Trial Outcomes & Findings for Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2) (NCT NCT00518687)

Last Updated: 2015-10-02

Results Overview

Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the Centers for Disease Control (CDC) Guidelines for Nosocomial infections (Garner JS, Jarvis WS, Emori TG, et al. CDC definitions for nosocomial infections. APIC Infect Control App Epidemiol 1996;A1-20). Bacteremia was defined as ≥1 positive blood culture for S. aureus regardless of the presence of clinical symptoms. A Staphylococcus aureus deep sternal wound infection included mediastinitis or a deep incisional surgical-site infection involving the sternal wound.

Recruitment status

TERMINATED

Study phase

PHASE2/PHASE3

Target enrollment

8031 participants

Primary outcome timeframe

Up to 90 days after surgery

Results posted on

2015-10-02

Participant Flow

Participant milestones

Participant milestones
Measure	V710 60 µg V710: 0.5-ml single injection of V710 (60 µg)	Placebo Placebo : 0.5-ml single injection of matching placebo
Overall Study STARTED	4005	4005
Overall Study Vaccinated	3981	3982
Overall Study COMPLETED	2568	2585
Overall Study NOT COMPLETED	1437	1420

Reasons for withdrawal

Reasons for withdrawal
Measure	V710 60 µg V710: 0.5-ml single injection of V710 (60 µg)	Placebo Placebo : 0.5-ml single injection of matching placebo
Overall Study Adverse Event	201	177
Overall Study Lost to Follow-up	144	155
Overall Study Physician Decision	42	48
Overall Study Progressive disease	2	2
Overall Study Protocol Violation	8	10
Overall Study Study terminated by sponsor	930	918
Overall Study Withdrawal by Subject	110	110

Baseline Characteristics

Efficacy, Immunogenicity, and Safety of a Single Dose of V710 in Adult Patients Scheduled for Cardiothoracic Surgery (V710-003 AM2)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	V710 60 µg n=4005 Participants V710: 0.5-ml single injection of V710 (60 µg)	Placebo n=4005 Participants Placebo : 0.5-ml single injection of matching placebo	Total n=8010 Participants Total of all reporting groups
Age, Continuous	63.6 years STANDARD_DEVIATION 12.6 • n=5 Participants	63.9 years STANDARD_DEVIATION 12.5 • n=7 Participants	63.8 years STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male Female	1328 Participants n=5 Participants	1336 Participants n=7 Participants	2664 Participants n=5 Participants
Sex: Female, Male Male	2677 Participants n=5 Participants	2669 Participants n=7 Participants	5346 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 90 days after surgery

Population: The population analyzed was the full analysis set: participants who were vaccinated and subsequently underwent cardiothoracic surgery involving full median sternotomy at least 14 days and at most 60 days after vaccination

Outcome measures

Outcome measures
Measure	V710 60 µg n=3528 Participants V710: 0.5-ml single injection of V710 (60 µg)	Placebo n=3517 Participants Placebo : 0.5-ml single injection of matching placebo
Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection	22 participants	27 participants

PRIMARY outcome

Timeframe: Up to 360 days after surgery

Population: The population analyzed included all vaccinated participants with follow-up results

Vaccine-related adverse experiences were those deemed by the investigator to be possibly, probably, or definitely vaccine related. A serious adverse experience was any adverse experience occurring at any dose that 1) resulted in death, 2) was life threatening, 3) resulted in a persistent or significant disability/incapacity, 4) resulted in or prolonged an existing inpatient hospitalization, 5) was a congenital anomaly/birth defect, 6) was a cancer, 7) was an overdose, or 8) jeopardized the participant and required medical or surgical intervention.

Outcome measures

Outcome measures
Measure	V710 60 µg n=3958 Participants V710: 0.5-ml single injection of V710 (60 µg)	Placebo n=3967 Participants Placebo : 0.5-ml single injection of matching placebo
Incidence Rate of Vaccine-related Serious Adverse Experiences	0.0 Events per 100 person-years	0.0 Events per 100 person-years

SECONDARY outcome

Timeframe: Up to 90 days after surgery

Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. An invasive Staphylococcus infection included bacteremia, deep sternal wound infection, deep-tissue organ/space infection at another surgical site, or any other deep-tissue infection.

