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Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox

Primary Purpose

Varicella, Chickenpox Vaccines

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Priorix-tetra™
Priorix™
Varilrix™
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella

Eligibility Criteria

11 Months - 22 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion criteria: Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol for the whole duration of the study. Male or female subject between 12 and 22 months of age at the time of the first vaccination. Subjects free of obvious health problems, as established by medical history and physical examination before entering the study. Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure. Subjects whose parents/guardians have direct access to telephone/mobile phone. Subjects: with at least one sibling (with negative history of varicella disease/vaccination) at home, or attending day care center, or attending childminders, i.e. someone taking care of several children, or who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes. Exclusion criteria: Previous vaccination against measles, mumps, rubella and/or varicella. History of previous measles, mumps, rubella and/or varicella/ herpes zoster diseases. Known exposure to measles, mumps, rubella and/or varicella/herpes zoster within 30 days prior to the start of the study. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical. Family history of congenital or hereditary immunodeficiency. History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin. Major congenital defects or serious chronic illness. Residence in the same household as newborns (0-4 weeks of age), pregnant women who are varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella. History of any neurologic disorders or seizures. Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period. Additional exclusion criteria for subjects included in the subset: - Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).

Sites / Locations

  • GSK Investigational Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

MMRV Group

OKAH Group

MMR Group

Arm Description

Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.

Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).

Outcomes

Primary Outcome Measures

Phase A: Number of Subjects With Confirmed Varicella Case
Confirmed varicella case = A case that met the clinical case definition [an illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause] at least in the opinion of the investigator and was confirmed by laboratory test [Polymerase Chain Reaction (PCR) (+)] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked [Epi (+)] to a valid index case.

Secondary Outcome Measures

Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case
Confirmed varicella case: A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease: 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).
Phase A: Number of Subjects With Probable or Confirmed Varicella Case
Probable or confirmed varicella case = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed [PCR (-)] AND was not epidemiologically linked [Epi (-)] to another probable or confirmed case.
Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations
Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV
Seronegative (S-) = Subjects with antibody concentration less than (<) 25 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration greater than or equal to (≥) 25 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects
Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects
Seronegative (S-) = Subjects with antibody concentration < 150 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 150 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects
Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).
Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects
Seronegative (S-) = Subjects with antibody concentration < 231 U/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 231 U/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects
Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in International Units per milliliter (IU/mL).
Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects
Seronegative (S-) = Subjects with antibody concentration < 4 IU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 4 IU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster
The number of subjects with confirmed cases of herpes zoster is reported.
Phase A: Number of Subjects Reporting Fever
All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.
Phase A: Number of Subjects Reporting Fever
All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related fever = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.
Phase A: Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom = Occurrence of any local symptom regardless of their intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than (>) 20 mm.
Phase A: Number of Subjects Reporting Meningism
Any = Occurrence of meningism regardless of its intensity grade. Grade 3 meningism = Prevented normal, everyday activities. Related = Assessed by the investigator to be causally related to the study vaccination.
Phase A: Number of Subjects Reporting Parotitis
Any = Occurrence of parotitis regardless of its intensity grade. Grade 3 parotitis = Swelling with accompanying general symptoms. Related = Assessed by the investigator to be causally related to the study.
Phase A: Number of Subjects Reporting Rash
Any = Occurrence of rash regardless of its intensity grade. Grade 3 rash = 101-500 lesions. Grade 4 rash = > 500 lesions. Related rash = Assessed by the investigator to be causally related to the study vaccination.
Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions
Any = Occurrence of meningism including febrile convulsions regardless of intensity grade.
Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE assessed included any AE 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness
Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).
Phase B: Number of Subjects With Confirmed Varicella Case
Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case.
Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case
Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease = 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).
Phase B: Number of Subjects With Probable or Confirmed Varicella Case
Probable or confirmed varicella = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed [PCR (-)] AND was not epidemiologically linked [Epi (-)] to another probable or confirmed case.
Phase B: Characteristics of Varicella Cases
Varicella cases were characterized by type, number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.
Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations
Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value
The anti-VZV antibody concentration cut-off value assessed was greater than or equal to (≥) 25 mIU/mL, in the sera of subjects seronegative before vaccination.
Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations
Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value
The anti-measles antibody concentration cut-off value assessed was ≥ 150 mIU/mL, in the sera of subjects seronegative before vaccination.
Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations
Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).
Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value
The anti-mumps antibody concentration cut-off value assessed was ≥ 231 U/mL, in the sera of subjects seronegative before vaccination.
Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations
Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value
The anti-rubella antibody concentration cut-off value assessed was ≥ 4 IU/mL, in the sera of subjects seronegative before vaccination.
Phase B: Characteristics of Zoster Cases
Zoster cases were characterized by number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.
Phase B: Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness
Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).

