A Study of a Vaccine Against Respiratory Syncytial Virus (RSV) When Given Alone and Together With a Vaccine Against Diphtheria, Pertussis and Tetanus (Tdap) Viruses Followed by a 2nd Dose of the RSV Vaccine to Healthy Non-Pregnant Women

NCT04138056 | Completed Phase 2 Results FDA Drug

• 2 other identifiers: 2091412019-002258-22
• Study Type: interventional
• Target: 509
• Locations: 3 countries
• Sites: 8

Brief Summary

The purpose of this study is to evaluate the safety, ability of GSK Biologicals' investigational RSV maternal vaccine (RSVPreF3) to generate an immune response and the degree to which the vaccine can cause side effects, when administered alone and in combination with Boostrix vaccine in healthy non-pregnant women 18-45 years of age. Two dose levels of RSVPreF3 and 2 Boostrix \[Diphtheria, Tetanus and acellular Pertussis (dTpa) vaccine\] formulations (US and ex-US) will be evaluated. A 2nd dose of RSVPreF3 will be administered in an extension of the study to assess the durability of the immune response after the first dose vaccination, and to assess the safety and immunogenicity following a second dose vaccination of the RSVPreF3 maternal vaccine.

Conditions

Respiratory Syncytial Virus Infections

Outcome Measures

Primary Outcomes (14)

• Percentage of Subjects With Any Solicited Local Adverse Event (AEs) [Primary Study]

  Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

  From Day 1 to Day 8

• Percentage of Subjects With Any Solicited General AEs [Primary Study]

  Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever (body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

  From Day 1 to Day 8

• Percentage of Subjects With Any Unsolicited AEs [Primary Study]

  An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

  From Day 1 to Day 31

• Number of Subjects With Any SAEs [Primary Study]

  A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

  From Day 1 to Day 31

• Percentage of Subjects With Any Solicited Local AEs [Extension Study]

  Assessed solicited local AEs are: erythema, pain and swelling. Any = occurrence of the adverse event regardless of intensity grade. Any erythema and swelling = adverse event reported with a surface diameter greater than 0 millimeters. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies.The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

  From the Day of 2nd vaccination to Day 8 post 2nd vaccination

• Percentage of Subjects Any Solicited General AEs [Extension Period]

  Assessed solicited general AEs are: fatigue, gastrointestinal symptoms, headache and fever(body temperature ≥ 38 degree celcius/100.4 degree Farenhit). Any = occurrence of the adverse event regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

  From the Day of 2nd vaccination to Day 8 post 2nd vaccination

• Percentage of Subjects With Any Unsolicited AEs [Extension Period]

  An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

  From the Day of 2nd vaccination to Day 31 post 2nd vaccination

• Number of Subjects With Any SAEs [Extension Period]

  A SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity or is a congenital anomaly/birth defect in the offspring of a study subject. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the safety response to RSVPreF3.

  From the Day of 2nd vaccination to Day 31 post 2nd vaccination

• RSV A Neutralizing Antibody Geometric Mean Titers (GMTs) at Screening [Primary Study]

  Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60 (Estimated Dilution 60). The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

  At Screening (Day -7 to Day 1)

• RSV A Neutralizing Antibody GMTs at Day 8 [Primary Study]

  Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

  At Day 8

• RSV A Neutralizing Antibody GMTs at Day 31 [Primary Study]

  Serological assays for the determination of antibodies against RSV-A were performed by neutralization assay and titers are expressed in ED60. The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

  At Day 31

• RSV PreF3 IgG Antibody Geometric Mean Concentration (GMCs) at Screening [Primary Study]

  Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA ). The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

  At Screening (Day -7 to Day 1)

• RSV PreF3 IgG GMCs at Day 8 [Primary Study]

  Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA). The analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

  At Day 8

• RSV PreF3 IgG GMCs at Day 31 [Primary Study]

  Serological assays for the determination of IgG antibodies against RSV PreF3 were performed by Enzyme-linked immunosorbent assay (ELISA). Analysis of this outcome measure was reported for the Pooled groups \[RSV120\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled), RSV60\_dTpa\_RSV120(Pooled), RSV120\_Placebo\_RSV120(Pooled) and dTpa\_Placebo\_RSV120(Pooled)\] as the two formulations of the dTpa vaccine (containing 300 μg or 500 μg of aluminum) showed similar immunogenicity and safety profiles in previous studies. The objective of this endpoint was to analyze the impact of the co-administration of RSVPreF3 with dTpa (Boostrix) (both formulations together) on the immunogenicity response to RSVPreF3.

  At Day 31

Secondary Outcomes (31)

• Percentage of Subjects With Any Solicited Local Adverse Event (AEs) by Each Boostrix Formulation [Primary Study]

  From Day 1 to Day 8

• Percentage of Subjects With Any Solicited General AEs by Each Boostrix Formulation [Primary Study]

  From Day 1 to Day 8

• Percentage of Subjects With Any Unsolicited AEs by Each Boostrix Formulation [Primary Study]

  From Day 1 to Day 31

• Number of Subjects With Any SAEs by Each Boostrix Formulation [Primary Study]

  From Day 1 to Day 31

• Number of Subjects With Any SAEs From 1st Vaccination to Day 181 [Primary Study]

  From Day 1 to Day 181

Study Arms (5)

RSV120_dTpa_RSV120(Pooled)

EXPERIMENTAL

Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and either one dose of 300 μg or 500 μg dTpa (Boostrix) vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

Biological: RSVPreF3 formulation 3; Biological: Boostrix-ex-US; Biological: Boostrix-US

RSV120_Placebo_RSV120(Pooled)

PLACEBO COMPARATOR

Subjects received one dose of 120 μg RSVPreF3 formulation 3 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received a second dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

Biological: RSVPreF3 formulation 3; Drug: Placebo

RSV60_dTpa_RSV120(Pooled)

EXPERIMENTAL

Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

Biological: RSVPreF3 formulation 3; Biological: RSVPreF3 formulation 2; Biological: Boostrix-ex-US; Biological: Boostrix-US

RSV60_Placebo_RSV120(Pooled)

PLACEBO COMPARATOR

Subjects received one dose of 60 μg RSVPreF3 formulation 2 vaccine and one dose of Placebo on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

Biological: RSVPreF3 formulation 3; Biological: RSVPreF3 formulation 2; Drug: Placebo

dTpa_Placebo_RSV120(Pooled)

PLACEBO COMPARATOR

Subjects received one dose of Placebo and either one dose of 300 μg or 500 μg dTpa vaccine on Day 1 of the Primary Study and were followed up until Day 181. The subjects that agreed to participate in the Extension Study received one dose of 120 μg RSVPreF3 formulation 3 vaccine 12 to 18 months post 1st vaccination and were followed up until the study end.

Biological: RSVPreF3 formulation 3; Biological: Boostrix-ex-US; Biological: Boostrix-US; Drug: Placebo

Interventions

RSVPreF3 formulation 3 BIOLOGICAL

One dose of RSVPreF3 formulation 3 vaccine administered intramuscularly in the left or in the non-dominant arm.

RSV120_Placebo_RSV120(Pooled); RSV120_dTpa_RSV120(Pooled); RSV60_Placebo_RSV120(Pooled); RSV60_dTpa_RSV120(Pooled); dTpa_Placebo_RSV120(Pooled)

RSVPreF3 formulation 2 BIOLOGICAL

One dose of RSVPreF3 formulation 2 vaccine administered intramuscularly in the left arm.

RSV60_Placebo_RSV120(Pooled); RSV60_dTpa_RSV120(Pooled)

Boostrix-ex-US BIOLOGICAL

One dose of the dTpa (Ex-US formulation) vaccine administered intramuscularly in the right arm.

RSV120_dTpa_RSV120(Pooled); RSV60_dTpa_RSV120(Pooled); dTpa_Placebo_RSV120(Pooled)

Boostrix-US BIOLOGICAL

One dose of the dTpa vaccine (US formulation) administered intramuscularly in the right arm.