Outcome measures

Outcome measures
Measure	V710 60 µg n=3528 Participants V710: 0.5-ml single injection of V710 (60 µg)	Placebo n=3517 Participants Placebo : 0.5-ml single injection of matching placebo
Number of Participants With Invasive Staphylococcus Aureus Infection	27 participants	31 participants

SECONDARY outcome

Timeframe: Up to 90 days after surgery

Diagnosis of the Staphylococcus aureus infections employed standardized definitions adapted from the CDC Guidelines for Nosocomial infections. A Staphylococcus infection surgical-site infection included any superficial incisional, deep incisional, or organ/space infection at the sternal site, the vascular harvest (donor) site, or any other site at which the surgery was performed.

Outcome measures

Outcome measures
Measure	V710 60 µg n=3528 Participants V710: 0.5-ml single injection of V710 (60 µg)	Placebo n=3517 Participants Placebo : 0.5-ml single injection of matching placebo
Number of Participants With Surgical-site Staphylococcus Aureus Infection	53 participants	75 participants

Adverse Events

V710 (60 µg) Lyophilized

Serious events: 291 serious events

Other events: 749 other events

Deaths: 0 deaths

Placebo

Serious events: 274 serious events

Other events: 343 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	V710 (60 µg) Lyophilized n=3958 participants at risk V710: 0.5-ml single injection of V710 (60 µg)	Placebo n=3967 participants at risk Placebo : 0.5-ml single injection of matching placebo
General disorders Injection site erythema	7.1% 280/3958 • Number of events 285 • All serious adverse events (SAEs): through Day 14 after vaccination; vaccine-related SAEs, SAEs resulting in death, and SAEs involving infection diagnosis: through Day 360 after surgery; other adverse events (AEs): through Day 14 after vaccination The population analyzed was all vaccinated participants with follow-up results	2.6% 102/3967 • Number of events 104 • All serious adverse events (SAEs): through Day 14 after vaccination; vaccine-related SAEs, SAEs resulting in death, and SAEs involving infection diagnosis: through Day 360 after surgery; other adverse events (AEs): through Day 14 after vaccination The population analyzed was all vaccinated participants with follow-up results
General disorders Injection site pain	13.5% 533/3958 • Number of events 575 • All serious adverse events (SAEs): through Day 14 after vaccination; vaccine-related SAEs, SAEs resulting in death, and SAEs involving infection diagnosis: through Day 360 after surgery; other adverse events (AEs): through Day 14 after vaccination The population analyzed was all vaccinated participants with follow-up results	5.8% 232/3967 • Number of events 244 • All serious adverse events (SAEs): through Day 14 after vaccination; vaccine-related SAEs, SAEs resulting in death, and SAEs involving infection diagnosis: through Day 360 after surgery; other adverse events (AEs): through Day 14 after vaccination The population analyzed was all vaccinated participants with follow-up results
General disorders Injection site swelling	5.5% 217/3958 • Number of events 222 • All serious adverse events (SAEs): through Day 14 after vaccination; vaccine-related SAEs, SAEs resulting in death, and SAEs involving infection diagnosis: through Day 360 after surgery; other adverse events (AEs): through Day 14 after vaccination The population analyzed was all vaccinated participants with follow-up results	2.0% 79/3967 • Number of events 79 • All serious adverse events (SAEs): through Day 14 after vaccination; vaccine-related SAEs, SAEs resulting in death, and SAEs involving infection diagnosis: through Day 360 after surgery; other adverse events (AEs): through Day 14 after vaccination The population analyzed was all vaccinated participants with follow-up results

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the sponsor as confidential must be deleted prior to submission.
Publication restrictions are in place

Restriction type: OTHER