V160 2-Dose and 3-Dose Regimens in Healthy Cytomegaloviru... | NCT03486834

ID	Type	Description	Link
2017-004233-86	EudraCT Number

Status Module

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
V160 3-Dose Regimen	Experimental	Participants received 3 doses of vaccine V160 (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant [MAPA], 4°C stable formulation) administered by intramuscular (IM) injection on Day 1, Month 2, and Month 6.	Biological: V160
V160 2-Dose Regimen	Experimental	Participants received 2 doses of vaccine V160 (100 Units/0.5 mL dose with MAPA, 4°C stable formulation) administered IM on Day 1 and Month 6 and a placebo-saline solution at Month 2.	Biological: V160 Drug: Placebo
Placebo	Placebo Comparator	Participants received placebo (saline solution) by IM injection on Day 1, Month 2, and Month 6.	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
V160	Biological	V160 was administered as a 0.5 mL (100 Units/0.5 mL dose with Merck aluminum phosphate adjuvant [MAPA], 4°C stable formulation) IM injection.	V160 2-Dose Regimen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group)	Cytomegalovirus infection (CMVi) was defined as the detection of wild-type cytomegalovirus (CMV) (non vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 3-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 3-dose regimen group compared to the placebo group was assessed.	4 weeks post last vaccination (Month 7) up to ~Month 24
Number of Participants With Solicited Injection-site Adverse Events	An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and pain.	Up to 5 days after each vaccination
Number of Participants With Solicited Systemic AEs	An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, joint pain/arthralgia, muscle pain/myalgia, and headache.	Up to 14 days after each vaccination

Secondary Outcomes

Measure	Description	Time Frame
Number of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group)	CMVi is defined as detection of wild-type CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 2-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 2-dose regimen group compared to the placebo group was assessed.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy based on medical history and physical examination.
Serologically confirmed to be CMV seronegative prior to receiving the first dose of V160/placebo
Have direct exposure to young children (≤5 years of age) at home or occupationally
Of childbearing potential
Agrees to avoid becoming pregnant during the 6-month treatment period and for at least 4 weeks after the last dose of study drug by either 1) practicing abstinence from heterosexual activity, or 2) use a highly-effective method of birth control (as specified in the protocol) during heterosexual activity.

Exclusion Criteria:

Has a history or current evidence of any condition, therapy, laboratory abnormality or other circumstance that might expose the participant to risk by participating in the trial, confound the results of the trial, or interfere with participation for the full duration of the trial, as assessed by the investigator
Has history of allergic reaction or anaphylactic reaction to any vaccine component that required medical intervention or of any severe allergic reaction to any vaccine component that required medical intervention.
Has a recent (<72 hours) history of febrile illness (temperature ≥100.4°F/38.0°C, oral equivalent)
Is currently immunocompromised or has been diagnosed as having a congenital or acquired immunodeficiency, human immunodeficiency virus (HIV) infection, lymphoma, leukemia, systemic lupus erythematosus, rheumatoid arthritis, juvenile rheumatoid arthritis, inflammatory bowel disease, or other autoimmune condition that requires immunosuppressive medication.
Has a condition in which repeated venipuncture or injections pose more than minimal risk for the participant.
A woman of childbearing potential (WOCBP) who has a positive pregnancy test at screening or within 24 hours before the first dose of study treatment.
Has previously received a CMV vaccine.
Had any live virus vaccine administered or scheduled to be administered in the period from 4 weeks prior to, and 4 weeks following receipt of any dose of trial vaccine.
Had any inactivated vaccine administered or scheduled within the period from 14 days prior to, through 14 days following, any dose of trial vaccine.
Had administration of any immune globulin or blood product within 90 days prior to injection with V160/placebo or scheduled within 30 days thereafter.
Received systemic corticosteroids (equivalent of ≥2 mg/kg total daily dose of prednisone or ≥20 mg/d for persons weighing >10 kg) for ≥14 consecutive days and has not completed treatment at least 30 days prior to trial entry.
Received systemic corticosteroids exceeding physiologic replacement doses (≈5 mg/d prednisone equivalent) within 14 days prior to the first vaccination (participants using inhaled, nasal, or topical steroids are considered eligible for the trial).
Received any anti-viral agent with proven or potential activity against CMV two weeks prior to vaccination or is likely to receive such an agent within 2 weeks after vaccination.
Receiving or has received in the year prior to enrollment immunosuppressive therapies or other therapies used for solid organ/cell transplant, radiation therapy, immunosuppressive/cytotoxic immunotherapy, chemotherapy and other immunosuppressive therapies known to interfere with the immune response. Topical tacrolimus is allowed provided that it is not used within 2 weeks prior to, or 2 weeks following a V160 dose.
Participated in another clinical trial in the past 4 weeks, or plans to participate in a treatment-based trial or a trial in which an invasive procedure is to be performed while enrolled in this trial.
Plans donation of eggs at any time from signing the informed consent through 1 month after receiving the last dose of the trial V160/placebo.

