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

Phase 3Active Not RecruitingNCT06736041

Sanofi Pasteur, a Sanofi Company1,714 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

1,714

Conditions

Pneumococcal Immunization

Interventions

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

Prevnar 20 vaccineBIOLOGICAL

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

M-M-R II vaccineBIOLOGICAL

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

RotaTeqBIOLOGICAL

Pharmaceutical form:Solution-Route of administration:Oral

Vaxelis vaccineBIOLOGICAL

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

VarivaxBIOLOGICAL

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

Hexaxim VaccineBIOLOGICAL

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

Eligibility

Sex: ALLMin age: 42 DaysMax age: 89 DaysHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (112)

Sun City Clinical Research- Site Number : 8400247

Glendale, Arizona, United States

Eclipse Clinical Research- Site Number : 8400029

Tucson, Arizona, United States

Northwest Arkansas Pediatric Clinic- Site Number : 8400030

Fayetteville, Arkansas, United States

Southland Clinical Research Center- Site Number : 8400243

Fountain Valley, California, United States

Century Research Institute- Site Number : 8400065

Huntington Park, California, United States

Outcomes

Primary Outcomes

Seroresponse rate for PCV21 serotypes

Serotype specific IgG concentration ≥ 0.35 µg/mL

Time frame: 30 days post-dose 3

IgG concentration for PCV21 serotypes

Serotype specific IgG Geometric Mean Concentration (GMC)

Time frame: 30 days post-dose 3

IgG concentration for PCV21 serotypes

Serotype specific IgG GMC post-dose 4

Time frame: 30 days post-dose 4

Secondary Outcomes

Anti- hepatitis B surface antigen (HBsAg) Ab

% Antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL)

Time frame: 30 days post-dose 3

Anti- polyribosylribitol phosphate (PRP) Ab

% Antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL)

Time frame: 30 days post-dose 3

Anti-poliovirus types (1, 2, and 3) Ab

% Antibody titers ≥ 1:8

Time frame: 30 days post-dose 3

Anti-diphtheria Ab concentrations

% Antibody concentrations ≥ 0.1 IU/mL

Time frame: 30 days post-dose 3

Anti-tetanus Ab concentrations

% Antibody concentrations ≥ 0.1 IU/mL

Time frame: 30 days post-dose 3

Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA))

Antibody GMC

Time frame: 30 days post-dose 3

Anti-rotavirus serum immunoglobulin A (IgA) Ab concentrations

Antibody GMC

Time frame: 30 days post-dose 3

Anti-measles Ab concentrations

% Antibody concentrations ≥ 225 milli international units per milliliter (mIU/mL)

Time frame: 30 days post-dose 4

Anti-measles Ab concentrations

Antibody GMC

Time frame: 30 days post-dose 4

Anti-mumps Ab concentrations

% Anti-mumps Ab concentrations ≥ 10 Ab units (AbU)/mL

Time frame: 30 days post-dose 4

Anti-mumps Ab concentrations

Antibody GMC

Time frame: 30 days post-dose 4

Anti-rubella Ab concentrations

% Anti-rubella Ab concentrations ≥ 10 IU/mL

Time frame: 30 days post-dose 4

Anti-rubella Ab concentrations

Antibody GMC

Time frame: 30 days post-dose 4

Anti-varicella Ab concentrations

Anti-varicella Ab concentrations ≥ 5 glycoprotein enzyme linked immunosorbent assay (gpELISA) units/mL

Time frame: 30 days post-dose 4

IgG concentration for the additional serotype 9N

Serotype 9N specific IgG concentration ≥ 0.35 µg/mL

Time frame: 30 days post-dose 3

IgG concentration for serotype 3

Serotype 3 specific IgG concentration ≥ 0.35 µg/mL

Time frame: 30 days post-dose 3

IgG concentration for additional serotype 9N

Serotype 9N specific IgG GMC

Time frame: 30 days post-dose 3

IgG concentration for serotype 3

Serotype 3 specific IgG GMC

Time frame: 30 days post-dose 3

Serotype 9N specific IgG GMC post-dose 4

Time frame: 30 days post-dose 4

IgG concentration for additional serotype 9N

Serotype 9N specific IgG GMC post-dose 4

Time frame: 30 days post-dose 4

IgG concentration for serotype 3

Serotype 3 specific IgG GMC post-dose 4

Time frame: 30 days post-dose 4

Seroresponse rate for PCV21 serotypes

Serotype specific IgG concentration ≥ 0.35 µg/mL

Time frame: 30 days post-dose 4

IgG concentration for PCV21 serotypes

Serotype specific IgG GMC prior to and post-dose 4

Time frame: Before dose 4 and 30 days post-dose 4

Serotype specific OPA titers for all serotypes included in PCV21

Antibody GMC

Time frame: 30 days post-dose 3

Serotype specific OPA titers ≥ lower limit of quantitation (LLOQ) for all serotypes included in PCV21

Antibody GMC

Time frame: 30 days post-dose 3

Serotype specific OPA titers for all serotypes included in PCV21

Antibody GMC prior to and post-dose 4

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Throughout the study (through 6 months post-last vaccine injection), approximately 20 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Matrix Clinical Research - Huntington Park- Site Number : 8400012

Huntington Park, California, United States

Matrix Clinical Research - Los Angeles- Site Number : 8400013

Los Angeles, California, United States

University of California Los Angeles Medical Center- Site Number : 8400238

Los Angeles, California, United States

Pasadena Clinical Trials - Pasadena - North Madison Avenue- Site Number : 8400259

Pasadena, California, United States

FOMAT Medical Research - Pediatric, Infant & Adolescence Medicine- Site Number : 8400063

Ventura, California, United States

...and 102 more locations