A Study to Evaluate the Safety, Tolerability, and Immunogenicity of Two Lots of V114 in Healthy Infants (V114-008)



Status:Completed
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any
Updated:10/18/2018
Start Date:March 21, 2017
End Date:October 4, 2018

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A Phase II, Double-Blind, Randomized, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Compared to Prevnar 13™ in Healthy Infants

This study is designed to evaluate the safety, tolerability, and immunogenicity of two
different lots of V114 in healthy infants 6 to 12 weeks (>=42 days to <=90 days) of age. The
primary hypothesis of the study is that the proportion of participants receiving V114 who
have serotype specific IgG >=0.35 mcg/mL for each of pneumococcal serotypes 1, 3, 4, 5, 6A,
6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F at 1 month after Dose 3 is non-inferior to that for
recipients of Prevnar 13™.


Inclusion Criteria:

- Infant approximately 2 months of age (42 days to 90 days), inclusive

- In good health

Exclusion Criteria:

- Prior administration of any pneumococcal vaccine

- Known hypersensitivity to any component of the pneumococcal conjugate vaccine or any
diphtheria toxoid-containing vaccine

- Known or suspected impairment of immunological function

- History of congenital or acquired immunodeficiency (eg, splenomegaly)

- Mother has documented human immunodeficiency virus (HIV) infection

- Mother has documented hepatitis B surface antigen-positive test result

- Known or history of functional or anatomic asplenia

- History of failure to thrive

- History of a coagulation disorder

- History of autoimmune disease

- Known neurologic or cognitive behavioral disorder

- Expects to require systemic corticosteroids within 30 days after each vaccination
during the trial

- Prior administration of a blood transfusion or blood products, including
immunoglobulin

- Participated in another clinical trial of an investigational product

- History of invasive pneumococcal disease or known history of other culture-positive
pneumococcal disease
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Syracuse, New York 13214
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1020 Walnut St
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