Full Information

First Posted
September 23, 2005
Last Updated
August 19, 2019
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT00226499
Brief Title
Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox
Official Title
Study in Healthy Children (<2 Years) to Evaluate the Safety and Efficacy of GSK Biologicals' Live Attenuated Varicella Vaccine (VarilrixTM) and of GSK Biologicals' Combined Measles-Mumps-Rubella-Varicella Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
September 1, 2005 (Actual)
Primary Completion Date
October 12, 2006 (Actual)
Study Completion Date
October 12, 2006 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
An observer-blind study to evaluate GlaxoSmithKline Biologicals' live attenuated varicella vaccine and GlaxoSmithKline Biologicals' combined measles-mumps-rubella-varicella vaccine in the prevention of varicella disease in children. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Detailed Description
According to treatment group allocation, participants will receive study vaccines and be followed for antibody titres and occurrence of varicella disease. This study is conducted in 2 phases. Phase A includes the vaccination period and an observation period for efficacy. The efficacy endpoints will be evaluated over at least two years after vaccination. During this period, the immunogenicity endpoints will be evaluated with respect to the immune response 43 days after vaccination and the persistence of antibodies over two years to varicella (for all subjects) and to measles, mumps and rubella (for a subset of subjects). Regarding the safety endpoints, SAEs (including any complicated varicella cases if observed) will be assessed for all subjects during the whole Phase A duration, whereas, solicited (local and general) and unsolicited adverse events will be assessed in a subset of subjects within a 43-day period after vaccination. Phase B is an extension of Phase A. It is a long-term follow-up until Year 10 to examine the long-term efficacy of the study vaccines against clinical varicella disease as well as the long-term persistence of antibodies to varicella (for all subjects) and to measles, mumps and rubella (in a subset of subjects) after vaccination.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella, Chickenpox Vaccines

