Kaysville, UT

Alliance for Multispecialty Research, LLC.

Respiratory Syncytial Virus Infections

Pneumococcal Infections

Pfizer

Merck Sharp & Dohme (MSD)

condition

allSponsorName

gender

Male

Female

overallStatus

Recruiting

Not yet recruiting

Active, not recruiting

Enrolling by invitation

Completed

Terminated

Withdrawn

Suspended

Unknown

type

Interventional

Observational

Expanded Access

phase

Early Phase 1

Phase 1

Phase 2

Phase 3

Phase 4

Not Applicable

funderTypes

Industry

Other U.S. Federal agency

All others

ageGroup

Child (birth-17)

Adult (18-64)

Older Adult (65+)

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

Alliance for Multispecialty Research, LLC. | Kaysville, UT

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

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