Streptococcus Pneumoniae
Conditions
Brief summary
The purpose of this study is to learn about the safety and tolerability of a pneumococcal vaccine in adults. Participants will receive either: * an experimental PG4 vaccine * a PG4 vaccine comparator * a standard 20vPnC vaccine comparator * placebo. A placebo does not have any medicine in it but looks just like the study medicine. Participants will take part in this study for up to 18 months depending on which group they are assigned to. During this time, the participants will receive up to two doses of study vaccine or comparator and take part in follow-up visits. At these clinic visits, participants will be asked if any side effects were experienced. The participants will also have to give blood samples during clinic visits.
Interventions
BIOLOGICALPG4 vaccine in Buffer 1 with low dose PA-001
Multivalent pneumococcal conjugate vaccine
BIOLOGICALPG4 in Buffer 1 with low dose PA-002
Multivalent pneumococcal conjugate vaccine
BIOLOGICALPG4 in Buffer 1 with high dose PA-001
Multivalent pneumococcal conjugate vaccine
BIOLOGICALPG4 vaccine in Buffer 1 with high dose PA-002
Multivalent pneumococcal conjugate vaccine
BIOLOGICALPG4 vaccine in Buffer 2
Multivalent pneumococcal conjugate vaccine
BIOLOGICAL20-valent pneumococcal conjugate vaccine
(20vPnC)
BIOLOGICALSaline injection
Placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
65 Years to 84 Years
Healthy volunteers
Yes
Inclusion criteria
Key Inclusion Criteria: * Healthy participants who are determined by medical history, physical examination (if required), and clinical judgment of the investigator to be eligible for inclusion in the study. * Participants either with no history of ever receiving a pneumococcal vaccine or who have received a pneumococcal vaccine more than 5 years prior to vaccination in this study Key
Exclusion criteria
• Participants with a history of microbiologically proven invasive disease caused by S pneumoniae.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants reporting prespecified local reactions after each dose. | Within 7 days after each study intervention. | Prespecified local reactions (redness, swelling, and pain at the injection site) occurring within 7 days of each dose administered in the study. |
| Percentage of participants reporting prespecified systemic reactions after each dose. | Within 7 days after each study intervention. | Prespecified systemic reactions (fever, vomiting, diarrhea, headache, fatigue, muscle pain, and joint pain) occurring within 7 days of each dose administered in the study. |
| Percentage of participants reporting adverse events. | From signing of the ICD to 1 month after last study intervention. | Adverse Events (AEs) occurring from Dose 1 through 1 month after the last vaccination |
| Percentage of participants reporting serious adverse events. | From signing of the ICD to 6 months after the last study intervention. | Serious Adverse Events (SAEs) occurring from Dose 1 through 6 months after the last vaccination. |
| Percentage of participants with abnormal hematology and chemistry laboratory values. | Within 2 weeks after each study intervention. | Any abnormal hematology or chemistry laboratory values as compared to baseline within 2 weeks after each study intervention. |
Countries
United States
Contacts
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed