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Healthy Volunteers (Meningococcal Infection)Phase 3MET41NCT03673462

Safety of a Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

A Phase 3 study testing Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine), Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®) and Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine in people with Healthy Volunteers (Meningococcal Infection), run by Sanofi Pasteur, a Sanofi Company at 69 sites in 2 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 primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate Vaccine when administered concomitantly with… Read more about this study

Who is it for?
Ages 42 to 89 daysHealthy volunteers can take part
What is being tested?
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine), Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®) and Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,797 participants
Where
69 sitesin 2 countries
Study dates
17 Sep 2018to 16 Mar 2023
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 42 to 89 days
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Aged >= 42 to <= 89 days on the day of the first study visit.
  • Healthy infants as determined by medical history, physical examination, and judgment of the investigator.
  • Informed consent form was signed and dated by the parent(s) or guardian (and by an independent witness if required by local regulations).
  • Participant and parent/guardian were able to attend all scheduled visits and complied with all trial procedures.
  • Infants who received the first dose of hepatitis B vaccine at least 28 days before the first study visit.

Who cannot join

  • Participation at the time of study enrollment or in the 4 weeks preceding the first trial vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure.
  • Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks before and / or following any trial vaccination except for influenza vaccination, which might be received at least 2 weeks before or 2 weeks after any study vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines.
  • Previous vaccination against meningococcal disease with either the trial vaccine or another vaccine (i.e., mono- or polyvalent, polysaccharide, or conjugate meningococcal vaccine containing serogroups A, C, Y, or W; or meningococcal B serogroup-containing vaccine).
  • Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis A, measles, mumps, rubella, varicella; and Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection or disease.
  • Receipt of more than 1 previous dose of hepatitis B vaccine.
  • Receipt of immune globulins, blood or blood-derived products since birth.
Show all 24Show fewer
  • Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks) since birth.
  • Family history of congenital or hereditary immunodeficiency until the immune competence of the potential vaccine recipient was demonstrated.
  • Individuals with blood dyscrasias, leukemia, lymphoma of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
  • Individuals with active tuberculosis.
  • History of any Neisseria meningitidis infection, confirmed either clinically, serologically, or microbiologically.
  • History of diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B, hepatitis A, measles, mumps, rubella, varicella, Haemophilus influenzae type b, Streptococcus pneumoniae, and /or rotavirus infection/disease.
  • At high risk for meningococcal infection during the trial (specifically, but not limited to, participants with persistent complement deficiency, with anatomic or functional asplenia, or participants traveling to countries with high endemic or epidemic disease).
  • History of intussusception.
  • History of any neurologic disorders, including seizures and progressive neurologic disorders.
  • History of Guillain-Barré syndrome.
  • Known systemic hypersensitivity to any of the vaccine components or to latex, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances, including neomycin, gelatin, and yeast .
  • Verbal report of thrombocytopenia contraindicating intramuscular vaccination in the Investigator's opinion.
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination in the Investigator's opinion.
  • Chronic illness (including, but not limited to, cardiac disorders, congenital heart disease, chronic lung disease, renal disorders, auto-immune disorders, diabetes, psychomotor diseases, and known congenital or genetic diseases) that in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion.
  • Any condition which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
  • Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature >= 38 degree Celsius [>= 100.4-degree Fahrenheit]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided.
  • Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
  • The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial locations and contacts

69 sites in 2 countries.