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
5803 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MMRV Group
Arm Type
Experimental
Arm Description
Subjects in this group received 2 doses of Priorix-Tetra vaccine, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Arm Title
OKAH Group
Arm Type
Experimental
Arm Description
Subjects in this group received 1 dose of Priorix at Day 0 (Visit 1) and 1 dose of Varilrix at Day 42 (Visit 2). Both vaccines were administered subcutaneously in the deltoid region of the left arm.
Arm Title
MMR Group
Arm Type
Active Comparator
Arm Description
Subjects in this group received 2 doses of Priorix, administered subcutaneously in the deltoid region of the left arm, one at Day 0 (Visit 1) and the other at Day 42 (Visit 2).
Intervention Type
Biological
Intervention Name(s)
Priorix-tetra™
Intervention Description
2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMRV Group
Intervention Type
Biological
Intervention Name(s)
Priorix™
Intervention Description
2 doses administered subcutaneously, one at Day 0 and the other at Day 42 to subjects in MMR Group and one dose administered subcutaneously at Day 0 to subjects in OKAH Group
Intervention Type
Biological
Intervention Name(s)
Varilrix™
Intervention Description
1 dose administered subcutaneously at Day 42 to subjects in OKAH Group
Primary Outcome Measure Information:
Title
Phase A: Number of Subjects With Confirmed Varicella Case
Description
Confirmed varicella case = A case that met the clinical case definition [an illness with acute onset of diffuse, generalized maculopapulovesicular rash (i.e. spots, papules and/or vesicles) without other apparent cause] at least in the opinion of the investigator and was confirmed by laboratory test [Polymerase Chain Reaction (PCR) (+)] OR a case that met the clinical definition confirmed by the Independent Data Monitoring Committee (IDMC) and was epidemiologically linked [Epi (+)] to a valid index case.
Time Frame
From 42 days post dose 2 until the end of Phase A
Secondary Outcome Measure Information:
Title
Phase A: Number of Subjects With Moderate or Severe Confirmed Varicella Case
Description
Confirmed varicella case: A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease: 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).
Time Frame
From 42 days post dose 2 until the end of Phase A
Title
Phase A: Number of Subjects With Probable or Confirmed Varicella Case
Description
Probable or confirmed varicella case = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed [PCR (-)] AND was not epidemiologically linked [Epi (-)] to another probable or confirmed case.
Time Frame
From 42 days post dose 2 until the end of Phase A
Title
Phase A: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations
Description
Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
Time Frame
At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Title
Phase A: Number of Subjects With Seroconversion/Seroresponse to VZV
Description
Seronegative (S-) = Subjects with antibody concentration less than (<) 25 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration greater than or equal to (≥) 25 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Time Frame
At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Title
Phase A: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations in a Subset of Subjects
Description
Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
Time Frame
At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Title
Phase A: Number of Subjects With Seroconversion/Seroresponse to Measles in a Subset of Subjects
Description
Seronegative (S-) = Subjects with antibody concentration < 150 mIU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 150 mIU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Time Frame
At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Title
Phase A: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations in a Subset of Subjects
Description
Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).
Time Frame
At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Title
Phase A: Number of Subjects With Seroconversion/Seroresponse to Mumps in a Subset of Subjects
Description
Seronegative (S-) = Subjects with antibody concentration < 231 U/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 231 U/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Time Frame
At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Title
Phase A: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations in a Subset of Subjects
Description
Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in International Units per milliliter (IU/mL).
Time Frame
At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Title
Phase A: Number of Subjects With a Seroconversion/Seroresponse to Rubella in a Subset of Subjects
Description
Seronegative (S-) = Subjects with antibody concentration < 4 IU/mL prior to vaccination. Seropositive (S+) = Subjects with antibody concentration ≥ 4 IU/mL prior to vaccination. Seroconversion was defined as the appearance of antibodies (i.e. titer greater than or equal to the cut-off value) in the serum of subjects seronegative before vaccination.
Time Frame
At Day 0, Day 42, Day 84, Year 1 and Year 2 time points
Title
Phase A: Number of Subjects With Confirmed Cases of Herpes Zoster
Description
The number of subjects with confirmed cases of herpes zoster is reported.
Time Frame
From Day 0 until the end of Phase A (Year 2)
Title
Phase A: Number of Subjects Reporting Fever
Description
All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.
Time Frame
Within 43 days (Day 0-42) post-vaccination period following each dose
Title
Phase A: Number of Subjects Reporting Fever
Description
All fever = Occurrence of any fever (measured rectally) regardless of its intensity grade or relationship to vaccination. Related fever = fever (measured rectally) assessed by the investigator to be causally related to the study vaccination. Medical Advice = seek for medical advice.
Time Frame
Within 15 days (Day 0-14) post-vaccination period following each dose
Title
Phase A: Number of Subjects Reporting Solicited Local Symptoms
Description
Solicited local symptoms assessed were pain, redness and swelling. Any solicited local symptom = Occurrence of any local symptom regardless of their intensity grade. Grade 3 pain = Cried when limb was moved/spontaneously painful. Grade 3 redness and swelling = greater than (>) 20 mm.
Time Frame
4 days post-vaccination period following each dose
Title
Phase A: Number of Subjects Reporting Meningism
Description
Any = Occurrence of meningism regardless of its intensity grade. Grade 3 meningism = Prevented normal, everyday activities. Related = Assessed by the investigator to be causally related to the study vaccination.
Time Frame
Within 43 days (Day 0-42) post-vaccination period following each dose
Title
Phase A: Number of Subjects Reporting Parotitis
Description
Any = Occurrence of parotitis regardless of its intensity grade. Grade 3 parotitis = Swelling with accompanying general symptoms. Related = Assessed by the investigator to be causally related to the study.
Time Frame
Within 43 days (Day 0-42) post-vaccination period following each dose
Title
Phase A: Number of Subjects Reporting Rash
Description
Any = Occurrence of rash regardless of its intensity grade. Grade 3 rash = 101-500 lesions. Grade 4 rash = > 500 lesions. Related rash = Assessed by the investigator to be causally related to the study vaccination.
Time Frame
Within 43 days (Day 0-42) post-vaccination period following each dose
Title
Phase A: Number of Subjects With Suspected Sign of Meningism Including Febrile Convulsions
Description
Any = Occurrence of meningism including febrile convulsions regardless of intensity grade.
Time Frame
Within 43 days (Day 0-42) post-vaccination period following each dose
Title
Phase A: Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Description
Unsolicited AE assessed included any AE 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 = Occurrence of any unsolicited symptom regardless of intensity grade or relation to vaccination.
Time Frame
Within 43 days (Day 0-42) post-vaccination period following each dose
Title
Phase A: Number of Subjects Reporting Serious Adverse Events (SAEs)
Description
SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
Time Frame
From Day 0 until the end of Phase A (Year 2)
Title
Phase A: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness
Description
Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).
Time Frame
During Phase A (from Day 0 up to Year 2)
Title
Phase B: Number of Subjects With Confirmed Varicella Case
Description
Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case.
Time Frame
From the beginning of Phase B (Year 2) up to study end (Year 10)
Title
Phase B: Number of Subjects With Moderate or Severe Confirmed Varicella Case
Description
Confirmed varicella case = A case that met the clinical case definition at least in the opinion of the investigator and was confirmed by laboratory test [PCR (+)] OR a case that met the clinical definition confirmed by the IDMC and was epidemiologically linked [Epi (+)] to a valid index case. Moderately severe disease = 8-15 points; severe disease: ≥ 16 points (scored by IDMC using the modified Vázquez scale).
Time Frame
From the beginning of Phase B (Year 2) up to study end (Year 10)
Title
Phase B: Number of Subjects With Probable or Confirmed Varicella Case
Description
Probable or confirmed varicella = A case that met the clinical case definition (as determined by the IDMC) but was not laboratory confirmed [PCR (-)] AND was not epidemiologically linked [Epi (-)] to another probable or confirmed case.
Time Frame
From the beginning of Phase B (Year 2) up to study end (Year 10)
Title
Phase B: Characteristics of Varicella Cases
Description
Varicella cases were characterized by type, number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.
Time Frame
From the beginning of Phase B (Year 2) up to study end (Year 10)
Title
Phase B: Immune Response to Varicella Vaccine With Respect to Anti-Varicella Zoster Virus (Anti-VZV) Antibody Concentrations
Description
Anti-VZV antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
Time Frame
At Year 4, Year 6, Year 8 and Year 10 time points
Title
Phase B: Number of Subjects With Anti-VZV Antibody Concentrations Above the Cut-off Value
Description
The anti-VZV antibody concentration cut-off value assessed was greater than or equal to (≥) 25 mIU/mL, in the sera of subjects seronegative before vaccination.
Time Frame
At Year 4, Year 6, Year 8 and Year 10 time points
Title
Phase B: Immune Response to Measles With Respect to Anti-measles Antibody Concentrations
Description
Anti-measles antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in milliinternational units per milliliter (mIU/mL).
Time Frame
At Year 4, Year 6, Year 8 and Year 10 time points
Title
Phase B: Number of Subjects With Anti-measles Antibody Concentrations Above the Cut-off Value
Description
The anti-measles antibody concentration cut-off value assessed was ≥ 150 mIU/mL, in the sera of subjects seronegative before vaccination.
Time Frame
At Year 4, Year 6, Year 8 and Year 10 time points
Title
Phase B: Immune Response to Mumps With Respect to Anti-mumps Antibody Concentrations
Description
Anti-mumps antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in units per milliliter (U/mL).
Time Frame
At Year 4, Year 6, Year 8 and Year 10 time points
Title
Phase B: Number of Subjects With Anti-mumps Antibody Concentrations Above the Cut-off Value
Description
The anti-mumps antibody concentration cut-off value assessed was ≥ 231 U/mL, in the sera of subjects seronegative before vaccination.
Time Frame
At Year 4, Year 6, Year 8 and Year 10 time points
Title
Phase B: Immune Response to Rubella With Respect to Anti-rubella Antibody Concentrations
Description
Anti-rubella antibody concentrations are presented as Geometric Mean Concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Time Frame
At Year 4, Year 6, Year 8 and Year 10 time points
Title
Phase B: Number of Subjects With Anti-rubella Antibody Concentrations Above the Cut-off Value
Description
The anti-rubella antibody concentration cut-off value assessed was ≥ 4 IU/mL, in the sera of subjects seronegative before vaccination.
Time Frame
At Year 4, Year 6, Year 8 and Year 10 time points
Title
Phase B: Characteristics of Zoster Cases
Description
Zoster cases were characterized by number and character of lesions, duration of rash, incidence of fever, systemic signs, the assessment by investigator, complications, treatment, outcome and intensity of severity.
Time Frame
From 6 weeks after Dose 2 until study end (Year 10)
Title
Phase B: Number of Subjects Reporting Serious Adverse Events (SAEs)
Description
SAEs assessed included medical occurrences that resulted in death, were life-threatening, required hospitalisation or prolongation of hospitalisation or resulted in disability/incapacity. Any SAE = occurrence of SAE regardless of intensity grade or relation to vaccination.
Time Frame
From the beginning of Phase B (Year 2) up to study end (Year 10)
Title
Phase B: Health Economics Analysis of Factors Leading to Indirect Costs Due to Varicella Illness
Description
Parameters assessed: 1. Number of hours lost from work by parents/guardians as a result of taking care of their child due to varicella. 2. Number of hours the child lost attendance in: day care/childminder, school, or in any extra-curricular activities (e.g. sports or recreation or any type of organised leisure activities) due to varicella. 3. Number of hours spent by a nurse, a babysitter or any type of existing paid caregiver to look after the child (if applicable).
Time Frame
During Phase B

