MeaslesPhase 3NCT00751348

Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136

A Phase 3 study testing PriorixTM, VarilrixTM and Priorix-Tetra® in people with Measles and Varicella, run by GlaxoSmithKline at 13 sites in South Korea.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea. Read more about this study

Who is it for?: Ages 11 to 24 monthsHealthy volunteers can take part
Conditions the study is for: Measles, Varicella, Mumps
What is being tested?: PriorixTM, VarilrixTM and Priorix-Tetra®
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 475 participants
Where: 13 sitesSouth Korea
Study dates: 1 Oct 2008to 27 May 2010
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 11 to 24 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including 11 and 24 months of age, at the time of the vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Who cannot join

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after the study vaccine dose with the exception of inactivated vaccines such as pneumococcal, Haemophilus influenzae type b conjugate vaccines, inactivated influenza, hepatitis A or B vaccine or diphtheria/tetanus-containing vaccines which can be administered up to eight days before the study vaccine dose.
Previous vaccination against measles, mumps, rubella and/or varicella.
History of measles, mumps, rubella and/or varicella/zoster diseases.

Show all 17Show fewer

Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to study start.
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
A family history of congenital or hereditary immunodeficiency.
History of allergic disease or reactions likely to be exacerbated by any component of the vaccine(s), including systemic hypersensitivity to neomycin.
Major congenital defects or serious chronic illness.
Acute disease at the time of enrolment.
Rectal temperature ≥ 38°C or axillary temperature ≥ 37.5°C at the time of vaccination.
Residence in the same household as a high risk person e.g.:
New-born infants (0-4 weeks of age)
Pregnant women who have a negative history of chickenpox
Persons with known immunodeficiency

Trial locations and contacts

13 sites in 1 country.

City, postcode or hospital

13 sites in 1 country

South Korea13 sites

GSK Investigational Site
Bucheon-si, 420-767
GSK Investigational Site
Daejeon, 301-723
GSK Investigational Site
Gwangju, 501-717
GSK Investigational Site
GyeongSangNam-do, 641-560
GSK Investigational Site
Iksan, 570-711
GSK Investigational Site
Incheon, 400-711
GSK Investigational Site
Jeonju Jeonbuk, 561-712
GSK Investigational Site
Seongnam-si, Gyeonggi-do, 463-712
GSK Investigational Site
Seoul, 130-702
GSK Investigational Site
Seoul, 150-719
GSK Investigational Site
Seoul, 150-950
GSK Investigational Site
Uijeongbu, Kyonggi-do, 480-130
GSK Investigational Site
Wonju-si Kangwon-do, 220-701

Other trials in South Korea

About this study

This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.

Conditions: Measles, Varicella, Mumps, Rubella
Being tested: PriorixTM, VarilrixTM, Priorix-Tetra®
Keywords: second year of life, one-dose schedule, varicella, rubella, measles, mumps
Medical subject headings: Measles, Chickenpox, Mumps, Rubella

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PriorixTMBiological
Subcutaneous administration in left upper arm
VarilrixTMBiological
Subcutaneous administration in right upper arm
Priorix-Tetra®Biological
Subcutaneous injection in left upper arm

Study groups in NCT00751348
Study group	Role	What they receive
PRIORIX-TETRA GROUP	Experimental	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm. Receives: Biological: Priorix-Tetra®
PRIORIX + VARILRIX GROUP	Active comparator	Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively. Receives: Biological: PriorixTM; Biological: VarilrixTM

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values
Seroconversion was defined as the appearance of antibodies [i.e. titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative [i.e. titer below (<) cut-off value] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.
Measured: At 42 days post-vaccination

Secondary outcomes (8)

