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A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of Age

Primary Purpose

Measles; Mumps; Rubella; Chickenpox

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Investigational MMRV(H)NS vaccine
Investigational MM(H)RVNS vaccine
Investigational M(L)M(L)R(L)V(L)NS vaccine
Marketed MMRV_Lot 1 and Lot 2 vaccine
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Measles; Mumps; Rubella; Chickenpox focused on measuring Measles, Mumps, Rubella, Varicella

Eligibility Criteria

4 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy participants as established by medical history and clinical examination before entering into the study. A male or female between, and including, 4 years and 6 years of age (i.e., from 4 year birthday until the day before the 7-year birthday) at the time of study intervention administration. Participant who previously received a first dose of varicella-containing vaccine in the second year of life. Participant who previously received a single dose of measles-, mumps-, rubella-containing vaccine in the second year of life. Written informed consent obtained from the participants' parent(s)/legally acceptable representative(s) (LAR[s]) prior to performance of any study-specific procedure (participant informed assent will be obtained from participants in line with local rules and regulations). Participants' parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of electronic diaries [eDiaries], return for follow-up visits). Exclusion Criteria: Medical Conditions History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). Hypersensitivity to latex. Major congenital defects, as assessed by the investigator. History of measles, mumps, rubella, or varicella disease. Recurrent history of or uncontrolled neurological disorders or seizures. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as body temperature >=38.0 degrees Celsius (°C) (100.4 degrees Fahrenheit [°F)] by any age-appropriate route. All study interventions can be administered to participants with a minor illness such as diarrhea, mild upper respiratory infection without fever. Participant with history of coronavirus disease 2019 (COVID-19) who is still symptomatic. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior and Concomitant Therapy Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or their planned use during the study period. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent >= 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants. Inhaled and topical steroids are allowed. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period. Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab). Previous vaccination with a second dose of varicella-containing vaccine or measles-, mumps-, rubella-containing vaccine. Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending at 43 days after the dose of study interventions administration* (Visit 3), with the exception of: inactivated influenza (flu) vaccine which may be given at any time during the study and administered at a different location than the study interventions and, routinely recommended licensed childhood DTPa-containing vaccines which can preferably be co-administered according to the local immunization practices of the participating country. Any other age-appropriate vaccine may be given starting at Visit 3 and anytime thereafter. In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local government recommendations and that GSK/IQVIA is notified accordingly. Prior/Concurrent Clinical Study Experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device). Other Exclusions Child in care. Any study personnel's immediate dependents, family, or household members. Participants with the following high-risk individuals in their household: Immunocompromised individuals Pregnant women without documented history of varicella. Newborn infants of mothers without documented history of varicella. Newborn infants born <28 weeks of gestation.

Sites / Locations

  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting
  • GSK Investigational SiteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

MMRV(H)NS Group

MM(H)RVNS Group

M(L)M(L)R(L)V(L)NS Group

MMRV_Lot 1 and Lot 2 Pooled Group

Arm Description

Healthy children aged 4 to 6 years of age receive 1 dose of an investigational measles, mumps, and rubella (MMR) at release potency and varicella at high (V[H]NS) potency vaccine on Day 1.

Healthy children aged 4 to 6 years of age receive 1 dose of an investigational measles, rubella (MR), and varicella (VNS) at release potency and mumps at high (M[H]) potency vaccine on Day 1.

Healthy children aged 4 to 6 years of age receive 1 dose of an investigational measles, mumps, rubella (MMR), and varicella (VNS), all at low (L) potency vaccine on Day 1.

Healthy children aged 4 to 6 years of age receive 1 dose of a marketed measles, mumps, rubella (MMR), and varicella (V) vaccine of Lot 1 or of 1 vaccine dose of a marketed MMRV vaccine of Lot 2 on Day 1.

