Pneumococcal Vaccines
Conditions
Keywords
31 Valent PCV, Pneumonia, Pneumococcal Infection
Brief summary
The objective of the study is to evaluate the safety, tolerability, and immunogenicity of 4 injections of VAX-31 (at 4 dose levels) compared to PCV20 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll approximately 352 subjects. Stage 3 of the study will enroll approximately 500 subjects.
Interventions
BIOLOGICAL0.5 mL of the low dose VAX-31
31 valent pneumococcal conjugate vaccine
BIOLOGICAL0.5 mL of the mid dose VAX-31
31 valent pneumococcal conjugate vaccine
BIOLOGICAL0.5 mL of the high dose VAX-31
31 valent pneumococcal conjugate vaccine
BIOLOGICAL0.5 mL dose of PCV20
20 valent pneumococcal conjugate vaccine
BIOLOGICAL0.5 mL of the High-PFS dose VAX-31
31 valent pneumococcal conjugate vaccine
Sponsors
Vaxcyte, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
42 Days to 89 Days
Healthy volunteers
Yes
Inclusion criteria
1. Healthy male or female infant ≥42 days to ≤89 days. 2. Full-term infant at least 37 weeks gestational age at birth. 3. Afebrile for ≥72 hours with an tympanic or rectal temperature \<38.0°C (\<100.4°F) before receipt of study vaccine.\*Criterion applies to each vaccination. If not met, visit may be rescheduled for a time when no longer febrile for ≥72 hours. 4. Able to attend all scheduled visits and comply with the study procedures. 5. Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent. 6. Subject's parent/legal guardian is able to fill out an eDiary of solicited AE and take daily tympanic temperature and measurements of local injection site reactions for the 7 days after each study vaccination. 7. Subject's parent/legal guardian has an email address and access to a computer or smartphone with internet to complete the eDiary.
Exclusion criteria
1. History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease. 2. Previous receipt of a licensed or investigational vaccine (excluding 1 dose of hepatitis B vaccine). 3. Known hypersensitivity to any vaccine. 4. Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency). 5. Use of any immunosuppressive therapy or planned use through the last blood draw (Visit 6). Receipt of a \<14-day course of systemic corticosteroids is not exclusionary if completed ≥1 month prior to first study vaccination. Topical and inhaled/nebulized steroids are also permitted. 6. History of failure to thrive or prior hospitalization for any chronic condition. 7. Subject has a bleeding disorder contraindicating IM vaccination. 8. Subject or his/her mother has documented hepatitis B surface antigen-positive test. 9. Subject has a known neurologic or cognitive behavioral disorder. 10. Subject has a known clinically significant congenital malformation or serious chronic disorder. 11. Receipt of a blood transfusion or blood products, including immunoglobulins. 12. Receipt of any investigational study product since birth, currently participating in another interventional investigational study, or plans to receive another investigational product while on study. 13. Any infant who cannot be adequately followed for safety according to the protocol plan. 14. Any other reason that in the opinion of the Investigator may interfere with the evaluation required by the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination | 7 days after each vaccination | Solicited local reactions include erythema, edema, and tenderness at the injection site |
| Percentage of subjects with any solicited systemic AE within 7 days after each vaccination | 7 days after each vaccination | Solicited systemic reactions include fever, irritability, decreased appetite, decreased sleep, and increased sleep |
| Percentage of subjects with any unsolicited AE within 1 month after each vaccination | 1 months after each vaccination | Percentage of subjects with unsolicited AE |
| Percentage of subjects with any medically attended adverse events (MAAE) within 6 months after last vaccination | 6 months after last vaccination | Percentage of subjects with MAAE |
| Percentage of subjects with any Serious Adverse Events (SAE) within 6 months after last vaccination | 6 months after last vaccination | Percentage of subjects with SAE |
| Percentage of subjects with any new onset of chronic illness (NOCI) within 6 months after last vaccination | 6 months after last vaccination | Percentage of subjects with NOCI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL 1 month after Dose 3 | 1 month after Dose 3 | Percentage of subjects achieving a serotype-specific anti-pneumococcal IgG antibody concentration ≥0.35 mcg/mL |
| Serotype-specific IgG antibody geometric mean concentration (GMC) 1 month after Dose 3 | 1 month after Dose 3 | Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31 |
| Serotype-specific IgG antibody GMC 1 month after Dose 4 | 1 month after Dose 4 | Antibody geometric mean concentrations as measured by IgG for the 31 pneumococcal serotypes in VAX-31 |
Countries
Puerto Rico, United States
Outcome results
None listed