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.
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Parallel
PG4 Multivalent Vaccine
Biological/VaccineMultivalent Pneumococcal Vaccine
PG4 Multivalent Vaccine
Biological/VaccineMultivalent Pneumococcal Vaccine
PG4 Multivalent Vaccine
Biological/VaccineMultivalent Pneumococcal Vaccine
20 Valent Pneumococcal Conjugate Vaccine (20vPnC)
Biological/Vaccine20 Valent Pneumococcal Conjugate Vaccine
Percentage of Participants with Prespecified Local Reactions Within 7 Days After Vaccination
Prompted local reactions after each dose
Percentage of Participants reporting Prespecified Systemic Events Within 7 Days after Vaccination
Prompted systemic events after each dose
Percentage of Participants with Adverse Events (AEs)
AEs occurring from Dose 1 to 1 month after the vaccination
Percentage of Participants with Serious Adverse Events (SAEs)
SAEs occurring from Dose 1 to 6 months after the vaccination
OPA Serotype-specific geometric mean titers (GMT) for PG4 vaccine serotypes
OPA GMTs at 1 month after vaccination
OPA geometric mean fold rise (GMFR) for PG4 vaccine serotypes
GMFRs in OPA titers from before to 1 month after vaccination
Percentages of participants with a ≥4-fold rise in opsonophagocytic activity (OPA) titers
Percentages of participants with a ≥4-fold rise in OPA titers from before to 1 month after vaccination
Percentages of participants with OPA titers ≥ lower limit of quantitation (LLOQ)
Percentages of participants with OPA titers ≥ lower limit of quantitation (LLOQ) from before vaccination to 1 month after vaccination