Outcomes

Primary Outcome Measures

Anti-measles antibody geometric mean concentrations (GMCs)
Antibody GMCs will be summarized for measles antigen by treatment group with their 2-sided 95% confidence interval (CI), minimum and maximum, derived considering log-transformed concentrations are normally distributed with unknown variance for antibodies against measles antigen. Antibody concentrations will be presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Anti-mumps antibody GMCs
Antibody GMCs will be summarized for mumps antigen by treatment group with their 2-sided 95% confidence interval (CI), minimum and maximum, derived considering log-transformed concentrations are normally distributed with unknown variance for antibodies against mumps antigen. Antibody concentrations will be presented as GMCs, expressed in Arbitrary unit per milliliter (AU/mL).
Anti-rubella antibody GMCs
Antibody GMCs will be summarized for rubella antigen by treatment group with their 2-sided 95% confidence interval (CI), minimum and maximum, derived considering log-transformed concentrations are normally distributed with unknown variance for antibodies against rubella antigen. Antibody concentrations will be presented as GMCs, expressed in International unit per milliliter (IU/mL).
Anti-glycoprotein E (gE) antibody GMCs
Antibody GMCs will be summarized for varicella antigen by treatment group with their 2-sided 95% confidence interval (CI), minimum and maximum, derived considering log-transformed concentrations are normally distributed with unknown variance for antibodies against varicella antigen. Anti gE antibody concentrations will be presented as GMCs, expressed in mIU/mL

Secondary Outcome Measures

Percentage of participants with seroresponse to anti-measles antibodies
Seroresponse rate for measles is defined as the percentage of participants for whom the post-dose antibody concentration as measured by the anti-measles Multiplex Luminex based Immuno assay is greater than or equal to (>=) 67 mIU/mL for each group.
Percentage of participants with seroresponse to anti-mumps antibodies
Seroresponse rate for mumps is defined as the percentage of participants for whom the post-dose antibody concentration as measured by the anti-mumps Multiplex Luminex based Immuno assay is >= 296 AU/mL for each group.
Percentage of participants with seroresponse to anti-rubella antibodies
Seroresponse rate for rubella is defined as the percentage of participants for whom the post-dose antibody concentration as measured by the anti-rubella Multiplex Luminex based Immuno assay is >= 17 IU/mL for each group.
Percentage of participants with seroresponse to varicella anti-gE antibodies
Seroresponse rate for varicella is defined as the percentage of participants for whom the post-dose anti-gE antibody concentration is >= 300 mIU/mL for each group.
Percentage of participants reporting each solicited administration site event
Solicited administration site events include injection site redness, pain and swelling.
Percentage of participants reporting each solicited systemic event in terms of drowsiness and loss of appetite
Solicited systemic events include drowsiness, loss of appetite, after the administration of study intervention for each group.
Percentage of participants reporting each solicited systemic event in terms of fever, measles/rubella-like rash, varicella-like rash and other rash (not measles/rubella-like rash or varicella-like rash)
Solicited systemic events include fever, measles/rubella-like rash, or varicella like rash, and other rash (not measles/rubella-like rash or varicella-like rash) after the administration of study interventions for each group. Fever is defined as temperature greater than or equal to (>=)38.0 degrees Celsius (°C) (100.4 degrees Fahrenheit [°F]) by any route (the preferred location for measuring temperature is the axilla).
Percentage of participants reporting unsolicited adverse events (AEs)
Unsolicited AEs include any AE reported in addition to solicited events during the study, or any "solicited" symptoms with onset outside of the specified period of follow-up for solicited symptoms, are assessed for each group after the administration of all vaccines.
Percentage of participants reporting serious adverse events (SAEs)
A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.