Name	Affiliation	Role
Medical Director	Merck Sharp & Dohme LLC	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Alabama Clinical Therapeutics ( Site 0025)		Birmingham	Alabama	35205	United States
Achieve Clinical Research, LLC ( Site 0055)

PubMed Identifier	Type	Citation	Retractions
37660711	Result	Das R, Blazquez-Gamero D, Bernstein DI, Gantt S, Bautista O, Beck K, Conlon A, Rosenbloom DIS, Wang D, Ritter M, Arnold B, Annunziato P, Russell KL; V160-002 study group. Safety, efficacy, and immunogenicity of a replication-defective human cytomegalovirus vaccine, V160, in cytomegalovirus-seronegative women: a double-blind, randomised, placebo-controlled, phase 2b trial. Lancet Infect Dis. 2023 Dec;23(12):1383-1394. doi: 10.1016/S1473-3099(23)00343-2. Epub 2023 Aug 31.

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	V160 3-Dose Regimen	Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
FG001	V160 2-Dose Regimen	Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	May 7, 2019

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Who Became Infected With Wild-Type Cytomegalovirus Infection Starting at 4 Weeks Post Last Dose (V160 3-dose Regimen Group and Placebo Group)

Cytomegalovirus infection (CMVi) was defined as the detection of wild-type cytomegalovirus (CMV) (non vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 3-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 3-dose regimen group compared to the placebo group was assessed.

The analysis population included participants who were CMV seronegative at Day 1 and CMV negative by polymerase chain reaction (PCR) for nonvaccine strain virus from post Day 1 through Month 7, had received all 3 injections/vaccinations within the vaccination visit window, and did not have any deviations from protocol deemed to potentially interfere with the evaluation of efficacy or immune response to injection of V160.

Posted

Count of Participants

Participants

4 weeks post last vaccination (Month 7) up to ~Month 24

ID	Title	Description
OG000	V160 3-Dose Regimen	Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
OG001	Placebo	Participants received placebo by IM injection on Day 1, Month 2, and Month 6.

Units	Counts
Participants	OG000556 OG001543

Title

Denominators

Categories

Title	Measurements
	OG00014 OG00124

Group IDs	Group Description	Statistical Method	Statistical Comment	P-Value	P-Value Comment	Parameter Type	Parameter Value	Dispersion Type	Dispersion Value	Confidence Interval Sides	Confidence Interval %	CI Lower Limit	CI Upper Limit	CI Lower Limit Comment	CI Upper Limit Comment	Estimate Comment	Tested Non-Inferiority	Non-Inferiority Type	Non-Inferiority Comment	Other Analysis Description
OG000 OG001						Incidence Rate Estimate	2.9			2-Sided	95	1.6	4.9					Other	The incidence rate per 100 person years (100 x number of CMVi cases/total person-years to CMVi or end of follow-up) is presented along with 95% confidence interval (CI).
OG000 OG001

Primary

Number of Participants With Solicited Injection-site Adverse Events

An adverse event (AE) is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited injection-site AEs was assessed. The solicited injection-site AEs assessed were redness/erythema, swelling, and pain.

The analysis population included all randomized participants who received at least 1 injection of V160 or placebo, had safety follow-up data, and had been assigned to the treatment arm corresponding to the actual clinical material received.

