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, 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
2 other identifiers
interventional
1,714
6 countries
112
Brief 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, 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Dec 2024
112 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2024
CompletedFirst Posted
Study publicly available on registry
December 16, 2024
CompletedStudy Start
First participant enrolled
December 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 17, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 17, 2027
April 22, 2026
April 1, 2026
2.4 years
December 11, 2024
April 21, 2026
Conditions
Outcome Measures
Primary Outcomes (3)
Seroresponse rate for PCV21 serotypes
Serotype specific IgG concentration ≥ 0.35 µg/mL
30 days post-dose 3
IgG concentration for PCV21 serotypes
Serotype specific IgG Geometric Mean Concentration (GMC)
30 days post-dose 3
IgG concentration for PCV21 serotypes
Serotype specific IgG GMC post-dose 4
30 days post-dose 4
Secondary Outcomes (31)
Anti- hepatitis B surface antigen (HBsAg) Ab
30 days post-dose 3
Anti- polyribosylribitol phosphate (PRP) Ab
30 days post-dose 3
Anti-poliovirus types (1, 2, and 3) Ab
30 days post-dose 3
Anti-diphtheria Ab concentrations
30 days post-dose 3
Anti-tetanus Ab concentrations
30 days post-dose 3
- +26 more secondary outcomes
Study Arms (2)
Group 1: PCV21
EXPERIMENTALParticipants 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.
Group 2: 20vPCV
ACTIVE COMPARATORParticipants 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.
Interventions
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Pharmaceutical form:Solution-Route of administration:Oral
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Powder, lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous or Intramuscular
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Laboratory-confirmed or known thrombocytopenia, as reported by the parent/legally acceptable representative (LAR), contraindicating intramuscular (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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (112)
Sun City Clinical Research- Site Number : 8400247
Glendale, Arizona, 85304, United States
Eclipse Clinical Research- Site Number : 8400029
Tucson, Arizona, 85745, United States
Northwest Arkansas Pediatric Clinic- Site Number : 8400030
Fayetteville, Arkansas, 72703, United States
Southland Clinical Research Center- Site Number : 8400243
Fountain Valley, California, 92708, United States
Century Research Institute- Site Number : 8400065
Huntington Park, California, 90255, United States
Matrix Clinical Research - Huntington Park- Site Number : 8400012
Huntington Park, California, 90255, United States
Matrix Clinical Research - Los Angeles- Site Number : 8400013
Los Angeles, California, 90057, United States
University of California Los Angeles Medical Center- Site Number : 8400238
Los Angeles, California, 90095, United States
Pasadena Clinical Trials - Pasadena - North Madison Avenue- Site Number : 8400259
Pasadena, California, 91101, United States
FOMAT Medical Research - Pediatric, Infant & Adolescence Medicine- Site Number : 8400063
Ventura, California, 93003, United States
Velocity Clinical Research - Washington DC- Site Number : 8400049
Washington D.C., District of Columbia, 20016, United States
PAS Research- Site Number : 8400123
Clearwater, Florida, 33756, United States
Prohealth Research Center- Site Number : 8400159
Doral, Florida, 33166, United States
NurtureGen Research- Site Number : 8400205
Homestead, Florida, 33030, United States
EMDA Clinical Research- Site Number : 8400237
Miami, Florida, 33126, United States
Dade Research Center- Site Number : 8400007
Miami, Florida, 33135, United States
Acevedo Clinical Research Associates- Site Number : 8400089
Miami, Florida, 33142, United States
Miami Clinical Research Tower- Site Number : 8400189
Miami, Florida, 33155, United States
Vasconcello-Cohen MD Research, LLC- Site Number : 8400248
Miami, Florida, 33183, United States
Bio-Medical Research- Site Number : 8400147
Miami, Florida, 33184, United States
High Quality Research- Site Number : 8400245
Miami, Florida, 33184, United States
Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400032
Miami Lakes, Florida, 33014, United States
