PCV-free liquid formulation of GSK's oral live attenuated HRV vaccineBiological
2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.
Lyophilized formulation of GSK's oral live attenuated HRV vaccineBiological
2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.

Study groups in NCT03954743
Study group	Role	What they receive
HRV PCV-free Liq Group	Experimental	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used. Receives: Biological: PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine
HRV Lyo group	Active comparator	Subjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. Receives: Biological: Lyophilized formulation of GSK's oral live attenuated HRV vaccine

What is being measured

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

Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination
Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Measured: During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1)
Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination
Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Measured: During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2)
Number of Subjects With Any Unsolicited AEs
An unsolicited AE is defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment, and reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Measured: During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2)
Number of Subjects With Any Serious Adverse Events (SAEs)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.
Measured: Throughout the study period (from Day 1 up to Month 7 or Month 8)

Timeline

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

19 Jul 201930 Nov 2020

First posted17 May 2019
Study start19 Jul 2019
Primary completion30 Nov 2020
Study completion30 Nov 2020

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 Infections, RotavirusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe 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: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 1,351 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03954743
Sponsor's protocol ID: 208236
Other IDs: 2018-001986-18, 2018
Status last verified: Feb 2022
First submitted: 15 May 2019
Last updated: 10 Mar 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: IPD for this study will be made available via the Clinical Study Data Request site.

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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All Infections, Rotavirus trials

Study at a glance

From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III, Observer-blind, Randomized, Multi-country Study to Assess the Reactogenicity and Safety of the Porcine Circovirus (PCV) Free Liquid Formulation of GSK's Oral Live Attenuated Human Rotavirus (HRV) Vaccine as Compared to the Lyophilized Formulation of the GSK's HRV Vaccine, When Administered as a 2-dose Vaccination in Infants Starting at Age 6-12 Weeks
ClinicalTrials.gov ID: NCT03954743
Acronym / sponsor ID: 208236
Conditions: Infections, Rotavirus
Keywords: HRV, Lyophilized formulation, Liquid formulation, Human rotavirus vaccine, Rotarix, Healthy infants, PCV-free, Porcine circovirus-free
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,351 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 19 Jul 2019 (actual)
Primary completion: 30 Nov 2020 (actual)
Study completion: 30 Nov 2020 (actual)
First posted: 17 May 2019 (actual)
Results: Posted 18 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
HRV PCV-free Liq Group	Experimental	Biological: PCV-free liquid formulation of GSK's oral live attenuated HRV vaccineSubjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) porcine circovirus (PCV)-free vaccine in liquid formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries. PCV-free implies no detection of PCV-1 and PCV-2 according to the limit of detection of the tests used.
HRV Lyo group	Active comparator	Biological: Lyophilized formulation of GSK's oral live attenuated HRV vaccineSubjects aged 6 to 12 weeks at the time of first vaccination, who received two doses of oral live-attenuated human rotavirus (HRV) vaccine in lyophilized formulation, one at Day 1 and one at Month 1 or Month 2, according to the immunization schedule for rotavirus (RV) vaccine administration in participating countries.

Who may qualify

Ages: 6 to 12 weeks
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Subjects' parent(s)/LAR(s) who, in the opinion of the investigator, can and will comply, with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits).
Written or witnessed/thumb printed informed consent obtained from the parent(s)/LAR(s) of the subject prior to performance of any study specific procedure.
Healthy subjects as established by medical history and clinical examination before entering into the study.
A male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination.

Key exclusion criteria (20 listed)

Medical conditions
Uncorrected congenital malformation (such as Meckel's diverticulum) of the gastrointestinal tract that would predispose for Intussusception (IS).
Very prematurely born infants (born ≤28 weeks of gestation).
History of IS.
Family history of congenital or hereditary immunodeficiency.

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
PCV-free liquid formulation of GSK's oral live attenuated HRV vaccine2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.	Biological	HRV PCV-free Liq Group
Lyophilized formulation of GSK's oral live attenuated HRV vaccine2 doses administered orally at Day 1 and at Month 1 or Month 2, according to the immunization schedule for RV vaccine administration in participating countries.	Biological	HRV Lyo group

