Pneumococcal ImmunizationPhase 3NCT06736041
Study of a 4-Dose Regimen 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 Pasteur, a Sanofi Company at 112 sites in 6 countries.
Trial summary
This study is a Phase 3, randomized, modified double-blind study which aims to measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccine (Prevnar 20… 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
- Type of treatment
- Vaccines, Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,714 participants
- Where
- 112 sitesin 6 countries
- Study dates
- 18 Dec 2024to 17 May 2027
- Phase
- Phase 3
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 vaccines being administered in the study
- History of seizure or significant stable or progressive neurological 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
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- Laboratory-confirmed or known thrombocytopenia, as reported by the parent/legally acceptable representative (LAR), 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 vaccine in the 4 weeks preceding the study intervention administration or planned receipt of any vaccine in the 4 weeks following the study intervention administration, except for US licensed influenza vaccination, which may 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, as applicable per local recommendations.
- Previous vaccination against S. pneumoniae
- Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, Haemophilus influenzae type b, and 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
112 sites in 6 countries.
112 sites in 6 countries
United States66 sites
University of New Mexico Health Sciences Center- Site Number : 8400240
Albuquerque, New Mexico, 87131-0001
Michigan Institute of Research- Site Number : 8400207
Allen Park, Michigan, 48101
Medical Research Partners - Ammon- Site Number : 8400239
Ammon, Idaho, 83406
Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400112
Baytown, Texas, 77521
Bingham Memorial Hospital - Blackfoot- Site Number : 8400084
Blackfoot, Idaho, 83221
PAS Research- Site Number : 8400123
Clearwater, Florida, 33756
KUR Research at Columbia MD - 6220 Old Dobbin Lane- Site Number : 8400242
Columbia, Maryland, 21045
University of Missouri Hospital- Site Number : 8400244
Columbia, Missouri, 65212
South Texas Clinical Research- Site Number : 8400025
Corpus Christi, Texas, 78413
FamilyHealthWatch - KeyPoint Clinical Research- Site Number : 8400173
Dallas, Texas, 75237
Dayton Clinical Research- Site Number : 8400087
Dayton, Ohio, 45409
Prohealth Research Center- Site Number : 8400159
Doral, Florida, 33166
Alliance for Multispeciality Research - El Dorado- Site Number : 8400010
El Dorado, Kansas, 67042
Allegheny Health Network - Health and Wellness Pavilion- Site Number : 8400111
Erie, Pennsylvania, 16506
Northwest Arkansas Pediatric Clinic- Site Number : 8400030
Fayetteville, Arkansas, 72703
Helios Clinical Research - Fort Worth - 8th Avenue- Site Number : 8400072
Fort Worth, Texas, 76104
Southland Clinical Research Center- Site Number : 8400243
Fountain Valley, California, 92708
Sun City Clinical Research- Site Number : 8400247
Glendale, Arizona, 85304
Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400005
Greenville, South Carolina, 29607
NurtureGen Research- Site Number : 8400205
Homestead, Florida, 33030
Ventavia Research Group - Houston - North Loop West- Site Number : 8400093
Houston, Texas, 77008
Gonzalez Family & Occupational Medicine- Site Number : 8400035
Houston, Texas, 77029
Private Practice - Dr. Chinyere N. Awa- Site Number : 8400252
Houston, Texas, 77057
La Providence Pediatrics & Family Clinics- Site Number : 8400026
Houston, Texas, 77071
Houston Clinical Research Associates- Site Number : 8400018
Houston, Texas, 77090
Century Research Institute- Site Number : 8400065
Huntington Park, California, 90255
Matrix Clinical Research - Huntington Park- Site Number : 8400012
Huntington Park, California, 90255
Hutchinson Clinic- Site Number : 8400061
Hutchinson, Kansas, 67502
Leavitt Women's Healthcare- Site Number : 8400085
Idaho Falls, Idaho, 83404
Snake River Research- Site Number : 8400060
Idaho Falls, Idaho, 83404
Biopharma Informatic - Katy - Katy Freeway- Site Number : 8400258
Katy, Texas, 77450
Vector Clinical Trials- Site Number : 8400249
Las Vegas, Nevada, 89128
Tanner Clinic - Layton Antelope A- Site Number : 8400241
Layton, Utah, 84041
Maximos Ob/Gyn- Site Number : 8400056
League City, Texas, 77573
Hawthorne- Bienstar Lindenwold- Site Number : 8400256
Lindenwold, New Jersey, 08021
Matrix Clinical Research - Los Angeles- Site Number : 8400013
Los Angeles, California, 90057
University of California Los Angeles Medical Center- Site Number : 8400238
Los Angeles, California, 90095
EMDA Clinical Research- Site Number : 8400237
Miami, Florida, 33126
Dade Research Center- Site Number : 8400007
Miami, Florida, 33135
Acevedo Clinical Research Associates- Site Number : 8400089
Miami, Florida, 33142
Miami Clinical Research Tower- Site Number : 8400189
Miami, Florida, 33155
Vasconcello-Cohen MD Research, LLC- Site Number : 8400248
Miami, Florida, 33183
Bio-Medical Research- Site Number : 8400147
Miami, Florida, 33184
High Quality Research- Site Number : 8400245
Miami, Florida, 33184
Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400032
Miami Lakes, Florida, 33014
BioResearch Partner (BRP) - Premium Healthcare Medical Center - Miami Lakes- Site Number : 8400203
Miami Lakes, Florida, 33016
Monroe Biomedical Research - Monroe- Site Number : 8400225
Monroe, North Carolina, 28112
Wasatch Pedicatrics- Site Number : 8400153
Murray, Utah, 84107
Coastal Carolina Research Center - North Charleston- Site Number : 8400064
North Charleston, South Carolina, 29405
Rio Clinical Trials - Canyon View- Site Number : 8400222
Ogden, Utah, 84404
Optimal Research Sites- Site Number : 8400232
Orange City, Florida, 32763
Pasadena Clinical Trials - Pasadena - North Madison Avenue- Site Number : 8400259
Pasadena, California, 91101
SEC Clinical Research - Pensacola- Site Number : 8400003
Pensacola, Florida, 32501
Clinical Research Prime Rexburg- Site Number : 8400250
Rexburg, Idaho, 83440
Pediatric Center - Richmond- Site Number : 8400068
Richmond, Texas, 77469
Clinical Research Partners - Richmond - Forest Avenue- Site Number : 8400236
Richmond, Virginia, 23220
LinQ Research, LLC - Rosharon- Site Number : 8400257
Rosharon, Texas, 77583
Hawthorne Health - Staten Island- Site Number : 8400254
Staten Island, New York, 10309
National Clinical Trials - Tampa- Site Number : 8400229
Tampa, Florida, 33612
PAS Research - Tampa- Site Number : 8400002
Tampa, Florida, 33613
Prime Global Research- Site Number : 8400246
The Bronx, New York, 10456
Cotton O'Neil Pediatrics- Site Number : 8400009
Topeka, Kansas, 66604
Eclipse Clinical Research- Site Number : 8400029
Tucson, Arizona, 85745
Oklahoma State University Center for Health Sciences- Site Number : 8400121
Tulsa, Oklahoma, 74107
FOMAT Medical Research - Pediatric, Infant & Adolescence Medicine- Site Number : 8400063
Ventura, California, 93003
Velocity Clinical Research - Washington DC- Site Number : 8400049
Washington D.C., District of Columbia, 20016
South Korea29 sites
Investigational Site Number : 4100020
Ansan-si, Gyeonggi-do, 15355
Investigational Site Number : 4100002
Anyang-si, Gyeonggi-do, 14068
Investigational Site Number : 4100013
Bucheon-si, Gyeonggi-do, 14584
Investigational Site Number : 4100029
Bucheon-si, Gyeonggi-do, 14647
Investigational Site Number : 4100017
Bupyeong-Gu, Incheon-gwangyeoksi, 21431
Investigational Site Number : 4100023
Busan, Busan, 49241
Investigational Site Number : 4100027
Changwon-Si, Gyeongsangnam-do, 51472
Investigational Site Number : 4100030
Daegu, Daegu, 41944
Investigational Site Number : 4100024
Daegu, Daegu, 42601
Investigational Site Number : 4100034
Gwangju, Gwangju, 61453
Investigational Site Number : 4100014
Hwaseong-si, Gyeonggi-do, 18450
Investigational Site Number : 4100006
Incheon, Incheon-gwangyeoksi, 21565
Investigational Site Number : 4100025
Jeonju, Jeollabuk-do, 54907
Investigational Site Number : 4100011
Seongnam-si, Gyeonggi-do, 13496
Investigational Site Number : 4100001
Seongnam-si, Gyeonggi-do, 13620
Investigational Site Number : 4100019
Seoul, Seoul-teukbyeolsi, 01812
Investigational Site Number : 4100008
Seoul, Seoul-teukbyeolsi, 01830
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi, 02841
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, 03080
Investigational Site Number : 4100009
Seoul, Seoul-teukbyeolsi, 03312
Investigational Site Number : 4100015
Seoul, Seoul-teukbyeolsi, 03722
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi, 05030
Investigational Site Number : 4100031
Seoul, Seoul-teukbyeolsi, 06273
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, 06351
Investigational Site Number : 4100026
Seoul, Seoul-teukbyeolsi, 06591
Investigational Site Number : 4100022
Seoul, Seoul-teukbyeolsi, 07345
Investigational Site Number : 4100018
Seoul, Seoul-teukbyeolsi, 07985
Investigational Site Number : 4100016
Seoul, Seoul-teukbyeolsi, 08308
Investigational Site Number : 4100010
Yangsan, Gyeongsangnam-do, 50612
Puerto Rico6 sites
Investigational Site Number : 6300004
Caguas, 00725
Investigational Site Number : 6300008
Guayama, 00786
Investigational Site Number : 6300003
Ponce, 00716
Investigational Site Number : 6300002
San Juan, 00918
Investigational Site Number : 6300006
San Juan, 00936
Investigational Site Number : 6300005
Trujillo Alto, 00976
Australia5 sites
Investigational Site Number : 0360004
Brisbane, Queensland, 4101
Investigational Site Number : 0360002
Parkville, Victoria, 3052
Investigational Site Number : 0360003
Perth, Western Australia, 6008
Investigational Site Number : 0360005
Southport, Queensland, 4215
Investigational Site Number : 0360001
Westmead, New South Wales, 2145
Honduras3 sites
Investigational Site Number : 3400001
San Pedro Sula
Investigational Site Number : 3400002
Tegucigalpa, 11101
Investigational Site Number : 3400003
Tegucigalpa, 11101
Thailand3 sites
Investigational Site Number : 7640007
Bangkok, 10330
Investigational Site Number : 7640005
Bangkok, 10700
Investigational Site Number : 7640004
Khon Kaen, 40002
About this study
Official title: A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 2-arm Study to Investigate the Safety and Immunogenicity 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 measure whether PCV21 vaccine (investigational pneumococcal conjugate vaccine) is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) compared with 20-valent pneumococcal vaccine (Prevnar 20, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines 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 20-valent pneumococcal vaccines) will be administered at approximately 2, 4, 6 and 12 to 15 months of age. Routine pediatric vaccines will be given at the same timepoints.
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.
- Conditions
- Pneumococcal Immunization
- Being tested
- PCV21 vaccine, Prevnar 20 vaccine, M-M-R II vaccine, RotaTeq, Vaxelis vaccine
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
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
Hexaxim VaccineBiological
Also called Hexaxim®
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Group 1: PCV21 | Experimental | Participants will be administered via intramuscular injection (IM) a 3-dose primary series of PCV21 at approximately 2, 4 and 6 months of age (MoA) co- administered with Vaxelis or Hexaxim (for participants included in South Korea only) and RotaTeq. At toddler age (12 to 15 MoA), a 4th dose of PCV21 will be administered concomitantly with a single dose of M-M-M-R II and Varivax. Receives: Biological: PCV21 vaccine; Biological: M-M-R II vaccine; Biological: RotaTeq; Biological: Vaxelis vaccine; Biological: Varivax; Biological: Hexaxim Vaccine |
| Group 2: 20vPCV | Active comparator | Participants will be administered via intramuscular injection (IM) a 3-dose primary series of 20vPCV at approximately 2, 4 and 6 months of age (MoA) co- administered with Vaxelis or Hexaxim (for participants included in South Korea only) and RotaTeq. At toddler age (12 to 15 MoA), a 4th dose of 20vPCV will be administered concomitantly with a single dose of M-M-M-R II and Varivax. Receives: Biological: Prevnar 20 vaccine; Biological: M-M-R II vaccine; Biological: RotaTeq; Biological: Vaxelis vaccine; Biological: Varivax; Biological: Hexaxim Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroresponse rate for PCV21 serotypes
Serotype specific IgG concentration ≥ 0.35 µg/mL
Measured: 30 days post-dose 3
IgG concentration for PCV21 serotypes
Serotype specific IgG Geometric Mean Concentration (GMC)
Measured: 30 days post-dose 3
IgG concentration for PCV21 serotypes
Serotype specific IgG GMC post-dose 4
Measured: 30 days post-dose 4
Secondary outcomes (31)
Anti- hepatitis B surface antigen (HBsAg) Ab
% Antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL)
Measured: 30 days post-dose 3
Anti- polyribosylribitol phosphate (PRP) Ab
% Antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL)
Measured: 30 days post-dose 3
Anti-poliovirus types (1, 2, and 3) Ab
% Antibody titers ≥ 1:8
Measured: 30 days post-dose 3
Anti-diphtheria Ab concentrations
% Antibody concentrations ≥ 0.1 IU/mL
Measured: 30 days post-dose 3
Anti-tetanus Ab concentrations
% Antibody concentrations ≥ 0.1 IU/mL
Measured: 30 days post-dose 3
Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))
Antibody GMC
Measured: 30 days post-dose 3
Anti-rotavirus serum immunoglobulin A (IgA) Ab concentrations
Antibody GMC
Measured: 30 days post-dose 3
Anti-measles Ab concentrations
% Antibody concentrations ≥ 225 milli international units per milliliter (mIU/mL)
Measured: 30 days post-dose 4
Anti-measles Ab concentrations
Antibody GMC
Measured: 30 days post-dose 4
Anti-mumps Ab concentrations
% Anti-mumps Ab concentrations ≥ 10 Ab units (AbU)/mL
Measured: 30 days post-dose 4
Anti-mumps Ab concentrations
Antibody GMC
Measured: 30 days post-dose 4
Anti-rubella Ab concentrations
% Anti-rubella Ab concentrations ≥ 10 IU/mL
Measured: 30 days post-dose 4
Anti-rubella Ab concentrations
Antibody GMC
Measured: 30 days post-dose 4
Anti-varicella Ab concentrations
Anti-varicella Ab concentrations ≥ 5 glycoprotein enzyme linked immunosorbent assay (gpELISA) units/mL
Measured: 30 days post-dose 4
IgG concentration for the additional serotype 9N
Serotype 9N specific IgG concentration ≥ 0.35 µg/mL
Measured: 30 days post-dose 3
IgG concentration for serotype 3
Serotype 3 specific IgG concentration ≥ 0.35 µg/mL
Measured: 30 days post-dose 3
IgG concentration for additional serotype 9N
Serotype 9N specific IgG GMC
Measured: 30 days post-dose 3
IgG concentration for serotype 3
Serotype 3 specific IgG GMC
Measured: 30 days post-dose 3
Serotype 9N specific IgG GMC post-dose 4
Serotype 9N specific IgG GMC post-dose 4
Measured: 30 days post-dose 4
IgG concentration for additional serotype 9N
Serotype 9N specific IgG GMC post-dose 4
Measured: 30 days post-dose 4
IgG concentration for serotype 3
Serotype 3 specific IgG GMC post-dose 4
Measured: 30 days post-dose 4
Seroresponse rate for PCV21 serotypes
Serotype specific IgG concentration ≥ 0.35 µg/mL
Measured: 30 days post-dose 4
IgG concentration for PCV21 serotypes
Serotype specific IgG GMC prior to and post-dose 4
Measured: Before dose 4 and 30 days post-dose 4
Serotype specific OPA titers for all serotypes included in PCV21
Antibody GMC
Measured: 30 days post-dose 3
Serotype specific OPA titers ≥ lower limit of quantitation (LLOQ) for all serotypes included in PCV21
Antibody GMC
Measured: 30 days post-dose 3
Serotype specific OPA titers for all serotypes included in PCV21
Antibody GMC prior to and post-dose 4
Measured: Before dose 4 and 30 days post-dose 4
Serotype specific OPA titers ≥ lower limit of quantitation (LLOQ) for all serotypes included in PCV21
Antibody GMC prior to and post-dose 4
Measured: Before dose 4 and 30 days post-dose 4
Presence of any immediate adverse events (AEs)
Number of participants experiencing solicited and unsolicited immediate AEs
Measured: Within 30 minutes after each vaccine injection
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
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
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 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start18 Dec 2024
- Primary completion17 May 2027 (estimated)
- Study completion17 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pneumococcal ImmunizationStudies of the same condition, open and under way.
- More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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
- 1,714 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06736041
- Sponsor's protocol ID
- PSK03
- Other IDs
- U1111-1294-7860
- Status last verified
- Apr 2026
- First submitted
- 11 Dec 2024
- Last updated
- 22 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
Publications
Pichon S, Ullery GM, Cousin L, Sadarangani M, Ryu JH, Monfredo C, Mari K, Pandey A, Personnic S, Pouzet C, Manson C, Silhadi W, Minutello AM. Safety and Immunogenicity of a Pneumococcal Conjugate Vaccine When Administered Concomitantly With Routine Pediatric Vaccines in Healthy Toddlers and Infants. Pediatr Infect Dis J. 2025 Oct 1;44(10):995-1008. doi: 10.1097/INF.0000000000004913. Epub 2025 Jul 31.
PubMed 40833801