NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults

NCT07794748

Not Yet RecruitingPhase 3

Sponsor: Pfizer

Conditions: Pneumococcal Disease

Interventions: PG4 Multivalent Vaccine, PG4 Multivalent Vaccine, PG4 Multivalent Vaccine, 20 Valent Pneumococcal Conjugate Vaccine (20vPnC)

Countries: United States

The purpose of this study is to provide safety data and demonstrate lot consistency with the PG4 vaccine by evaluating the immunogenicity of 3 different lots of this vaccine. This study will compare a new pneumococcal vaccine with the vaccine currently in use to see if they are similarly safe. It will also compare three batches of the new vaccine to make sure they work the same way. Blood samples will be taken to measure how the body responds to the vaccines. The study will be conducted in the United States. Participants will be assigned to 1 of 4 groups. Group 1: PG4 vaccine lot 1; Group 2: PG4 vaccine lot 2; Group 3: PG4 vaccine lot 3; Group 4: 20vPnC. Within each group, participants will be assigned by chance in a 2:2:2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) lot 1, PG4 lot 2, PG4 Lot 3 or 20vPnC, given in the arm. This means that for every 7 participants, about 2 will receive either PG4 lot 1, lot 2 or lot 3 and about 1 will receive 20vPnC. Each participant will take part in the study for approximately 6 months.

Eligibility overview

Sex: ALL

Age: 18 Years to 49 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

Adults 18 through 49 years of age, who have no history of receiving a pneumococcal vaccine after 5 years of age.

Exclusion Criteria:

Individuals with a history of severe allergic reactions to a vaccine or its components, serious chronic medical disorders, significant psychiatric conditions, known or suspected immunodeficiency, substance abuse issues, asplenia, bleeding diathesis or prolonged bleeding, a history of a prior confirmed invasive pneumococcal infection, and pregnant or breastfeeding females will be excluded from enrollment in the trial.

Locations (25)

Lake Forest, California, United States
Walnut Creek, California, United States
Milford, Connecticut, United States
Doral, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Miami Lakes, Florida, United States
West Palm Beach, Florida, United States
Fayetteville, Georgia, United States
Stockbridge, Georgia, United States
Honolulu, Hawaii, United States
Melrose Park, Illinois, United States
Sioux City, Iowa, United States
Grosse Pointe Woods, Michigan, United States
Chesterfield, Missouri, United States
Grand Island, Nebraska, United States
Wilmington, North Carolina, United States
Cincinnati, Ohio, United States
Moncks Corner, South Carolina, United States
Myrtle Beach, South Carolina, United States
Mesquite, Texas, United States
Sugar Land, Texas, United States
Tomball, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States