Full Information

First Posted
November 24, 2022
Last Updated
January 16, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT05630846
Brief Title
A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of Age
Official Title
A Phase II, Single-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of a Measles, Mumps, Rubella, Varicella Vaccine Compared With ProQuad, Administered in Healthy Children 4-6 Years of Age
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2022 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
June 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The main purpose of this study is to assess immune response and safety of various potencies of a measles, mumps, rubella, and varicella (MMRVNS) vaccines given to healthy children of 4 to 6 years of age.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Measles; Mumps; Rubella; Chickenpox
Keywords
Measles, Mumps, Rubella, Varicella

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Single-blind study. recipients and care providers will be unaware of vaccine administered.
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MMRV(H)NS Group
Arm Type
Experimental
Arm Description
Healthy children aged 4 to 6 years of age receive 1 dose of an investigational measles, mumps, and rubella (MMR) at release potency and varicella at high (V[H]NS) potency vaccine on Day 1.
Arm Title
MM(H)RVNS Group
Arm Type
Experimental
Arm Description
Healthy children aged 4 to 6 years of age receive 1 dose of an investigational measles, rubella (MR), and varicella (VNS) at release potency and mumps at high (M[H]) potency vaccine on Day 1.
Arm Title
M(L)M(L)R(L)V(L)NS Group
Arm Type
Experimental
Arm Description
Healthy children aged 4 to 6 years of age receive 1 dose of an investigational measles, mumps, rubella (MMR), and varicella (VNS), all at low (L) potency vaccine on Day 1.
Arm Title
MMRV_Lot 1 and Lot 2 Pooled Group
Arm Type
Active Comparator
Arm Description
Healthy children aged 4 to 6 years of age receive 1 dose of a marketed measles, mumps, rubella (MMR), and varicella (V) vaccine of Lot 1 or of 1 vaccine dose of a marketed MMRV vaccine of Lot 2 on Day 1.
Intervention Type
Biological
Intervention Name(s)
Investigational MMRV(H)NS vaccine
Intervention Description
1 dose of a measles, mumps, and rubella at release potency and VNS at high (H) potency vaccine administered subcutaneously.
Intervention Type
Biological
Intervention Name(s)
Investigational MM(H)RVNS vaccine
Intervention Description
1 dose of a measles, rubella, and varicella at release potency and mumps at high (H) potency vaccine administered subcutaneously.
Intervention Type
Biological
Intervention Name(s)
Investigational M(L)M(L)R(L)V(L)NS vaccine
Intervention Description
1 dose of measles, mumps, rubella, and varicella, all at low (L) potency vaccine administered subcutaneously.
Intervention Type
Biological
Intervention Name(s)
Marketed MMRV_Lot 1 and Lot 2 vaccine
Other Intervention Name(s)
ProQuad
Intervention Description
1 dose of a marketed measles, mumps, rubella, and varicella of Lot 1 or 1 dose of a marketed measles, mumps, rubella, and varicella of Lot 2 vaccine administered subcutaneously.
Primary Outcome Measure Information:
Title
Anti-measles antibody geometric mean concentrations (GMCs)
Description
Antibody GMCs will be summarized for measles antigen by treatment group with their 2-sided 95% confidence interval (CI), minimum and maximum, derived considering log-transformed concentrations are normally distributed with unknown variance for antibodies against measles antigen. Antibody concentrations will be presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Time Frame
At Day 43
Title
Anti-mumps antibody GMCs
Description
Antibody GMCs will be summarized for mumps antigen by treatment group with their 2-sided 95% confidence interval (CI), minimum and maximum, derived considering log-transformed concentrations are normally distributed with unknown variance for antibodies against mumps antigen. Antibody concentrations will be presented as GMCs, expressed in Arbitrary unit per milliliter (AU/mL).
Time Frame
At Day 43
Title
Anti-rubella antibody GMCs
Description
Antibody GMCs will be summarized for rubella antigen by treatment group with their 2-sided 95% confidence interval (CI), minimum and maximum, derived considering log-transformed concentrations are normally distributed with unknown variance for antibodies against rubella antigen. Antibody concentrations will be presented as GMCs, expressed in International unit per milliliter (IU/mL).
Time Frame
At Day 43
Title
Anti-glycoprotein E (gE) antibody GMCs
Description
Antibody GMCs will be summarized for varicella antigen by treatment group with their 2-sided 95% confidence interval (CI), minimum and maximum, derived considering log-transformed concentrations are normally distributed with unknown variance for antibodies against varicella antigen. Anti gE antibody concentrations will be presented as GMCs, expressed in mIU/mL
Time Frame
At Day 43
Secondary Outcome Measure Information:
Title
Percentage of participants with seroresponse to anti-measles antibodies
Description
