Back to results

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

Primary Purpose

Varicella, Rubella, Mumps

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Priorix-Tetra™ (MMRV vaccine 208136)

ProQuad®

Havrix®

Prevnar®

About this trial

This is an interventional prevention trial for Varicella focused on measuring Vaccines, Rubella, Varicella Vaccine, Children, Humans, Mumps, Immunogenicity, Safety, Measles, Combined Vaccine

Eligibility Criteria

12 Months - 14 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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.
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®).

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Group A

Group B

Group C

Arm Description

Subjects 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

Subjects 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

Subjects received ProQuad® co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180

Outcomes

Primary Outcome Measures

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.

Concentration of Antibodies to Varicella Virus (VZV)

Concentrations are given as Geometric Mean Concentrations (GMCs).

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.

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.

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.

Concentration of Antibodies to Hepatitis A Virus (HAV)

Concentrations are given as Geometric Mean Concentrations (GMCs).

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

Concentrations are given as Geometric Mean Concentrations (GMCs).

Secondary Outcome Measures

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.

Concentration of Antibodies to Measles Virus

Concentrations are given as Geometric Mean Concentrations (GMCs).

Concentration of Antibodies to Rubella Virus

Concentrations are given as Geometric Mean Concentrations (GMCs).

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.

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).

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).

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).

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).

Number of Subjects Reporting Solicited Local Symptoms

Solicited local symptoms assessed include pain, redness and swelling.

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.

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.

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

Number of Subjects Reporting Investigator-confirmed Varicella-like Rash

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

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.

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.

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.

Full Information

NCT ID

NCT00578175

First Posted

December 20, 2007

Last Updated

September 5, 2018

Sponsor

GlaxoSmithKline

1. Study Identification

Unique Protocol Identification Number

NCT00578175

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

November 20, 2007 (undefined)

Primary Completion Date

February 24, 2009 (Actual)

Study Completion Date

March 17, 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

GlaxoSmithKline

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

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

Varicella, Rubella, Mumps, Measles

Keywords

Vaccines, Rubella, Varicella Vaccine, Children, Humans, Mumps, Immunogenicity, Safety, Measles, Combined Vaccine

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantOutcomes Assessor

Allocation

Randomized

Enrollment

1851 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A

Arm Type

Experimental

Arm Description

Subjects 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

Arm Title

Group B

Arm Type

Experimental

Arm Description

Subjects 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

Arm Title

Group C

Arm Type

Active Comparator

Arm Description

Subjects received ProQuad® co-administered with Havrix® and Prevnar® at Day 0 and a second dose of Havrix® at Day 180

Intervention Type

Biological

Intervention Name(s)

Priorix-Tetra™ (MMRV vaccine 208136)

Intervention Description

One subcutaneous injection.

Intervention Type

Biological

Intervention Name(s)

ProQuad®

Intervention Description

One subcutaneous injection.

Intervention Type

Biological

Intervention Name(s)

Havrix®

Intervention Description

Two intramuscular injections.

Intervention Type

Biological

Intervention Name(s)

Prevnar®

Intervention Description

One intramuscular injection.

Primary Outcome Measure Information:

Title

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

Description

Time Frame

At Day 42 after vaccination

Title

Concentration of Antibodies to Varicella Virus (VZV)

Description

Concentrations are given as Geometric Mean Concentrations (GMCs).

Time Frame

At Day 42 after vaccination

Title

Number of Subjects With Seroresponse for Antibodies to Mumps Virus

Description

Time Frame

At Day 42 after vaccination

Title

Number of Subjects With Seroresponse for Antibodies to Measles Virus

Description

Time Frame

At Day 42 after vaccination

Title

Number of Subjects With Seroresponse for Antibodies to Rubella Virus

Description

Time Frame

At Day 42 after vaccination

Title

Concentration of Antibodies to Hepatitis A Virus (HAV)

Description

Concentrations are given as Geometric Mean Concentrations (GMCs).

Time Frame

At Day 42 after vaccination

Title

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

Description

Concentrations are given as Geometric Mean Concentrations (GMCs).

Time Frame

At Day 42 after vaccination

Secondary Outcome Measure Information:

Title

Antibody Titers to Mumps Virus

Description

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.

Time Frame

At Day 42 after vaccination

Title

Concentration of Antibodies to Measles Virus

Description

Concentrations are given as Geometric Mean Concentrations (GMCs).

Time Frame

At Day 42 after vaccination

Title

Concentration of Antibodies to Rubella Virus

Description

Concentrations are given as Geometric Mean Concentrations (GMCs).

