20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

Completed · Phase 3

Conditions studied: Pneumococcal Disease

In brief

20-valent Pneumococcal Conjugate Vaccine Safety and Immunogenicity Study of a 4-Dose Series in Healthy Infants

Key facts

Study ID

NCT04382326

Run by

Pfizer

People needed

1997

Starts

2020-05-20

Expected to finish

2022-09-02

Last updated by the study team

2023-12-06

Who can join

Age: 0 and older, up to 0. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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
• Previous receipt of >1 dose of hepatitis B vaccine; or receipt of a single hepatitis B vaccine dose administered at >30 days old, or previous receipt of any licensed or investigational pneumococcal vaccine, or planned receipt through study participation

Where it is running

• UAB Pediatric Primary Care Clinic at Children's of Alabama — Birmingham, Alabama, United States
• Southeastern Pediatric Associates — Dothan, Alabama, United States
• MedPharmics, LLC — Phoenix, Arizona, United States
• Northwest Arkansas Pediatrics — Fayetteville, Arkansas, United States
• The Children's Clinic of Jonesboro, P.A. — Jonesboro, Arkansas, United States
• Gardens Medical Center — Bell Gardens, California, United States
• Coast Clinical Research, LLC — Bellflower, California, United States
• Priti Desai, M.D. Inc. — Covina, California, United States
• Universal Biopharma Research Institute Inc. — Fresno, California, United States
• Matrix Clinical Research — Gardena, California, United States
• Advanced Investigative Medicine, Inc. — Hawthorne, California, United States
• Kaiser Permanente Oakland — Oakland, California, United States
• Orange County Research Institute — Ontario, California, United States
• Center for Clinical Trials of San Gabriel — West Covina, California, United States
• Children's Colorado Health Pavilion (Child Health Clinic) — Aurora, Colorado, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• Optumcare Colorado Springs, LLC — Colorado Springs, Colorado, United States
• Optumcare Colorado Springs, LLC — Colorado Springs, Colorado, United States
• Gentle Medicine Associates — Boynton Beach, Florida, United States
• Sarkis Clinical Trials — Gainesville, Florida, United States
• Benton Pediatrics — Gainesville, Florida, United States
• Qway Research — Hialeah, Florida, United States
• Next Phase Research Alliance — Homestead, Florida, United States
• Axcess Medical Research — Loxahatchee Groves, Florida, United States
• Children's of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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