A Phase 1, Single-arm, Open-label Study To Confirm The Safety, Tolerability, And Immunogenicity Of A 4-antigen Staphylococcus Aureus Vaccine (sa4ag) In Healthy Adults Aged 18 To <65 Years

NCT02364596 Phase 1 COMPLETED

The purpose of this study is to evaluate the safety and immunogenicity of a single vaccination of an investigational vaccine against Staphylococcus aureus (SA4Ag) in healthy adults aged 18 to \<65 years.

Details

Lead sponsor	Pfizer
Phase	Phase 1
Status	COMPLETED
Enrolment	100
Start date	2015-01
Completion	2015-02

Conditions

• Staphylococcal Infections

Interventions

• SA4Ag vaccine
• Blood sample

Primary outcomes

• Number of subjects reporting local reactions (redness, swelling, and pain at the injection site) as self-reported on electronic diaries (e-diaries) for 10 days after vaccination. — 10 days
• Number of subjects reporting systemic events (fever, fatigue, headache, vomiting, diarrhea, muscle pain, and joint pain) as self-reported on e-diaries for 10 days after vaccination. — 10 days
• Number of subjects reporting adverse events (AEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA). — 1 month
• Number of subjects reporting serious adverse events (SAEs) categorized according to the Medical Dictionary for Regulatory Activities (MedDRA). — 1 month
• Opsonophagocytic activity titers measured as geometric mean titers against S. aureus isolates — 1 month

Countries

United States