AzTrials
AzTrials

Pneumococcal ImmunizationPhase 3NCT06824194

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

A Phase 3 study testing PCV21 vaccine, Prevnar 20 vaccine and M-M-R II vaccine in people with Pneumococcal Immunization, run by Sanofi at 132 sites in 6 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days). Read more about this study

Who is it for?
Ages 42 to 89 daysHealthy volunteers can take part
Conditions the study is for
Pneumococcal Immunization
What is being tested?
PCV21 vaccine, Prevnar 20 vaccine and M-M-R II vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,360 participants
Where
132 sitesin 6 countries
Study dates
18 Feb 2025to 22 Oct 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 inclusion
  • Participants who are healthy as determined by medical evaluation including medical history and physical examination
  • Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg or born after a gestation period above 28 (> 28 weeks) through 36 weeks with a birth weight ≥ 1.5 kg, and in both cases medically stable as assessed by the investigator

Who cannot join

  • Participants are excluded from the study if any of the following criteria apply:
  • 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
  • History of microbiologically confirmed Streptococcus pneumoniae infection or disease
  • Any contraindication to the routine pediatric vaccine being administered in the study
  • History of seizure or significant stable or progressive neurologic disorders such as infantile spasms, inflammatory nervous system diseases, encephalopathy, cerebral palsy
  • Known systemic hypersensitivity to any of the study interventions components, or history of a life-threatening reaction to the study interventions used in the study or to a product containing any of the same substances
Show all 18Show fewer
  • Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legal acceptable representative (LAR(s)), contraindicating intramuscular (IM) injection
  • Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM injection
  • Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with study conduct or completion
  • Moderate or severe acute illness/infection (according to investigator judgment) or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]) on the day of study intervention administration. A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
  • Receipt of any non-US Food and Drug Administration (FDA) approved vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any non-US FDA approved vaccine in the 4 weeks following the study intervention administration, including monovalent pandemic influenza vaccines and multivalent influenza vaccines, as applicable per local recommendations.
  • Receipt of any Bacillus of Calmette and Guerin (BCG) vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period
  • Previous vaccination against S. pneumoniae
  • Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, poliovirus
  • Receipt of more than 1 dose of hepatitis B vaccine
  • Receipt of immune globulins, blood or blood-derived products since birth
  • Participation at the time of study enrollment (or in the 6 weeks preceding the first study intervention administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
  • Note: The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.

Trial locations and contacts

132 sites in 6 countries.

132 sites in 6 countries

United States103 sites

  • Michigan Institute of Research- Site Number : 8400131

    Allen Park, Michigan, 48101

  • Morehouse School of Medicine - Atlanta- Site Number : 8400093

    Atlanta, Georgia, 30310

  • Austin Regional Clinic - ARC Four Points- Site Number : 8400082

    Austin, Texas, 78726

  • Kentucky Pediatric Research- Site Number : 8400014

    Bardstown, Kentucky, 40004

  • Alabama Clinical Therapeutics - Birmingham - St. Vincent's Drive- Site Number : 8400013

