This is a Phase 3, randomized, double-blind study to evaluate the safety and immunogenicity of VAX-31 and seasonal influenza vaccine in pneumococcal-naïve adults ≥ 50 years when the two vaccines are administered at the same visit or separately.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
1,300
0.5 mL of VAX-31 will be administered into the deltoid muscle
0.5 mL of SIV into the deltoid muscle
0.5mL of placebo (normal saline) into the deltoid muscle
For each of the 32 serotypes (the 31 serotypes included in VAX-31, and serotype 20B), the ratio (co-administration group to sequential administration group) of opsonophagocytic activity (OPA) geometric mean titers (GMT) in evaluable participants
Time frame: 1 Month after VAX-31 vaccination
For each of the strains in SIV, the ratio (co-administration group to sequential administration group) of hemagglutination inhibition (HAI) GMT in evaluable participants
Time frame: 1 Month after SIV administration
Percentage of participants reporting solicited local adverse events (AE) within 7 days after Day 1 and Month 1 vaccination (redness, swelling, and pain at injection site) in each group
Time frame: 7 days after each vaccination
Percentage of participants reporting solicited systemic AE within 7 days after Day 1 and Month 1 vaccination (fever, headache, fatigue, muscle pain, and joint pain) in each group
Time frame: 7 days after each vaccination
Percentage of participants reporting unsolicited AE within 1 month after Day 1 and Month 1 vaccination in each group
Time frame: 7 days after each vaccination
Percentage of participants reporting NOCI, MAAE, and SAE within 6 months after last vaccination in each group
Time frame: 6 Months after last vaccination
For each of the 32 serotypes (the 31 serotypes included in VAX-31, and serotype 20B), the ratio (co-administration group to sequential administration group) of IgG geometric mean concentrations (GMC) in evaluable participants
Time frame: 1 month after VAX-31 administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Hope Research Institute
Phoenix, Arizona, United States
RECRUITINGTekton Research at Fort Collins
Fort Collins, Colorado, United States
RECRUITINGUniversity Clinical Research - Deland
DeLand, Florida, United States
RECRUITINGCenExel Research Centers of America
Hollywood, Florida, United States
RECRUITINGHealth Awareness
Jupiter, Florida, United States
RECRUITINGAccel Research Sites - Lakeland
Lakeland, Florida, United States
RECRUITINGAccel Research Sites - Largo
Largo, Florida, United States
RECRUITINGPrecision Clinical Research
Sunrise, Florida, United States
RECRUITINGVelocity Valparaiso
Valparaiso, Indiana, United States
RECRUITINGJohnson County ClinTrials
Lenexa, Kansas, United States
RECRUITING...and 15 more locations