69 sites in 2 countries

United States67 sites

  • Emmaus Research Center, Inc-Site Number:8400057

    Anaheim, California, 92804

  • ARC Clinical Research at Wilson Parke-Site Number:8400071

    Austin, Texas, 78726

  • Advanced Clinical Research - Rancho Paseo-Site Number:8400087

    Banning, California, 92220

  • Kentucky Pediatics / Adult Research-Site Number:8400044

    Bardstown, Kentucky, 40004

  • Rainbow Pediatrics-Site Number:8400074

    Barnwell, South Carolina, 29812

  • The Children's Center Rehabilitation Hospital-Site Number:8400104

    Bethany, Oklahoma, 73008

  • MedPharmics Biloxi-Site Number:8400052

    Biloxi, Mississippi, 39531

  • Birmingham Pediatric Associates-Site Number:8400049

    Birmingham, Alabama, 35205

  • Craig Spiegel, MD-Site Number:8400067

    Bridgeton, Missouri, 63044

  • PMG Research-Bristol-Site Number:8400009

    Bristol, Tennessee, 37620

  • Benchmark Research - Buda-Site Number:8400016

    Buda, Texas, 78610

  • Coastal Pediatric Research Charleston-Site Number:8400037

    Charleston, South Carolina, 29414

  • Pediatric Medical Research of Charlottesville-Site Number:8400077

    Charlottesville, Virginia, 22902

  • Tanner Clinic-Site Number:8400079

    Clinton, Utah, 84015

  • Optum Clinical Research-Site Number:8400076

    Colorado Springs, Colorado, 80922

  • Crossroads Clinical Research-Site Number:8400058

    Corpus Christi, Texas, 78413

  • Ohio Pediatric Research-Site Number:8400064

    Dayton, Ohio, 45414

  • PriMed Clinical Research-Site Number:8400033

    Dayton, Ohio, 45419

  • Avail Clinical Research, LLC-Site Number:8400055

    DeLand, Florida, 32720-0834

  • Southeastern Pediatric Associates-Site Number:8400034

    Dothan, Alabama, 36305

  • Premier Health Research Center, LLC-Site Number:8400039

    Downey, California, 90240

  • Pediatric Associates of Fall River-Site Number:8400103

    Fall River, Massachusetts, 02721

  • Northwest Arkansas Pediatric Clinic-Site Number:8400042

    Fayetteville, Arkansas, 72703

  • Advanced Research for Health Improvement-Site Number:8400096

    Fort Myers, Florida, 33907

  • Sarkis Clinical Trials-Site Number:8400003

    Gainesville, Florida, 32607

  • Medication Management-Site Number:8400072

    Greensboro, North Carolina, 27360

  • Cyn3rgy Research-Site Number:8400035

    Gresham, Oregon, 97030

  • HealthStar Research, LLC-Site Number:8400100

    Hot Springs, Arkansas, 71913

  • The Children's Clinic of Jonesboro, PA-Site Number:8400059

    Jonesboro, Arkansas, 72401

  • Center for Pharmaceutical Research-Site Number:8400080

    Kansas City, Missouri, 64114

  • Wee Care Pediatrics-Site Number:8400065

    Kaysville, Utah, 84037

  • Holston Medical Group, Pediatrics at Stone Plaza-Site Number:8400015

    Kingsport, Tennessee, 37660

  • Midwest Childrens Health Research Institute-Site Number:8400060

    Lincoln, Nebraska, 68504

  • University of Louisville-Site Number:8400082

    Louisville, Kentucky, 40202

  • Brownsboro Park Pediatrics-Site Number:8400040

    Louisville, Kentucky, 40207

  • All Children Pediatrics-Site Number:8400069

    Louisville, Kentucky, 40243

  • Meridian Clinical Research-Site Number:8400114

    Macon, Georgia, 31210

  • Marshfield Clinic-Site Number:8400054

    Marshfield, Wisconsin, 54449-5777

  • MedPharmics-Site Number:8400048

    Metairie, Louisiana, 70006

  • De Armas Research Center,-Site Number:8400088

    Miami, Florida, 33174

  • Healthy Life Research-Site Number:8400075

    Miami, Florida, 33175

  • Acevedo Clinical Research Associates-Site Number:8400032

    Miami, Florida, 33186

  • Crystal Biomedical Research-Site Number:8400018

    Miami Lakes, Florida, 33014

  • MOC Research-Site Number:8400095

    Mishawaka, Indiana, 46544

  • PMG Research of Charleston, LLC-Site Number:8400102

    Mt. Pleasant, South Carolina, 29464

  • Murray Pediatrics-Site Number:8400019

    Murray, Utah, 84107

  • Advanced Research for Health Improvement-Site Number:8400005

    Naples, Florida, 8400011

  • Palmetto Pediatrics, PA-Site Number:8400089

    North Charleston, South Carolina, 29406

  • Utah Valley Pediatrics - Timpanogos-Site Number:8400038

    Orem, Utah, 84057

  • Center for Clinical Trials, LLC-Site Number:8400056

    Paramount, California, 90723

  • MedPharmics, LLC - Phoenix-Site Number:8400043

    Phoenix, Arizona, 85015

  • Pediatric Care-Site Number:8400045

    Provo, Utah, 84064

  • Legacy Pediatrics-Site Number:8400004

    Rochester, New York, 14618

  • J. Lewis Research-Site Number:8400053

    Salt Lake City, Utah, 84109

  • Foothill Family Research-South-Site Number:8400036

    Salt Lake City, Utah, 84121

  • Benchmark Research - San Angelo-Site Number:8400011

    San Angelo, Texas, 76904

  • Southwest Children's Research Associates, P.A.-Site Number:8400002

    San Antonio, Texas, 78229

  • Senders Pediatrics-Site Number:8400061

    South Euclid, Ohio, 44121

  • Copperview Medical Center-Site Number:8400068

    South Jordan, Utah, 84095

  • J Lewis Research Inc-Site Number:8400050

    South Jordan, Utah, 84095

  • Alliance for Multispecialty Research Syracuse-Site Number:8400066

    Syracuse, Utah, 84075-9645

  • IMMUNOe Research Centers - Thornton-Site Number:8400022

