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VaricellaPhase 2NCT00578175

Immunogenicity and Safety of GlaxoSmithKline Biologicals' MMRV Vaccine vs. ProQuad® in Children 12-14 Months of Age

A Phase 2 study testing Priorix-Tetra™ (MMRV vaccine 208136), ProQuad® and Havrix® in people with Varicella and Rubella, run by GlaxoSmithKline at 141 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this observer blinded study is to provide information on vaccine immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when administered with Hepatitis A vaccine and Pneumococcal vaccine. Read more about this study

Who is it for?
Ages 12 to 14 monthsHealthy volunteers can take part
Conditions the study is for
Varicella, Rubella, Mumps
What is being tested?
Priorix-Tetra™ (MMRV vaccine 208136), ProQuad® and Havrix®
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,851 participants
Where
141 sitesUnited States
Study dates
20 Nov 2007to 17 Mar 2009
Phase
Phase 2
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 14 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol.
  • Male or female between 12 and 14 months of age at the time of first vaccination.
  • Written informed consent obtained from the parent/guardian of the subject.
  • Healthy subjects as established by medical history and clinical examination before entering into the study.
  • Have previously received 3 doses of 7-valent pneumococcal conjugate vaccine within the first year of life.

Who cannot join

  • Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
  • Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational product.
  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
  • Planned administration/ administration of a vaccine not foreseen by the study protocol from 30 days prior to vaccination until 42 days after vaccination, except for influenza vaccine.
  • Previous vaccination against measles, mumps, rubella and/or varicella.
  • Previous vaccination against hepatitis A or receipt of a fourth dose of pneumococcal conjugate vaccine.
Show all 21Show fewer
  • History of measles, mumps, rubella and/or varicella/zoster diseases.
  • Known exposure to measles, mumps, rubella and/or varicella/zoster within 30 days prior to the start of the study.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination, including human immunodeficiency virus infection.
  • A family history of congenital or hereditary immunodeficiency.
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccines.
  • Major congenital defects or serious chronic illness.
  • History of any neurologic disorders or seizures. Uncomplicated febrile convulsions are not an exclusion criterion.
  • Residence in the same household as the following persons:
  • New-born infants (0-4 weeks of age).
  • Pregnant mother/women with a negative history of chickenpox disease and without recorded vaccination against chickenpox.
  • Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella disease history.
  • Persons with known immunodeficiency.
  • Acute disease at the time of enrolment. All vaccines can be administered to persons with a minor illness.
  • Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.
  • Contra-indications to commercially available vaccines used in this study (Havrix®, Prevnar®, ProQuad®).

Trial locations and contacts

141 sites in 1 country.