Time Frame

At Day 42 after vaccination

Title

Number of Subjects With Vaccine Response to Havrix

Description

Time Frame

At Day 42 after vaccination

Title

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

Description

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

Time Frame

At Day 42 after vaccination

Title

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

Description

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

Time Frame

At Day 42 after vaccination

Title

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

Description

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

Time Frame

At Day 42 after vaccination

Title

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

Description

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

Time Frame

At Day 42 after vaccination

Title

Number of Subjects Reporting Solicited Local Symptoms

Description

Solicited local symptoms assessed include pain, redness and swelling.

Time Frame

During the 4 day follow up period following vaccination

Title

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

Description

Fever was measured rectally.

Time Frame

During the 15-day follow-up period following vaccination

Title

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

Description

Fever was measured rectally.

Time Frame

During the 43-day follow-up period following vaccination

Title

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

Time Frame

During the 43-day follow-up period after vaccination

Title

Number of Subjects Reporting Investigator-confirmed Varicella-like Rash

Time Frame

During the 43-day follow-up period after vaccination

Title

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

Time Frame

During the 43-day follow-up period after vaccination

Title

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

Description

Time Frame

During the 43-day follow-up period after vaccination

Title

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

Description

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

Time Frame

For approximately 6 months (Day 0-180)

Title

Number of Subjects Reporting Serious Adverse Events

Description

Time Frame

For approximately 6 months (Day 0-180)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Months

Maximum Age & Unit of Time

14 Months

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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. Exclusion Criteria: 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. 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®).

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

Birmingham

State/Province

Alabama

ZIP/Postal Code

35205

Country

United States

Facility Name

GSK Investigational Site

City

Birmingham

State/Province

Alabama

ZIP/Postal Code

35244

Country

United States

Facility Name

GSK Investigational Site

City

Tuscaloosa

State/Province

Alabama

ZIP/Postal Code

35401

Country

United States

Facility Name

GSK Investigational Site

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85003

Country

United States

Facility Name

GSK Investigational Site

City

Benton

State/Province

Arkansas

ZIP/Postal Code

72015

Country

United States

Facility Name

GSK Investigational Site

City

Jonesboro

State/Province

Arkansas

ZIP/Postal Code

72401

Country

United States

Facility Name

GSK Investigational Site

City

Little Rock

State/Province

Arkansas

ZIP/Postal Code

72205

Country

United States

Facility Name

GSK Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92804

Country

United States

Facility Name

GSK Investigational Site

City

Anaheim

State/Province

California

ZIP/Postal Code

92805

Country

United States

Facility Name

GSK Investigational Site

City

Buena Park

State/Province

California

ZIP/Postal Code

90620

Country

United States

Facility Name

GSK Investigational Site

City

Downey

State/Province

California

ZIP/Postal Code

90241

Country

United States

Facility Name

GSK Investigational Site

City

Fountain Valley

State/Province

California

ZIP/Postal Code

92708

Country

United States

Facility Name

GSK Investigational Site

City

Fremont

State/Province

California

ZIP/Postal Code

94538

Country

United States

Facility Name

GSK Investigational Site

City

Fresno

State/Province

California

ZIP/Postal Code

93720

Country

United States

Facility Name

GSK Investigational Site

City

Hayward

State/Province

California

ZIP/Postal Code

94545

Country

United States

Facility Name

GSK Investigational Site

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92647

Country

United States

Facility Name

GSK Investigational Site

City

Lakewood

State/Province

California

ZIP/Postal Code

90711

Country

United States

Facility Name

GSK Investigational Site

City

Oakland

State/Province

California

ZIP/Postal Code

94611

Country

United States

Facility Name

GSK Investigational Site

City

Paramount

State/Province

California

ZIP/Postal Code

90723

Country

United States

Facility Name

GSK Investigational Site

City

Pleasanton

State/Province

California

ZIP/Postal Code

94588

Country

United States

Facility Name

GSK Investigational Site

City

San Francisco

State/Province

California

ZIP/Postal Code

94115

Country

United States

Facility Name

GSK Investigational Site

City

San Jose

State/Province

California

ZIP/Postal Code

95119

Country

United States

Facility Name

GSK Investigational Site

City

Torrance

State/Province

California

ZIP/Postal Code

90502

Country

United States

Facility Name

GSK Investigational Site

City

Vacaville

State/Province

California

ZIP/Postal Code

95688

Country

United States

Facility Name

GSK Investigational Site

City

West Covina

State/Province

California

ZIP/Postal Code

91790

Country

United States

Facility Name

GSK Investigational Site

City

Centennial

State/Province

Colorado

ZIP/Postal Code

80112

Country

United States

Facility Name

GSK Investigational Site

City

Thornton

State/Province

Colorado

ZIP/Postal Code

80233

Country

United States

Facility Name

GSK Investigational Site

City

Westminster

State/Province

Colorado

ZIP/Postal Code

80234

Country

United States

Facility Name

GSK Investigational Site

City

Boynton Beach

State/Province

Florida

ZIP/Postal Code

33437

Country

United States

Facility Name

GSK Investigational Site

City

Opa-locka

State/Province

Florida

ZIP/Postal Code

33054

Country

United States

Facility Name

GSK Investigational Site

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

GSK Investigational Site

City

West Palm Beach

State/Province

Florida

ZIP/Postal Code

33407

Country

United States

Facility Name

GSK Investigational Site

City

Carrollton

State/Province

Georgia

ZIP/Postal Code

30117

Country

United States

Facility Name

GSK Investigational Site

City

Dalton

State/Province

Georgia

ZIP/Postal Code

30721

Country

United States

Facility Name

GSK Investigational Site

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30062

Country

United States

Facility Name

GSK Investigational Site

City

Tifton

State/Province

Georgia

ZIP/Postal Code

31794

Country

United States

Facility Name

GSK Investigational Site

City

Tucker

State/Province

Georgia

ZIP/Postal Code

30084

Country

United States

Facility Name

GSK Investigational Site

City

Woodstock

State/Province

Georgia

ZIP/Postal Code

30189

Country

United States

Facility Name

GSK Investigational Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96814

Country

United States

Facility Name

GSK Investigational Site

City

Honolulu

State/Province

Hawaii

ZIP/Postal Code

96819

Country

United States

Facility Name

GSK Investigational Site

City

Nampa

State/Province

Idaho

ZIP/Postal Code

208 463 3126

Country

United States

Facility Name

GSK Investigational Site

City

DeKalb

State/Province

Illinois

ZIP/Postal Code

60115

Country

United States

Facility Name

GSK Investigational Site

City

Fishers

State/Province

Indiana

ZIP/Postal Code

46038

Country

United States

Facility Name

GSK Investigational Site

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46229

Country

United States

Facility Name

GSK Investigational Site

City

Lafayette

State/Province

Indiana

ZIP/Postal Code

47904

Country

United States

Facility Name

GSK Investigational Site

City

New Albany

State/Province

Indiana

ZIP/Postal Code

47150

Country

United States

Facility Name

GSK Investigational Site

City

Dubuque

State/Province

Iowa

ZIP/Postal Code

52001

Country

United States

Facility Name

GSK Investigational Site

City

Dubuque

State/Province

Iowa

ZIP/Postal Code

52002

Country

United States

Facility Name

GSK Investigational Site

City

Waukee

State/Province

Iowa

ZIP/Postal Code

50263

Country

United States

Facility Name

GSK Investigational Site

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50266

Country

United States

Facility Name

GSK Investigational Site

City

Arkansas City

State/Province

Kansas

ZIP/Postal Code

67005

Country

United States

Facility Name

GSK Investigational Site

City

Overland Park

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

GSK Investigational Site

City

Topeka

State/Province

Kansas

ZIP/Postal Code

66608

Country

United States

Facility Name

GSK Investigational Site

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67208

Country

United States

Facility Name

GSK Investigational Site

City

Bardstown

State/Province

Kentucky

ZIP/Postal Code

40004

Country

United States

Facility Name

GSK Investigational Site

City

Lexington

State/Province

Kentucky

ZIP/Postal Code

40503

Country

United States

Facility Name

GSK Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40202

Country

United States

Facility Name

GSK Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40272

Country

United States

Facility Name

GSK Investigational Site

City

Louisville

State/Province

Kentucky

ZIP/Postal Code

40291

Country

United States

Facility Name

GSK Investigational Site

City

Owensboro

State/Province

Kentucky

ZIP/Postal Code

43202

Country

United States

Facility Name

GSK Investigational Site

City

Springfield

State/Province

Kentucky

ZIP/Postal Code

40069

Country

United States

Facility Name

GSK Investigational Site

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21201

Country

United States

Facility Name

GSK Investigational Site

City

Frederick

State/Province

Maryland

ZIP/Postal Code

21702

Country

United States

Facility Name

GSK Investigational Site

City

Fall River

State/Province

Massachusetts

ZIP/Postal Code

02724

Country

United States

Facility Name

GSK Investigational Site

City

Woburn

State/Province

Massachusetts

ZIP/Postal Code

01801

Country

United States

Facility Name

GSK Investigational Site

City

Kalamazoo

State/Province

Michigan

ZIP/Postal Code

49008

Country

United States

Facility Name

GSK Investigational Site

City

Niles

State/Province

Michigan

ZIP/Postal Code

49120

Country

United States

Facility Name

GSK Investigational Site

City

Portage

State/Province

Michigan

ZIP/Postal Code

49024

Country

United States

Facility Name

GSK Investigational Site

City

Richland

State/Province

Michigan

ZIP/Postal Code

49083

Country

United States

Facility Name

GSK Investigational Site

City

Stevensville

State/Province

Michigan

ZIP/Postal Code

49127

Country

United States

Facility Name

GSK Investigational Site

City

Brainerd

State/Province

Minnesota

ZIP/Postal Code

56401

Country

United States

Facility Name

GSK Investigational Site

City

Saint Paul

State/Province

Minnesota

ZIP/Postal Code

55108

Country

United States

Facility Name

GSK Investigational Site

City

Bridgeton

State/Province

Missouri

ZIP/Postal Code

63044

Country

United States

Facility Name

GSK Investigational Site

City

Columbia

State/Province

Missouri

ZIP/Postal Code

65203

Country

United States

Facility Name

GSK Investigational Site

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

Facility Name

GSK Investigational Site

City

Bellevue

State/Province

Nebraska

ZIP/Postal Code

68123

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68131

Country

United States

Facility Name

GSK Investigational Site

City

Omaha

State/Province

Nebraska

ZIP/Postal Code

68132

Country

United States

Facility Name

GSK Investigational Site

City

Henderson

State/Province

Nevada

ZIP/Postal Code

89015

Country

United States

Facility Name

GSK Investigational Site

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89101

Country

United States

Facility Name

GSK Investigational Site

City

White House Station

State/Province

New Jersey

ZIP/Postal Code

08889

Country

United States

Facility Name

GSK Investigational Site

City

Johnson City

State/Province

New York

ZIP/Postal Code

13790

Country

United States

Facility Name

GSK Investigational Site

City

Lake Success

State/Province

New York

ZIP/Postal Code

11040

Country

United States

Facility Name

GSK Investigational Site

City

Mineola

State/Province

New York

ZIP/Postal Code

11501

Country

United States

Facility Name

GSK Investigational Site

City

Rochester

State/Province

New York

ZIP/Postal Code

14618

Country

United States

Facility Name

GSK Investigational Site

City

Stony Brook

State/Province

New York

ZIP/Postal Code

11794

Country

United States

Facility Name

GSK Investigational Site

City

Syracuse

State/Province

New York

ZIP/Postal Code

13205

Country

United States

Facility Name

GSK Investigational Site

City

Utica

State/Province

New York

ZIP/Postal Code

13502

Country

United States

Facility Name

GSK Investigational Site

City

Boone

State/Province

North Carolina

ZIP/Postal Code

28607

Country

United States

Facility Name

GSK Investigational Site

City

Cary

State/Province

North Carolina

ZIP/Postal Code

27518

Country

United States

Facility Name

GSK Investigational Site

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27609

Country

United States

Facility Name

GSK Investigational Site

City

Sylva

State/Province

North Carolina

ZIP/Postal Code

28779

Country

United States

Facility Name

GSK Investigational Site

City

Fargo

State/Province

North Dakota

ZIP/Postal Code

58103

Country

United States

Facility Name

GSK Investigational Site

City

Minot

State/Province

North Dakota

ZIP/Postal Code

58701

Country

United States

Facility Name

GSK Investigational Site

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45245

Country

United States

Facility Name

GSK Investigational Site

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45406

Country

United States

Facility Name

GSK Investigational Site

City

Fairfield

State/Province

Ohio

ZIP/Postal Code

45014

Country

United States

Facility Name

GSK Investigational Site

City

Huber Heights

State/Province

Ohio

ZIP/Postal Code

45424

Country

United States

Facility Name

GSK Investigational Site

City

Tulsa

State/Province

Oklahoma

ZIP/Postal Code

