A Phase 2/3 interventional study of V710 and Placebo in Staphylococcus Aureus, Bacteremia and Mediastinitis, sponsored by Merck Sharp & Dohme LLC. Terminated. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-02.
Sponsored by Merck Sharp & Dohme LLC (part of Merck & Co., Inc) · Phase 2/3, Interventional, and Prevention
This study will assess the efficacy of a single dose of V710 vaccine to prevent serious Staphylococcus aureus infections following elective cardiothoracic surgery. The study will also evaluate the immune response and general safety of the V710 vaccine.
303 studies on the registry are indexed under Staphylococcal Infections; 34 are open to participants now.
This study's enrollment of 8,031 is above the median of 124 across 198 interventional studies indexed under Staphylococcal Infections.
Browse Staphylococcal Infections studies →Merck Sharp & Dohme LLC is the lead sponsor of 2,166 studies on the registry; 132 are open to participants now.
Of its 501 completed or terminated interventional studies of FDA-regulated products, 370 (74%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biological: V710
Biological: Placebo
0.5-mL single injection of V710 (60 µg)
Also known as: Merck 0657nI Staphylococcus aureus vaccine
0.5-mL single injection of matching placebo
Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection
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.
Time frame: Up to 90 days after surgery
Incidence Rate of Vaccine-related Serious Adverse Experiences
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.
Time frame: Up to 360 days after surgery
Number of Participants With Invasive Staphylococcus Aureus Infection
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.
Time frame: Up to 90 days after surgery
Number of Participants With Surgical-site Staphylococcus Aureus Infection
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.
Time frame: Up to 90 days after surgery
| Milestone | V710 60 µg | Placebo |
|---|---|---|
| Started | 4005 | 4005 |
| Vaccinated | 3981 | 3982 |
| Completed | 2568 | 2585 |
| Not completed | 1437 | 1420 |
| Withdrew: Adverse event | 201 | 177 |
| Withdrew: Lost to follow-up | 144 | 155 |
| Withdrew: Physician decision | 42 | 48 |
| Withdrew: Progressive disease | 2 | 2 |
| Withdrew: Protocol violation | 8 | 10 |
| Withdrew: Study terminated by sponsor | 930 | 918 |
| Withdrew: Withdrawal by subject | 110 | 110 |
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.
| participants | V710 60 µg | Placebo |
|---|---|---|
| Number of Participants With Staphylococcus Aureus Bacteremia and/or Deep Sternal Wound Infection | 22 | 27 |
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.
| Events per 100 person-years | V710 60 µg | Placebo |
|---|---|---|
| Incidence Rate of Vaccine-related Serious Adverse Experiences | 0.0 | 0.0 |
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.
| participants | V710 60 µg | Placebo |
|---|---|---|
| Number of Participants With Invasive Staphylococcus Aureus Infection | 27 | 31 |
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.
| participants | V710 60 µg | Placebo |
|---|---|---|
| Number of Participants With Surgical-site Staphylococcus Aureus Infection | 53 | 75 |
Collected over 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. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| V710 (60 µg) Lyophilized | — | 291/3,958 (7.4%) | 749/3,958 (18.9%) |
| Placebo | — | 274/3,967 (6.9%) | 343/3,967 (8.6%) |
| Event | V710 (60 µg) Lyophilized | Placebo |
|---|---|---|
| Multi-organ failureGeneral disorders | 31/3958 | 17/3967 |
| Wound infection staphylococcalInfections and infestations | 25/3958 | 27/3967 |
| Cardiogenic shockCardiac disorders | 23/3958 | 18/3967 |
| Cardiac arrestCardiac disorders | 18/3958 | 21/3967 |
| Staphylococcal bacteraemiaInfections and infestations | 18/3958 | 19/3967 |
| Cardiac failureCardiac disorders | 12/3958 | 6/3967 |
| Acute myocardial infarctionCardiac disorders | 6/3958 | 11/3967 |
| Staphylococcal mediastinitisInfections and infestations | 8/3958 | 9/3967 |
| Circulatory collapseVascular disorders | 3/3958 | 9/3967 |
| Cardio-respiratory arrestCardiac disorders | 8/3958 | 2/3967 |
| Event | V710 (60 µg) Lyophilized | Placebo |
|---|---|---|
| Injection site painGeneral disorders | 533/3958 | 232/3967 |
| Injection site erythemaGeneral disorders | 280/3958 | 102/3967 |
| Injection site swellingGeneral disorders | 217/3958 | 79/3967 |
| Age, Continuous(years) | V710 60 µg | Placebo | Total |
|---|---|---|---|
| Mean | 63.6 ± 12.6 | 63.9 ± 12.5 | 63.8 ± 12.5 |
| Sex: Female, Male(Participants) | V710 60 µg | Placebo | Total |
|---|---|---|---|
| Female | 1328 | 1336 | 2664 |
| Male | 2677 | 2669 | 5346 |
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This study is terminated, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: V710