141 sites in 1 country

United States141 sites

  • GSK Investigational Site

    Altoona, Pennsylvania, 16602

  • GSK Investigational Site

    Amarillo, Texas, 79124

  • GSK Investigational Site

    Anaheim, California, 92804

  • GSK Investigational Site

    Anaheim, California, 92805

  • GSK Investigational Site

    Arkansas City, Kansas, 67005

  • GSK Investigational Site

    Baltimore, Maryland, 21201

  • GSK Investigational Site

    Bardstown, Kentucky, 40004

  • GSK Investigational Site

    Bellevue, Nebraska, 68123

  • GSK Investigational Site

    Benton, Arkansas, 72015

  • GSK Investigational Site

    Birmingham, Alabama, 35205

  • GSK Investigational Site

    Birmingham, Alabama, 35244

  • GSK Investigational Site

    Boone, North Carolina, 28607

  • GSK Investigational Site

    Boynton Beach, Florida, 33437

  • GSK Investigational Site

    Brainerd, Minnesota, 56401

  • GSK Investigational Site

    Brentwood, Tennessee, 37027

  • GSK Investigational Site

    Bridgeton, Missouri, 63044

  • GSK Investigational Site

    Bristol, Tennessee, 37620

  • GSK Investigational Site

    Bryan, Texas, 77802

  • GSK Investigational Site

    Buena Park, California, 90620

  • GSK Investigational Site

    Carrollton, Georgia, 30117

  • GSK Investigational Site

    Cary, North Carolina, 27518

  • GSK Investigational Site

    Centennial, Colorado, 80112

  • GSK Investigational Site

    Charleston, South Carolina, 29406

  • GSK Investigational Site

    Charlottesville, Virginia, 22902

  • GSK Investigational Site

    Charlottesville, Virginia, 22903

  • GSK Investigational Site

    Chesapeake, Virginia, 23321

  • GSK Investigational Site

    Cincinnati, Ohio, 45245

  • GSK Investigational Site

    Columbia, Missouri, 65203

  • GSK Investigational Site

    Corpus Christi, Texas, 78411

  • GSK Investigational Site

    Dalton, Georgia, 30721

  • GSK Investigational Site

    Dayton, Ohio, 45406

  • GSK Investigational Site

    DeKalb, Illinois, 60115

  • GSK Investigational Site

    Downey, California, 90241

  • GSK Investigational Site

    Dubuque, Iowa, 52001

  • GSK Investigational Site

    Dubuque, Iowa, 52002

  • GSK Investigational Site

    East Norriton, Pennsylvania, 19401

  • GSK Investigational Site

    Eugene, Oregon, 97402

  • GSK Investigational Site

    Fairfield, Ohio, 45014

  • GSK Investigational Site

    Fall River, Massachusetts, 02724

  • GSK Investigational Site

    Fargo, North Dakota, 58103

  • GSK Investigational Site

    Fishers, Indiana, 46038

  • GSK Investigational Site

    Fountain Valley, California, 92708

  • GSK Investigational Site

    Frederick, Maryland, 21702

  • GSK Investigational Site

    Fremont, California, 94538

  • GSK Investigational Site

    Fresno, California, 93720

  • GSK Investigational Site

    Gresham, Oregon, 97030

  • GSK Investigational Site

    Hayward, California, 94545

  • GSK Investigational Site

    Henderson, Nevada, 89015

  • GSK Investigational Site

    Honolulu, Hawaii, 96814

  • GSK Investigational Site

    Honolulu, Hawaii, 96819

  • GSK Investigational Site

    Huber Heights, Ohio, 45424

  • GSK Investigational Site

    Huntington, West Virginia, 25701

  • GSK Investigational Site

    Huntington Beach, California, 92647

  • GSK Investigational Site

    Indianapolis, Indiana, 46229

  • GSK Investigational Site

    Johnson City, New York, 13790

  • GSK Investigational Site

    Jonesboro, Arkansas, 72401

  • GSK Investigational Site

    Kalamazoo, Michigan, 49008

  • GSK Investigational Site

    Kansas City, Missouri, 64108

  • GSK Investigational Site

    Kingsport, Tennessee, 37660

  • GSK Investigational Site

    Kittanning, Pennsylvania, 16201

  • GSK Investigational Site

    La Crosse, Wisconsin, 54601

  • GSK Investigational Site

    Lafayette, Indiana, 47904

  • GSK Investigational Site

    Lake Success, New York, 11040

  • GSK Investigational Site

    Lakewood, California, 90711

  • GSK Investigational Site

    Las Vegas, Nevada, 89101

  • GSK Investigational Site

    Latrobe, Pennsylvania, 15650

  • GSK Investigational Site

    Layton, Utah, 84041

  • GSK Investigational Site

    Lexington, Kentucky, 40503

  • GSK Investigational Site

    Little Rock, Arkansas, 72205

  • GSK Investigational Site

    Louisville, Kentucky, 40202

  • GSK Investigational Site

    Louisville, Kentucky, 40272

  • GSK Investigational Site

    Louisville, Kentucky, 40291

  • GSK Investigational Site

    Lubbock, Texas, 79430

  • GSK Investigational Site

    Madison, Wisconsin, 53792

  • GSK Investigational Site

    Marietta, Georgia, 30062

  • GSK Investigational Site

    Marshfield, Wisconsin, 54449

  • GSK Investigational Site

    Midlothian, Virginia, 23113

  • GSK Investigational Site

    Mineola, New York, 11501

  • GSK Investigational Site

    Minot, North Dakota, 58701

  • GSK Investigational Site

    Nampa, Idaho, 208 463 3126

  • GSK Investigational Site

    Nashville, Tennessee, 37203

  • GSK Investigational Site

    New Albany, Indiana, 47150

  • GSK Investigational Site

    Niles, Michigan, 49120

  • GSK Investigational Site

    Oakland, California, 94611

  • GSK Investigational Site

    Ogden, Utah, 84405

  • GSK Investigational Site

    Omaha, Nebraska, 68131

  • GSK Investigational Site

    Omaha, Nebraska, 68132

  • GSK Investigational Site

    Opa-locka, Florida, 33054

  • GSK Investigational Site

    Overland Park, Kansas, 66215

  • GSK Investigational Site

    Owensboro, Kentucky, 43202

  • GSK Investigational Site

    Paramount, California, 90723

  • GSK Investigational Site

    Phoenix, Arizona, 85003

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15213

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15217

  • GSK Investigational Site

    Pittsburgh, Pennsylvania, 15236

  • GSK Investigational Site

    Plantation, Florida, 33324

  • GSK Investigational Site

    Pleasanton, California, 94588

  • GSK Investigational Site

    Portage, Michigan, 49024

  • GSK Investigational Site

    Provo, Utah, 84604

  • GSK Investigational Site

    Raleigh, North Carolina, 27609

  • GSK Investigational Site

    Richland, Michigan, 49083

  • GSK Investigational Site

    Rochester, New York, 14618

  • GSK Investigational Site

    Saint Paul, Minnesota, 55108

  • GSK Investigational Site

    San Antonio, Texas, 78205

  • GSK Investigational Site

    San Antonio, Texas, 78212

  • GSK Investigational Site

    San Antonio, Texas, 78215

  • GSK Investigational Site

    San Antonio, Texas, 78229

  • GSK Investigational Site

    San Francisco, California, 94115

  • GSK Investigational Site

    San Jose, California, 95119

  • GSK Investigational Site

    Sellersville, Pennsylvania, 18960

  • GSK Investigational Site

    South Jordan, Utah, 84095

  • GSK Investigational Site

    Springfield, Kentucky, 40069

  • GSK Investigational Site

    St. George, Utah, 84790

  • GSK Investigational Site

    Stevensville, Michigan, 49127

  • GSK Investigational Site

    Stony Brook, New York, 11794

  • GSK Investigational Site

    Sugar Land, Texas, 77479

  • GSK Investigational Site

    Sylva, North Carolina, 28779

  • GSK Investigational Site

    Syracuse, New York, 13205

  • GSK Investigational Site

    Thornton, Colorado, 80233

  • GSK Investigational Site

    Tifton, Georgia, 31794

  • GSK Investigational Site

    Topeka, Kansas, 66608

  • GSK Investigational Site

    Torrance, California, 90502

  • GSK Investigational Site

    Tucker, Georgia, 30084

  • GSK Investigational Site

    Tulsa, Oklahoma, 74107

  • GSK Investigational Site

    Tuscaloosa, Alabama, 35401

  • GSK Investigational Site

    Uniontown, Pennsylvania, 15401

  • GSK Investigational Site

    Utica, New York, 13502

  • GSK Investigational Site

    Vacaville, California, 95688

  • GSK Investigational Site

    Vienna, Virginia, 22180

  • GSK Investigational Site

    Virginia Beach, Virginia, 23454

  • GSK Investigational Site

    Waukee, Iowa, 50263

  • GSK Investigational Site

    West Covina, California, 91790

  • GSK Investigational Site

    West Des Moines, Iowa, 50266

  • GSK Investigational Site

    West Jordan, Utah, 84088

  • GSK Investigational Site

    West Palm Beach, Florida, 33407

  • GSK Investigational Site

    Westminster, Colorado, 80234

  • GSK Investigational Site

    Wexford, Pennsylvania, 15090

  • GSK Investigational Site

    Whitehouse Station, New Jersey, 08889

  • GSK Investigational Site

    Wichita, Kansas, 67208

  • GSK Investigational Site

    Woburn, Massachusetts, 01801

  • GSK Investigational Site

    Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: Immunogenicity of GlaxoSmithKline Biologicals' MMRV Vaccine (208136) vs. ProQuad®, When Coadministered With Hepatitis A and Pneumococcal Conjugate Vaccines to Children 12-14 Months of Age.

The purpose of this observer blinded study is to provide information on vaccine immunogenicity and reactogenicity in comparison with the US standard of care (ProQuad®) when administered with Hepatitis A vaccine and Pneumococcal vaccine.