Posted

Count of Participants

Participants

Up to 5 days after each vaccination

ID	Title	Description
OG000	V160 3-Dose Regimen	Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
OG001	V160 2-Dose Regimen	Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
OG002	Placebo

Primary

Number of Participants With Solicited Systemic AEs

An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. Following vaccination with V160 or placebo, the number of participants with solicited systemic AEs was assessed. The solicited systemic AEs assessed were fatigue, joint pain/arthralgia, muscle pain/myalgia, and headache.

Posted

Count of Participants

Participants

Up to 14 days after each vaccination

ID	Title	Description
OG000	V160 3-Dose Regimen	Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
OG001	V160 2-Dose Regimen	Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
OG002	Placebo

Primary

Number of Participants With Vaccine-related Serious Adverse Events

A serious adverse event (SAE) is an AE that is life-threatening, requires or prolongs an existing hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, or is another important medical event deemed such by medical or scientific judgment. Relatedness of an SAE to the study vaccine was determined by the investigator. Following vaccination with V160 or placebo, the number of participants with vaccine-related serious adverse events was assessed.

Posted

Count of Participants

Participants

Up to 14 days after each vaccination

ID	Title	Description
OG000	V160 3-Dose Regimen	Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
OG001	V160 2-Dose Regimen	Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
OG002	Placebo

Secondary

Number of Participants Who Became Infected With Wild-Type CMV Infection Starting at 4 Weeks Post Last Dose (V160 2-dose Regimen Group and Placebo Group)

CMVi is defined as detection of wild-type CMV (non-vaccine type) by polymerase chain reaction in a single saliva or urine sample in a previously CMV-uninfected participant. CMVi cases in the 2-dose regimen and placebo groups were reported and incidence rate (per 100 person-years) calculated based on follow-up time starting at 4 weeks post last dose (Month 7) through approximately Month 24 (or time point to reach required cases for assessment). The percent reduction in CMVi incidence rate in the 2-dose regimen group compared to the placebo group was assessed.

The analysis population included participants who were CMV seronegative at Day 1 and CMV negative by polymerase chain reaction (PCR) for nonvaccine strain virus from post Day 1 through Month 7, had received all 2 injections/vaccinations within the vaccination visit window, and did not have any deviations from protocol deemed to potentially interfere with the evaluation of efficacy or immune response to injection of V160.

Posted

Count of Participants

Participants

4 weeks post last vaccination (Month 7) up to ~Month 24

ID	Title	Description
OG000	V160 2-Dose Regimen	Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
OG001	Placebo	Participants received placebo by IM injection on Day 1, Month 2, and Month 6.

Serious Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Cardiac arrest	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Tachycardia	Cardiac disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Abdominal pain	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0021 events1 affected732 at risk
Abdominal pain lower	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Oesophageal ulcer	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Salivary gland calculus	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Asthenia	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Chest pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Cholelithiasis	Hepatobiliary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0012 events2 affected729 at risk EG0020 events0 affected732 at risk
Appendicitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0021 events1 affected732 at risk
Appendicitis perforated	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Breast abscess	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
COVID-19 pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Cellulitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Epstein-Barr virus infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Pharyngotonsillitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Pneumonia	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0012 events2 affected729 at risk EG0020 events0 affected732 at risk
Pyelonephritis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
Pyelonephritis acute	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Urinary tract infection	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0012 events2 affected729 at risk EG0020 events0 affected732 at risk
Ankle fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0012 events2 affected729 at risk EG0021 events1 affected732 at risk
Chest injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Concussion	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Intentional overdose	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Pelvic bone injury	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Procedural haemorrhage	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Radius fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
Rib fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Splenic rupture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Tendon rupture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Tibia fracture	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Traumatic arthropathy	Injury, poisoning and procedural complications	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
Intervertebral disc protrusion	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Cervix carcinoma	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
Enchondromatosis	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
Ovarian germ cell teratoma benign	Neoplasms benign, malignant and unspecified (incl cysts and polyps)	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Epilepsy	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Idiopathic intracranial hypertension	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
Seizure	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
Abortion missed	Pregnancy, puerperium and perinatal conditions	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
Abortion spontaneous	Pregnancy, puerperium and perinatal conditions	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected728 at risk EG0016 events6 affected729 at risk EG0027 events7 affected732 at risk
Anembryonic gestation	Pregnancy, puerperium and perinatal conditions	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0022 events2 affected732 at risk
Eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0022 events2 affected732 at risk
Postpartum haemorrhage	Pregnancy, puerperium and perinatal conditions	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Pre-eclampsia	Pregnancy, puerperium and perinatal conditions	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Ruptured ectopic pregnancy	Pregnancy, puerperium and perinatal conditions	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Threatened labour	Pregnancy, puerperium and perinatal conditions	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0022 events1 affected732 at risk
Alcohol abuse	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Anxiety	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
Depression	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0002 events2 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
Suicidal ideation	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Suicide attempt	Psychiatric disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Renal colic	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0012 events1 affected729 at risk EG0020 events0 affected732 at risk
Renal impairment	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Ureterolithiasis	Renal and urinary disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Adnexal torsion	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0001 events1 affected728 at risk EG0010 events0 affected729 at risk EG0020 events0 affected732 at risk
Intermenstrual bleeding	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Ovarian cyst	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0021 events1 affected732 at risk
Ovarian cyst ruptured	Reproductive system and breast disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Pulmonary embolism	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0010 events0 affected729 at risk EG0021 events1 affected732 at risk
Haemorrhage	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk
Hypotension	Vascular disorders	MedDRA 24.0	Systematic Assessment	EG0000 events0 affected728 at risk EG0011 events1 affected729 at risk EG0020 events0 affected732 at risk