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Months
Maximum Age & Unit of Time
22 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Subjects for whom the investigator believes that their parents/guardians can and will comply with the requirements of the protocol for the whole duration of the study. Male or female subject between 12 and 22 months of age at the time of the first vaccination. Subjects free of obvious health problems, as established by medical history and physical examination before entering the study. Written informed consent obtained from the parents/guardians of the subject after they have been informed on the risks and benefits of the study, in a language they clearly understand and before performance of any study procedure. Subjects whose parents/guardians have direct access to telephone/mobile phone. Subjects: with at least one sibling (with negative history of varicella disease/vaccination) at home, or attending day care center, or attending childminders, i.e. someone taking care of several children, or who are in contact for at least once a week with other children without a known positive history of varicella disease/vaccination, while playing in close physical contact for more than 5 minutes. Exclusion criteria: Previous vaccination against measles, mumps, rubella and/or varicella. History of previous measles, mumps, rubella and/or varicella/ herpes zoster diseases. Known exposure to measles, mumps, rubella and/or varicella/herpes zoster within 30 days prior to the start of the study. Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose. Administration of immunoglobulins and/or any blood products within three months prior to the first vaccine dose or planned administration during the study period. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical. Family history of congenital or hereditary immunodeficiency. History of allergic diseases or reactions likely to be exacerbated by any component of the vaccines, including systemic allergy to egg proteins or neomycin. Major congenital defects or serious chronic illness. Residence in the same household as newborns (0-4 weeks of age), pregnant women who are varicella-susceptible, persons with a known immunodeficiency or any other persons at high risk for varicella. History of any neurologic disorders or seizures. Use of any investigational or non-registered product (drug/vaccine other than the study vaccines) within 14 days prior to vaccination and planned use during the study period. Additional exclusion criteria for subjects included in the subset: - Administration of a licensed vaccine within 14 days prior to vaccination and planned use until approximately 42 days after the last study vaccine dose (Day 84) with the exception of oral polio vaccine (OPV).
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
Brno
ZIP/Postal Code
628 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Chomutov
ZIP/Postal Code
43003
Country
Czechia
Facility Name
GSK Investigational Site
City
Decin
ZIP/Postal Code
405 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Havlickuv Brod
ZIP/Postal Code
580 22
Country
Czechia
Facility Name
GSK Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Humpolec
ZIP/Postal Code
396 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Kolin
ZIP/Postal Code
28002
Country
Czechia
Facility Name
GSK Investigational Site
City
Liberec
ZIP/Postal Code
46015
Country
Czechia
Facility Name
GSK Investigational Site
City
Moravska Ostrava
ZIP/Postal Code
702 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Nachod
ZIP/Postal Code
547 01
Country
Czechia
Facility Name
GSK Investigational Site
City
Ostrava
ZIP/Postal Code
728 92
Country
Czechia
Facility Name
GSK Investigational Site
City
Pardubice
ZIP/Postal Code
532 03
Country
Czechia
Facility Name
GSK Investigational Site
City
Plzen
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 4
ZIP/Postal Code
140 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 4
ZIP/Postal Code
14200
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 5
ZIP/Postal Code
150 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 6
ZIP/Postal Code
160 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Praha 9
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
GSK Investigational Site
City
Znojmo
Country
Czechia
Facility Name
GSK Investigational Site
City
Arta
ZIP/Postal Code
471 00
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
115 22
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
115 27
Country
Greece
Facility Name
GSK Investigational Site
City
Athens
ZIP/Postal Code
25236
Country
Greece
Facility Name
GSK Investigational Site
City
Giannitsa
ZIP/Postal Code
581 00
Country
Greece
Facility Name
GSK Investigational Site
City
Karditsa
ZIP/Postal Code
43100
Country
Greece
Facility Name
GSK Investigational Site
City
Komotini
ZIP/Postal Code
69 100
Country
Greece
Facility Name
GSK Investigational Site
City
Ptolemaida
ZIP/Postal Code
50200
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece
Facility Name
GSK Investigational Site
City
Tripolis
ZIP/Postal Code
22100
Country
Greece
Facility Name
GSK Investigational Site
City
Veria
ZIP/Postal Code
591 00
Country
Greece
Facility Name
GSK Investigational Site
City
Quarto (NA)
State/Province
Campania
ZIP/Postal Code
80010
Country
Italy
Facility Name
GSK Investigational Site
City
Ferrara
State/Province
Emilia-Romagna
ZIP/Postal Code
44100
Country
Italy
Facility Name
GSK Investigational Site
City
Udine
State/Province
Friuli-Venezia-Giulia
ZIP/Postal Code
33100
Country
Italy
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
GSK Investigational Site
City
Novara
State/Province
Piemonte
ZIP/Postal Code
28100
Country
Italy
Facility Name
