Chicken-pox Illness (Varicella Virus Disease)Phase 3NCT02570126
A Safety and Immune Study of 2 Types of GlaxoSmithKline's Varicella Vaccines Given as a 2-doses Course to Healthy Children 12-23 Months of Age.
A Phase 3 study testing Varilrix HSA-free and Varilrix™ in people with Chicken-pox Illness (Varicella Virus Disease) and Chickenpox, run by GlaxoSmithKline at 23 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the safety and immunogenicity of 2 formulations of GSK Biologicals' varicella vaccines given as a 2-dose course in the second year of life. Read more about this study
- Who is it for?
- Ages 12 to 23 monthsHealthy volunteers can take part
- Conditions the study is for
- Chicken-pox Illness (Varicella Virus Disease), Chickenpox
- What is being tested?
- Varilrix HSA-free and Varilrix™
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,236 participants
- Where
- 23 sitesin 5 countries
- Study dates
- 13 Nov 2015to 25 Oct 2016
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 23 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects' parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 23 months of age (i.e. 12 months to a day before 24 months) at the time of the first study vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- Subjects in stable health as determined by investigator's clinical examination and assessment of subject's medical history.
- Subjects must have had prior administration of a dose of measles, mumps and rubella (MMR) vaccine at least 30 days (Day -31 or earlier) prior to study vaccination at Day 0.
Who cannot join
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Visit 1/Day 0) or planned use during the entire study period.
- Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product.
- Chronic administration (defined as 14 or more consecutive days) of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.
- For corticosteroids, this will mean prednisone ≥0.5 mg/kg/day or equivalent.
- Inhaled and topical steroids are allowed.
Show all 22Show fewer
- Planned administration/ administration of a live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1/Day 0 until study end. Non study live viral vaccines can be administered at Visit 3 (Day 84) after completion of study procedures.
- Planned administration/ administration of an inactivated vaccine not foreseen by the study protocol during the period starting 7 days prior to each vaccination (at Visit 1/Day 0 and Visit 2/Day 42) and ending 14 days after each vaccination. Outside of this period, non-study inactivated vaccines can be administered as per standard of care.
- Administration of immunoglobulins and/or any blood products during the period starting 180 days prior to the first vaccine dose or planned administration from the date of first study vaccination through the entire study.
- History of varicella or zoster.
- Known exposure to varicella/zoster during the period starting within 30 days prior to first study vaccination.
- Previous vaccination against varicella.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
- Subjects with blood dyscrasias, leukemia, and lymphomas of any type.
- A family history of congenital or hereditary immunodeficiency
- History of allergic disease or reactions likely to be exacerbated by any component of the vaccines, including hypersensitivity to neomycin or latex.
- Major congenital defects or serious chronic illness.
- Acute disease and/or fever at the time of enrolment.
- Fever is defined as temperature ≥38. 0°C/100.4°F by any age appropriate route.
- Subjects with a minor illness without fever may be enrolled at the discretion of the investigator.
- Active untreated tuberculosis based on medical history.
- Any other condition which, in the opinion of the investigator, prevents the child from participating in the study.
Trial locations and contacts
23 sites in 5 countries.
