Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine in Healthy Infants

Completed · Phase 2

Conditions studied: Pneumococcal Infections

In brief

A Phase 2, Randomized, Double-Blind Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Infants

Key facts

Study ID

NCT03512288

Run by

Pfizer

People needed

460

Starts

2018-04-16

Expected to finish

2020-02-11

Last updated by the study team

2021-03-02

Who can join

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

You may qualify if…

• Male or female infant born at >36 weeks of gestation and aged 2 months (42 to 98 days) at the time of consent (the day of birth is considered day of life 1).
• Healthy infant determined by medical history, physical examination, and clinical judgment to be eligible for the study.

You may not qualify if…

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• Prior receipt of diphtheria, tetanus, pertussis, or polio vaccines.
• Previous receipt of >1 dose of hepatitis B vaccine.
• Prior hepatitis B vaccine must have been administered at age <30 days.
• Major known congenital malformation or serious chronic disorder. Receipt of blood/plasma products or immunoglobulins

Where it is running

• Northwest Arkansas Pediatrics — Fayetteville, Arkansas, United States
• Premier Health Research Center, LLC — Downey, California, United States
• St. Joseph Heritage Healthcare — Huntington Beach, California, United States
• Kaiser Permanente Oakland — Oakland, California, United States
• Orange County Research Institute — Ontario, California, United States
• Kaiser Permanente South Sacramento — Sacramento, California, United States
• Kaiser Permanente San Jose — San Jose, California, United States
• Kaiser Permanente Santa Clara — Santa Clara, California, United States
• ACC Pediatric Research — Haughton, Louisiana, United States
• MedPharmics, LLC — Metairie, Louisiana, United States
• LSUHSC Shreveport — Shreveport, Louisiana, United States
• University Health Shreveport — Shreveport, Louisiana, United States
• Children's Physicians, Creighton University Medical Center — Omaha, Nebraska, United States
• Child Health Care Associates — East Syracuse, New York, United States
• Blue Ridge Pediatric and Adolescent Medicine, Inc. — Boone, North Carolina, United States
• Capitol Pediatrics & Adolescent Center PLLC — Raleigh, North Carolina, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cincinnati Children's Medical Center — Cincinnati, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
• Pediatric Associates of Mt. Carmel, Inc. — Cincinnati, Ohio, United States
• Ohio Pediatric Research Association, Inc. — Dayton, Ohio, United States
• Senders Pediatrics — South Euclid, Ohio, United States
• Oklahoma State University - Center for Health Sciences — Tulsa, Oklahoma, United States
• Allegheny Health and Wellness Pavilion — Erie, Pennsylvania, United States

Full record on ClinicalTrials.gov

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