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

NCT06975878 | Active Not Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: PSK042023-507600-32U1111-1295-6064
• Study Type: interventional
• Target: 1,092
• Locations: 8 countries
• Sites: 49

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.

Conditions

Pneumococcal Immunization; Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

• Seroresponse rate for PCV21 and 15vPCV serotypes

  Serotype specific IgG concentration ≥ 0.35 µg/mL

  30 days post-toddler dose

• IgG concentration for PCV21 and 15vPCV serotypes

  Serotype specific IgG Geometric Mean Concentration (GMC)

  30 days post-toddler dose

Secondary Outcomes (23)

• Anti- hepatitis B surface antigen (HBsAg) Ab

  30 days post-toddler dose

• Anti- polyribosylribitol phosphate (PRP) Ab

  30 days post-toddler dose

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

  30 days post-toddler dose

• Anti-diphtheria Ab concentrations

  30 days post-toddler dose

• Anti-tetanus Ab concentrations

  30 days post-toddler dose

Study Arms (2)

Group 1: PCV21

EXPERIMENTAL

Participants will be administered via intramuscular injection (IM) a 2-dose primary series of PCV21 at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of PCV21 co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice

Biological: PCV21 vaccine; Biological: Hexyon vaccine; Biological: M-M-RvaxPro vaccine; Biological: Varivax vaccine

Group 2: 15vPCV

ACTIVE COMPARATOR

Participants will be administered via intramuscular injection (IM) a 2-dose primary series of 15vPCV at approximately 2 and 4 months of age (MoA) or a 3-dose primary series (preterm infants) at 2, 3, and 4 MoA co- administered with Hexyon. At 11 to 15 MoA, participants will receive a 3rd dose or 4th dose (for preterm infants) of 15vPCV co-administered with Hexyon and M M RvaxPro; Varivax will also be co-administered unless not possible as per local practice

Biological: Vaxneuvance vaccine; Biological: Hexyon vaccine; Biological: M-M-RvaxPro vaccine; Biological: Varivax vaccine

Interventions

Vaxneuvance vaccine BIOLOGICAL

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

Also known as: Vaxneuvance ™

Group 2: 15vPCV

Hexyon vaccine BIOLOGICAL

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

Also known as: Hexyon®

Group 1: PCV21; Group 2: 15vPCV

M-M-RvaxPro vaccine BIOLOGICAL

Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous

Also known as: M-M-RVAX-PRO®

Group 1: PCV21; Group 2: 15vPCV

Varivax vaccine BIOLOGICAL

Pharmaceutical form:Powder and solvent for suspension for injection-Route of administration:Intramuscular or Subcutaneous

Also known as: Varivax®

Group 1: PCV21; Group 2: 15vPCV

PCV21 vaccine BIOLOGICAL

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

Also known as: 515

Group 1: PCV21

Eligibility Criteria

• Age: 42 Days - 112 Days
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Sanofi: lead

Study Sites (49)

Investigational Site Number : 0560004

Alken, 3570, Belgium

Location

Investigational Site Number : 0560001

Bruges, 8000, Belgium

Location

Investigational Site Number : 0560002

Edegem, 2650, Belgium

Location

Investigational Site Number : 0560005

Gozée, 6534, Belgium

Location

Investigational Site Number : 0560007

Leuven, 3000, Belgium

Location

Investigational Site Number : 0560003

Roeselare, 8800, Belgium

Location

Investigational Site Number : 2030001

Jindřichův Hradec, 377 01, Czechia

Location

Investigational Site Number : 2030009

Krnov, 79401, Czechia

Location

Investigational Site Number : 2030006

Pilsen, 301 00, Czechia

Location

Investigational Site Number : 2030008

Prague, 18000, Czechia

Location

Investigational Site Number : 2330001

Paide, 72713, Estonia

Location

Investigational Site Number : 2330004

Tallinn, 10617, Estonia

Location

Investigational Site Number : 2330002

Tartu, 50106, Estonia

Location

Investigational Site Number : 2460008

Espoo, 02230, Finland

Location

Investigational Site Number : 2460001

Helsinki, 00100, Finland

Location

Investigational Site Number : 2460010

Helsinki, 00290, Finland

Location

Investigational Site Number : 2460005

Jarvenpaa, 04400, Finland

Location

Investigational Site Number : 2460003

Kokkola, 67100, Finland

Location

Investigational Site Number : 2460004

Oulu, 90220, Finland

Location

Investigational Site Number : 2460002

Seinäjoki, 60100, Finland

Location

Investigational Site Number : 2460007

Tampere, 33100, Finland

Location

Investigational Site Number : 2460009

Turku, 20520, Finland

Location

Investigational Site Number : 2760005

Herxheim, 76863, Germany

Location

Investigational Site Number : 2760006

Hürth, 50354, Germany

Location

Investigational Site Number : 2760014

Hürth, 50354, Germany

Location

Investigational Site Number : 2760013

Krefeld, 47799, Germany

Location

Investigational Site Number : 2760010

Mönchengladbach, 41236, Germany

Location

Investigational Site Number : 2760012

Mönchengladbach, 41236, Germany

Location

Investigational Site Number : 2760008

Schönau am Königssee, 83471, Germany

Location

Investigational Site Number : 2760003

Wolfsburg, 38448, Germany

Location

Investigational Site Number : 3000001

Athens, 11527, Greece

Location

Investigational Site Number : 3000002

Athens, 12462, Greece

Location

Investigational Site Number : 3000006

Ioannina, 45500, Greece

Location

Investigational Site Number : 3000005

Thessaloniki, 54642, Greece

Location

Investigational Site Number : 3800004

Rome, Lazio, 00168, Italy

Location

Investigational Site Number : 3800002

Rome, Roma, 00161, Italy

Location

Investigational Site Number : 3800001

Bari, 70124, Italy

Location

Investigational Site Number : 3800008

Foggia, 71122, Italy

Location

Investigational Site Number : 3800010

Lecce, 73100, Italy

Location

Investigational Site Number : 3800007

Milan, 20122, Italy

Location

Investigational Site Number : 3800009

Parma, 43126, Italy

Location

Investigational Site Number : 6160001

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-048, Poland

Location

Investigational Site Number : 6160007

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

Location

Investigational Site Number : 6160009

Krakow, Lesser Poland Voivodeship, 30-348, Poland

Location

Investigational Site Number : 6160003

Trzebnica, Lower Silesian Voivodeship, 55-100, Poland

Location

Investigational Site Number : 6160008

Wroclaw, Lower Silesian Voivodeship, 50-368, Poland

Location

Investigational Site Number : 6160011

Warsaw, Masovian Voivodeship, 02-647, Poland

Location

Investigational Site Number : 6160005

Łomianki, Masovian Voivodeship, 05-092, Poland

Location

Investigational Site Number : 6160002

Siemianowice Śląskie, Silesian Voivodeship, 41-103, Poland

Location

Related Links

• PSK04 Plain Language Results Summary

MeSH Terms

Interventions

DTaP-IPV-HB-PRP-T vaccine; Chickenpox Vaccine

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2025
• First Posted: May 16, 2025
• Study Start: May 22, 2025
• Primary Completion (Estimated): August 25, 2027
• Study Completion (Estimated): August 25, 2027
• Last Updated: March 2, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share

Locations

DE (8); PL (8); GR (4); IT (7); CZ (4); BE (6); FI (9); ES (3)