ACTIVE_NOT_RECRUITING

Study of the Safety and Immunogenicity of Catch-up Vaccination With a 21-valent Pneumococcal Conjugate Vaccine (PCV21) in Healthy Infants, Toddlers, Children, and Adolescents

Conditions

Pneumococcal Infections Pneumococcal Vaccines Pneumococcal Conjugate Vaccine Healthy Participants

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The purpose of this study is to evaluate the safety and immunogenicity of PCV21 versus 20vPCV ( 20-valent pneumococcal conjugate vaccine, Prevnar 20) for catch-up vaccination in infants (7 to 11 MoA-Months of age), toddlers (12 to 23 MoA), and children/adolescents (2 to 5 YoA and 6 to 17 YoA-years of age).

Official Title

A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group Study to Investigate the Safety and Immunogenicity of Catch-up Vaccination Regimens of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants, Toddlers, Children, and Adolescents

Quick Facts

Study Start:2025-02-28

Study Completion:2026-12-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06838000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:7 Months to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
* Aged 7 months to 17 years 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 * A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies: * Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or surgically sterile. OR * Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study vaccine administration until at least 4 weeks after the study vaccine administration. A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours of before the first dose of study vaccine. * Assent form has been signed and dated by the participant (based on local regulations), and if applicable, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (LAR) and by an independent witness, if required by local regulations * Participant and parent(s) / LAR(s) are able to attend all scheduled visits and to comply with all study procedures	* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy * History of microbiologically confirmed S. pneumoniae infection or disease * History of seizure or significant stable or progressive neurological disorders such as inflammatory nervous system diseases, encephalopathy, and cerebral palsy * Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a product containing any of the same substances * Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent(s) / 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 vaccine administration. * Previous vaccination against S. pneumonia * Previous vaccination with pneumococcal polysaccharide vaccine * Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion * Receipt of any vaccine in the 4 weeks preceding the vaccine administration or planned receipt of any vaccine in the 4 weeks following the vaccine 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 * Receipt of immune globulins, blood or blood-derived products in the past 3 months * Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw * Participation at the time of study enrollment (or in the 6 weeks preceding the first vaccine administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure * Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily * Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

Inclusion Criteria

Exclusion Criteria

* Aged 7 months to 17 years 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
* A female participant is eligible to participate if she is not pregnant or breastfeeding and one of the following conditions applies:
* Is of non-childbearing potential. To be considered of non-childbearing potential, a female must be pre-menarche or surgically sterile. OR
* Is of childbearing potential and agrees to use an effective contraceptive method or abstinence from at least 4 weeks prior to the study vaccine administration until at least 4 weeks after the study vaccine administration. A female participant of childbearing potential must have a negative highly sensitive pregnancy test (urine or serum as required by local regulation) within 25 hours of before the first dose of study vaccine.
* Assent form has been signed and dated by the participant (based on local regulations), and if applicable, and informed consent form has been signed and dated by the parent(s) or another legally acceptable representative (LAR) and by an independent witness, if required by local regulations
* Participant and parent(s) / LAR(s) are able to attend all scheduled visits and to comply with all study procedures

* Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy
* History of microbiologically confirmed S. pneumoniae infection or disease
* History of seizure or significant stable or progressive neurological disorders such as inflammatory nervous system diseases, encephalopathy, and cerebral palsy
* Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccines used in the study or to a product containing any of the same substances
* Laboratory-confirmed thrombocytopenia, or known thrombocytopenia, as reported by the parent(s) / 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 vaccine administration.
* Previous vaccination against S. pneumonia
* Previous vaccination with pneumococcal polysaccharide vaccine
* Alcohol, prescription drug, or substance abuse that, in the opinion of the Investigator, might interfere with the study conduct or completion
* Receipt of any vaccine in the 4 weeks preceding the vaccine administration or planned receipt of any vaccine in the 4 weeks following the vaccine 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
* Receipt of immune globulins, blood or blood-derived products in the past 3 months
* Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw
* Participation at the time of study enrollment (or in the 6 weeks preceding the first vaccine administration) or planned participation during the present study period in another clinical study investigating a vaccine, drug, medical device, or medical procedure
* Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
* Identified as an Investigator or employee of the Investigator or study center with direct involvement in the proposed study, or identified as an immediate family member (ie, parent, spouse, natural or adopted child) of the Investigator or employee with direct involvement in the proposed study

Contacts and Locations

Principal Investigator

Clinical Sciences & Operations Study Director

STUDY_DIRECTOR

Sanofi

Study Locations (Sites)

Site # 8400008

Paramount, California, 90723

United States

Site # 8400024

Doral, Florida, 33166

United States

Site # 8400007

Hialeah, Florida, 33012

United States

Site # 8400014

Melbourne, Florida, 32934

United States

Site # 8400009

Miami, Florida, 33166

United States

Site # 8400016

Miami, Florida, 33166

United States

Site # 8400021

Fayetteville, Georgia, 30214

United States

Site # 8400004

Union City, Georgia, 30291

United States

Site # 8400003

Sioux City, Iowa, 51106

United States

Site # 8400023

Erlanger, Kentucky, 41018

United States

Site # 8400018

Biloxi, Mississippi, 39531

United States

Site # 8400012

Ridgeland, Mississippi, 39531

United States

Site # 8400002

Omaha, Nebraska, 68114

United States

Site #8400010

Binghamton, New York, 13905

United States

Site # 8400025

Rochester, New York, 14642

United States

Site # 8400001

Houston, Texas, 77065

United States

Site # 8400017

Stephenville, Texas, 76401

United States

Collaborators and Investigators

Sponsor: Sanofi Pasteur, a Sanofi Company

Clinical Sciences & Operations Study Director, STUDY_DIRECTOR, Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-02-28

Study Completion Date2026-12-01

Study Record Updates

Study Start Date2025-02-28

Study Completion Date2026-12-01

Terms related to this study

Keywords Provided by Researchers

Pneumococcal Vaccines
Pneumococcal Conjugate Vaccine
Healthy Participants

Additional Relevant MeSH Terms

Pneumococcal Infections