23 sites in 5 countries
Germany13 sites
GSK Investigational Site
Aschaffenburg, Bavaria, 63739
GSK Investigational Site
Berlin, 13055
GSK Investigational Site
Detmold, North Rhine-Westphalia, 32756
GSK Investigational Site
Frankenthal, Rhineland-Palatinate, 67227
GSK Investigational Site
Kehl, Baden-Wurttemberg, 77694
GSK Investigational Site
Neumünster, 24534
GSK Investigational Site
Schönau am Königssee, Bavaria, 83471
GSK Investigational Site
Solingen, North Rhine-Westphalia, 42719
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70469
GSK Investigational Site
Stuttgart, Baden-Wurttemberg, 70499
GSK Investigational Site
Tauberbischofsheim, Baden-Wurttemberg, 97941
GSK Investigational Site
Vellmar, Hesse, 34246
GSK Investigational Site
Wurzen, Saxony, 04808
United Kingdom4 sites
GSK Investigational Site
Bristol, BS2 8AE
GSK Investigational Site
London, SW17 0RE
GSK Investigational Site
Oxford, OX3 7LJ
GSK Investigational Site
Southampton, SO16 6YD
Estonia3 sites
GSK Investigational Site
Tallinn, 10617
GSK Investigational Site
Tallinn
GSK Investigational Site
Tartu, 50106
Mexico2 sites
GSK Investigational Site
Mérida, Yucatán, 97070
GSK Investigational Site
Mexico City, 04530
About this study
Official title: Safety and Immunogenicity Study of 2 Formulations of GSK Biologicals' Varicella Vaccines Given as a 2-dose Course in the Second Year of Life.
The purpose of this study is to evaluate the safety and immunogenicity of 2 formulations of GSK Biologicals' varicella vaccines given as a 2-dose course in the second year of life.
Read the detailed description
GSK Biologicals has removed human serum albumin (a stabilizer) from its varicella vaccine to minimize as much as possible the use of animal or human-derived products in the production of vaccines. The study is intended to provide information on the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' candidate varicella vaccine formulated without human serum albumin (HSA) in contrast to Varilrix™ (GSK) which contains HSA when both are used in a two-dose schedule, with the first and second doses given approximately 42 days apart in the second year of life.
The immunogenicity sub-cohort will be comprised of approximately 400 subjects, representing approximately 100 subjects enrolled in each of the participating countries.
Rationale for amendment 1: Sites in the UK can perform home visits. For subjects participating through home visits, the subject's parent(s) / Legally Acceptable Representative(s) [LAR(s)] will be requested to sign a Recruitment/Randomisation agreement to provide personal information and to agree to have their child randomised before providing written consent to participate in the study (to be provided at the 1st home visit).
- Being tested
- Varilrix HSA-free, Varilrix™
- Keywords
- Immunogenicity, Varicella, Safety, Human serum albumin, Healthy children, 12 to 23 months
- Medical subject headings
- Chickenpox
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Varilrix HSA-freeBiological
2 doses will be administered, one at Day 0 and the other at Day 42
Varilrix™Biological
2 doses will be administered, one at Day 0 and the other at Day 42
| Study group | Role | What they receive |
|---|---|---|
| VAR_HSA_F Group | Experimental | 2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), will be given to the subjects in this group. The vaccine will be administered subcutaneously in the triceps region of the left arm Receives: Biological: Varilrix HSA-free |
| VAR Group | Active comparator | 2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), will be given to the subjects in this group. The vaccine will be administered subcutaneously in the triceps region of the left arm Receives: Biological: Varilrix™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Reporting Fever
Fever was defined as axillary temperature above (>) 39.0 °C (> 102.2°F)
Measured: 15-days (Days 0-14) post Dose 1 of varicella vaccination
Secondary outcomes (9)
Number of Subjects Reporting Fever
Fever was defined as axillary temperature greater than or equal to (≥) 38.0°C (≥ 100.4°F)
Measured: 15 days post each dose of varicella vaccination
Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort)
Anti-VZY antibody concentrations were expressed in terms of Geometric Mean Concentrations (GMCs)
Measured: At Day 42 and Day 84 post vaccination
Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort)
For VZV, seroresponse was defined as, post-vaccination anti-VZV antibody concentration ≥ 50 mIU/mL among subjects who were seronegative (antibody concentration below (< ) 25 mIU/mL) before vaccination
Measured: At Day 42 and Day 84 post vaccination
Number of Subjects Reporting Solicited Local Symptoms
Solicited local symptoms assessed were pain, injection site redness and swelling. Any = occurrence of the specified solicited local symptom regardless of its intensity. Grade 3 pain = subject crying when limb was moved or as spontaneously painful. Grade 3 redness and swelling = above (>) 20 mm
Measured: 4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Fever
