SA4Ag Safety, Tolerability, and Immunogenicity Study in Japanese Adults

Pfizer

Status and phase: Completed; Phase 2

Conditions: Staphylococcal Infections

Treatments: Biological: Staphylococcus aureus 4-antigen vaccine; Biological: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02492958

6123K1-1006 (Other Identifier)

B3451003

Details and patient eligibility

About

The purpose of this study is to evaluate the safety, tolerability, and immunogenicity of a single dose of Staphylococcus aureus 4 antigen vaccine in Japanese adults aged 20 to <86 years.

Enrollment: 136 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Japanese male and female adults aged 20 to <86 years,
2. Determined as healthy by the investigator (Subjects with preexisting chronic medical conditions determined to be stable may be included),
3. Must be available for the 12 month duration of the study,
4. Subjects must agree to use an acceptable method of birth control for 3 months after study vaccination (if the subject or the subject's partner are/is capable of having children).

Exclusion criteria

1. Any contraindication to vaccination or vaccine components, including previous anaphylactic reaction to any vaccine or vaccine-related components,
2. Unstable or serious chronic medical condition that would increase the subject's risk of participation,
3. Immune system suppression or treatment with medications that suppress the immune system,
4. Receipt of blood products or immunoglobulins within the past 12 months,
5. Any infection proven or suspected to be caused by S.aureus within the past 6 months,
6. A staff member at this site nor a relative of those site staff members, nor a sponsor's employee directly involved in the conduct of this research study,
7. Living in a nursing home, long-term care facility or other institution or requiring any types of nursing care,
8. A pregnant or a breast feeding woman.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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136 participants in 2 patient groups, including a placebo group

SA4Ag

Experimental group

Description:

Staphylococcus aureus 4-antigen vaccine

Treatment:

Biological: Staphylococcus aureus 4-antigen vaccine

Placebo

Placebo Comparator group

Description:

a lyophile match to the vaccine, consisting of excipients of SA4Ag formulation minus the active ingredients

Treatment:

Biological: Placebo