GSK Investigational Site
City
Alghero (SS)
State/Province
Sardegna
ZIP/Postal Code
07041
Country
Italy
Facility Name
GSK Investigational Site
City
Ozieri (SS)
State/Province
Sardegna
ZIP/Postal Code
07014
Country
Italy
Facility Name
GSK Investigational Site
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50139
Country
Italy
Facility Name
GSK Investigational Site
City
Alytus
ZIP/Postal Code
LT-63164
Country
Lithuania
Facility Name
GSK Investigational Site
City
Kaunas
ZIP/Postal Code
LT-48259
Country
Lithuania
Facility Name
GSK Investigational Site
City
Klaipeda
ZIP/Postal Code
LT-94007
Country
Lithuania
Facility Name
GSK Investigational Site
City
Panevezys
ZIP/Postal Code
LT-37355
Country
Lithuania
Facility Name
GSK Investigational Site
City
Siauliai
ZIP/Postal Code
LT-76346
Country
Lithuania
Facility Name
GSK Investigational Site
City
Vilnius
ZIP/Postal Code
LT -10207
Country
Lithuania
Facility Name
GSK Investigational Site
City
Vilnius
ZIP/Postal Code
LT-02169
Country
Lithuania
Facility Name
GSK Investigational Site
City
Vilnius
ZIP/Postal Code
LT-11200
Country
Lithuania
Facility Name
GSK Investigational Site
City
Bekkestua
ZIP/Postal Code
1319
Country
Norway
Facility Name
GSK Investigational Site
City
Moelv
ZIP/Postal Code
N-2390
Country
Norway
Facility Name
GSK Investigational Site
City
Paradis
ZIP/Postal Code
5231
Country
Norway
Facility Name
GSK Investigational Site
City
Skien
ZIP/Postal Code
N-03730
Country
Norway
Facility Name
GSK Investigational Site
City
Trondheim
ZIP/Postal Code
N-7036
Country
Norway
Facility Name
GSK Investigational Site
City
Bydgoszcz
ZIP/Postal Code
85-021
Country
Poland
Facility Name
GSK Investigational Site
City
Debica
ZIP/Postal Code
39-200
Country
Poland
Facility Name
GSK Investigational Site
City
Krakow
ZIP/Postal Code
31-202
Country
Poland
Facility Name
GSK Investigational Site
City
Olesnica
ZIP/Postal Code
56-400
Country
Poland
Facility Name
GSK Investigational Site
City
Poznan
ZIP/Postal Code
61-709
Country
Poland
Facility Name
GSK Investigational Site
City
Siemianowice Slaskie
ZIP/Postal Code
41-103
Country
Poland
Facility Name
GSK Investigational Site
City
Tarnow
ZIP/Postal Code
33-100
Country
Poland
Facility Name
GSK Investigational Site
City
Trzebnica
ZIP/Postal Code
55-100
Country
Poland
Facility Name
GSK Investigational Site
City
Wesola
ZIP/Postal Code
05-077
Country
Poland
Facility Name
GSK Investigational Site
City
Wroclaw
ZIP/Postal Code
52-312
Country
Poland
Facility Name
GSK Investigational Site
City
Brasov
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
050098
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
077190
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
20395
Country
Romania
Facility Name
GSK Investigational Site
City
Bucharest
ZIP/Postal Code
22102
Country
Romania
Facility Name
GSK Investigational Site
City
Cluj-Napoca
ZIP/Postal Code
400217
Country
Romania
Facility Name
GSK Investigational Site
City
Constanta
ZIP/Postal Code
900709
Country
Romania
Facility Name
GSK Investigational Site
City
Sibiu
Country
Romania
Facility Name
GSK Investigational Site
City
Timisoara
ZIP/Postal Code
300593
Country
Romania
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620085
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ekaterinburg
ZIP/Postal Code
620109
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Ivanteevka Moscow Region
ZIP/Postal Code
141280
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115 478
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Murmansk
ZIP/Postal Code
183046
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Novokuznetsk
ZIP/Postal Code
654063
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Novosibirsk
ZIP/Postal Code
630112
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Samara
ZIP/Postal Code
443079
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Sankt-Peterburg
ZIP/Postal Code
191123
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Saratov
ZIP/Postal Code
410010
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Tomsk
ZIP/Postal Code
634001
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Volgograd
ZIP/Postal Code
400130
Country
Russian Federation
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
841 08
Country
Slovakia
Facility Name
GSK Investigational Site
City
Bratislava
ZIP/Postal Code
851 05
Country
Slovakia
Facility Name
GSK Investigational Site
City
Dlha nad Oravou
ZIP/Postal Code
027 55
Country
Slovakia
Facility Name
GSK Investigational Site
City
Dolny Kubin
ZIP/Postal Code
026 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Dubnica Nad Vahom
ZIP/Postal Code
018 41
Country
Slovakia
Facility Name
GSK Investigational Site
City
Nova Dubnica
ZIP/Postal Code
018 51
Country
Slovakia
Facility Name
GSK Investigational Site
City
Nove Mesto nad Vahom
ZIP/Postal Code
915 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Nove Zamky
ZIP/Postal Code
940 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Puchov
ZIP/Postal Code
020 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Ruzomberok
ZIP/Postal Code
034 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Sturovo
ZIP/Postal Code
943 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Surany
ZIP/Postal Code
942 18
Country
Slovakia
Facility Name
GSK Investigational Site
City
Trencin
ZIP/Postal Code
911 01
Country
Slovakia
Facility Name
GSK Investigational Site
City
Linköping
ZIP/Postal Code
SE-581 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Facility Name
GSK Investigational Site
City
Norrköping
ZIP/Postal Code
SE-602 39
Country
Sweden
Facility Name
GSK Investigational Site
City
Umeå
ZIP/Postal Code
SE-901 85
Country
Sweden
Facility Name
GSK Investigational Site
City
Örebro
ZIP/Postal Code
SE-702 11
Country
Sweden