    Thornton, Colorado, 80233

  • Pediatric Clinical Trials Tullahoma-Site Number:8400062

    Tullahoma, Tennessee, 37388

  • Oklahoma State University - Center for Health Sciences-Site Number:8400008

    Tulsa, Oklahoma, 74127

  • Center for Clinical Trials of San Gabriel-Site Number:8400051

    West Covina, California, 91790

  • Center for Clinical Trials of San Gabriel-Site Number:8400099

    West Covina, California, 91790

  • Ford, Simpson, Lively & Rice Pediatrics-Site Number:8400021

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico2 sites

  • Investigational Site Number :6300014

    San Juan, 00918

  • Investigational Site Number :6300108

    San Juan, 00918

Other trials in Puerto Rico

About this study

Official title: A Randomized Study to Describe the Safety of an Investigational Quadrivalent Meningococcal Conjugate Vaccine Administered Concomitantly With Routine Pediatric Vaccines in Healthy Infants and Toddlers

The primary objective of this study was to describe the safety profile of Meningococcal Polysaccharide (Serogroups A, C, Y, and W) Tetanus Toxoid (MenACYW) Conjugate Vaccine and Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 (MENVEO®) Conjugate Vaccine when administered concomitantly with routine pediatric vaccines in healthy infants and toddlers.

Read the detailed description

Study duration per participant was approximately 16 months, which includes a safety follow-up contact at 6 months after the final vaccination.

Being tested
Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine), Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®), Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine, Pneumococcal 13-valent Conjugate Vaccine, Rotavirus Vaccine
Medical subject headings
Meningococcal Infections

What participants receive

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

  • Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine)Biological

    Pharmaceutical form: Liquid solution. Route of administration: Intramuscular

  • Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®)Biological

    Pharmaceutical form: Lyophilized powder combined with liquid components Route of administration: Intramuscular

  • Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b VaccineBiological

    Pharmaceutical form: Liquid DTaP-IPV to reconstitute lyophilized ActHIB Route of administration: Intramuscular

  • Pneumococcal 13-valent Conjugate VaccineBiological

    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

  • Rotavirus VaccineBiological

    Pharmaceutical form: Oral solution Route of administration: Oral

  • Hepatitis B VaccineBiological

    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular

  • Measles, Mumps, and Rubella Virus VaccineBiological

    Pharmaceutical form: Lyophilized live virus vaccine Route of administration: Subcutaneous

  • Varicella Virus VaccineBiological

    Pharmaceutical form: Suspension for injection Route of administration: Subcutaneous

Study groups in NCT03673462
Study groupRoleWhat they receive
Group 1: MenACYW Conjugate VaccineExperimentalHealthy infants aged greater than equal to (>=) 42 to less than equal to (<=) 89 days (at the time of enrollment) received MenACYW Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 months of age; PREVNAR 13® (pneumococcal 13-valent conjugate vaccine; PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.
Receives: Biological: Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine); Biological: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine; Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Rotavirus Vaccine; Biological: Hepatitis B Vaccine; Biological: Measles, Mumps, and Rubella Virus Vaccine; Biological: Varicella Virus Vaccine
Group 2: MENVEO®Active comparatorHealthy infants aged >= 42 to <= 89 days (at the time of enrollment) received MENVEO® Conjugate Vaccine at the age of Months 2, 4, 6, and 12 along with Pentacel® (DTaP-IPV/Hib vaccine) at 2, 4, and 6 months of age; PREVNAR 13® (PCV13) at 2, 4, 6, and 12 months of age; RotaTeq® (rotavirus vaccine) at 2, 4, and 6 months of age; ENGERIX-B® (hepatitis B vaccine) at 2 and 6 months of age; and M-M-R® II (measles, mumps, and rubella vaccine) and VARIVAX® (varicella vaccine) at 12 months of age.
Receives: Biological: Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®); Biological: Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine; Biological: Pneumococcal 13-valent Conjugate Vaccine; Biological: Rotavirus Vaccine; Biological: Hepatitis B Vaccine; Biological: Measles, Mumps, and Rubella Virus Vaccine; Biological: Varicella Virus Vaccine

What is being measured

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

  1. Number of Participants With Immediate Unsolicited Systemic Adverse Events (AEs)

    An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product and which did not have any causal relationship with the treatment. An unsolicited AE was an observed AE that did not fulfill the conditions prelisted in the case report book (CRB) in terms of diagnosis and/or onset window post-vaccination. Immediate adverse events are unsolicited systemic adverse events occurring in the 30 minutes after injection. Reported AEs for each arm were presented as pre-specified in protocol.

