A Phase 2, Randomized, Double-Blind, Active-Controlled, Dose-Finding Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 in Healthy Infants Given 4 Doses at 2, 4, 6, and 12-15 Months of Age Concomitantly With Routine Pediatric Vaccines
Overview
- Phase
- Phase 2
- Intervention
- 0.5 mL of the low dose VAX-31
- Conditions
- Pneumococcal Vaccines
- Sponsor
- Vaxcyte, Inc.
- Enrollment
- 905
- Locations
- 82
- Primary Endpoint
- Percentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination
- Status
- Active, not recruiting
- Last Updated
- 3 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Healthy male or female infant ≥42 days to ≤89 days.
- •Full-term infant at least 37 weeks gestational age at birth.
- •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.
- •Able to attend all scheduled visits and comply with the study procedures.
- •Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
- •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.
- •Subject's parent/legal guardian has an email address and access to a computer or smartphone with internet to complete the eDiary.
Exclusion Criteria
- •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.
- •Previous receipt of a licensed or investigational vaccine (excluding 1 dose of hepatitis B vaccine).
- •Known hypersensitivity to any vaccine.
- •Known or suspected impairment of immunological function (e.g., asplenia, human immunodeficiency virus, primary immunodeficiency).
- •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.
- •History of failure to thrive or prior hospitalization for any chronic condition.
- •Subject has a bleeding disorder contraindicating IM vaccination.
- •Subject or his/her mother has documented hepatitis B surface antigen-positive test.
- •Subject has a known neurologic or cognitive behavioral disorder.
- •Subject has a known clinically significant congenital malformation or serious chronic disorder.
Arms & Interventions
VAX-31 Low
Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.
Intervention: 0.5 mL of the low dose VAX-31
VAX-31 Mid
Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.
Intervention: 0.5 mL of the mid dose VAX-31
VAX-31 High
Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.
Intervention: 0.5 mL of the high dose VAX-31
PCV20
Participants will receive 4 doses of PCV20 administered as an intramuscular injection of the standard dose at 2, 4, 6, and 12-15 months of age.
Intervention: 0.5 mL dose of PCV20
VAX-31 High-PFS
Participants will receive 4 doses of VAX-31 administered as an intramuscular injection at 2, 4, 6, and 12-15 months of age at one of four dose levels.
Intervention: 0.5 mL of the High-PFS dose VAX-31
Outcomes
Primary Outcomes
Percentage of subjects with any solicited local injection site adverse events (AE) within 7 days after each vaccination
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 6 months after last vaccination
Percentage of subjects with NOCI
Secondary Outcomes
- 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)
- Serotype-specific IgG antibody geometric mean concentration (GMC) 1 month after Dose 3(1 month after Dose 3)
- Serotype-specific IgG antibody GMC 1 month after Dose 4(1 month after Dose 4)