Antibody Concentrations Against Measles
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in milli-international units per milliliter (mIU/mL).
Measured: At 42-days post-vaccination
Antibody Concentrations Against Mumps
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in units per milliliter (U/mL).
Measured: At 42-days post-vaccination
Antibody Concentrations Against Rubella
Antibody concentrations were presented as geometric mean concentrations (GMCs), expressed in international units per milliliter (IU/mL).
Measured: At 42-days post-vaccination
Antibody Titers Against Varicela Viruses
Antibody titers were presented as geometric mean titers (GMTs).
Measured: At 42-days post-vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Solicited local symptoms assessed were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = cry when limb was moved/spontaneously painful. Grade 3 redness/swelling = redness/swelling spreading beyond 20 millimeters (mm) of injection site.
Measured: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Solicited general symptoms assessed were fever [defined as rectal temperature ≥38.0 degrees Celsius (°C)], rash, meningism and parotid gland swelling. Any= incidence of the specified symptoms regardless of intensity grade or relationship to study vaccine. Grade 3 fever= rectal temperature above (>) 39.5°C. Grade 3 rash= more than 150 lesions. Grade 3 meningism and parotid gland swelling= meningism/parotid gland swelling symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the vaccination.
Measured: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. Any was defined as an adverse event (AE) reported in addition to those solicited during the clinical study. Any solicited symptom with onset outside the specified period of follow-up for solicited symptoms was reported as an unsolicited adverse event.
Measured: Within the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Serious adverse events (SAEs) assessed include medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject.
Measured: During the entire study period (from Day 0 up to Day 43 or Day 57)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 200827 May 2010

First posted11 Sep 2008 (estimated)
Study start1 Oct 2008
Primary completion27 May 2010
Study completion27 May 2010

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 MeaslesStudies 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: None (open label)
Enrolment: 475 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00751348
Sponsor's protocol ID: 110876
Status last verified: May 2017
First submitted: 10 Sep 2008
Last updated: 8 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Sung-Ho Cha et al. Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella (MMRV) vaccine: an open-labeled, randomized trial in healthy Korean children. Abstract presented at the Fall Meeting of Korean Vaccine Society (KVS). Seoul, Korea, 31 August 2013.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Measles trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity & Safety Study of GSK Biologicals' Combined Measles-mumps-rubella-varicella Vaccine 208136
ClinicalTrials.gov ID: NCT00751348
Acronym / sponsor ID: 110876
Conditions: Measles, Varicella, Mumps, Rubella
Keywords: second year of life, one-dose schedule, varicella, rubella, measles, mumps
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 475 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Oct 2008
Primary completion: 27 May 2010 (actual)
Study completion: 27 May 2010 (actual)
First posted: 11 Sep 2008 (estimated)
Results: Posted 24 Apr 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

This Phase 3b study is being conducted for the purpose of registration of the GSK208136 vaccine in Korea.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
PRIORIX-TETRA GROUP	Experimental	Biological: Priorix-Tetra®Healthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix-Tetra® vaccine at Day 0, administered subcutaneously in the deltoid region of the left upper arm.
PRIORIX + VARILRIX GROUP	Active comparator	Biological: PriorixTM, Biological: VarilrixTMHealthy male and female subjects between, and including 11 and 24 months of age, who received one dose of Priorix™ vaccine together with one dose of Varilrix™ vaccine at Day 0, administered subcutaneously in the deltoid regions of the left or right upper arm, respectively.

Who may qualify

Ages: 11 to 24 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (4 listed)

Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol should be enrolled in the study.
A male or female between, and including 11 and 24 months of age, at the time of the vaccination.
Written informed consent obtained from the parent or guardian of the subject.
Healthy subjects as established by medical history and clinical examination before entering into the study.

Key exclusion criteria (17 listed)

Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the dose of study vaccine, or planned use during the study period.
Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the vaccine dose.
Administration of immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days prior to until 42 days after the study vaccine dose with the exception of inactivated vaccines such as pneumococcal, Haemophilus influenzae type b conjugate vaccines, inactivated influenza, hepatitis A or B vaccine or diphtheria/tetanus-containing vaccines which can be administered up to eight days before the study vaccine dose.
Previous vaccination against measles, mumps, rubella and/or varicella.

