A Study to Evaluate the Safety and Immunogenicity of a Candidate Ebola Vaccine in Children

NCT02548078 | Completed Phase 2 Results

• 2 other identifiers: 2020902014-004714-28
• Study Type: interventional
• Target: 600
• Locations: 2 countries
• Sites: 2

Brief Summary

The purpose of this study is to assess the safety and reactogenicity of a single IM dose of the GSK3390107A (ChAd3 EBO-Z) vaccine, overall and in children aged 1 to 5, 6 to 12, and 13 to 17 years, separately. Considering the risk of exposure to Ebola and the potential (based on animal data) for the investigational GSK3390107A (ChAd3-EBO-Z) vaccine to afford at least partial protection, all children in the study will receive the investigational GSK3390107A (ChAd3 EBO-Z) vaccine. The children in the Group GSK3390107A+Nimenrix will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine at Day 0 of the study, whereas the children in the Group Nimenrix+GSK3390107A will receive Nimenrix at Day 0 (as a control). At Month 6, the children in the Group Nimenrix+GSK3390107A will receive the investigational GSK3390107A (ChAd3-EBO-Z) vaccine (provided that no safety concerns are raised), whereas the children in the Group GSK3390107A+Nimenrix will receive Nimenrix.

Conditions

Virus Diseases

Keywords

Protection against Ebola Zaire virus

Outcome Measures

Primary Outcomes (42)

• Number of Subjects With Solicited Local Symptoms, Overall

  Assessed solicited local symptoms included: pain and swelling at the injections site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying at limb movement/spontaneous pain.Grade 3 swelling = swelling extending on a surface higher than (\>) 30 millimeters (mm). Solicited local symptoms, for this endpoint, were assessed in all subjects, in both groups.

  During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)

• Number of Subjects With Solicited Local Symptoms, by Age Stratum

  Assessed solicited local symptoms included: pain and swelling at the injections site. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = crying at limb movement/spontaneous pain.Grade 3 swelling = swelling extending on a surface higher than (\>) 30 millimeters (mm), for children between 1-5 years old; \> 50 mm for children between 6-12 years old and \>100 mm for children between 13-17 years old.

  During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)

• Number of Subjects With Solicited General Symptoms, Overall

  Solicited general symptoms assessed included: fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue/headache/drowsiness/gastrointestinal symptoms = fatigue/headache/drowsiness/gastrointestinal symptoms that prevented normal activity. Grade 3 fever = temperature \> 39.5°C. Grade 3 irritability/fussiness = crying that couldn't be comforted. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. Solicited general symptoms, for this endpoint, were assessed in all subjects, in both groups.

  During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)

• Number of Subjects With Solicited General Symptoms, by Age Stratum

  Solicited general symptoms assessed included: fatigue, fever \[defined as axillary temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, drowsiness, irritability/fussiness and loss of appetite. Any = occurrence of the symptom regardless of intensity grade. Grade 3 fatigue/headache/drowsiness/gastrointestinal symptoms = fatigue/headache/drowsiness/gastrointestinal symptoms that prevented normal activity. Grade 3 fever = temperature \> 39.5°C. Grade 3 irritability/fussiness = crying that couldn't be comforted. Grade 3 loss of appetite = not eating at all. Related = symptom assessed by the investigator as related to the vaccination. Solicited general symptoms, for this endpoint, were assessed in subjects aged 1-5 years, 6-12 years and 13-17 years. Symptoms with no values were not assessed for those specific age groups.

  During a 7-day follow-up period after each vaccination (i.e. the day of vaccination and 6 subsequent days)

• Number of Subjects With Unsolicited Adverse Events (AEs), Overall

  An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited adverse events, for this endpoint, were assessed in all subjects, in both groups.

  During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)

• Number of Subjects With Unsolicited Adverse Events (AEs), by Age Stratum

  An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Unsolicited AEs, for this endpoint, were assessed in subjects between 1-5 years of age, 6-12 years of age and 13-17 years of age.

  During the 30-day follow-up period after each vaccination (i.e. the day of vaccination and 29 subsequent days)

• Percentage of Subjects With Haematological Laboratory Abnormalities, Overall

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Screening.

• Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Screening

• Percentage of Subjects With Haematological Laboratory Abnormalities, Overall

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Day 3.

• Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Day 3

• Percentage of Subjects With Haematological Laboratory Abnormalities, Overall

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Day 6.

• Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Day 6

• Percentage of Subjects With Haematological Laboratory Abnormalities, Overall

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Day 30.

• Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Day 30

• Percentage of Subjects With Haematological Laboratory Abnormalities, Overall

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Month 6.

• Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Month 6

• Percentage of Subjects With Haematological Laboratory Abnormalities, Overall

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Month 6 + 6 Days.

• Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Month 6 + 6 Days

• Percentage of Subjects With Haematological Laboratory Abnormalities, Overall

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Month 6 + 30 Days.

• Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Month 6 + 30 Days

• Percentage of Subjects With Haematological Laboratory Abnormalities, Overall

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Month 12.

• Percentage of Subjects With Haematological Laboratory Abnormalities, by Age Stratum

  Haematological parameters assessed included: complete blood count (red blood cells \[RBC\], neutrophils, lymphocytes, white blood cells \[WBC\], haemoglobin, as well as differential count and platelet count for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Month 12

• Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Screening.

• Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Screening

• Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Day 3.

• Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Day 3

• Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Day 6.

• Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Day 6

• Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Day 30.

• Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Day 30

• Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Month 6.

• Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Month 6

• Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Month 6 + 6 Days.

• Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Month 6 + 6 Days

• Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Month 6 + 30 Days.

• Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Month 6 + 30 Days

• Percentage of Subjects With Biochemical Laboratory Abnormalities, Overall

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for all subjects, in both groups. Reference range indicators used were: high, low, normal.

  At Month 12.

• Percentage of Subjects With Biochemical Laboratory Abnormalities, by Age Stratum

  Biochemical parameters assessed included: alanine aminotransferase \[ALT\], creatinine \[CRE\] for subjects aged 1-5 years, 6-12 years and 13-17 years. Reference range indicators used were: high, low, normal.

  At Month 12

• Number of Subjects With Adverse Events of Specific Interest (AESI), Overall

  AESI included clinical symptoms of thrombocytopenia for all subjects, in both groups.

  During the 7 day follow-up period after vaccination at Day 0 (i.e., Day 0 up to Day 6)

• Number of Subjects With Adverse Events of Specific Interest (AESI), by Age Stratum

  AESI included clinical symptoms of thrombocytopenia for subjects aged 1-5 years, 6-12 years and 13-17 years.

  During the 7 day follow-up period after vaccination at Day 0 (i.e. Day 0 up to Day 6)

• Number of Subjects With Serious Adverse Events, Overall

  Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. SAEs, for this endpoint, were assessed in all subjects, in both groups.

  During the entire study period: From Screening to Month 12

• Number of Subjects With Serious Adverse Events, by Age Stratum

  Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity. SAEs, for this endpoint, were assessed in subjects aged 1-5 years, 6-12 years and 13-17 years.

  During the entire study period: From Screening to Month 12

Secondary Outcomes (4)

• Anti-glycoprotein (GP) Ebola Virus Zaire (EBOV) Antibody Titers, Overall

  At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12.

• Anti-GP EBOV Antibody Titers, by Age Stratum

  At Day 0, Day 30, Month 6, Month 6 + 30 Days and Month 12

• Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, Overall

  At Day 0, Day 30, Month 6 and Month 6 + 30 Days.

• Percentage of Seronegative/Seropositive Subjects for Anti-GP EBOV Antibodies, by Age Stratum

  At Day 0, Day 30, Month 6 and Month 6 + 30 Days

Study Arms (2)

GSK3390107A+Nimenrix Group

EXPERIMENTAL

Subjects in the GSK3390107A+Nimenrix Group received the investigational GSK3390107A vaccine at the Day 0 visit and Nimenrix at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.

Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A); Biological: Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine

Nimenrix+GSK3390107A Group

EXPERIMENTAL

Subjects in the Nimenrix +GSK3390107A Group received Nimenrix at the Day 0 visit and the investigational GSK3390107A vaccine at the Month 6 visit, intramuscularly into the deltoid region, or thigh region for smaller children.