    Measured: Within 30 minutes post-any vaccination

  2. Number of Participants With Solicited Injection Site Reactions

    A solicited reaction was an "expected" adverse reaction (AR) (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited injection site reactions included Injection site tenderness, Injection site erythema, and Injection site swelling and were planned to be collected and reported for each vaccine separately; and not planned to be collected for Rotavirus vaccine as the vaccine was administered orally, and no injection site reactions were expected to occur. Reported AEs for each arm were presented as pre-specified in protocol.

    Measured: Within 7 days post any vaccination

  3. Number of Participants With Solicited Systemic Reactions

    A solicited reaction was an "expected" AR (sign or symptom) observed and reported under the conditions (nature and onset) pre-listed in the protocol and CRB and considered as related to the product administered. Solicited systemic reactions included fever, vomiting, crying abnormal, drowsiness, appetite loss, and irritability. Reported AEs for each arm were presented as pre-specified in protocol.

    Measured: Within 7 days post-any vaccination

  4. Number of Participants With Unsolicited Adverse Events

    An AE was any untoward medical occurrence in a clinical investigation participant administered a medicinal product, and which does not necessarily have a causal relationship with this treatment. An unsolicited AE was an observed AE that does not fulfill the conditions prelisted in the CRB in terms of diagnosis and/or onset window post-vaccination. Unsolicited AEs includes both serious adverse events (SAEs) and non-serious unsolicited AEs. Reported AEs for each arm were presented as pre-specified in protocol.

    Measured: Within 30 days post any vaccination

  5. Number of Participants With Serious Adverse Events (SAEs) and Adverse Event of Special Interest (AESIs)

    A SAE was any untoward medical occurrence that at any dose resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, or was an important medical event. An AESI (serious or non-serious) was defined as one of scientific and medical concern specific to the Sponsor's product or program, for which ongoing monitoring and rapid communication by the Investigator to the Sponsor was appropriate. Reported AEs for each arm were presented as pre-specified in protocol.

    Measured: From day of first vaccination (i.e., at the age of 2 months) up to 6 months after last vaccination (i.e., up to the age of 18 months)

  6. Number of Participants With Medically Attended Adverse Event (MAAEs)

    A MAAE was defined as a new onset of a condition that prompts the participant or participant's parent/guardian to seek unplanned medical advice at a health care provider's office or Emergency Department. Reported AEs for each arm were presented as pre-specified in protocol.

    Measured: From day of first vaccination (i.e., at the age of 2 months) up to 6 months after last vaccination (i.e., up to the age of 18 months)

Timeline

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

  1. First posted17 Sep 2018
  2. Study start17 Sep 2018
  3. Primary completion16 Mar 2023
  4. Study completion16 Mar 2023

Resources

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
2,797 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03673462
Sponsor's protocol ID
MET41
Other IDs
U1111-1183-6261, 2019-004459-35, 2019
Acronym
MET41
Status last verified
Dec 2023
First submitted
13 Sep 2018
Last updated
14 Dec 2023
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org

Publications

  • Moskow A, Gupta S, Dhingra MS, Zambrano B, Gan L, B'Chir S, Syrkina O, Hagenbach A, Lyabis O, Rehm C. Safety of a quadrivalent meningococcal conjugate vaccine (MenACYW-TT) administered concomitantly with routine pediatric vaccines in healthy infants and toddlers in USA and Puerto Rico: Results from a Phase III, randomized, active-controlled study. Hum Vaccin Immunother. 2026 Dec;22(1):2716508. doi: 10.1080/21645515.2026.2716508. Epub 2026 Aug 25.

    PubMed 42642862

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Meningococcal polysaccharide (serogroups A,C,Y and W) tetanus toxoid Conjugate vaccine (MenACYW Conjugate vaccine), Meningococcal (Groups A, C, Y and W 135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine (MENVEO®) and Diphtheria, Tetanus, Acellular Pertussis, Poliovirus and Haemophilus b Vaccine in people with Healthy Volunteers (Meningococcal Infection), run by Sanofi Pasteur, a Sanofi Company at 69 sites in 2 countries.

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 24 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 14 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 69 sites in United States, Puerto Rico. 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 5 Oct 2023). 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 With Immediate Unsolicited Systemic Adverse Events (AEs) (time frame: Within 30 minutes post-any vaccination). The study lists 6 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 NCT03673462, which also lists 1 linked publication.

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 14 Dec 2023.

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