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NCT Number: NCT06824181

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Pneumococcal Immunization

Age range

42 day–89 day

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Investigational Site Number : 1520001, Santiago, Reg Metropolitana de Santiago, Chile

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PCV21 vaccine

Biological

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

Other names: 515

Prevnar 20 vaccine

Biological

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

Other names: Prevnar20™

M-M-R II vaccine

Biological

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

Other names: M-M-R™ II

Rotarix

Biological

Pharmaceutical form:Solution-Route of administration:Oral

Other names: Rotarix™

RotaTeq

Biological

Pharmaceutical form:Solution-Route of administration:Oral

Other names: RotaTeq™

Vaxelis vaccine

Biological

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

Other names: Vaxelis™

Varivax

Biological

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

Other names: Varivax™

Priorix

Biological

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

Other names: Priorix™

Vaqta

Biological

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

Other names: VAQTA™

Havrix

Biological

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

Other names: Havrix™

Primary outcomes

  1. Presence of any immediate adverse events (AEs)

    Time frame: Within 30 minutes after each vaccination

    Number of participants experiencing solicited and unsolicited immediate AEs

  2. Presence of solicited injection site and systemic reactions through 7 days after each vaccine injection

    Time frame: Through 7 days after each vaccine injection

    Number of participants experiencing solicited injection site and systemic reactions

  3. Presence of unsolicited (spontaneously reported) injection site reactions and unsolicited systemic AEs through 30 days after each vaccine injection

    Time frame: Through 30 days after each vaccine injection

    Number of participants experiencing unsolicited injection site reactions and unsolicited systemic AEs

  4. Presence of serious adverse events (SAEs) throughout the study (through 6 months post- last vaccine injection)

    Time frame: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months

    Number of participants experiencing SAEs

  5. Presence adverse events of special interest (AESIs) throughout the study (through 6 months post- last vaccine injection)

    Time frame: Throughout the study (through 6 months post-last vaccine injection), approximately 19 months

    Number of participants experiencing AESIs

  6. Serotype Specific IgG GMCs for Each Pneumococcal Serotype at 30 Days PD4

    Time frame: 30 days PD4

    The GMCs for serotype-specific pneumococcal IgG antibodies are measured using electro-chemiluminescence assay (ECL)

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study title

A Phase 3, Randomized, Modified Double-blind, Active-controlled, Parallel-group, 4-arm Study to Investigate the Mixed Vaccination Schedules of a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants and Toddlers

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Feb 13, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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