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



Status:Recruiting
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:3/1/2019
Start Date:June 1, 2018
End Date:June 9, 2020
Contact:Pfizer CT.gov Call Center
Email:ClinicalTrials.gov_Inquiries@pfizer.com
Phone:1-800-718-1021

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A PHASE 2, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE GIVEN WITH, OR SEPARATELY FROM, 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN HEALTHY INFANTS

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).


Inclusion Criteria:

- 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.

Exclusion Criteria:

- 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.
We found this trial at
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860 Peachwood Drive
DeLand, Florida 32720
(386) 740-0770
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301 University Blvd
Galveston, Texas 77555
(409) 772-1011
University of Texas Medical Branch Established in 1891 as the University of Texas Medical Department,...
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3800 Houma Blvd., Suite 335
Metairie, Louisiana 70006
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Boynton Beach, Florida 33435
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Bridgeton, Missouri 63044
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Charleston, South Carolina 29414
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800 Talbotton Road
Columbus, Georgia 31904
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Dayton, Ohio 45409
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East Syracuse, New York 13057
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4247 West Ridge Road
Erie, Pennsylvania 16506
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Fresno, California 93720
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525 Verdae Boulevard
Greenville, South Carolina 29607
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Hermitage, Pennsylvania 16148
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Huntington, West Virginia 25701
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2212 East 4th Street
Huntington Beach, California 92648
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Kansas City, Missouri 64111
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Keller, Texas 76248
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Madera, California 93637
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Ontario, California 91762
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San Antonio, Texas 78240
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