    Birmingham, Alabama, 35205

  • University of Alabama at Birmingham- Site Number : 8400130

    Birmingham, Alabama, 35233

  • Bingham Memorial Hospital - Blackfoot- Site Number : 8400114

    Blackfoot, Idaho, 83221

  • Elite Clinical Trials - Blackfoot- Site Number : 8400017

    Blackfoot, Idaho, 83221

  • SUNY Downstate Medical Center- Site Number : 8400039

    Brooklyn, New York, 11203

  • Neighbors Pediatrics- Site Number : 8400068

    Charleston, South Carolina, 29407

  • Atrium Health - Myers Park- Site Number : 8400080

    Charlotte, North Carolina, 28207

  • Atrium Health - STRIVE Vaccine Research Clinic- Site Number : 8400060

    Charlotte, North Carolina, 28207

  • Eagle Clinical Research- Site Number : 8400087

    Chicago, Illinois, 60621

  • University of Chicago Medical Center- Site Number : 8400062

    Chicago, Illinois, 60637

  • Haywood Pediatric and Adolescent Medicine Group- Site Number : 8400051

    Clyde, North Carolina, 28721

  • The Pediatric Center- Site Number : 8400075

    Columbia, Maryland, 21045

  • Cedar Health Research - Dallas- Site Number : 8400092

    Dallas, Texas, 75251

  • Vida Clinical Studies - Dearborn- Site Number : 8400094

    Dearborn, Michigan, 48124

  • D&H Doral Research Center- Site Number : 8400095

    Doral, Florida, 33122

  • Dolphin Medical Research, LLC- Site Number : 8400120

    Doral, Florida, 33172

  • Nextlevel Research Center- Site Number : 8400065

    Doral, Florida, 33172

  • Child Health Care Associates - East Syracuse- Site Number : 8400005

    East Syracuse, New York, 13057

  • PAS Research - Children's Care Clinic- Site Number : 8400012

    Edinburg, Texas, 78539

  • The Pediatric Center of Frederick- Site Number : 8400074

    Frederick, Maryland, 21702

  • Helping Hands Healthcare Group - Fullerton- Site Number : 8400063

    Fullerton, California, 92831

  • Full Circle Family Medicine- Site Number : 8400110

    Germantown, Wisconsin, 53022

  • East Carolina University- Site Number : 8400061

    Greenville, North Carolina, 27858

  • Cyn3rgy Research- Site Number : 8400029

    Gresham, Oregon, 97030

  • Lakeview Clinical Research- Site Number : 8400054

    Guntersville, Alabama, 35976

  • Advanced Investigative Medicine- Site Number : 8400055

    Hawthorne, California, 90250

  • PAS Research - Henderson- Site Number : 8400033

    Henderson, Nevada, 89014

  • Kid's Way Pediatrics- Site Number : 8400119

    Hermitage, Pennsylvania, 16148

  • The University of Texas Health Science Center- Site Number : 8400024

    Houston, Texas, 77030

  • Biopharma Informatic - Houston - Business Center Drive- Site Number : 8400108

    Houston, Texas, 77043

  • Mercury Clinical Research - Houston - Savoy Drive- Site Number : 8400049

    Houston, Texas, 77070

  • Pediatric Associates - Houston- Site Number : 8400101

    Houston, Texas, 77087

  • Pioneer Research Solutions - Houston - Stancliff Road- Site Number : 8400126

    Houston, Texas, 77099

  • Century Research Institute- Site Number : 8400118

    Huntington Park, California, 90255

  • Matrix Clinical Research - Huntington Park- Site Number : 8400117

    Huntington Park, California, 90255

  • GRO Clinical- Site Number : 8400109

    Hyde Park, New York, 12538

  • Clinical Research Prime- Site Number : 8400022

    Idaho Falls, Idaho, 83404

  • Jefferson City Medical Group- Site Number : 8400129

    Jefferson City, Missouri, 65109

  • The Children's Clinic- Site Number : 8400079

    Jonesboro, Arkansas, 72401

  • Wee Care Pediatrics - Kaysville- Site Number : 8400028

    Kaysville, Utah, 84037

  • CuraCare- Site Number : 8400125

    Kendall, Florida, 33176

  • Velocity Clinical Research - Lafayette- Site Number : 8400046

    Lafayette, Louisiana, 70508

  • Wee Care Pediatrics - Layton- Site Number : 8400044

    Layton, Utah, 84041

  • University of Kentucky Chandler Medical Center- Site Number : 8400034

    Lexington, Kentucky, 40536

  • Midwest Children's Health Research Institute - Lincoln - Salt Creek Circle- Site Number : 8400019

    Lincoln, Nebraska, 68504

  • Midwest Children's Health Research Institute- Site Number : 8400016

    Lincoln, Nebraska, 68505

  • Be Well Clinical Studies - Lincoln- Site Number : 8400031

    Lincoln, Nebraska, 68516

  • Midwest Childrens Health Research Institute- Site Number : 8400021

    Lincoln, Nebraska, 68516

  • Midwest Children's Health Research Institute - Lincoln - West A Street- Site Number : 8400045

