A Study to Evaluate the Safety, Tolerability and Immunogenicity of V114 in Healthy Adults and Infants (V114-004)



Status:Recruiting
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:Any - 49
Updated:7/11/2015
Start Date:January 2014
End Date:August 2016
Contact:Toll Free Number
Phone:1-888-577-8839

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A Phase I-II, Randomized, Double-Blind, Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 in Healthy Adults and Infants

This study is designed to assess the effect of different dose levels of pneumococcal
polysaccharide and adjuvant on the safety and immunogenicity of V114 in healthy adults and
infants.

This study will consist of 2 stages. In stage 1, adult participants will be administered a
single dose of V114. After completion of a review of safety data from the adult cohort,
stage 2 of the study will enroll infants. Infants will receive a 4-dose schedule of either
an active comparator or 1 of 5 dose/adjuvant combinations of V114.

Inclusion Criteria:

Infants -Healthy and able to attend all scheduled visits.

Adults:

-Highly unlikely to conceive from vaccination through to 6 weeks after administration of
the vaccine.

Exclusion Criteria:

Infants and Adults

- Prior administration of any pneumococcal vaccine, any non-live vaccine within 14 days
or any live vaccine within 30 days

- History of invasive pneumococcal disease

- Known hypersensitivity to any vaccine component

- Received systemic corticosteroids within 14 days of first vaccination

- Known or suspected impairment of immune function

- Febrile illness within 72 hours before vaccination

- Received blood transfusion or blood products within 30 days. Infants

- Mother has documented human immunodeficiency virus or is hepatitis B surface antigen
positive

- Has asplenia or failure to thrive. Adults

- Is breastfeeding.
We found this trial at
23
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