Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (NCT06824181) — Mexico Trial Details

Condition(s) studied

Pneumococcal Immunization

Investigational drug(s) / intervention(s)

PCV21 vaccine →Prevnar 20 vaccine →M-M-R II vaccine →Rotarix →RotaTeq →Vaxelis vaccine →Varivax →Priorix →VAQTA →Havrix →

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

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

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

Priorix: Pharmaceutical form:Lyophilized, for suspension for reconstitution-Route of administration:Subcutaneous

VAQTA: Pharmaceutical form:Suspension for Injection-Route of administration:Intramuscular

Havrix: 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 the investigational pneumococcal conjugate vaccine PCV21 is safe and can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) when it is given after 1 dose, 2 doses, or 3 doses of a licensed 20-valent pneumococcal vaccine compared to when 20-valent pneumococcal vaccine is given as a complete series 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 20vPCV) will be administered at approximately 2, 4, 6 and 12 to 15 months of age (MoA). Routine pediatric vaccines will be given as per local recommendations.

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. * History of seizure or significant stable or progressive neurologic disorders such as 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 * Thrombocytopenia, or known thrombocytopenia, as reported by the parent/legal 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. * Previous vaccination against Streptococcus pneumoniae * 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)

Presence of any immediate adverse events (AEs) — Within 30 minutes after each vaccination
Number of participants experiencing solicited and unsolicited immediate AEs
Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection — Through 7 days after each vaccine injection
Number of participants experiencing solicited injection site and systemic reactions
Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection — Through 30 days after each vaccine injection
Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs
Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection) — Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Number of participants experiencing SAEs
Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection) — Throughout the study (through 6 months post-last vaccine injection), approximately 19 months
Number of participants experiencing AESIs
Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days PD4 — 30 days PD4
The GMCs for serotype-specific pneumococcal IgG antibodies are measured using electro-chemiluminescence assay (ECL)

Trial sites (27)

Facility	City	Region
Kaiser Permanente - Los Angeles Medical Center- Site Number : 8400025	Los Angeles	California
The Medici Medical Research- Site Number : 8400008	Hollywood	Florida
Clinsearch Inc at Dr. Gala, LLC- Site Number : 8400027	Miami	Florida
Atlantis Clinical Research- Site Number : 8400009	Miami	Florida
Velocity Clinical Research - Sioux City- Site Number : 8400007	Sioux City	Iowa
Private Practice - Dr. Michael W. Simon- Site Number : 8400001	Lexington	Kentucky
Velocity Clinical Research - New Orleans- Site Number : 8400006	New Orleans	Louisiana
Finger Lakes Medical Research - Cortland- Site Number : 8400022	Cortland	New York
University of Rochester Medical Center- Site Number : 8400019	Rochester	New York
SUNY Upstate Medical University - Syracuse- Site Number : 8400015	Syracuse	New York
Kid's Way Pediatrics- Site Number : 8400013	Hermitage	Pennsylvania
Carolina Family Care - Charleston- Site Number : 8400014	Charleston	South Carolina
Helios Clinical Research - BUR PEDI- Site Number : 8400016	Burleson	Texas
Clinsearch Inc at VAST Clinical Research- Site Number : 8400028	Euless	Texas
DM Clinical Research - Houston - Jones Road- Site Number : 8400012	Houston	Texas
University of Texas Medical Branch at Galveston- Site Number : 8400005	League City	Texas
Javara - Privia Medical Group North Texas - Stephenville- Site Number : 8400024	Stephenville	Texas
Investigational Site Number : 1520003	Santiago	Reg Metropolitana de Santiago
Investigational Site Number : 1520002	Santiago	Reg Metropolitana de Santiago
Investigational Site Number : 1520001	Santiago	Reg Metropolitana de Santiago
Investigational Site Number : 4840003	León	Guanajuato
Investigational Site Number : 4840001	Mexico City	Mexico City
Investigational Site Number : 4840002	Temixco	Morelos
Investigational Site Number : 4840004	Tlaltizapán	Morelos
Investigational Site Number : 6080001	Cebu City	Philippines
Investigational Site Number : 6080002	Quezon City	Philippines
Investigational Site Number : 6080003	Quezon City	Philippines

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