Last updated: 11/04/2018 00:25:22

Immunogenicity & Safety of Hepatitis A Vaccine co-admin with a Measles/Mumps/Rubella & a Varicella Vaccine in Children

GSK study ID
208109/231
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: 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
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Parallel Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:

Anti-hepatitis A virus (HAV) antibody concentrations in HAV and HAV+MMR+V groups.

Timeframe: 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

Timeframe: 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

Timeframe: 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

Timeframe: 42 days following administration of M-M-R®II and VARIVAX®

Secondary outcomes:

Anti-measles, anti-mumps, anti-rubella and anti-varicella antibody titers in HAV+MMR+V and MMR+V→HAV groups

Timeframe: 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

Timeframe: 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

Timeframe: 42 days following the first dose of Havrix®

Anti-hepatitis A virus (HAV) antibody concentrations in MMR+V→HAV Group

Timeframe: 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

Timeframe: 31 days following the second dose of Havrix®

Number of subjects with vaccine response to Havrix®

Timeframe: 31 days following the second dose of Havrix®

Number of subjects reporting solicited local symptoms

Timeframe: During the 4-day period following each dose of vaccine

Number of subjects reporting solicited general symptoms

Timeframe: During the 4-day period following each dose of vaccine

Number of subjects reporting measles, mumps, rubella and varicella specific solicited general adverse events

Timeframe: During the 43-day period following each dose of vaccine

Number of subjects reporting unsolicited adverse events (AEs)

Timeframe: During the 31-day period following each dose of vaccine

Number of subjects reporting serious adverse events (SAEs)

Timeframe: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)

Number of subjects reporting new chronic illnesses

Timeframe: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)

Number of subjects reporting medically significant events

Timeframe: During the Active Phase (from Day 0 up to Day 31 after the second dose) and the Extended Safety Follow-up Phase of the study (from Day 31 after the second dose up to study end)

Interventions:
Biological/vaccine: Havrix®
Biological/vaccine: M-M-R®II
Biological/vaccine: VARIVAX®
Enrollment:
1474
Observational study model:
Not applicable
Primary completion date:
2009-09-06
Time perspective:
Not applicable
Clinical publications:
Rinderknecht S et al. (2011) 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. 30(10):e179-185.
Medical condition
Hepatitis A
Product
SB208109
Collaborators
Not applicable
Study date(s)
October 2003 to June 2009
Type
Interventional
Phase
3

Participation criteria

Sex
Female & Male
Age
12 - 13 months
Accepts healthy volunteers
Yes
  • 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
  • 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.)

Trial location(s)

Location
Status
Contact us
Contact us
Location
GSK Investigational Site
Beaver Falls, Pennsylvania, United States, 15010
Status
Study Complete
Location
GSK Investigational Site
Rolling Hills Estates, California, United States, 90274
Status
Study Complete
Location
GSK Investigational Site
Norfolk, Virginia, United States, 23510
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21201
Status
Study Complete
Location
GSK Investigational Site
Oakland, California, United States, 94609
Status
Study Complete
Location
GSK Investigational Site
Tulsa, Oklahoma, United States, 74104
Status
Study Complete
Location
GSK Investigational Site
Marietta, Georgia, United States, 30062
Status
Study Complete
Location
GSK Investigational Site
San Antonio, Texas, United States, 78205-2489
Status
Study Complete
Location
GSK Investigational Site
University Heights, Ohio, United States, 44118
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37664
Status
Study Complete
Location
GSK Investigational Site
Sellersville, Pennsylvania, United States, 18960
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40503
Status
Study Complete
Location
GSK Investigational Site
Temple, Texas, United States, 76508
Status
Study Complete
Location
GSK Investigational Site
Lumberton, North Carolina, United States, 28358
Status
Study Complete
Location
GSK Investigational Site
Bossier City, Louisiana, United States, 71111
Status
Study Complete
Location
GSK Investigational Site
North Little Rock, Arkansas, United States, 72117
Status
Study Complete
Location
GSK Investigational Site
Jacksonville, Florida, United States, 32209
Status
Study Complete
Location
GSK Investigational Site
Waterloo, Iowa, United States, 50702
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Status
Study Complete
Location
GSK Investigational Site
Norwich, Connecticut, United States, 06360
Status
Study Complete
Location
GSK Investigational Site
Huntington Beach, California, United States, 92647
Status
Study Complete
Location
GSK Investigational Site
Rydal, Pennsylvania, United States, 19046
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89014
Status
Study Complete
Location
GSK Investigational Site
Sylva, North Carolina, United States, 28779
Status
Study Complete
Location
GSK Investigational Site
Cleveland, Ohio, United States, 44109
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15213
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Austin, Texas, United States, 78758
Status
Study Complete
Location
GSK Investigational Site
Warwick, Rhode Island, United States, 02886
Status
Study Complete
Location
GSK Investigational Site
Bristol, Tennessee, United States, 37620
Status
Study Complete
Location
GSK Investigational Site
Layton, Utah, United States, 84041
Status
Study Complete
Location
GSK Investigational Site
Norristown, Pennsylvania, United States, 19401
Status
Study Complete
Location
GSK Investigational Site
South Jordan, Utah, United States, 84095
Status
Study Complete
Location
GSK Investigational Site
Henderson, Nevada, United States, 89015
Status
Study Complete
Location
GSK Investigational Site
Cabot, Arkansas, United States, 72023
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Albany, New York, United States, 12208
Status
Study Complete
Location
GSK Investigational Site
Waukee, Iowa, United States, 50263
Status
Study Complete
Location
GSK Investigational Site
Rochester, New York, United States, 14620
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Brooklyn, New York, United States, 11203
Status
Study Complete

Study documents

Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English

If you wish to request for full study report, please contact - [email protected]

Results overview

Results posted on ClinicalTrials.gov

Recruitment status
Completed
Actual primary completion date
2009-09-06
Actual study completion date
2009-09-06

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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