Study to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Vaccine Given With Prevnar 13 in Healthy Infants

Stopped early · Phase 2

Conditions studied: Pneumococcal Infections

In brief

This is a Phase 2, randomized, active-controlled, open-label study with a 3-arm parallel design. Healthy 2-month old infants (42 to 98 days of age) with no history of pneumococcal vaccination will be randomized in a 1:1:1 ratio to receive a 4-dose series of: multivalent pneumococcal conjugate vaccine coadministered with Prevnar 13 (Group 1); multivalent pneumococcal conjugate vaccine given 1 month after Prevnar 13 (Group 2); or Prevnar 13 with a single dose of multivalent pneumococcal conjugate vaccine (Group 3).

Key facts

Study ID

NCT03550313

Run by

Pfizer

People needed

565

Starts

2018-06-01

Expected to finish

2020-11-05

Last updated by the study team

2021-11-30

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.

You may not qualify if…

• Previous vaccination with licensed or investigational pneumococcal vaccine.
• Prior receipt of routine pediatric vaccines, with the exception of hepatitis B vaccine.
• 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

• Mobile Pediatric Clinic — Mobile, Alabama, United States
• Harrisburg Family Medical Center — Harrisburg, Arkansas, United States
• Emmaus Research Center, Inc. — Anaheim, California, United States
• Hoag Memorial Hospital Presbyterian — Huntington Beach, California, United States
• Madera Family Medical Group — Madera, California, United States
• Orange County Research Institute — Ontario, California, United States
• Center for Clinical Trials, LLC — Paramount, California, United States
• Center for Clinical Trials — Paramount, California, United States
• Gentle Medicine Associates — Boynton Beach, Florida, United States
• Avail Clinical Research, LLC — DeLand, Florida, United States
• Next Phase Research Alliance — Homestead, Florida, United States
• Acevedo Clinical Research Associates — Miami, Florida, United States
• Bio-Medical Research, LLC — Miami, Florida, United States
• Crystal Biomedical Research, LLC — Miami Lakes, Florida, United States
• IACT Health — Columbus, Georgia, United States
• Advocate Children's Hospital — Park Ridge, Illinois, United States
• MOC Research — Mishawaka, Indiana, United States
• Michael W. Simon, MD, PSC — Lexington, Kentucky, United States
• All Children Pediatrics — Louisville, Kentucky, United States
• Meridian Clinical Research, LLC — Baton Rouge, Louisiana, United States
• MedPharmics, LLC — Metairie, Louisiana, United States
• LSUHSC-Shreveport — Shreveport, Louisiana, United States
• Ochsner-LSU Health Shreveport — Shreveport, Louisiana, United States
• Floating Hospital for Children at Tufts Medical Center — Boston, Massachusetts, United States
• Pediatric Phlebotomy — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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