Primary outcome

Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination
Time frame: During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1)
Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination
Time frame: During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2)
Assessed solicited general AEs were fever (defined as temperature ≥ 38.0°C/100.4°F, the preferred location for measuring temperature in this study being the oral cavity, the axilla and the rectum), irritability/fussiness, diarrhea (defined as passage of three or more looser than normal stools within a day), vomiting (defined as one or more episodes of forceful emptying of partially digested stomach contents ≥1 hour after feeding within a day), loss of appetite and cough/runny nose. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Number of Subjects With Any Unsolicited AEs
Time frame: During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2)
An unsolicited AE is defined as any untoward medical occurrence in a clinical study subject, temporally associated with the use of a study treatment, whether or not considered related to the study treatment, and reported in addition to those solicited during the clinical study and any 'solicited' AE with onset outside the specified period of follow-up for solicited symptoms. Any = occurrence of AE regardless of intensity grade or relation to study vaccination.
Number of Subjects With Any Serious Adverse Events (SAEs)
Time frame: Throughout the study period (from Day 1 up to Month 7 or Month 8)
An SAE is defined as any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization and/or results in disability/incapacity. Any = occurrence of SAE regardless of intensity grade or relation to study vaccination.

Results and safety

Results posted to the registry on 18 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
HRV PCV-free Liq Group	677	653
HRV Lyo Group	674	657

Primary outcome: Number of Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination

Time frame: During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1). Count of participants. Unit: Participants

Measure	HRV PCV-free Liq Group n = 677	HRV Lyo Group n = 674
Cough / Runny Nose, Any	139	166
Diarrhea, Any	41	47
Fever, ≥ 38.0°C	27	21
Irritability / Fussiness, Any	431	428
Loss of appetite, Any	201	186
Vomiting, Any	113	122

Population analysed: Analysis was performed on the Exposed set (ES), which included all subjects with at least one study vaccine administration documented and with the diary card completed after the first vaccination.

Primary outcome: Number of Subjects With Any Solicited General Adverse Events (AEs) After the Second Vaccination

Time frame: During the 8-day follow-up period after the second vaccination (vaccines administered at Month 1 or Month 2). Count of participants. Unit: Participants

Measure	HRV PCV-free Liq Group n = 663	HRV Lyo Group n = 657
Cough / Runny Nose, Any	147	145
Diarrhea, Any	28	36
Fever, ≥ 38.0°C	46	40
Irritability / Fussiness, Any	368	362
Loss of appetite, Any	170	168
Vomiting, Any	82	88

Primary outcome: Number of Subjects With Any Unsolicited AEs

Time frame: During the 31-day follow-up period across doses (vaccines administered at Day 1 and at Month 1 or Month 2). Count of participants. Unit: Participants

Measure	HRV PCV-free Liq Group n = 677	HRV Lyo Group n = 674
Value	201	206

Population analysed: Analysis was performed on the Exposed set (ES), which included all subjects with at least one study vaccine administration documented.

Primary outcome: Number of Subjects With Any Serious Adverse Events (SAEs)

Time frame: Throughout the study period (from Day 1 up to Month 7 or Month 8). Count of participants. Unit: Participants

Measure	HRV PCV-free Liq Group n = 677	HRV Lyo Group n = 674
Value	39	38

Population analysed: Analysis was performed on the Exposed set (ES), which included all subjects with at least one study vaccine administration documented.

Adverse events

Time frame: Solicited AEs: During the 8-day (Day 1 to Day 8) follow-up period after each HRV vaccination. Unsolicited AEs: During the 31-day (Day 1 to Day 31) follow-up period after any HRV vaccination. SAEs: Throughout the study period (from Day 1 up to Month 7 or Month 8).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
HRV PCV-free Liq Group	39 of 677 (5.8%)	591 of 677 (87.3%)	0 of 677
HRV Lyo Group	38 of 674 (5.6%)	571 of 674 (84.7%)	0 of 674

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. IPD for this study will be made available via the Clinical Study Data Request site.

Related trials for Infections, Rotavirus

Active, not recruitingPhase 1
CDC-9 Inactivated Rotavirus Vaccine (IRV) Microneedle Patch (MNP) in Healthy Adults
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RecruitingObservational study
Risk Assessment of Community Spread of Multiple Endemic Infectious Diseases in a One Health Perspective
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Active, not recruitingPhase 3
The Efficacy of Oral Rotavirus Vaccine 116E (ROTAVAC 5D) in Chilean Infants
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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.

GSK Clinical Trials study director

GlaxoSmithKline

37 sites in 5 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 20 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 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in United States, Canada, Taiwan, Turkey (Türkiye), Hong Kong. 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 18 Jun 2021). 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 Subjects With Any Solicited General Adverse Events (AEs) After the First Vaccination (time frame: During the 8-day follow-up period after the first vaccination (vaccines administered at Day 1)). 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 NCT03954743.

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 2022.