Low dose multivalent pneumococcal conjugate vaccine formulation A
OtherBiological
NCT Number: NCT05831124
The purpose of this clinical trial is to learn about a pneumococcal vaccine with a new ingredient (PF-07872411) intended to enhance the effects of the vaccine. This pneumococcal vaccine with the new ingredient may prevent the diseases caused by pneumococcal bacteria like meningitis, sepsis, ear infections and sinusitis.
Meningitis is an infection in which the tissue around the brain and spine is swollen.
Sepsis is a very serious infection in your blood caused by a germ (a bacteria). Sinusitis is when your sinuses (the air-filled spaces inside your nose and head), are infected.
This study is seeking for healthy participants who:
* are above 50 years of age and less than 64 years of age. * have not taken any vaccine for pneumococcal diseases before. * have not taken any vaccines with additional ingredients within 1 year before administration of the study vaccine.
All participants will receive a single study vaccine shot in the upper arm muscle at the study clinic. The study will compare the experiences of people receiving the vaccine with a new ingredient in the vaccine to those without the new ingredient. This will be done by comparing 2 different dose levels of the new ingredient. It will also be compared against people who receive the vaccine without the new ingredient and at different dose levels. This will help the study team establish if the vaccine with a new ingredient is safe and effective.
Participants will take part in this study for about 12 months. During this time participants will have up to 6 clinic 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 these visits.
Some participants will need to have blood taken for laboratory tests before they can be judged to be eligible to be included in the study.
Looking for future studies?
Notify Me50 year–64 year
All sexes
Interventional
Phase 1
Indago Research & Health Center, Inc, Hialeah, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Biological
Biological
low dose multivalent pneumococcal conjugate vaccine
Other names: Primary control
multivalent pneumococcal conjugate vaccine
Other names: Control
Time frame: 7 days
Local reactions (redness, swelling, pain at the injection site) after vaccination.
Time frame: 7 days
Systemic events (fever, vomiting, diarrhea, headache, fatigue, chills, muscle pain, and joint pain) after vaccination.
Time frame: 1 month
Adverse Events occurring within 1 month after vaccination.
Time frame: 6 months
SAEs occurring within 6 months after vaccination.
Time frame: 12 months
SAEs occurring within 12 months after vaccination.
Time frame: 6 months
NDCMCs occurring within 6 months after vaccination.
Time frame: 12 months
NDCMCs occurring within 12 months after vaccination.
Time frame: 6 months
MAAEs occurring within 6 months after vaccination.
Time frame: 12 months
MAAEs occurring within 12 months after vaccination.
Time frame: 2 weeks
Abnormal hematology and chemistry laboratory values occurring 2 weeks after vaccination.
Time frame: 1 month
OPA geometric mean titers (GMTs) 1 month after vaccination
Pfizer
Industry
A PHASE 1, RANDOMIZED, DOUBLE-BLIND STUDY OF THE SAFETY AND IMMUNOGENICITY OF A MULTIVALENT PNEUMOCOCCAL CONJUGATE VACCINE WITH AN ADJUVANT ADMINISTERED IN ADULTS 50 THROUGH 64 YEARS OF AGE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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