Being tested
Priorix-Tetra™ (MMRV vaccine 208136), ProQuad®, Havrix®, Prevnar®
Keywords
Vaccines, Rubella, Varicella Vaccine, Children, Humans, Mumps, Immunogenicity, Safety, Measles, Combined Vaccine
Medical subject headings
Chickenpox, Rubella, Mumps, Measles

What participants receive

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

  • Priorix-Tetra™ (MMRV vaccine 208136)Biological

    One subcutaneous injection.

  • ProQuad®Biological

    One subcutaneous injection.

  • Havrix®Biological

    Two intramuscular injections.

  • Prevnar®Biological

    One intramuscular injection.

Study groups in NCT00578175
Study groupRoleWhat they receive
Group AExperimentalSubjects received refrigerator-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation A) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180
Receives: Biological: Priorix-Tetra™ (MMRV vaccine 208136); Biological: Havrix®; Biological: Prevnar®
Group BExperimentalSubjects received freezer-stored Priorix-Tetra™ (MMRV vaccine 208136 formulation B) co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180
Receives: Biological: Priorix-Tetra™ (MMRV vaccine 208136); Biological: Havrix®; Biological: Prevnar®
Group CActive comparatorSubjects received ProQuad® co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180
Receives: Biological: ProQuad®; Biological: Havrix®; Biological: Prevnar®

What is being measured

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

  1. Number of Subjects With Seroresponse for Antibodies to Varicella Virus (VZV)

    Seroresponse for antibodies to VZV is defined as the appearance post-vaccination of anti-VZV antibodies [concentration greater than or equal to the threshold of 75 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 25 mIU/mL before vaccination.

    Measured: At Day 42 after vaccination

  2. Concentration of Antibodies to Varicella Virus (VZV)

    Concentrations are given as Geometric Mean Concentrations (GMCs).

    Measured: At Day 42 after vaccination

  3. Number of Subjects With Seroresponse for Antibodies to Mumps Virus

    Seroresponse for antibodies to mumps virus is defined as the appearance post-vaccination of anti-mumps virus antibodies [titer greater than or equal to the threshold of 51 Effective Doses (ED50)] in the serum of subjects below the assay cut-off value of 24 ED50 before vaccination.

    Measured: At Day 42 after vaccination

  4. Number of Subjects With Seroresponse for Antibodies to Measles Virus

    Seroresponse for antibodies to measles virus is defined as the appearance post-vaccination of anti-measles virus antibodies [concentration greater than or equal to the threshold of 200 milli-international units per milliliter (mIU/mL)] in the serum of subjects below the assay cut-off value of 150 mIU/mL before vaccination.

    Measured: At Day 42 after vaccination

  5. Number of Subjects With Seroresponse for Antibodies to Rubella Virus

    Seroresponse for antibodies to rubella virus is defined as the appearance post-vaccination of anti-rubella virus antibodies [concentration greater than or equal to the threshold of 10 international units per milliliter (IU/mL)] in the serum of subjects below the assay cut-off value of 4 IU/mL before vaccination.

    Measured: At Day 42 after vaccination

  6. Concentration of Antibodies to Hepatitis A Virus (HAV)

    Concentrations are given as Geometric Mean Concentrations (GMCs).

    Measured: At Day 42 after vaccination

  7. Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F

    Concentrations are given as Geometric Mean Concentrations (GMCs).

    Measured: At Day 42 after vaccination

Secondary outcomes (17)

  1. Antibody Titers to Mumps Virus

    Data are expressed as Geometric Mean Titers (GMTs). The titer is the serum dilution giving a 50 percent reduction of the signal compared to a control without serum.

    Measured: At Day 42 after vaccination

  2. Concentration of Antibodies to Measles Virus

    Concentrations are given as Geometric Mean Concentrations (GMCs).

    Measured: At Day 42 after vaccination

  3. Concentration of Antibodies to Rubella Virus

    Concentrations are given as Geometric Mean Concentrations (GMCs).

    Measured: At Day 42 after vaccination

  4. Number of Subjects With Vaccine Response to Havrix

    Vaccine response to Havrix is defined as the appearance post-vaccination of anti-hepatitis A virus (anti-HAV) antibodies [concentration greater than or equal to 15 milli-international units per milliliter (mIU/mL)] in the serum of subjects seronegative before vaccination (concentration below the assay cut-off value of 15 mIU/mL) or having a 2-fold increase above the pre-vaccination concentration in subjects who were seropositive before vaccination.