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 is available via the Clinical Study Data Request site (click on the link provided below)
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.
IPD Sharing URL
https://clinicalstudydatarequest.com
Citations:
PubMed Identifier
29224964
Citation
Henry O, Brzostek J, Czajka H, Leviniene G, Reshetko O, Gasparini R, Pazdiora P, Plesca D, Desole MG, Kevalas R, Gabutti G, Povey M, Innis B. One or two doses of live varicella virus-containing vaccines: Efficacy, persistence of immune responses, and safety six years after administration in healthy children during their second year of life. Vaccine. 2018 Jan 8;36(3):381-387. doi: 10.1016/j.vaccine.2017.11.081. Epub 2017 Dec 7. Erratum In: Vaccine. 2018 Oct 29;36(45):6894.
Results Reference
background
PubMed Identifier
24485548
Citation
Prymula R, Bergsaker MR, Esposito S, Gothefors L, Man S, Snegova N, Stefkovicova M, Usonis V, Wysocki J, Douha M, Vassilev V, Nicholson O, Innis BL, Willems P. Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine versus one dose of monovalent varicella vaccine: a multicentre, observer-blind, randomised, controlled trial. Lancet. 2014 Apr 12;383(9925):1313-1324. doi: 10.1016/S0140-6736(12)61461-5. Epub 2014 Jan 29. Erratum In: Lancet. 2020 Jan 25;395(10220):272.
Results Reference
background
PubMed Identifier
31345639
Citation
Carryn S, Feyssaguet M, Povey M, Di Paolo E. Long-term immunogenicity of measles, mumps and rubella-containing vaccines in healthy young children: A 10-year follow-up. Vaccine. 2019 Aug 23;37(36):5323-5331. doi: 10.1016/j.vaccine.2019.07.049. Epub 2019 Jul 22.
Results Reference
background
PubMed Identifier
33736915
Citation
Habib MA, Prymula R, Carryn S, Esposito S, Henry O, Ravault S, Usonis V, Wysocki J, Gillard P, Povey M. Correlation of protection against varicella in a randomized Phase III varicella-containing vaccine efficacy trial in healthy infants. Vaccine. 2021 Jun 8;39(25):3445-3454. doi: 10.1016/j.vaccine.2021.02.074. Epub 2021 Mar 16.
Results Reference
derived
PubMed Identifier
30765242
Citation
Povey M, Henry O, Riise Bergsaker MA, Chlibek R, Esposito S, Flodmark CE, Gothefors L, Man S, Silfverdal SA, Stefkovicova M, Usonis V, Wysocki J, Gillard P, Prymula R. Protection against varicella with two doses of combined measles-mumps-rubella-varicella vaccine or one dose of monovalent varicella vaccine: 10-year follow-up of a phase 3 multicentre, observer-blind, randomised, controlled trial. Lancet Infect Dis. 2019 Mar;19(3):287-297. doi: 10.1016/S1473-3099(18)30716-3. Epub 2019 Feb 11. Erratum In: Lancet Infect Dis. 2020 Feb;20(2):e26.
Results Reference
derived
Links:
URL
https://www.clinicalstudydatarequest.com
Description
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.
Available IPD and Supporting Information:
Available IPD/Information Type
Individual Participant Data Set
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100388
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Statistical Analysis Plan
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100388
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Study Protocol
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100388
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Informed Consent Form
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100388
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Dataset Specification
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100388
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register
Available IPD/Information Type
Clinical Study Report
Available IPD/Information URL
https://www.clinicalstudydatarequest.com
Available IPD/Information Identifier
100388
Available IPD/Information Comments
For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

Evaluate Vaccine Against Chickenpox and a Combined Vaccine Against 4 Viral Childhood Diseases: Measles, Mumps, Rubella and Chickenpox

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