RSV120_dTpa_RSV120(Pooled); RSV60_dTpa_RSV120(Pooled); dTpa_Placebo_RSV120(Pooled)

Placebo DRUG

One dose of placebo (NaCl solution) administered intramuscularly in either the left or the right arm.

RSV120_Placebo_RSV120(Pooled); RSV60_Placebo_RSV120(Pooled); dTpa_Placebo_RSV120(Pooled)

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Primary study
• Subjects who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
• Written or witnessed/thumb printed informed consent obtained from the subject prior to performance of any study specific procedure.
• Healthy female subjects; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination;
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to primary vaccination, and
• has a negative pregnancy test on the day of primary vaccination, and
• has agreed to continue adequate contraception for 90 days after completion of the vaccination.
• No local condition precluding injection in both left and right deltoid muscles.
• Extension study
• Completed primary study and received 1st dose of a study vaccine.
• Written or witnessed/thumb printed informed consent obtained from the subject prior to performance of any study specific procedure to the study extension.
• All subjects must satisfy ALL the following criteria:
• Subjects who can and will comply with the requirements of the protocol.
• Female subjects remain healthy; as established by medical history and clinical examination, aged 18 to 45 years at the time of the 1st vaccination;

You may not qualify if:

• Primary study
• Medical conditions
• History of any reaction/hypersensitivity likely to be exacerbated by any vaccines' component;
• Any confirmed/suspected immunosuppressive/immunodeficient condition, based on medical history and physical examination;
• Hypersensitivity to latex;
• Major congenital defects;
• Acute/chronic clinically significant pulmonary, cardiovascular, hepatic/renal functional abnormality;
• Significant/uncontrolled psychiatric illness;
• Recurrent history/uncontrolled neurological disorders/seizures;
• Documented HIV-positive subject;
• History of/current autoimmune disease;
• Body mass index (BMI)\>40 kg/m\^2;
• Any clinically significant hematological parameter and/or biochemical laboratory abnormality.
• Any other clinical condition that might pose additional risk to the subject due to participation in the study.
• Prior/Concomitant therapy

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (8)

GSK Investigational Site

Miami, Florida, 33143, United States

Location

GSK Investigational Site

Lenexa, Kansas, 66219, United States

Location

GSK Investigational Site

Rochester, New York, 14609, United States

Location

GSK Investigational Site

Seattle, Washington, 98105, United States

Location

GSK Investigational Site

Ghent, 9000, Belgium

Location

GSK Investigational Site

Leuven, 3000, Belgium

Location

GSK Investigational Site

Truro, Nova Scotia, B2N 1L2, Canada

Location

GSK Investigational Site

London, Ontario, N5W 6A2, Canada

Location

Related Publications (1)

• Hermida N, Ferguson M, Leroux-Roels I, Pagnussat S, Yaplee D, Hua N, van den Steen P, Anspach B, Dieussaert I, Kim JH. Safety and Immunogenicity of Respiratory Syncytial Virus Prefusion Maternal Vaccine Coadministered With Diphtheria-Tetanus-Pertussis Vaccine: A Phase 2 Study. J Infect Dis. 2024 Aug 16;230(2):e353-e362. doi: 10.1093/infdis/jiad560.

  PMID: 38133639 BACKGROUND

MeSH Terms

Conditions

Respiratory Syncytial Virus Infections

Condition Hierarchy (Ancestors)

Pneumovirus Infections; Paramyxoviridae Infections; Mononegavirales Infections; RNA Virus Infections; Virus Diseases; Infections

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Data will be collected in an observer-blind manner. In an observer-blind study, the subject and the site and sponsor personnel involved in the clinical evaluation of the subjects are blinded while other study personnel may be aware of the treatment assignment. By observer-blind, it is meant that during the course of the study, the vaccine(s) recipient and those responsible for the evaluation of any study endpoint (e.g. safety, reactogenicity) will all be unaware of which vaccines were administered.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2019
• First Posted: October 24, 2019
• Study Start: November 5, 2019
• Primary Completion: February 25, 2020
• Study Completion: November 22, 2021
• Last Updated: August 21, 2024
• Results First Posted: December 19, 2022

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD is made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

BE (2); US (4); CA (2)