Immunogenicity & Safety of Hepatitis A Vaccine Co-admin With a Measles/Mumps/Rubella & a Varicella Vaccine in Children
Immunogenicity & Safety of GSK Biologicals' Inactivated Hepatitis A Vaccine (Havrix™) Co-administered With Merck & Company, Inc. Measles-Mumps-Rubella Vaccine (M-M-RII) & Merck & Co Varicella Vaccine (VARIVAX™) to Children 15 Months of Age
1 other identifier
interventional
1,474
1 country
42
Brief Summary
This is a study to evaluate the immune response and safety of GSK Biologicals 2-dose inactivated hepatitis A vaccine when administered with a measles/mumps/rubella vaccine and a varicella (chickenpox) vaccine in children as young as 15 months of age. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Oct 2003
Longer than P75 for phase_3
42 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 6, 2003
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 9, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
June 9, 2009
CompletedResults Posted
Study results publicly available
April 1, 2010
CompletedJuly 31, 2018
October 1, 2016
5.7 years
September 13, 2005
March 11, 2010
July 2, 2018
Conditions
Outcome Measures
Primary Outcomes (4)
Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups.
Concentrations are given as geometric mean concentrations (GMCs) expressed as milli-international units per milliliter (mIU/mL).
31 days following the second dose of Havrix®
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups
Anti-HAV antibody cut-off value assessed include 15 milli-international units per milliliter (mIU/mL).
31 days following the second dose of Havrix®
Number of Subjects Seroconverted for Anti-measle, Anti-mumps and Anti-varicella Antibodies in HAV+MMR+V and MMR+V→HAV Groups
Seroconversion is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off values assessed include 150 milli-international units per milliliter (mIU/mL) for anti-measles antibodies, 28 Effective Dose 50 (ED50) for anti-mumps antibodies and 1:5 for anti-varicella antibodies.
42 days following the administration of M-M-R®II and VARIVAX®
Number of Subjects With Vaccine Response for Anti-rubella Antibodies in HAV+MMR+V and MMR+V→HAV Groups
Vaccine response is defined as the appearance of antibodies with titers greater than or equal to the predefined cut-off value in the serum of subject seronegative before vaccination. Cut-off value assessed include 10 milli-international units per milliliter (mIU/mL).
42 days following administration of M-M-R®II and VARIVAX®
Secondary Outcomes (13)
Anti-measles, Anti-mumps, Anti-rubella and Anti-varicella Antibody Titers in HAV+MMR+V and MMR+V→HAV Groups
42 days following the administration of M-M-R®II and VARIVAX®
Anti-hepatitis A Virus (HAV) Antibody Concentrations in HAV and HAV+MMR+V Groups
42 days following the first dose of Havrix®
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentration Equal or Above the Cut-off Value in HAV and HAV+MMR+V Groups
42 days following the first dose of Havrix®
Anti-hepatitis A Virus (HAV) Antibody Concentrations in MMR+V→HAV Group
31 days following the second dose of Havrix®
Number of Subjects With Anti-hepatitis A Virus (HAV) Antibody Concentrations Above the Cut-off Value in MMR+V→HAV Group
31 days following the second dose of Havrix®
- +8 more secondary outcomes
Study Arms (3)
HAV Group
ACTIVE COMPARATORSubjects received 2 doses of Havrix® (1 dose at Day 0 and 1 dose between Month 6 and Month 9)
HAV+MMR+V Group
EXPERIMENTALSubjects received 1 dose of Havrix®, coadministered with M-M-R®II and VARIVAX®, at Day 0 and 1 dose of Havrix® between Month 6 and Month 9
MMR+V→HAV Group
ACTIVE COMPARATORSubjects received 1 dose of M-M-R®II and VARIVAX® at Day 0 and then 2 doses of Havrix® (1 dose at Day 42 and 1 dose between Month 7.5 and Month 10.5)
Interventions
Eligibility Criteria
You may qualify if:
- Subjects whose parents/guardians are believed by the investigator to be willing to comply with the requirements of the protocol
- A male or female child 12 and 13 months of age at the time of entry into the Enrollment Phase
- Written informed consent obtained from the parents or guardian of the subject,
- Free of obvious health problems as established by medical history and history-directed physical examination before entering into the study, and
- Parents/guardian of the subject must have a telephone or be able to be contacted by telephone
You may not qualify if:
- Use of any investigational or non-registered drug or vaccine other than the study vaccine(s) within 42 days preceding the first dose of study vaccine, or planned use during the study period, Chronic administration (defined as more than 14 days) of immuno-suppressant or other immune-modifying drugs within six months prior to vaccination or planned administration at any time during the study period. (For corticosteroids, this will mean prednisone, or equivalent, ≥0.5 mg/kg/day. Inhaled, nasal and topical steroids are allowed.) Planned administration or administration of any vaccine not foreseen by the study protocol during the period 31 days before and 31 days after each dose of study vaccine(s).