    Lincoln, Nebraska, 68522

  • Matrix Clinical Research - Los Angeles- Site Number : 8400026

    Los Angeles, California, 90057

  • Matrix Clinical Research - Los Angeles- Site Number : 8400123

    Los Angeles, California, 90057

  • Novak Center For Children's Health- Site Number : 8400073

    Louisville, Kentucky, 40202

  • Bluegrass Clinical Research - Louisville - Blankenbaker Parkway- Site Number : 8400056

    Louisville, Kentucky, 40243

  • PAS RESEARCH-Lutz- Site Number : 8400103

    Lutz, Florida, 33549

  • Alliance Research Institute - Lynwood- Site Number : 8400099

    Lynwood, California, 90262

  • Madera Family Medical Group- Site Number : 8400011

    Madera, California, 93637

  • FOMAT-Golden Valley Health Centers- Site Number : 8400084

    Merced, California, 95340

  • Abba Medical Research- Site Number : 8400064

    Miami, Florida, 33176

  • Clinical Research Institute - Minneapolis- Site Number : 8400002

    Minneapolis, Minnesota, 55402

  • MidValley Research - Moline- Site Number : 8400096

    Moline, Illinois, 61265

  • NOLA Research Works- Site Number : 8400035

    New Orleans, Louisiana, 70125

  • D&H National Research Center- Site Number : 8400085

    North Miami, Florida, 33169

  • Rio Clinical Trials - Canyon View- Site Number : 8400132

    Ogden, Utah, 84404

  • Legacy Clinical Trials Oklahoma City- Site Number : 8400097

    Oklahoma City, Oklahoma, 73103

  • Midway Medical Clinic- Site Number : 8400091

    Oneonta, Alabama, 35121

  • Utah Valley Pediatrics - Orem- Site Number : 8400053

    Orem, Utah, 84057

  • Stanford University Medical Center CTRU - 800 Welch Road- Site Number : 8400072

    Palo Alto, California, 94304

  • Center for Clinical Trials - Paramount- Site Number : 8400100

    Paramount, California, 90723

  • Alfa Medical Research LLC- Site Number : 8400111

    Pembroke Pines, Florida, 33029

  • GLRI - McAllen Research- Site Number : 8400098

    Pharr, Texas, 78577

  • Pas Research - Pittsburgh- Site Number : 8400050

    Pittsburgh, Pennsylvania, 15227

  • AIM Trials- Site Number : 8400052

    Plano, Texas, 75093

  • Ogden Clinic - Mountain View - CCT Research- Site Number : 8400032

    Pleasant View, Utah, 84404

  • Pediatric Care - Provo- Site Number : 8400041

    Provo, Utah, 84604

  • Pediatric Center - Richmond- Site Number : 8400122

    Richmond, Texas, 77469

  • National Clinical Research- Site Number : 8400010

    Richmond, Virginia, 23294

  • Wee Care Pediatrics - Roy- Site Number : 8400070

    Roy, Utah, 84067

  • J. Lewis Research - Foothill Family Clinic - Salt Lake City- Site Number : 8400058

