Pneumococcal Disease
Conditions
Brief summary
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.
Interventions
BIOLOGICALPG4 Multivalent Vaccine
Multivalent Pneumococcal Vaccine
BIOLOGICAL20 Valent Pneumococcal Conjugate Vaccine (20vPnC)
20 Valent Pneumococcal Conjugate Vaccine
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 49 Years
Healthy volunteers
Yes
Inclusion criteria
Adults 18 through 49 years of age, who have no history of receiving a pneumococcal vaccine after 5 years of age.
Exclusion criteria
Individuals with a history of severe allergic reactions to a vaccine or its components, serious chronic medical disorders, significant psychiatric conditions, known or suspected immunodeficiency, substance abuse issues, asplenia, bleeding diathesis or prolonged bleeding, a history of a prior confirmed invasive pneumococcal infection, and pregnant or breastfeeding females will be excluded from enrollment in the trial.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants with Serious Adverse Events (SAEs) | From Vaccination to 6 months after Vaccination | SAEs occurring from Dose 1 to 6 months after the vaccination |
| OPA geometric mean ratios (GMR) between each pair of PG4 vaccine lots | 1 month after Vaccination | OPA GMRs between each pair of PG4 vaccine lots at 1 month after vaccination |
| Percentage of Participants with Prespecified Local Reactions Within 7 Days After Vaccination | Within 7 days after Vaccination | Prompted local reactions after each dose |
| Percentage of Participants reporting Prespecified Systemic Events Within 7 Days after Vaccination | Within 7 days after Vaccination | Prompted systemic events after each dose |
| Percentage of Participants with Adverse Events (AEs) | From Vaccination to 1 month after Vaccination | AEs occurring from Dose 1 to 1 month after the vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| OPA geometric mean fold rise (GMFR) for PG4 vaccine serotypes | From before vaccination to 1 month after vaccination | GMFRs in OPA titers from before to 1 month after vaccination |
| Percentages of participants with OPA titers ≥ lower limit of quantitation (LLOQ) | From before vaccination to 1 month after vaccination | Percentages of participants with OPA titers ≥ lower limit of quantitation (LLOQ) from before vaccination to 1 month after vaccination |
| OPA Serotype-specific geometric mean titers (GMT) for PG4 vaccine serotypes | 1 month after Vaccination | OPA GMTs at 1 month after vaccination |
| Percentages of participants with a ≥4-fold rise in opsonophagocytic activity (OPA) titers | From Vaccination to 6 months after Vaccination | Percentages of participants with a ≥4-fold rise in OPA titers from before to 1 month after vaccination |
Countries
United States
Contacts
CONTACTPfizer CT.gov Call Center
STUDY_DIRECTORPfizer CT.gov Call Center
Pfizer
Outcome results
None listed