    Measured: At Day 42 after vaccination

  5. Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value

    Cut-off value assessed include 0.05 micrograms per milliliter (µg/mL).

    Measured: At Day 42 after vaccination

  6. Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value

    Cut-off value assessed include 0.2 micrograms per milliliter (µg/mL).

    Measured: At Day 42 after vaccination

  7. Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value

    Cut-off value assessed include 0.5 micrograms per milliliter (µg/mL).

    Measured: At Day 42 after vaccination

  8. Number of Subjects With Concentration of Antibodies to S. Pneumoniae Serotypes 4, 6B, 9V, 14, 18C, 19F and 23F Equal or Above the Cut-off Value

    Cut-off value assessed include 1.0 micrograms per milliliter (µg/mL).

    Measured: At Day 42 after vaccination

  9. Number of Subjects Reporting Solicited Local Symptoms

    Solicited local symptoms assessed include pain, redness and swelling.

    Measured: During the 4 day follow up period following vaccination

  10. Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 15-day Follow up Period After Vaccination

    Fever was measured rectally.

    Measured: During the 15-day follow-up period following vaccination

  11. Number of Subjects Reporting Fever ≥ 38.0°C/100.4°F and > 39.5°C/103.1°F During the 43-day Follow-up Period After Vaccination

    Fever was measured rectally.

    Measured: During the 43-day follow-up period following vaccination

  12. Number of Subjects Reporting Investigator-confirmed Measles/Rubella-like Rash

    Measured: During the 43-day follow-up period after vaccination

  13. Number of Subjects Reporting Investigator-confirmed Varicella-like Rash

    Measured: During the 43-day follow-up period after vaccination

  14. Number of Subjects Reporting Investigator-confirmed Parotid/Salivary Gland Swelling

    Measured: During the 43-day follow-up period after vaccination

  15. Number of Subjects Reporting Unsolicited Adverse Events and Medically-attended Adverse Events (Excluding Rash and Parotid/Salivary Gland Swelling)

    Unsolicited adverse event covers any adverse event 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.

    Medically-attended adverse event covers any adverse event which received medical attention. Medical attention is defined as hospitalization, an emergency room visit or a visit to or from medical personnel.

    Measured: During the 43-day follow-up period after vaccination

  16. Number of Subjects Reporting New Onset Chronic Illnesses and Conditions Prompting Emergency Room Visits

    New onset chronic illnesses include autoimmune disorders, asthma, type I diabetes and allergies.

    Measured: For approximately 6 months (Day 0-180)

  17. Number of Subjects Reporting Serious Adverse Events

    Serious adverse events assessed include medical occurrences that result in death, is life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject.

    Measured: For approximately 6 months (Day 0-180)

Timeline

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

  1. First posted21 Dec 2007 (estimated)
  2. Study start20 Nov 2007
  3. Primary completion24 Feb 2009
  4. Study completion17 Mar 2009

Resources

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 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
1,851 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00578175
Sponsor's protocol ID
110058
Status last verified
Oct 2016
First submitted
20 Dec 2007
Last updated
9 Oct 2018
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

  • Blatter MM, Klein NP, Shepard JS, Leonardi M, Shapiro S, Schear M, Mufson MA, Martin JM, Varman M, Grogg S, London A, Cambron P, Douha M, Nicholson O, da Costa C, Innis BL. Immunogenicity and safety of two tetravalent (measles, mumps, rubella, varicella) vaccines coadministered with hepatitis a and pneumococcal conjugate vaccines to children twelve to fourteen months of age. Pediatr Infect Dis J. 2012 Aug;31(8):e133-40. doi: 10.1097/INF.0b013e318259fc8a.

    PubMed 22622699

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Priorix-Tetra™ (MMRV vaccine 208136), ProQuad® and Havrix® in people with Varicella and Rubella, run by GlaxoSmithKline at 141 sites in United States.

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 21 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 9 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 141 sites in United States. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 26 Aug 2010). 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 With Seroresponse for Antibodies to Varicella Virus (VZV) (time frame: At Day 42 after vaccination). The study lists 7 primary outcomes in all. 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 NCT00578175, 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 9 Oct 2018.

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