Pneumococcal Immunization, Healthy Volunteers
Conditions
Brief 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 15vPCV (Vaxneuvance, licensed pneumococcal conjugate vaccine) when they are administered with routine pediatric vaccines in infants aged from approximately 2 months (42 to 112 days). The study duration per participant will be up to approximately 20 months. The study vaccines (either PCV21 or 15-valent pneumococcal vaccines) will be administered at approximately 2, 4, and 11 to 15 months of age or at approximately 2, 3, 4, and 11 to 15 months of age (for preterm infants). Routine pediatric vaccines will be given at the same timepoints, as per local practice / recommendations. • There will be 5 (for full-term infants) or 6 (for preterm infants) study visits: * Full-term infants: Visit (V)01, V02 separated from V01 by 60 days, V03 separated from V02 by 30 days, V04 at 11 months of age until 15 months of age, V05 separated from V04 by 30 days. * Preterm infants: Visit (V)01, V02 separated from V01 by 30 days, V03 separated from V02 by 30 days, V04 separated from V03 by 30 days, V05 at 11 months of age until 15 months of age, V06 separated from V05 by 30 days.
Interventions
BIOLOGICALPCV21 vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICALVaxneuvance vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICALHexyon vaccine
Pharmaceutical form:Suspension for injection-Route of administration:Intramuscular
BIOLOGICALM-M-RvaxPro vaccine
Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous
BIOLOGICALVarivax vaccine
Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous
Sponsors
Sanofi
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Modified double-blind * Blinding for vaccine group assignment: participants and participant's parent(s) / legally acceptable representative(s) (LARs), outcome assessors, Investigators, laboratory personnel, and Sponsor study staff * No blinding for vaccine group assignment: those preparing and administering the study interventions
Eligibility
Sex/Gender
ALL
Age
42 Days to 112 Days
Healthy volunteers
Yes
Inclusion criteria
* Aged 42 to 112 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 oral rotavirus vaccine, which may be received anytime during the study including at study visits and for influenza vaccination or meningococcal b vaccine, which may be received at least 14 days before or 14 days 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroresponse rate for PCV21 and 15vPCV serotypes | 30 days post-toddler dose | Serotype specific IgG concentration ≥ 0.35 µg/mL |
| IgG concentration for PCV21 and 15vPCV serotypes | 30 days post-toddler dose | Serotype specific IgG Geometric Mean Concentration (GMC) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti- hepatitis B surface antigen (HBsAg) Ab | 30 days post-toddler dose | % Antibody concentrations ≥ 10 milli international units per milliliter (mIU/mL) |
| Anti- polyribosylribitol phosphate (PRP) Ab | 30 days post-toddler dose | % Antibody concentrations ≥ 0.15 micrograms per milliliter (µg/mL) |
| Anti-poliovirus types (1, 2, and 3) Ab | 30 days post-toddler dose | % Antibody titers ≥ 1:8 |
| Anti-diphtheria Ab concentrations | 30 days post-toddler dose | % Antibody concentration ≥ 0.1 IU/mL |
| Anti-tetanus Ab concentrations | 30 days post-toddler dose | % Antibody concentration ≥ 0.1 IU/mL |
| Anti-pertussis Ab concentrations (Pertussis toxin (PT) and Filamentous Hemagglutinin (FHA)) | 30 days post-toddler dose | Antibody GMC |
| Anti-measles Ab concentrations | 30 days post-toddler dose | Antibody GMC |
| Anti-mumps Ab concentrations | 30 days post-toddler dose | Antibody GMC |
| Anti-rubella Ab concentrations | 30 days post-toddler dose | Antibody GMC |
| Anti-varicella Ab concentrations | 30 days post-toddler dose | Antibody GMC |
| Anti HBsAg concentrations | 30 days post-primary series | % Antibody concentrations ≥ 10 mIU/mL |
| Anti-PRP Ab concentrations | 30 days post-primary series | % Antibody concentrations ≥ 0.15 µg/mL |
| Anti-poliovirus types (1, 2, and 3) Ab titers | 30 days post-primary series | % Antibody titers ≥ 1:8 |
| Anti-pertussis Ab concentrations (PT and FHA) | 30 days post-primary series | Antibody GMC |
| Serotype specific OPA titers for all serotypes included in PCV21 | 30 days post-primary series | Antibody Geometric mean titer (GMT) |
| Presence of any immediate adverse events (AEs) | Within 30 minutes after each vaccine injection | Number of participants experiencing 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 20 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 20 months | Number of participants experiencing AESIs |
Countries
Belgium, Czechia, Estonia, Finland, Germany, Greece, Italy, Poland
Outcome results
None listed