A Study to Assess the Safety, Tolerability, and Immunogenicity of 3 Lots of a Multivalent Pneumococcal Conjugate Vaccine Administered to Adults
Part of paid clinical trials in Lake Forest, California.
- Sponsor
- Pfizer
- Study ID
- NCT07794748
- Phase
- PHASE3
- Status
- Not Yet Recruiting
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Conditions
- Pneumococcal Disease
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 49 Years
- Healthy Volunteers
- Accepted
Interventions
- PG4 Multivalent Vaccine — BIOLOGICALMultivalent Pneumococcal Vaccine
- PG4 Multivalent Vaccine — BIOLOGICALMultivalent Pneumococcal Vaccine
- PG4 Multivalent Vaccine — BIOLOGICALMultivalent Pneumococcal Vaccine
- 20 Valent Pneumococcal Conjugate Vaccine (20vPnC) — BIOLOGICAL20 Valent Pneumococcal Conjugate Vaccine
Study Details
The purpose of this study is to provide safety data and demonstrate lot consistency with the PG4 vaccine by evaluating the immunogenicity of 3 different lots of this vaccine. This study will compare a new pneumococcal vaccine with the vaccine currently in use to see if they are similarly safe. It will also compare three batches of the new vaccine to make sure they work the same way. Blood samples will be taken to measure how the body responds to the vaccines. The study will be conducted in the United States. Participants will be assigned to 1 of 4 groups. Group 1: PG4 vaccine lot 1; Group 2: PG4 vaccine lot 2; Group 3: PG4 vaccine lot 3; Group 4: 20vPnC. Within each group, participants will be assigned by chance in a 2:2:2:1 ratio to receive 1 vaccine injection (shot) with either PG4 (new vaccine) lot 1, PG4 lot 2, PG4 Lot 3 or 20vPnC, given in the arm. This means that for every 7 participants, about 2 will receive either PG4 lot 1, lot 2 or lot 3 and about 1 will receive 20vPnC. Each participant will take part in the study for approximately 6 months.
Key Dates
- First listed
- Aug 31, 2026
- Start date
- Sep 8, 2026
- Status verified
- Aug 2026
- Primary completion
- Jun 7, 2027
- Completion
- Jun 7, 2027
Study Design
- Enrollment
- 4,670 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- PREVENTION
Arms
- Experimental: PG4 Vaccine Lot 1Multivalent Pneumococcal Vaccine
- Experimental: PG4 Vaccine Lot 2Multivalent Pneumococcal Vaccine
- Experimental: PG4 Vaccine Lot 3Multivalent Pneumococcal Vaccine
- Active Comparator: 20 Valent Pneumococcal Conjugate Vaccine (20vPnC)20 Valent Pneumococcal Conjugate Vaccine
Primary Outcome Measure
Percentage of Participants with Prespecified Local Reactions Within 7 Days After Vaccination [ Time Frame: Within 7 days after Vaccination ]
Central Contacts
- Pfizer CT.gov Call Center1-800-718-1021
Locations (25)
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