74107

Country

United States

Facility Name

GSK Investigational Site

City

Eugene

State/Province

Oregon

ZIP/Postal Code

97402

Country

United States

Facility Name

GSK Investigational Site

City

Gresham

State/Province

Oregon

ZIP/Postal Code

97030

Country

United States

Facility Name

GSK Investigational Site

City

Altoona

State/Province

Pennsylvania

ZIP/Postal Code

16602

Country

United States

Facility Name

GSK Investigational Site

City

East Norriton

State/Province

Pennsylvania

ZIP/Postal Code

19401

Country

United States

Facility Name

GSK Investigational Site

City

Kittanning

State/Province

Pennsylvania

ZIP/Postal Code

16201

Country

United States

Facility Name

GSK Investigational Site

City

Latrobe

State/Province

Pennsylvania

ZIP/Postal Code

15650

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15213

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15217

Country

United States

Facility Name

GSK Investigational Site

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15236

Country

United States

Facility Name

GSK Investigational Site

City

Sellersville

State/Province

Pennsylvania

ZIP/Postal Code

18960

Country

United States

Facility Name

GSK Investigational Site

City

Uniontown

State/Province

Pennsylvania

ZIP/Postal Code

15401

Country

United States

Facility Name

GSK Investigational Site

City

Wexford

State/Province

Pennsylvania

ZIP/Postal Code

15090

Country

United States

Facility Name

GSK Investigational Site

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29406

Country

United States

Facility Name

GSK Investigational Site

City

Brentwood

State/Province

Tennessee

ZIP/Postal Code

37027

Country

United States

Facility Name

GSK Investigational Site

City

Bristol

State/Province

Tennessee

ZIP/Postal Code

37620

Country

United States

Facility Name

GSK Investigational Site

City

Kingsport

State/Province

Tennessee

ZIP/Postal Code

37660

Country

United States

Facility Name

GSK Investigational Site

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

GSK Investigational Site

City

Amarillo

State/Province

Texas

ZIP/Postal Code

79124

Country

United States

Facility Name

GSK Investigational Site

City

Bryan

State/Province

Texas

ZIP/Postal Code

77802

Country

United States

Facility Name

GSK Investigational Site

City

Corpus Christi

State/Province

Texas

ZIP/Postal Code

78411

Country

United States

Facility Name

GSK Investigational Site

City

Lubbock

State/Province

Texas

ZIP/Postal Code

79430

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78205

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78212

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78215

Country

United States

Facility Name

GSK Investigational Site

City

San Antonio

State/Province

Texas

ZIP/Postal Code

78229

Country

United States

Facility Name

GSK Investigational Site

City

Sugar Land

State/Province

Texas

ZIP/Postal Code

77479

Country

United States

Facility Name

GSK Investigational Site

City

Layton

State/Province

Utah

ZIP/Postal Code

84041

Country

United States

Facility Name

GSK Investigational Site

City

Ogden

State/Province

Utah

ZIP/Postal Code

84405

Country

United States

Facility Name

GSK Investigational Site

City

Provo

State/Province

Utah

ZIP/Postal Code

84604

Country

United States

Facility Name

GSK Investigational Site

City

Saint George

State/Province

Utah

ZIP/Postal Code

84790

Country

United States

Facility Name

GSK Investigational Site

City

South Jordan

State/Province

Utah

ZIP/Postal Code

84095

Country

United States

Facility Name

GSK Investigational Site

City

West Jordan

State/Province

Utah

ZIP/Postal Code

84088

Country

United States

Facility Name

GSK Investigational Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22902

Country

United States

Facility Name

GSK Investigational Site

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

GSK Investigational Site

City

Chesapeake

State/Province

Virginia

ZIP/Postal Code

23321

Country

United States

Facility Name

GSK Investigational Site

City

Midlothian

State/Province

Virginia

ZIP/Postal Code

23113

Country

United States

Facility Name

GSK Investigational Site

City

Vienna

State/Province

Virginia

ZIP/Postal Code

22180

Country

United States

Facility Name

GSK Investigational Site

City

Virginia Beach

State/Province

Virginia

ZIP/Postal Code

23454

Country

United States

Facility Name

GSK Investigational Site

City

Huntington

State/Province

West Virginia

ZIP/Postal Code

25701

Country

United States

Facility Name

GSK Investigational Site

City

La Crosse

State/Province

Wisconsin

ZIP/Postal Code

54601

Country

United States

Facility Name

GSK Investigational Site

City

Madison

State/Province

Wisconsin

ZIP/Postal Code

53792

Country

United States

Facility Name

GSK Investigational Site

City

Marshfield

State/Province

Wisconsin

ZIP/Postal Code

54449

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Citations:

PubMed Identifier

22622699

Citation

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.

Results Reference

background

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

Annotated Case Report Form

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110058

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

110058

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

110058

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Available IPD/Information Type

Individual Participant Data Set

Available IPD/Information URL

https://www.clinicalstudydatarequest.com

Available IPD/Information Identifier

110058

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

110058

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

110058

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

110058

Available IPD/Information Comments

For additional information about this study please refer to the GSK Clinical Study Register

Learn more about this trial

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

We'll reach out to this number within 24 hrs

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

Varicella, Rubella, Mumps

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial