Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age

Purpose

This is a phase 3 randomized, modified double-blind study whose purpose is to measure whether 3 lots of the investigational pneumococcal vaccine PCV21 can help the body to develop germ-fighting agents called "antibodies" (immunogenicity) in a similar way (ie, same immune response) when they are given to infants aged from approximately 2 months (42 to 89 days) and are safe compared to a licensed 20-valent pneumococcal vaccine (20vPCV) (Prevnar 20™). The study duration per participant will be up to approximately 17 months. The study vaccines (either PCV21 or 20vPCV) will be administered at approximately 2, 4, 6 and 12 months of age. Cohort A will include randomization to three PCV21 formulation groups or one 20vPCV comparator group (Group 1-4, approximately 896 total participants), whereas Cohort B will include randomization to three PCV21 formulation groups only (Groups 1-3, approximately 1299 total participants). 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, V06 separated from V05 by 30 days

Conditions

  • Pneumococcal Immunization
  • Healthy Volunteers

Eligibility

Eligible Ages
Between 42 Days and 89 Days
Eligible Sex
All
Accepts Healthy Volunteers
Yes

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

Exclusion Criteria

  • 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 vaccine being administered in the study - History of seizure or significant stable or progressive neurologic 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 substances3 - Laboratory-confirmed or known thrombocytopenia, as reported by the parent(s) / legally acceptable representative (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 study intervention administration. - Receipt of any BCG vaccine within 4 weeks preceding the first study intervention administration or planned receipt any BCG vaccine within the study period - Previous vaccination against Streptococcus pneumoniae - Previous vaccination against the following antigens: diphtheria, tetanus, pertussis, H. influenzae type b, 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
Participants, participant's parent(s) / LAR(s), Sponsor study staff, investigators and study staff, will remain blinded during the study conduct, except dedicated study staff preparing/administering the study interventions who will be blinded regarding the PCV21 lot but unblinded regarding the participants, randomized in the 20vPCV arm. The unblinded study staff will not be involved in any safety evaluation.

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Group 1: PCV21 		Participants will be administered via intramuscular injection (IM) PCV21 vaccine lot 1 for Doses 1, 2 and 3; PCV21 lot 1, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
  • Biological: PCV21 vaccine
    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
    Other names:
    • 515
Experimental
Group 2: PCV21 		Participants will be administered via IM injection PCV21 vaccine lot 2 for Doses 1, 2 and 3; PCV21 lot 2, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
  • Biological: PCV21 vaccine
    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
    Other names:
    • 515
Experimental
Group 3: PCV21 		Participants will be administered via IM injection PCV21 vaccine lot 3 for Doses 1, 2 and 3; PCV21 lot 3, or different lot if needed, for Dose 4 at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
  • Biological: PCV21 vaccine
    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
    Other names:
    • 515
Active Comparator
Group 4: 20vPCV (Cohort A only) 		Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.
  • Biological: 20vPCV licensed vaccine
    Pharmaceutical form: Suspension for injection Route of administration: Intramuscular
    Other names:
    • Prevnar 20™

Recruiting Locations

Northwest Arkansas Pediatric Clinic- Site Number : 8400039
Fayetteville, Arkansas 72703

Matrix Clinical Research - Huntington Park- Site Number : 8400029
Huntington Park, California 90255

Community Clinical Research- Site Number : 8400030
Los Angeles, California 90008

Matrix Clinical Research - Los Angeles- Site Number : 8400028
Los Angeles, California 90057

PAS Research - Tampa- Site Number : 8400034
Tampa, Florida 33613

Kentucky Pediatric Research- Site Number : 8400036
Bardstown, Kentucky 40004

Michigan Institute of Research- Site Number : 8400004
Allen Park, Michigan 48101

Tribe Clinical Research At Neighbors Pediatrics- Site Number : 8400008
Charleston, South Carolina 29407

Parkside Pediatrics - Simpsonville- Site Number : 8400005
Simpsonville, South Carolina 29681

Tribe Clinical Research - Spartanburg- Site Number : 8400026
Spartanburg, South Carolina 29301

PAS Research - Children's Care Clinic- Site Number : 8400035
Edinburg, Texas 78539

Pediatric Center - Richmond- Site Number : 8400038
Richmond, Texas 77469

Rio Clinical Trials - Canyon View- Site Number : 8400031
Ogden, Utah 84404

Investigational Site Number : 6300005
Guayama, Puerto Rico 00786

Investigational Site Number : 6300006
San Juan, Puerto Rico 00918

Investigational Site Number : 6300007
Trujillo Alto, Puerto Rico 00976

More Details

Status
Recruiting
Sponsor
Sanofi

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
800-633-1610
Contact-US@sanofi.com