Any fever (≥ 38°C) = occurrence of any fever regardless of its intensity grade or relationship to vaccination. Grade 3 fever = temperature > 39.5°C. Related fever = assessed by the investigator as causally related to study vaccination
Measured: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Rash
Any rash = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 rash = rash which prevented normal, everyday activities. Related rash = assessed by the investigator as causally related to study vaccination
Measured: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Febrile Convulsions
Any febrile convulsion = occurrence of the specified solicited general symptom regardless of its intensity. Grade 3 febrile convulsion = febrile convulsion which prevented normal, everyday activities. Related febrile convulsion = assessed by the investigator as causally related to study vaccination
Measured: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Unsolicited AE covers 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
Measured: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
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
Measured: From Day 0 through the end of study (Day 84)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2015 (estimated)
- Study start13 Nov 2015
- Primary completion25 Oct 2016
- Study completion25 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chicken-pox Illness (Varicella Virus Disease)Studies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,236 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02570126
- Sponsor's protocol ID
- 200147
- Other IDs
- 2013-003535-30
- Status last verified
- Nov 2019
- First submitted
- 5 Oct 2015
- Last updated
- 25 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: IPD is available via the Clinical Study Data Request site (click on the link provided below)
Publications
Faust SN, Le Roy M, Pancharoen C, Weber MAR, Cathie K, Behre U, Bernatoniene J, Snape MD, Helm K, Medina Pech CE, Henry O, Baccarini C, Povey M, Gillard P. Safety and immunogenicity of a varicella vaccine without human serum albumin (HSA) versus a HSA-containing formulation administered in the second year of life: a phase III, double-blind, randomized study. BMC Pediatr. 2019 Feb 7;19(1):50. doi: 10.1186/s12887-019-1425-7.
PubMed 30732648
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity Study of 2 Formulations of GSK Biologicals' Varicella Vaccines Given as a 2-dose Course in the Second Year of Life.
- ClinicalTrials.gov ID
- NCT02570126
- Acronym / sponsor ID
- 200147
- Keywords
- Immunogenicity, Varicella, Safety, Human serum albumin, Healthy children, 12 to 23 months
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,236 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 13 Nov 2015 (actual)
- Primary completion
- 25 Oct 2016 (actual)
- Study completion
- 25 Oct 2016 (actual)
- First posted
- 7 Oct 2015 (estimated)
- Results
- Posted 11 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety and immunogenicity of 2 formulations of GSK Biologicals' varicella vaccines given as a 2-dose course in the second year of life.
Detailed description
GSK Biologicals has removed human serum albumin (a stabilizer) from its varicella vaccine to minimize as much as possible the use of animal or human-derived products in the production of vaccines. The study is intended to provide information on the safety and immunogenicity of GlaxoSmithKline (GSK) Biologicals' candidate varicella vaccine formulated without human serum albumin (HSA) in contrast to Varilrix™ (GSK) which contains HSA when both are used in a two-dose schedule, with the first and second doses given approximately 42 days apart in the second year of life.
The immunogenicity sub-cohort will be comprised of approximately 400 subjects, representing approximately 100 subjects enrolled in each of the participating countries.
Rationale for amendment 1: Sites in the UK can perform home visits. For subjects participating through home visits, the subject's parent(s) / Legally Acceptable Representative(s) [LAR(s)] will be requested to sign a Recruitment/Randomisation agreement to provide personal information and to agree to have their child randomised before providing written consent to participate in the study (to be provided at the 1st home visit).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VAR_HSA_F Group | Experimental | Biological: Varilrix HSA-free2 doses of Varilrix HSA-free vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), will be given to the subjects in this group. The vaccine will be administered subcutaneously in the triceps region of the left arm |
| VAR Group | Active comparator | Biological: Varilrix™2 doses of Varilrix™ vaccine, one at Visit 1 (Day 0) and the other at Visit 2 (Day 42), will be given to the subjects in this group. The vaccine will be administered subcutaneously in the triceps region of the left arm |
Who may qualify
- Ages
- 12 to 23 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Subjects' parent(s)/ LAR(s) who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- A male or female between, and including, 12 and 23 months of age (i.e. 12 months to a day before 24 months) at the time of the first study vaccination.
- Written informed consent obtained from the parent(s)/LAR(s) of the subject prior to performing any study specific procedure.
- Subjects in stable health as determined by investigator's clinical examination and assessment of subject's medical history.
- Subjects must have had prior administration of a dose of measles, mumps and rubella (MMR) vaccine at least 30 days (Day -31 or earlier) prior to study vaccination at Day 0.
Key exclusion criteria (22 listed)
- Child in care.
- Use of any investigational or non-registered product other than the study vaccines during the period starting 30 days before the day of study vaccination (i.e., 30 days prior to Visit 1/Day 0) or planned use during the entire study period.
- Concurrently participating in another clinical study, in which the child has been or will be exposed to an investigational or a non-investigational product.
- Chronic administration (defined as 14 or more consecutive days) of immunosuppressants, or other immune-modifying drugs during the period starting 180 days prior to the first vaccine dose or any planned administration of immunosuppressive and immune-modifying drugs during the entire study.
- Planned administration/ administration of a live viral vaccine not foreseen by the study protocol during the period starting 30 days prior to study vaccination at Visit 1/Day 0 until study end. Non study live viral vaccines can be administered at Visit 3 (Day 84) after completion of study procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Varilrix HSA-free2 doses will be administered, one at Day 0 and the other at Day 42 | Biological | VAR_HSA_F Group |
| Varilrix™2 doses will be administered, one at Day 0 and the other at Day 42 | Biological | VAR Group |
Primary outcome
Number of Subjects Reporting Fever
Time frame: 15-days (Days 0-14) post Dose 1 of varicella vaccination
Fever was defined as axillary temperature above (>) 39.0 °C (> 102.2°F)
9 secondary outcomes
Number of Subjects Reporting Fever
Time frame: 15 days post each dose of varicella vaccination
Evaluation of Immune Response to Varicella Vaccine With Respect to Anti Varicella Zoster Virus (Anti-VZV) Antibody Concentrations (Immuno-sub Cohort)
Time frame: At Day 42 and Day 84 post vaccination
Number of Subjects With a Seroresponse to VZV (Immuno Sub Cohort)
Time frame: At Day 42 and Day 84 post vaccination
Number of Subjects Reporting Solicited Local Symptoms
Time frame: 4-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Fever
Time frame: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Rash
Time frame: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Febrile Convulsions
Time frame: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Unsolicited Adverse Events (AEs)
Time frame: 43-day post vaccination period following Dose 1 (Day 0) and Dose 2 (Day 42)
Number of Subjects Reporting Serious Adverse Events (SAEs)
Time frame: From Day 0 through the end of study (Day 84)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 30732648Faust SN, Le Roy M, Pancharoen C, Weber MAR, Cathie K, Behre U, Bernatoniene J, Snape MD, Helm K, Medina Pech CE, Henry O, Baccarini C, Povey M, Gillard P. Safety and immunogenicity of a varicella vaccine without human serum albumin (HSA) versus a HSA-containing formulation administered in the second year of life: a phase III, double-blind, randomized study. BMC Pediatr. 2019 Feb 7;19(1):50. doi: 10.1186/s12887-019-1425-7.
- Individual participant dataSharing planned: Yes. IPD is available via the Clinical Study Data Request site (click on the link provided below)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
23 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Varilrix HSA-free and Varilrix™ in people with Chicken-pox Illness (Varicella Virus Disease) and Chickenpox, run by GlaxoSmithKline at 23 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Germany, United Kingdom, Estonia, Mexico, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Oct 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Reporting Fever (time frame: 15-days (Days 0-14) post Dose 1 of varicella vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02570126, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Nov 2019.