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
PriorixTMSubcutaneous administration in left upper arm	Biological	PRIORIX + VARILRIX GROUP
VarilrixTMSubcutaneous administration in right upper arm	Biological	PRIORIX + VARILRIX GROUP
Priorix-Tetra®Subcutaneous injection in left upper arm	Biological	PRIORIX-TETRA GROUP

Primary outcome

Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values
Time frame: At 42 days post-vaccination
Seroconversion was defined as the appearance of antibodies [i.e. titer greater than or equal to (≥) the cut-off value] in the sera of subjects seronegative [i.e. titer below (<) cut-off value] before vaccination. Cut-off values were the following: Anti-measles concentration ≥ 150 milli-international units per milliliter (mIU/mL); Anti-mumps concentration ≥ 231 units per milliliter (U/mL); Anti-rubella concentration ≥ 4 international units per milliliter (IU/mL); Anti-VZV titer ≥ 1:4 dilution.

8 secondary outcomes

Antibody Concentrations Against Measles
Time frame: At 42-days post-vaccination
Antibody Concentrations Against Mumps
Time frame: At 42-days post-vaccination
Antibody Concentrations Against Rubella
Time frame: At 42-days post-vaccination
Antibody Titers Against Varicela Viruses
Time frame: At 42-days post-vaccination
Number of Subjects With Any and Grade 3 Solicited Local Symptoms
Time frame: During the 4-day (Days 0-3) post-vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms
Time frame: During the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Any Unsolicited Adverse Events (AEs)
Time frame: Within the 43-day (Days 0-42) post-vaccination period
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period (from Day 0 up to Day 43 or Day 57)

Results and safety

Results posted to the registry on 24 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Priorix-Tetra Group	313	307
Priorix + Varilrix Group	161	159

Primary outcome: Number of Subjects Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values

Time frame: At 42 days post-vaccination. Count of participants. Unit: Participants

Measure	Priorix-Tetra Group n = 300	Priorix + Varilrix Group n = 157
Anti-Measles	294	155
Anti-Mumps	262	145
Anti-Rubella	297	157
Anti-VZV	280	151

Priorix-Tetra Group vs Priorix + Varilrix Group: Difference in percentage: -1.36 (95% CI -3.77 to 1.66), p <0.05, Fisher Exact
Priorix-Tetra Group vs Priorix + Varilrix Group: Difference in percentage: -5.34 (95% CI -10.4 to 0.38), p <0.05, Fisher Exact
Priorix-Tetra Group vs Priorix + Varilrix Group: Difference in percentage: -0.34 (95% CI -1.88 to 2.06), p <0.05, Fisher Exact

Population analysed: The analysis was performed on the According-To-Protocol (ATP) cohort for immunogenicity,which included all evaluable subjects who were seronegative for at least one vaccine antigen at baseline and for whom pre-vaccination and post-vaccination serology results were available.

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local: during the 4-day (Days 0-3) post-vaccination period. Solicited general symptoms and unsolicited AEs: during the 43-day (Days 0-42) post-vaccination period. SAEs: during the entire study period (from Day 0 up to Day 43 or 57).. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Priorix-Tetra Group	25 of 313 (8%)	243 of 313 (77.6%)	0 of 313
Priorix + Varilrix Group	12 of 161 (7.5%)	113 of 161 (70.2%)	0 of 161

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
BackgroundSung-Ho Cha et al. Immunogenicity and safety of a tetravalent measles-mumps-rubella-varicella (MMRV) vaccine: an open-labeled, randomized trial in healthy Korean children. Abstract presented at the Fall Meeting of Korean Vaccine Society (KVS). Seoul, Korea, 31 August 2013.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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

13 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PriorixTM, VarilrixTM and Priorix-Tetra® in people with Measles and Varicella, run by GlaxoSmithKline at 13 sites in South Korea.

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 4 inclusion and 17 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 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in South Korea. 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 24 Apr 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 Seroconverted for Measles, Mumps, Rubella and Varicella Zoster Virus (VZV) Antibodies Above the Cut-off Values (time frame: At 42 days post-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 NCT00751348, 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 8 Jun 2018.