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Clinical Trials in Australia / NCT06736041
Active, not recruiting Phase 3

Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age

NCT06736041 · tracked via the Priya Life Science Australia tracker
Phase
Phase 3
Started
2024-12-18
Last updated
2026-04-22

Condition(s) studied

Pneumococcal Immunization

Investigational drug(s) / intervention(s)

PCV21 vaccine →Prevnar 20 vaccine →M-M-R II vaccine →RotaTeq →Vaxelis vaccine →Varivax →Hexaxim Vaccine

PCV21 vaccine: Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

Prevnar 20 vaccine: Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular

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

RotaTeq: Pharmaceutical form:Solution-Route of administration:Oral

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

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

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

Study 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.

Eligibility

Sex
ALL
Min age
42 Days
Max age
89 Days
Healthy volunteers
Accepted
Inclusion Criteria: * 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 Exclusion Criteria: 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 * 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.

Primary outcome measure(s)

Trial sites (112)

FacilityCityRegionStatus
Sun City Clinical Research- Site Number : 8400247 Glendale Arizona
Eclipse Clinical Research- Site Number : 8400029 Tucson Arizona
Northwest Arkansas Pediatric Clinic- Site Number : 8400030 Fayetteville Arkansas
Southland Clinical Research Center- Site Number : 8400243 Fountain Valley California
Century Research Institute- Site Number : 8400065 Huntington Park California
Matrix Clinical Research - Huntington Park- Site Number : 8400012 Huntington Park California
Matrix Clinical Research - Los Angeles- Site Number : 8400013 Los Angeles California
University of California Los Angeles Medical Center- Site Number : 8400238 Los Angeles California
Pasadena Clinical Trials - Pasadena - North Madison Avenue- Site Number : 8400259 Pasadena California
FOMAT Medical Research - Pediatric, Infant & Adolescence Medicine- Site Number : 8400063 Ventura California
Velocity Clinical Research - Washington DC- Site Number : 8400049 Washington D.C. District of Columbia
PAS Research- Site Number : 8400123 Clearwater Florida
Prohealth Research Center- Site Number : 8400159 Doral Florida
NurtureGen Research- Site Number : 8400205 Homestead Florida
EMDA Clinical Research- Site Number : 8400237 Miami Florida
Dade Research Center- Site Number : 8400007 Miami Florida
Acevedo Clinical Research Associates- Site Number : 8400089 Miami Florida
Miami Clinical Research Tower- Site Number : 8400189 Miami Florida
Vasconcello-Cohen MD Research, LLC- Site Number : 8400248 Miami Florida
Bio-Medical Research- Site Number : 8400147 Miami Florida
High Quality Research- Site Number : 8400245 Miami Florida
Riveldi Biomedical Research and Associates - Miami Lakes- Site Number : 8400032 Miami Lakes Florida
BioResearch Partner (BRP) - Premium Healthcare Medical Center - Miami Lakes- Site Number : 8400203 Miami Lakes Florida
Optimal Research Sites- Site Number : 8400232 Orange City Florida
SEC Clinical Research - Pensacola- Site Number : 8400003 Pensacola Florida
National Clinical Trials - Tampa- Site Number : 8400229 Tampa Florida
PAS Research - Tampa- Site Number : 8400002 Tampa Florida
Medical Research Partners - Ammon- Site Number : 8400239 Ammon Idaho
Bingham Memorial Hospital - Blackfoot- Site Number : 8400084 Blackfoot Idaho
Leavitt Women's Healthcare- Site Number : 8400085 Idaho Falls Idaho
Snake River Research- Site Number : 8400060 Idaho Falls Idaho
Clinical Research Prime Rexburg- Site Number : 8400250 Rexburg Idaho
Alliance for Multispeciality Research - El Dorado- Site Number : 8400010 El Dorado Kansas
Hutchinson Clinic- Site Number : 8400061 Hutchinson Kansas
Cotton O'Neil Pediatrics- Site Number : 8400009 Topeka Kansas
KUR Research at Columbia MD - 6220 Old Dobbin Lane- Site Number : 8400242 Columbia Maryland
Michigan Institute of Research- Site Number : 8400207 Allen Park Michigan
University of Missouri Hospital- Site Number : 8400244 Columbia Missouri
Vector Clinical Trials- Site Number : 8400249 Las Vegas Nevada
Hawthorne- Bienstar Lindenwold- Site Number : 8400256 Lindenwold New Jersey

+ 72 more sites — see the full list on the official registry below.

More Sanofi Pasteur, a Sanofi Company trials in Australia

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06736041 on ClinicalTrials.gov ↗ ← All trials in Australia