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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

896 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-20

Study Completion Date

2028-01-19

Brief Summary

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This is a phase 3 randomized, modified double-blind study which 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 in 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 vaccines) will be administered at approximately 2, 4, 6 and 12 months of age. 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

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Detailed Description

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Conditions

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Pneumococcal Immunization Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

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 patients randomized in the 20vPCV arm. The unblinded study staff will not be involved in any safety evaluation.

Study Groups

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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.

Group Type EXPERIMENTAL

PCV21 vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

Vaxelis Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

Rotavirus vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Solution or Suspension for oral use

Route of administration: Oral

Measles Mumps and Rubella Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Liquid solution

Route of administration: Oral

Varivax vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Powder, lyophilized, for suspension for reconstitution

Route of administration: Subcutaneous or IM

Hepatitis A Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: single-dose vial or single dose prefilled syringe or suspension for injection

Route of Administration: IM

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.

Group Type EXPERIMENTAL

PCV21 vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

Vaxelis Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

Rotavirus vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Solution or Suspension for oral use

Route of administration: Oral

Measles Mumps and Rubella Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Liquid solution

Route of administration: Oral

Varivax vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Powder, lyophilized, for suspension for reconstitution

Route of administration: Subcutaneous or IM

Hepatitis A Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: single-dose vial or single dose prefilled syringe or suspension for injection

Route of Administration: IM

Group 4: 20vPCV

Participants will be administered via IM injection 20vPCV at 2, 4, 6 and 12 months of age co-administered with routine pediatric vaccines.

Group Type ACTIVE_COMPARATOR

20vPCV licensed vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

Vaxelis Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

Rotavirus vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Solution or Suspension for oral use

Route of administration: Oral

Measles Mumps and Rubella Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Liquid solution

Route of administration: Oral

Varivax vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Powder, lyophilized, for suspension for reconstitution

Route of administration: Subcutaneous or IM

Hepatitis A Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: single-dose vial or single dose prefilled syringe or suspension for injection

Route of Administration: IM

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.

Group Type EXPERIMENTAL

PCV21 vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

Vaxelis Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

Rotavirus vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Solution or Suspension for oral use

Route of administration: Oral

Measles Mumps and Rubella Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Liquid solution

Route of administration: Oral

Varivax vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: Powder, lyophilized, for suspension for reconstitution

Route of administration: Subcutaneous or IM

Hepatitis A Vaccine

Intervention Type BIOLOGICAL

Pharmaceutical form: single-dose vial or single dose prefilled syringe or suspension for injection

Route of Administration: IM

Interventions

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PCV21 vaccine

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

Intervention Type BIOLOGICAL

20vPCV licensed vaccine

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

Intervention Type BIOLOGICAL

Vaxelis Vaccine

Pharmaceutical form: Suspension for injection

Route of administration: Intramuscular

Intervention Type BIOLOGICAL

Rotavirus vaccine

Pharmaceutical form: Solution or Suspension for oral use

Route of administration: Oral

Intervention Type BIOLOGICAL

Measles Mumps and Rubella Vaccine

Pharmaceutical form: Liquid solution

Route of administration: Oral

Intervention Type BIOLOGICAL

Varivax vaccine

Pharmaceutical form: Powder, lyophilized, for suspension for reconstitution

Route of administration: Subcutaneous or IM

Intervention Type BIOLOGICAL

Hepatitis A Vaccine

Pharmaceutical form: single-dose vial or single dose prefilled syringe or suspension for injection

Route of Administration: IM

Intervention Type BIOLOGICAL

Other Intervention Names

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515 Prevnar 20™ Vaxelis™ Rotarix™ or RotaTeq™ M-M-R II™ or Priorix™ VARIVAX™ VAQTA™ or Havrix™

Eligibility Criteria

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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.

Minimum Eligible Age

42 Days

Maximum Eligible Age

89 Days

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes