Immunogenicity of GSKs' MMR Vaccine (209762) vs. M-M-R® II, When Given With Routine Vaccines at 12-15 Months of Age

NCT ID: NCT00861744

Last Updated: 2020-01-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 1259 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-03
• Study Completion Date: 2012-06-18

Brief Summary

The purpose of this study is to compare two measles, mumps and rubella conjugate vaccines (manufactured by GSK and Merck and Company ) in terms of the immune response elicited and safety with a six month follow-up after first vaccination. Additionally, antibody persistence will be assessed one and two years after administration of MMR vaccine.

The Protocol Posting has been updated following Protocol amendment 1 and 2, Oct 2009.

Conditions

Rubella; Mumps; Measles; Measles-Mumps-Rubella Vaccine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Priorix 1 Group

Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 1) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

Group Type: EXPERIMENTAL

GSK Biological's investigational vaccine 209762

Intervention Type: BIOLOGICAL

Subcutaneous injection, one dose

Varivax®

Intervention Type: BIOLOGICAL

Subcutaneous injection, one dose

Havrix®

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Prevnar®

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Priorix 2 Group

Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 2) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

Group Type: EXPERIMENTAL

GSK Biological's investigational vaccine 209762

Intervention Type: BIOLOGICAL

Subcutaneous injection, one dose

Varivax®

Intervention Type: BIOLOGICAL

Subcutaneous injection, one dose

Havrix®

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Prevnar®

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Priorix 3 Group

Subjects between 12 and 15 months of age at the time of study vaccination who received one dose of Priorix investigational vaccine (Lot 3) subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

Group Type: EXPERIMENTAL

GSK Biological's investigational vaccine 209762

Intervention Type: BIOLOGICAL

Subcutaneous injection, one dose

Varivax®

Intervention Type: BIOLOGICAL

Subcutaneous injection, one dose

Havrix®

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Prevnar®

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

MMR-II Group

Subjects between 12 and 15 months of age at the time of study vaccination who randomly received one dose of one of three different commercially-available lot of M-M-R II (Merck and Co.) vaccine subcutaneously in the right upper arm. Subjects concomitantly received one dose of Havrix and Prevnar vaccines intramuscularly in the left and the right thigh, respectively and one dose of Varivax vaccine subcutaneously in the left upper arm. Subjects had previously received three doses of Prevnar vaccine within the first year of life with the third dose administered at least 30 days prior to enrollment and vaccination with study vaccines.

Group Type: ACTIVE_COMPARATOR

M-M-R® II (Merck and Co)

Intervention Type: BIOLOGICAL

Subcutaneous injection, one dose

Varivax®

Intervention Type: BIOLOGICAL

Subcutaneous injection, one dose

Havrix®

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Prevnar®

Intervention Type: BIOLOGICAL

Intramuscular injection, one dose

Interventions

GSK Biological's investigational vaccine 209762

Subcutaneous injection, one dose

Intervention Type: BIOLOGICAL

M-M-R® II (Merck and Co)

Subcutaneous injection, one dose

Intervention Type: BIOLOGICAL

Varivax®

Subcutaneous injection, one dose

Intervention Type: BIOLOGICAL

Havrix®

Intramuscular injection, one dose

Intervention Type: BIOLOGICAL

Prevnar®

Intramuscular injection, one dose

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects for whom the investigator believes their parents/guardians can and will comply with the requirements of the protocol (e.g. completion of the diary cards, return for follow-up visits) should be enrolled in the study.
• Male or female between 12 and 15 months of age (e.g. from age 12 months until the day before age 16 months) at the time of 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 three doses of 7-valent pneumococcal conjugate vaccine within the first year of life with the third dose administered at least 30 days prior to enrolment and vaccination with study vaccines.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) 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 (pharmaceutical product or device).
• Chronic administration (defined as more than 14 days) 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 and Hib 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, varicella/zoster and hepatitis A 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 (no laboratory testing required), 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 vaccines.
• Hypersensitivity to latex
• Major congenital defects or serious chronic illness.
• History of any neurologic disorders or seizures, including febrile seizures.
• Acute disease at the time of enrolment.
• Administration of polyclonal immunoglobulins and/or any blood products during the six months before entering the study or planned administration during the study period.