Biological: GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A); Biological: Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine

Interventions

GlaxoSmithKline (GSK) Biologicals' investigational recombinant chimpanzee adenovirus Type 3-vectored Ebola Zaire vaccine (ChAd3-EBO-Z) (GSK3390107A) BIOLOGICAL

A single dose administered intramuscular

GSK3390107A+Nimenrix Group; Nimenrix+GSK3390107A Group

Nimenrix powder and solvent for solution for injection in pre-filled syringe; Meningococcal group A, C, W-135 and Y conjugate vaccine BIOLOGICAL

A single dose administered intramuscular

GSK3390107A+Nimenrix Group; Nimenrix+GSK3390107A Group

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Subject's parent(s)/ legally acceptable representative(s) (LAR\[s\]) who, in the opinion of the Investigator, can and will comply with the requirements of the protocol (e.g. availability for Diary Card completion, return for follow-up visits, availability for clinical follow-up throughout the study period).
• Written/ thumb printed informed consent obtained from the subject' parent(s)/ LAR\[s\] prior to performing any study specific procedure. In addition, written/ thumb printed in-formed assent should be obtained if appropriate (from all subjects aged 13 to 17 years and from younger subjects as per local requirements).
• A male or female child aged 1 to 17 years inclusive at the time of Screening.
• Subjects with a negative RDT test for Malaria within 30 days prior to randomisation into the study.
• OR Subjects with a positive RDT test for Malaria who completed antimalarial treatment at least 5 days prior to randomisation into the study.
• Healthy subjects as per Investigator judgement, as estab-lished by medical history, clinical examination and haema-tology/ biochemistry laboratory parameters screening be-fore entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Non-childbearing potential is defined as pre-menarche or ovariectomy.
• Female subjects of childbearing potential may be enrolled in the study, if the subject:
• has practiced adequate contraception for 30 days prior to the Day 0 visit, and
• has a negative pregnancy test at the Day 0 visit, and
• has agreed to continue adequate contraception until 30 days after the Month 6 visit

You may not qualify if:

• Child in care.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine during the period starting 30 days before the Day 0 visit, or planned use during the study period.
• Previous vaccination with an investigational EBOV or Marburg vaccine, or previous vaccination with a chim-panzee adenoviral vectored investigational vaccine.
• Known prior EBOV or SUDV disease.
• Travel to country affected by the EBOV epidemic or direct contact with person with EVD within 21 days prior to the Day 0 visit.
• History of any reaction or hypersensitivity (such as ana-phylaxis, urticaria (hives), respiratory difficulty, angioe-dema, or abdominal pain) likely to be exacerbated by any component of the study vaccine.
• Planned administration/ administration of a vaccine not foreseen by the study protocol in the period starting 30 days before and ending 30 days after each vaccination visit.
• Acute or chronic illness determined by medical history, clinical examination and laboratory screening tests in-cluding, but not limited to:
• Clinically significant immunosuppressive or immunodeficient condition (e.g. clinical acquired immune deficiency syndrome \[AIDS\]).
• Major congenital defects.
• Malnutrition (defined as weight for age Z-score less than -3, or other clinical signs of malnutrition).
• Any clinically significant haematological or biochemical laboratory abnormality.
• Pregnant female.
• Any condition that in the Investigator's opinion may po-tentially compromise subject safety or interfere with sub-ject assessment or compliance.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Bamako, Mali

Location

GSK Investigational Site

Dakar, Senegal

Location

Related Publications (1)

• Tapia MD, Sow SO, Mbaye KD, Thiongane A, Ndiaye BP, Ndour CT, Mboup S, Keshinro B, Kinge TN, Vernet G, Bigna JJ, Oguche S, Koram KA, Asante KP, Gobert P, Hogrefe WR, De Ryck I, Debois M, Bourguignon P, Jongert E, Ballou WR, Koutsoukos M, Roman F; Zaire EBola Research Alliance group. Safety, reactogenicity, and immunogenicity of a chimpanzee adenovirus vectored Ebola vaccine in children in Africa: a randomised, observer-blind, placebo-controlled, phase 2 trial. Lancet Infect Dis. 2020 Jun;20(6):719-730. doi: 10.1016/S1473-3099(20)30019-0. Epub 2020 Mar 19.

  PMID: 32199492 DERIVED

MeSH Terms

Conditions

Virus Diseases

Interventions

halofantrine; Solvents; Solutions; Injections

Condition Hierarchy (Ancestors)

Infections

Intervention Hierarchy (Ancestors)

Specialty Uses of Chemicals; Chemical Actions and Uses; Pharmaceutical Preparations; Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

aal77632@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: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 10, 2015
• First Posted: September 14, 2015
• Study Start: November 9, 2015
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: May 3, 2018
• Results First Posted: May 3, 2018

Record last verified: 2018-03

Locations

MA (1); SE (1)