    Salt Lake City, Utah, 84109

  • CenExel - iResearch - Savannah- Site Number : 8400057

    Savannah, Georgia, 31405

  • Integrated Clinical Research LLC- Site Number : 8400027

    Sherman Oaks, California, 91356-4173

  • Helios CR, Inc. - Little Rock- Site Number : 8400090

    Sherwood, Arkansas, 72120

  • Virgo Carter Pediatrics- Site Number : 8400001

    Silver Spring, Maryland, 20910

  • Tribe Clinical Research - Simpsonville- Site Number : 8400069

    Simpsonville, South Carolina, 29680

  • Parkside Pediatrics - Simpsonville- Site Number : 8400078

    Simpsonville, South Carolina, 29681

  • South Bend Clinic - Main Campus- Site Number : 8400023

    South Bend, Indiana, 46617

  • Tribe Clinical Research - Spartanburg- Site Number : 8400083

    Spartanburg, South Carolina, 29301

  • Piedmont Healthcare - Family Medicine- Site Number : 8400077

    Statesville, North Carolina, 28625

  • SUNY Upstate Medical University - Syracuse- Site Number : 8400115

    Syracuse, New York, 13210

  • Wee Care Pediatrics - Syracuse- Site Number : 8400066

    Syracuse, Utah, 84075

  • PAS Research - Tampa- Site Number : 8400113

    Tampa, Florida, 33613

  • PAS Research-Bronx- Site Number : 8400104

    The Bronx, New York, 10460

  • Advantage Clinical Trials- Site Number : 8400030

    The Bronx, New York, 10468

  • North Houston Internal Medicine & Pediatric Clinic- Site Number : 8400018

    Tomball, Texas, 77375

  • Noble Clinical Research- Site Number : 8400121

    Tucson, Arizona, 85704

  • Emerson Clinical Research Institute - Washington - Connecticut Avenue- Site Number : 8400102

    Washington D.C., District of Columbia, 20009

  • Emanate Health - Queen of the Valley Hospital- Site Number : 8400105

    West Covina, California, 91790

  • Integrated Clinical Trial Services- Site Number : 8400059

    West Des Moines, Iowa, 50265

  • All In One Clinic- Site Number : 8400127

    Whittier, California, 90601

  • Amicis Research Center-Winnetka- Site Number : 8400128

    Winnetka, California, 91306

Other trials in United States

Turkey (Türkiye)9 sites

  • Investigational Site Number : 7920004

    Ankara, 06230

  • Investigational Site Number : 7920002

    Ankara, 06620

  • Investigational Site Number : 7920006

    Ankara, 06800

  • Investigational Site Number : 7920003

    Istanbul, 34098

  • Investigational Site Number : 7920007

    Istanbul, 34384

  • Investigational Site Number : 7920009

    Izmir, 35100

  • Investigational Site Number : 7920005

    Izmir, 35120

  • Investigational Site Number : 7920008

    Izmir, 35540

  • Investigational Site Number : 7920010

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Puerto Rico8 sites

  • Investigational Site Number : 6300001

    Bayamón, 00961

  • Investigational Site Number : 6300002

    Bayamón, 00961

  • Investigational Site Number : 6300005

    Guayama, 00786

  • Investigational Site Number : 6300008

    Ponce, 00716

  • Investigational Site Number : 6300004

    Ponce, 00717

  • Investigational Site Number : 6300003

    San Juan, 00907

  • Investigational Site Number : 6300006

    San Juan, 00918

  • Investigational Site Number : 6300007

    Trujillo Alto, 00976

Other trials in Puerto Rico

Mexico6 sites

  • Investigational Site Number : 4840009

    Cuernavaca, Morelos, 62290

  • Investigational Site Number : 4840008

    Ecatepec de Morelos, 55075

  • Investigational Site Number : 4840003

    León, Guanajuato, 37320

  • Investigational Site Number : 4840001

    Mexico City, Mexico City, 04530

  • Investigational Site Number : 4840007

    Morelia, Michoacán, 58350

  • Investigational Site Number : 4840002

    Temixco, Morelos, 62587

Other trials in Mexico

Honduras3 sites

  • Investigational Site Number : 3400001

    San Pedro Sula, 21104

  • Investigational Site Number : 3400002

    Tegucigalpa, 11101

  • Investigational Site Number : 3400003

    Tegucigalpa, 11101

Other trials in Honduras

Thailand3 sites

  • Investigational Site Number : 7640002

    Bangkok, 10400

  • Investigational Site Number : 7640001

    Chiang Mai, 50180

  • Investigational Site Number : 7640003

    Hat Yai, 90110

Other trials in Thailand

About this study

Official title: A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2 Arm Study to Investigate the Safety of a 4-dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

This study is a Phase 3, randomized, modified double-blind study which aims to document the safety profile of the PCV21 vaccine (investigational pneumococcal vaccine) compared to a licensed 20-valent pneumococcal conjugate vaccine in infants aged from approximately 2 months (42 to 89 days).