- Previous vaccination against hepatitis A,
- History of hepatitis A,
- Known exposure to hepatitis A,
- Previous vaccination against measles, mumps, rubella and/or varicella,
- History of measles, mumps, rubella and/or varicella,
- Known exposure to measles, mumps, rubella and/or varicella within 30 days prior to the start of the study,
- Planned chronic use of salicylates during the 6-week period following administration of the doses of study vaccine(s),
- Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection,
- A family history of congenital, hereditary or infectious immunodeficiency or parental risk factors for HIV infection,
- History of allergic disease/reactions or hypersensitivity likely to be exacerbated by any component of HavrixTM, M-M-RII or VARIVAXTM, including 2-phenoxyethanol, neomycin and gelatin,
- History of anaphylactic or anaphylactoid reactions to egg proteins,
- History of hypersensitivity/allergic reaction to latex. Note: The tip cap and the rubber plunger of the HavrixTM needleless pre-filled syringes contain dry natural latex rubber.
- Major congenital defects or serious chronic illness,
- Active untreated tuberculosis,
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (42)
GSK Investigational Site
Cabot, Arkansas, 72023, United States
GSK Investigational Site
Jonesboro, Arkansas, 72401, United States
GSK Investigational Site
North Little Rock, Arkansas, 72117, United States
GSK Investigational Site
Huntington Beach, California, 92647, United States
GSK Investigational Site
Oakland, California, 94609, United States
GSK Investigational Site
Rolling Hills Estates, California, 90274, United States
GSK Investigational Site
Norwich, Connecticut, 06360, United States
GSK Investigational Site
Jacksonville, Florida, 32209, United States
GSK Investigational Site
Marietta, Georgia, 30062, United States
GSK Investigational Site
Waterloo, Iowa, 50702, United States
GSK Investigational Site
Waukee, Iowa, 50263, United States
GSK Investigational Site
Lexington, Kentucky, 40503, United States
GSK Investigational Site
Bossier City, Louisiana, 71111, United States
GSK Investigational Site
Baltimore, Maryland, 21201, United States
GSK Investigational Site
Henderson, Nevada, 89015, United States
GSK Investigational Site
Las Vegas, Nevada, 89014, United States
GSK Investigational Site
Albany, New York, 12208, United States
GSK Investigational Site
Brooklyn, New York, 11203, United States
GSK Investigational Site
Rochester, New York, 14620, United States
GSK Investigational Site
Syracuse, New York, 13210, United States
GSK Investigational Site
Lumberton, North Carolina, 28358, United States
GSK Investigational Site
Sylva, North Carolina, 28779, United States
GSK Investigational Site
Cleveland, Ohio, 44109, United States
GSK Investigational Site
University Heights, Ohio, 44118, United States
GSK Investigational Site
Tulsa, Oklahoma, 74104, United States
GSK Investigational Site
Beaver Falls, Pennsylvania, 15010, United States
GSK Investigational Site
Norristown, Pennsylvania, 19401, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15213, United States
GSK Investigational Site
Pittsburgh, Pennsylvania, 15241, United States
GSK Investigational Site
Rydal, Pennsylvania, 19046, United States
GSK Investigational Site
Sellersville, Pennsylvania, 18960, United States
GSK Investigational Site
Warwick, Rhode Island, 02886, United States
GSK Investigational Site
Bristol, Tennessee, 37620, United States
GSK Investigational Site
Kingsport, Tennessee, 37660, United States
GSK Investigational Site
Kingsport, Tennessee, 37664, United States
GSK Investigational Site
Austin, Texas, 78758, United States
GSK Investigational Site
San Antonio, Texas, 78205-2489, United States
GSK Investigational Site
Temple, Texas, 76508, United States
GSK Investigational Site
Layton, Utah, 84041, United States
GSK Investigational Site
South Jordan, Utah, 84095, United States
GSK Investigational Site
Norfolk, Virginia, 23510, United States
GSK Investigational Site
Marshfield, Wisconsin, 54449, United States
Related Publications (1)
Rinderknecht S, Michaels MG, Blatter M, Gaglani M, Andrews W, Abughali N, Chandreshekaran V, Trofa AF. Immunogenicity and safety of an inactivated hepatitis A vaccine when coadministered with measles-mumps-rubella and varicella vaccines in children less than 2 years of age. Pediatr Infect Dis J. 2011 Oct;30(10):e179-85. doi: 10.1097/INF.0b013e31822256a5.
PMID: 21617573BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 20, 2005
Study Start
October 6, 2003
Primary Completion
June 9, 2009
Study Completion
June 9, 2009
Last Updated
July 31, 2018
Results First Posted
April 1, 2010
Record last verified: 2016-10
Data Sharing
- IPD Sharing
- Will share
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.