A Study to Learn About How a New Pneumococcal Vaccine Works in Infants

Pfizer

Status and phase: Enrolling; Phase 2

Conditions: Pneumococcal Disease

Treatments: Biological: PG4; Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT06524414

C4931002

Details and patient eligibility

About

The purpose of this study is to learn about the safety and immune effects of a new pneumococcal vaccine in infants. The immune response is how the body's cells, tissues and organs work together to protect the body from infection. Blood samples will be used to measure the amount of antibodies produced after the vaccination. Antibodies are proteins that protect you when an unwanted germ enters the body. This will help us understand how well the new pneumococcal vaccine works. This vaccine can possibly provide protection against pneumococcal disease, which include a variety of infections caused by a specific germ, Streptococcus pneumoniae.

This study is seeking participants who are:

• male or female infants who are 2 months of age,
• infants born at 36 weeks (about 8 and a half months) of pregnancy or later; and,
• said to be healthy by the study doctor

The participants will be assigned to one of two groups to receive 4 doses of either PG4 (the new vaccine being studied) or 20vPnC (Prevnar 20) at 2, 4, 6, and 12 to 15 months of age. The vaccines will be given as a single shot into the left thigh muscle. Participants will take part in this study for about 16 to 19 months (about 1 and a half years). During this time, participants will have 6 study clinic visits and 1 to 2 phone calls. At these study clinic visits, parent(s) or legal guardian(s) will be asked if the participant experienced any side effects. A side effect is an unintentional or unexpected reaction to a vaccine. Participants in both groups will have 3 blood draws.

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Enrollment: 400 estimated patients

Sex: All

Ages: 42 to 98 days old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female infants born at >36 weeks of gestation and 2 months of age at the time of consent.
• Healthy infants determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study.

Exclusion criteria

• History of severe adverse reaction associated with a vaccine and/or severe allergic reaction (eg, anaphylaxis).
• Major known congenital malformation or serious chronic disorder.
• Other acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
• Previous vaccination with any licensed or investigational pneumococcal vaccine, or planned receipt through study participation.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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400 participants in 4 patient groups

Group 1 PG4

Experimental group

Description:

Multivalent Pneumococcal Vaccine

Treatment:

Biological: PG4

Group 1 20-valent pneumococcal conjugate vaccine (20vPnC)

Active Comparator group

Description:

20-valent pneumococcal conjugate vaccine (20vPnC)

Treatment:

Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)

Group 2 PG4

Experimental group

Description:

Multivalent Pneumococcal Vaccine

Treatment:

Biological: PG4

Group 2 20-valent pneumococcal conjugate vaccine (20vPnC)

Active Comparator group

Description:

20-valent pneumococcal conjugate vaccine (20vPnC)

Treatment:

Biological: 20-valent pneumococcal conjugate vaccine (20vPnC)