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 |
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™.
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
We found this trial at
31
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League City, Texas 77573
Phone: 409-772-5278
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Louisville, Kentucky 40202
Phone: 502-852-3774
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3175 Chemin de la Côte-Sainte-Catherine
Montreal, Quebec H3T 1C5
Montreal, Quebec H3T 1C5
Phone: 5143454675
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1020 Walnut St
Philadelphia, Pennsylvania 19107
Philadelphia, Pennsylvania 19107
(215) 955-6000
Phone: 215-955-2357
Thomas Jefferson University We are dedicated to the health sciences and committed to educating professionals,...
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Syracuse, New York 13214
Phone: 315-464-5102
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