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Nausea	Gastrointestinal disorders	MedDRA 24.0	Systematic Assessment	EG00050 events45 affected728 at risk EG00168 events55 affected729 at risk EG00254 events46 affected732 at risk
Fatigue	General disorders	MedDRA 24.0	Systematic Assessment	EG0001,128 events457 affected728 at risk EG0011,077 events461 affected729 at risk EG002843 events357 affected732 at risk
Injection site erythema	General disorders	MedDRA 24.0	Systematic Assessment	EG000400 events254 affected728 at risk EG001273 events208 affected729 at risk EG00239 events30 affected732 at risk
Injection site pain	General disorders	MedDRA 24.0	Systematic Assessment	EG0001,943 events680 affected728 at risk EG0011,524 events664 affected729 at risk EG002374 events239 affected732 at risk
Injection site pruritus	General disorders	MedDRA 24.0	Systematic Assessment	EG00054 events44 affected728 at risk EG00134 events26 affected729 at risk EG0025 events4 affected732 at risk
Injection site swelling	General disorders	MedDRA 24.0	Systematic Assessment	EG000404 events248 affected728 at risk EG001311 events233 affected729 at risk EG00226 events21 affected732 at risk
Pyrexia	General disorders	MedDRA 24.0	Systematic Assessment	EG00093 events75 affected728 at risk EG001112 events90 affected729 at risk EG00242 events27 affected732 at risk
Nasopharyngitis	Infections and infestations	MedDRA 24.0	Systematic Assessment	EG00059 events53 affected728 at risk EG00156 events53 affected729 at risk EG00240 events37 affected732 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG000226 events162 affected728 at risk EG001249 events162 affected729 at risk EG002121 events76 affected732 at risk
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 24.0	Systematic Assessment	EG000996 events455 affected728 at risk EG001818 events424 affected729 at risk EG002336 events200 affected732 at risk
Headache	Nervous system disorders	MedDRA 24.0	Systematic Assessment	EG000988 events434 affected728 at risk EG001976 events450 affected729 at risk EG002795 events368 affected732 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 24.0	Systematic Assessment	EG00081 events62 affected728 at risk EG00180 events65 affected729 at risk EG00280 events69 affected732 at risk

ID	Title	Description
BG000	V160 3-Dose Regimen	Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.
BG001	V160 2-Dose Regimen	Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.
BG002	Placebo	Participants received placebo by IM injection on Day 1, Month 2, and Month 6.
BG003	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	V160 3-Dose Group	Participants received V160 vaccination by intramuscular (IM) injection on Day 1, Month 2, and Month 6.	733	22	728	697	728
EG001	V160 2-Dose Group	Participants received V160 vaccination by IM injection on Day 1 and Month 6 and placebo at Month 2.	733	29	729	700	729
EG002	Placebo Group	Participants received placebo by IM injection on Day 1, Month 2, and Month 6.	734	26	732	557	732