A Phase 1, Randomized, Controlled, Observer-blinded Trial to Evaluate the Safety and Immunogenicity of a Multivalent Pneumococcal Conjugate Vaccine in Healthy Adults Aged 18 to 49 Years



Status:Completed
Conditions:Pneumonia, Infectious Disease
Therapuetic Areas:Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases
Healthy:No
Age Range:18 - 49
Updated:9/13/2018
Start Date:November 3, 2016
End Date:August 1, 2017

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A Phase 1, Randomized, Controlled, Observer-blinded Trial To Evaluate The Safety And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults Aged 18 To 49 Years

This is a Phase 1 first-in-human, randomized, controlled, observer-blinded study with a 2-arm
parallel design. Healthy adults aged 18 to 49 years of age with no history of pneumococcal
vaccination will be randomized equally to receive either a single intramuscular dose of
multivalent pneumococcal conjugate vaccine or a licensed tetanus, diphtheria, acellular
pertussis combination vaccine (Tdap) (control group).


Inclusion Criteria:

1. Male or female adults 18 to 49 years of age.

2. Healthy adults determined by medical history, physical examination, laboratory
screening, and clinical judgment to be eligible for the study.

3. Negative serum pregnancy test for all female subjects who are of childbearing
potential.

Exclusion Criteria:

1. Baseline laboratory test results outside of the normal reference range considered
clinically significant.

2. History of severe adverse reaction and/or severe allergic reaction (eg, anaphylaxis)
associated with a vaccine.

3. History of culture-proven invasive disease caused by S pneumoniae.

4. Previous vaccination with any licensed or investigational pneumococcal vaccine, or
planned receipt through study participation.

5. Vaccination with diphtheria-, pertussis-, or tetanus-containing vaccine(s) from 12
months before investigational product administration, or planned receipt through study
participation.

6. Male subjects and female subjects of childbearing potential who are unwilling or
unable to use a highly effective method of contraception as outlined in this protocol
for the duration of the study participation and for at least 6 months after the last
dose of investigational product.
We found this trial at
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New Haven, Connecticut 06511
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New Haven, CT
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