Seroresponse rate for measles is defined as the percentage of participants for whom the post-dose antibody concentration as measured by the anti-measles Multiplex Luminex based Immuno assay is greater than or equal to (>=) 67 mIU/mL for each group.
Time Frame
Day 43
Title
Percentage of participants with seroresponse to anti-mumps antibodies
Description
Seroresponse rate for mumps is defined as the percentage of participants for whom the post-dose antibody concentration as measured by the anti-mumps Multiplex Luminex based Immuno assay is >= 296 AU/mL for each group.
Time Frame
Day 43
Title
Percentage of participants with seroresponse to anti-rubella antibodies
Description
Seroresponse rate for rubella is defined as the percentage of participants for whom the post-dose antibody concentration as measured by the anti-rubella Multiplex Luminex based Immuno assay is >= 17 IU/mL for each group.
Time Frame
Day 43
Title
Percentage of participants with seroresponse to varicella anti-gE antibodies
Description
Seroresponse rate for varicella is defined as the percentage of participants for whom the post-dose anti-gE antibody concentration is >= 300 mIU/mL for each group.
Time Frame
Day 43
Title
Percentage of participants reporting each solicited administration site event
Description
Solicited administration site events include injection site redness, pain and swelling.
Time Frame
During the 4-day period (day of administration and 3 following days) after the administration of study interventions (administered at Day 1)
Title
Percentage of participants reporting each solicited systemic event in terms of drowsiness and loss of appetite
Description
Solicited systemic events include drowsiness, loss of appetite, after the administration of study intervention for each group.
Time Frame
During the 4-day (day of administration and 3 following days) period after the administration of study interventions (administered at Day 1)
Title
Percentage of participants reporting each solicited systemic event in terms of fever, measles/rubella-like rash, varicella-like rash and other rash (not measles/rubella-like rash or varicella-like rash)
Description
Solicited systemic events include fever, measles/rubella-like rash, or varicella like rash, and other rash (not measles/rubella-like rash or varicella-like rash) after the administration of study interventions for each group. Fever is defined as temperature greater than or equal to (>=)38.0 degrees Celsius (°C) (100.4 degrees Fahrenheit [°F]) by any route (the preferred location for measuring temperature is the axilla).
Time Frame
During the 43-day period (day of administration and 42 following days) after the administration of study interventions (administered at Day 1)
Title
Percentage of participants reporting unsolicited adverse events (AEs)
Description
Unsolicited AEs include any AE reported in addition to solicited events during the study, or any "solicited" symptoms with onset outside of the specified period of follow-up for solicited symptoms, are assessed for each group after the administration of all vaccines.
Time Frame
During the 43-day (day of administration and 42 following days) period after the administration of study interventions (administered at Day 1)
Title
Percentage of participants reporting serious adverse events (SAEs)
Description
A SAE is an AE which results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or other situations that are considered serious per medical or scientific judgment.
Time Frame
Throughout the entire study period (From Day 1 to Day 181)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
4 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy participants as established by medical history and clinical examination before entering into the study. A male or female between, and including, 4 years and 6 years of age (i.e., from 4 year birthday until the day before the 7-year birthday) at the time of study intervention administration. Participant who previously received a first dose of varicella-containing vaccine in the second year of life. Participant who previously received a single dose of measles-, mumps-, rubella-containing vaccine in the second year of life. Written informed consent obtained from the participants' parent(s)/legally acceptable representative(s) (LAR[s]) prior to performance of any study-specific procedure (participant informed assent will be obtained from participants in line with local rules and regulations). Participants' parent(s)/LAR(s), who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of electronic diaries [eDiaries], return for follow-up visits). Exclusion Criteria: Medical Conditions History of any reaction or hypersensitivity likely to be exacerbated by any component of the study interventions including hypersensitivity to neomycin or gelatin. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required). Hypersensitivity to latex. Major congenital defects, as assessed by the investigator. History of measles, mumps, rubella, or varicella disease. Recurrent history of or uncontrolled neurological disorders or seizures. Acute disease at the time of enrollment. Acute disease is defined as the presence of a moderate or severe illness with or without fever. Fever is defined as body temperature >=38.0 degrees Celsius (°C) (100.4 degrees Fahrenheit [°F)] by any age-appropriate route. All study interventions can be administered to participants with a minor illness such as diarrhea, mild upper respiratory infection without fever. Participant with history of coronavirus disease 2019 (COVID-19) who is still symptomatic. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study. Prior and Concomitant Therapy Use of any investigational or non-registered product (drug, vaccine, or medical device) other than the study interventions during the period beginning 30 days before the dose of study interventions (Day -29 to Day 1), or their planned use during the study period. Chronic administration (defined as more than 14 days in total) of immunosuppressants or other immune-modifying drugs during the period starting 90 days prior to the study intervention administration. For corticosteroids, this will mean prednisone equivalent >= 0.5 mg/kg/day or 20 mg/day whichever is the maximum dose for pediatric participants. Inhaled and topical steroids are allowed. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 180 days before the dose of study interventions or planned administration during the study period. Administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab). Previous vaccination with a second dose of varicella-containing vaccine or measles-, mumps-, rubella-containing vaccine. Administration or planned administration of a vaccine not foreseen by the study protocol in the period starting 30 days before the dose and ending at 43 days after the dose of study interventions administration* (Visit 3), with the exception of: inactivated influenza (flu) vaccine which may be given at any time during the study and administered at a different location than the study interventions and, routinely recommended licensed childhood DTPa-containing vaccines which can preferably be co-administered according to the local immunization practices of the participating country. Any other age-appropriate vaccine may be given starting at Visit 3 and anytime thereafter. In case an emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if necessary for that vaccine, provided it is used according to the local government recommendations and that GSK/IQVIA is notified accordingly. Prior/Concurrent Clinical Study Experience • Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention (drug/invasive medical device). Other Exclusions Child in care. Any study personnel's immediate dependents, family, or household members. Participants with the following high-risk individuals in their household: Immunocompromised individuals Pregnant women without documented history of varicella. Newborn infants of mothers without documented history of varicella. Newborn infants born <28 weeks of gestation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name or Official Title & Degree
EU GSK Clinical Trials Call Center
Phone
+44 (0) 20 89904466
Email
GSKClinicalSupportHD@gsk.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Kevin G Rouse
Facility Name
GSK Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Teena L. Hughes
Facility Name
GSK Investigational Site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40291
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
John B Blair
Facility Name
GSK Investigational Site
City
Lincoln
State/Province
Nebraska
ZIP/Postal Code
68505
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Sue A Springman
Facility Name
GSK Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45414
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Julie S Shepard
Facility Name
GSK Investigational Site
City
Tullahoma
State/Province
Tennessee
ZIP/Postal Code
37388
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Clifford Seyler
Facility Name
GSK Investigational Site
City
Layton
State/Province
Utah
ZIP/Postal Code
84041
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Colton Ragsdale
Facility Name
GSK Investigational Site
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Joshua Fuller
Facility Name
GSK Investigational Site
City
Roy
State/Province
Utah
ZIP/Postal Code
84067
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Daniel B Neumann
Facility Name
GSK Investigational Site
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
US GSK Clinical Trials Call Center
Phone
877-379-3718
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
EU GSK Clinical Trials Call Centre
Phone
+44 (0) 20 8990 4466
Email
GSKClinicalSupportHD@gsk.com
First Name & Middle Initial & Last Name & Degree
Mary D Tipton

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the 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 can be granted, when justified, for up to another 12 months.

Learn more about this trial

A Study on the Immune Response and Safety of a Combined Measles, Mumps, Rubella, Chickenpox Vaccine Compared to a Marketed Combined Vaccine, Given to Healthy Children 4 to 6 Years of Age

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