• Minimum Eligible Age: 12 Months
• Maximum Eligible Age: 15 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Tuscaloosa, Alabama, United States

GSK Investigational Site

Conway, Arkansas, United States

GSK Investigational Site

Jonesboro, Arkansas, United States

GSK Investigational Site

Little Rock, Arkansas, United States

GSK Investigational Site

Anaheim, California, United States

GSK Investigational Site

Downey, California, United States

GSK Investigational Site

Fresno, California, United States

GSK Investigational Site

Huntington Beach, California, United States

GSK Investigational Site

Paramount, California, United States

GSK Investigational Site

Santa Ana, California, United States

GSK Investigational Site

West Covina, California, United States

GSK Investigational Site

Altamonte Springs, Florida, United States

GSK Investigational Site

Dalton, Georgia, United States

GSK Investigational Site

Marietta, Georgia, United States

GSK Investigational Site

Nampa, Idaho, United States

GSK Investigational Site

DeKalb, Illinois, United States

GSK Investigational Site

Arkansas City, Kansas, United States

GSK Investigational Site

Bardstown, Kentucky, United States

GSK Investigational Site

Bossier City, Louisiana, United States

GSK Investigational Site

Metairie, Louisiana, United States

GSK Investigational Site

Baltimore, Maryland, United States

GSK Investigational Site

Fall River, Massachusetts, United States

GSK Investigational Site

Kansas City, Missouri, United States

GSK Investigational Site

Great Falls, Montana, United States

GSK Investigational Site

Henderson, Nevada, United States

GSK Investigational Site

Utica, New York, United States

GSK Investigational Site

Cary, North Carolina, United States

GSK Investigational Site

Raleigh, North Carolina, United States

GSK Investigational Site

Cincinnati, Ohio, United States

GSK Investigational Site

Dayton, Ohio, United States

GSK Investigational Site

Tulsa, Oklahoma, United States

GSK Investigational Site

Gresham, Oregon, United States

GSK Investigational Site

East Norriton, Pennsylvania, United States

GSK Investigational Site

Rydal, Pennsylvania, United States

GSK Investigational Site

Charleston, South Carolina, United States

GSK Investigational Site

Bristol, Tennessee, United States

GSK Investigational Site

Kingsport, Tennessee, United States

GSK Investigational Site

Corpus Christi, Texas, United States

GSK Investigational Site

Layton, Utah, United States

GSK Investigational Site

Provo, Utah, United States

GSK Investigational Site

Springville, Utah, United States

GSK Investigational Site

St. George, Utah, United States

GSK Investigational Site

West Jordan, Utah, United States

GSK Investigational Site

Virginia Beach, Virginia, United States

GSK Investigational Site

Huntington, West Virginia, United States

GSK Investigational Site

Bayamón, , Puerto Rico

GSK Investigational Site

San Germán, , Puerto Rico

GSK Investigational Site

San Juan, , Puerto Rico

Countries

United States; Puerto Rico

References

Mufson MA, Diaz C, Leonardi M, Harrison CJ, Grogg S, Carbayo A, Carlo-Torres S, JeanFreau R, Quintero-Del-Rio A, Bautista G, Povey M, Da Costa C, Nicholson O, Innis BL. Safety and Immunogenicity of Human Serum Albumin-Free MMR Vaccine in US Children Aged 12-15 Months. J Pediatric Infect Dis Soc. 2015 Dec;4(4):339-48. doi: 10.1093/jpids/piu081. Epub 2014 Aug 7.

Reference Type: BACKGROUND

PMID: 26582873 (View on PubMed)

Berry AA, Abu-Elyazeed R, Diaz-Perez C, Mufson MA, Harrison CJ, Leonardi M, Twiggs JD, Peltier C, Grogg S, Carbayo A, Shapiro S, Povey M, Baccarini C, Innis BL, Henry O. Two-year antibody persistence in children vaccinated at 12-15 months with a measles-mumps-rubella virus vaccine without human serum albumin. Hum Vaccin Immunother. 2017 Jul 3;13(7):1516-1522. doi: 10.1080/21645515.2017.1309486. Epub 2017 May 8.

Reference Type: DERIVED

PMID: 28481690 (View on PubMed)

Study Documents

Document Type: Clinical Study Report

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

View Document

Document Type: Statistical Analysis Plan

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

View Document

Document Type: Annotated Case Report Form

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

View Document

Document Type: Individual Participant Data Set

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

View Document

Document Type: Dataset Specification

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

View Document

Document Type: Study Protocol

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

View Document

Document Type: Informed Consent Form

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

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

2011-005860-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

111870

Identifier Type: -

Identifier Source: org_study_id