BioResearch Partner (BRP) - Premium Healthcare Medical Center - Miami Lakes- Site Number : 8400203
Miami Lakes, Florida, 33016, United States
Optimal Research Sites- Site Number : 8400232
Orange City, Florida, 32763, United States
SEC Clinical Research - Pensacola- Site Number : 8400003
Pensacola, Florida, 32501, United States
National Clinical Trials - Tampa- Site Number : 8400229
Tampa, Florida, 33612, United States
PAS Research - Tampa- Site Number : 8400002
Tampa, Florida, 33613, United States
Medical Research Partners - Ammon- Site Number : 8400239
Ammon, Idaho, 83406, United States
Bingham Memorial Hospital - Blackfoot- Site Number : 8400084
Blackfoot, Idaho, 83221, United States
Leavitt Women's Healthcare- Site Number : 8400085
Idaho Falls, Idaho, 83404, United States
Snake River Research- Site Number : 8400060
Idaho Falls, Idaho, 83404, United States
Clinical Research Prime Rexburg- Site Number : 8400250
Rexburg, Idaho, 83440, United States
Alliance for Multispeciality Research - El Dorado- Site Number : 8400010
El Dorado, Kansas, 67042, United States
Hutchinson Clinic- Site Number : 8400061
Hutchinson, Kansas, 67502, United States
Cotton O'Neil Pediatrics- Site Number : 8400009
Topeka, Kansas, 66604, United States
KUR Research at Columbia MD - 6220 Old Dobbin Lane- Site Number : 8400242
Columbia, Maryland, 21045, United States
Michigan Institute of Research- Site Number : 8400207
Allen Park, Michigan, 48101, United States
University of Missouri Hospital- Site Number : 8400244
Columbia, Missouri, 65212, United States
Vector Clinical Trials- Site Number : 8400249
Las Vegas, Nevada, 89128, United States
Hawthorne- Bienstar Lindenwold- Site Number : 8400256
Lindenwold, New Jersey, 08021, United States
University of New Mexico Health Sciences Center- Site Number : 8400240
Albuquerque, New Mexico, 87131-0001, United States
Hawthorne Health - Staten Island- Site Number : 8400254
Staten Island, New York, 10309, United States
Prime Global Research- Site Number : 8400246
The Bronx, New York, 10456, United States
Monroe Biomedical Research - Monroe- Site Number : 8400225
Monroe, North Carolina, 28112, United States
Dayton Clinical Research- Site Number : 8400087
Dayton, Ohio, 45409, United States
Oklahoma State University Center for Health Sciences- Site Number : 8400121
Tulsa, Oklahoma, 74107, United States
Allegheny Health Network - Health and Wellness Pavilion- Site Number : 8400111
Erie, Pennsylvania, 16506, United States
Tribe Clinical Research - Greenville - Verdae Boulevard- Site Number : 8400005
Greenville, South Carolina, 29607, United States
Coastal Carolina Research Center - North Charleston- Site Number : 8400064
North Charleston, South Carolina, 29405, United States
Inquest Clinical Research - Baytown - West Baker Road- Site Number : 8400112
Baytown, Texas, 77521, United States
South Texas Clinical Research- Site Number : 8400025
Corpus Christi, Texas, 78413, United States
FamilyHealthWatch - KeyPoint Clinical Research- Site Number : 8400173
Dallas, Texas, 75237, United States
Helios Clinical Research - Fort Worth - 8th Avenue- Site Number : 8400072
Fort Worth, Texas, 76104, United States
Ventavia Research Group - Houston - North Loop West- Site Number : 8400093
Houston, Texas, 77008, United States
Gonzalez Family & Occupational Medicine- Site Number : 8400035
Houston, Texas, 77029, United States
Private Practice - Dr. Chinyere N. Awa- Site Number : 8400252
Houston, Texas, 77057, United States
La Providence Pediatrics & Family Clinics- Site Number : 8400026
Houston, Texas, 77071, United States
Houston Clinical Research Associates- Site Number : 8400018
Houston, Texas, 77090, United States
Biopharma Informatic - Katy - Katy Freeway- Site Number : 8400258
Katy, Texas, 77450, United States
Maximos Ob/Gyn- Site Number : 8400056
League City, Texas, 77573, United States
Pediatric Center - Richmond- Site Number : 8400068
Richmond, Texas, 77469, United States
LinQ Research, LLC - Rosharon- Site Number : 8400257
Rosharon, Texas, 77583, United States
Tanner Clinic - Layton Antelope A- Site Number : 8400241
Layton, Utah, 84041, United States
Wasatch Pedicatrics- Site Number : 8400153
Murray, Utah, 84107, United States
Rio Clinical Trials - Canyon View- Site Number : 8400222
Ogden, Utah, 84404, United States
Clinical Research Partners - Richmond - Forest Avenue- Site Number : 8400236
Richmond, Virginia, 23220, United States
Investigational Site Number : 0360001
Westmead, New South Wales, 2145, Australia
Investigational Site Number : 0360004
Brisbane, Queensland, 4101, Australia
Investigational Site Number : 0360005
Southport, Queensland, 4215, Australia
Investigational Site Number : 0360002
Parkville, Victoria, 3052, Australia
Investigational Site Number : 0360003
Perth, Western Australia, 6008, Australia
Investigational Site Number : 3400001
San Pedro Sula, Honduras
Investigational Site Number : 3400002
Tegucigalpa, 11101, Honduras
Investigational Site Number : 3400003
Tegucigalpa, 11101, Honduras
Investigational Site Number : 6300004
Caguas, 00725, Puerto Rico
Investigational Site Number : 6300008
Guayama, 00786, Puerto Rico
Investigational Site Number : 6300003
Ponce, 00716, Puerto Rico
Investigational Site Number : 6300002
San Juan, 00918, Puerto Rico
Investigational Site Number : 6300006
San Juan, 00936, Puerto Rico
Investigational Site Number : 6300005
Trujillo Alto, 00976, Puerto Rico
Investigational Site Number : 4100023
Busan, Busan, 49241, South Korea
Investigational Site Number : 4100030
Daegu, Daegu, 41944, South Korea
Investigational Site Number : 4100024
Daegu, Daegu, 42601, South Korea
Investigational Site Number : 4100034
Gwangju, Gwangju, 61453, South Korea
Investigational Site Number : 4100020
Ansan-si, Gyeonggi-do, 15355, South Korea
Investigational Site Number : 4100002
Anyang-si, Gyeonggi-do, 14068, South Korea
Investigational Site Number : 4100013
Bucheon-si, Gyeonggi-do, 14584, South Korea
Investigational Site Number : 4100029
Bucheon-si, Gyeonggi-do, 14647, South Korea
Investigational Site Number : 4100014
Hwaseong-si, Gyeonggi-do, 18450, South Korea
Investigational Site Number : 4100011
Seongnam-si, Gyeonggi-do, 13496, South Korea
Investigational Site Number : 4100001
Seongnam-si, Gyeonggi-do, 13620, South Korea
Investigational Site Number : 4100027
Changwon-Si, Gyeongsangnam-do, 51472, South Korea
Investigational Site Number : 4100010
Yangsan, Gyeongsangnam-do, 50612, South Korea
Investigational Site Number : 4100017
Bupyeong-Gu, Incheon-gwangyeoksi, 21431, South Korea
Investigational Site Number : 4100006
Incheon, Incheon-gwangyeoksi, 21565, South Korea
Investigational Site Number : 4100025
Jeonju, Jeollabuk-do, 54907, South Korea
Investigational Site Number : 4100019
Seoul, Seoul-teukbyeolsi, 01812, South Korea
Investigational Site Number : 4100008
Seoul, Seoul-teukbyeolsi, 01830, South Korea
Investigational Site Number : 4100005
Seoul, Seoul-teukbyeolsi, 02841, South Korea
Investigational Site Number : 4100004
Seoul, Seoul-teukbyeolsi, 03080, South Korea
Investigational Site Number : 4100009
Seoul, Seoul-teukbyeolsi, 03312, South Korea
Investigational Site Number : 4100015
Seoul, Seoul-teukbyeolsi, 03722, South Korea
Investigational Site Number : 4100007
Seoul, Seoul-teukbyeolsi, 05030, South Korea
Investigational Site Number : 4100031
Seoul, Seoul-teukbyeolsi, 06273, South Korea
Investigational Site Number : 4100003
Seoul, Seoul-teukbyeolsi, 06351, South Korea
Investigational Site Number : 4100026
Seoul, Seoul-teukbyeolsi, 06591, South Korea
Investigational Site Number : 4100022
Seoul, Seoul-teukbyeolsi, 07345, South Korea
Investigational Site Number : 4100018
Seoul, Seoul-teukbyeolsi, 07985, South Korea
Investigational Site Number : 4100016
Seoul, Seoul-teukbyeolsi, 08308, South Korea
Investigational Site Number : 7640007
Bangkok, 10330, Thailand
Investigational Site Number : 7640005
Bangkok, 10700, Thailand
Investigational Site Number : 7640004
Khon Kaen, 40002, Thailand
Related Publications (1)
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.
PMID: 40833801DERIVED
Related Links
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Modified double-blind * Blinding for vaccine group assignment: participants and participant's parent(s) / legally acceptable representative(s) (LARs), outcome assessors, Investigators, laboratory personnel, and Sponsor study staff * No blinding for vaccine group assignment: those preparing and administering the study interventions
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 11, 2024
First Posted
December 16, 2024
Study Start
December 18, 2024
Primary Completion (Estimated)
May 17, 2027
Study Completion (Estimated)
May 17, 2027
Last Updated
April 22, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
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