The study duration per participant will be up to approximately 19 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given as per local recommendations.

Read more

There will be 6 study visits:

Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 60 days, V04 separated from V03 by 30 days, V05 at 12 months of age until 15 months of age, V06 separated from V05 by 30 days.

Being tested
PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccine, Rotarix, RotaTeq

What participants receive

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

  • PCV21 vaccineBiological

    Also called 515

    Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

  • Prevnar 20 vaccineBiological

    Also called Prevnar20™

    Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

  • M-M-R II vaccineBiological

    Also called M-M-R™ II

    Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular

  • RotarixBiological

    Also called Rotarix™

    Pharmaceutical form:Solution-Route of administration:Oral

  • RotaTeqBiological

    Also called RotaTeq™

    Pharmaceutical form:Solution-Route of administration:Oral

  • Vaxelis vaccineBiological

    Also called Vaxelis™

    Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

  • VarivaxBiological

    Also called Varivax™

    Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular

  • PriorixBiological

    Also called Priorix™

    Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous

  • VAQTABiological

    Also called VAQTA™

    Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular

  • HavrixBiological

    Also called Havrix™

    Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular

Study groups in NCT06824194
Study groupRoleWhat they receive
Group 1: PCV21ExperimentalParticipants will be administered via intramuscular injection (IM) a 4-dose PCV21 regimen at approximately 2, 4, 6 and 12 to 15 MoA
Receives: Biological: PCV21 vaccine; Biological: M-M-R II vaccine; Biological: Rotarix; Biological: RotaTeq; Biological: Vaxelis vaccine; Biological: Varivax; Biological: Priorix; Biological: VAQTA; Biological: Havrix
Group 2: 20vPCVActive comparatorParticipants will be administered via intramuscular injection (IM) a 4-dose 20vPCV regimen at approximately 2, 4, 6 and 12 to 15 MoA
Receives: Biological: Prevnar 20 vaccine; Biological: M-M-R II vaccine; Biological: Rotarix; Biological: RotaTeq; Biological: Vaxelis vaccine; Biological: Varivax; Biological: Priorix; Biological: VAQTA; Biological: Havrix

What is being measured

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

  1. Presence of any immediate adverse events (AEs)

    Number of participants experiencing solicited and unsolicited immediate AEs

    Measured: Within 30 minutes after each vaccination

  2. Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection

    Number of participants experiencing solicited injection site and systemic reactions

    Measured: Through 7 days after each vaccine injection

  3. Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection

    Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs

    Measured: Through 30 days after each vaccine injection

  4. Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)

    Number of participants experiencing SAEs

    Measured: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months

  5. Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)

    Number of participants experiencing AESIs

    Measured: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months

Timeline

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

  1. First posted13 Feb 2025
  2. Study start18 Feb 2025
  3. Primary completion22 Oct 2027 (estimated)
  4. Study completion22 Oct 2027 (estimated)

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
2,360 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06824194
Sponsor's protocol ID
PSK05
Other IDs
U1111-1295-5983
Status last verified
Apr 2026
First submitted
7 Feb 2025
Last updated
13 Apr 2026
Results posted
No
Data monitoring committee
Yes
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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PCV21 vaccine, Prevnar 20 vaccine and M-M-R II vaccine in people with Pneumococcal Immunization, run by Sanofi at 132 sites in 6 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 3 inclusion and 18 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: under way, not looking for participants, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 132 sites in United States, Turkey (Türkiye), Puerto Rico, Mexico, Honduras and 1 more country. 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?

This study is still under way. Results are not available in the source record yet.

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?

Presence of any immediate adverse events (AEs) (time frame: Within 30 minutes after each vaccination). 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?

On the ClinicalTrials.gov record for NCT06824194.

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 13 Apr 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in