A Trial To Evaluate A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50-85 Years Of Age
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Pneumonia, Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 50 - 85 |
| Updated: | 12/19/2018 |
| Start Date: | October 12, 2017 |
| End Date: | May 24, 2019 |
A Phase 1/2, Randomized, Observer-blinded Trial To Evaluate The Safety, Tolerability, And Immunogenicity Of A Multivalent Pneumococcal Conjugate Vaccine In Healthy Adults 50 Through 85 Years Of Age
This is a 2-stage, phase 1/2, randomized, active-controlled, observer-blinded study with a
2-arm parallel design in each stage.
In Stage 1 healthy adults 50 to 64 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).
In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2
months prior to investigational product administration will be randomized equally to receive
either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the
licensed 23-valent pneumococcal polysaccharide vaccine (control group).
2-arm parallel design in each stage.
In Stage 1 healthy adults 50 to 64 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).
In Stage 2 healthy adults 65 to 85 years of age previously vaccinated with Prevnar 13 >=2
months prior to investigational product administration will be randomized equally to receive
either a single intramuscular dose of multivalent pneumococcal conjugate vaccine or the
licensed 23-valent pneumococcal polysaccharide vaccine (control group).
Inclusion Criteria:
- Stage 1: Healthy male or female adults 50 to 64 years of age with no history of
pneumococcal vaccination
- Stage 2: Healthy male or female adults 65 to 85 years of age previously vaccinated
with Prevnar 13 >= 2 months prior to investigational product administration
Exclusion Criteria:
- Stage 1: Vaccination within 12 months before investigational product administration
with diphtheria-, pertussis-, or tetanus-containing vaccine
- Stage 2: Previous vaccination with any pneumococcal vaccine other than a single prior
dose of Prevnar 13
We found this trial at
17
sites
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Site Overview Achieve has two clinical research sites in Birmingham, AL. Our Birmingham sites are conveniently located...
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PMG Research of Wilmington PMG Research of Wilmington has two offices situated in a 1...
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