Last updated: 11/03/2018 08:40:38
Safety of Hib-MenCY-TT vaccine versus licensed Hib conjugate vaccine, given at 12 to 15 months of age.
GSK study ID
105988
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Single-blind, randomized, controlled, multinational study for the evaluation of safety of GSK Biologicals' Hib-MenCY-TT vaccine compared to monovalent Hib control vaccine in healthy infants at 2, 4, 6, and 12 to 15 months of age.
Trial description: The booster phase of the study will evaluate the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine at 12 to 15 months of age.This protocol posting deals with objectives & outcome measures of the booster phase. The objectives & outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00345579).No new recruitment will take place during this booster phase of the study.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:
Single (Care Provider)
Allocation:
Randomized
Primary outcomes:
Number of subjects reporting Serious Adverse Events (SAEs)
Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of subjects reporting New Onset of Chronic illnesses (NOCIs)
Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of subjects reporting rash
Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of subjects reporting Adverse Events resulting in Emergency Room (ER) visits
Timeframe: From fourth dose up to Day 30 after fourth dose vaccination (from study Month 10-13 up to study Month 11-14)
Number of subjects with Serious Adverse Events (SAEs)
Timeframe: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Number of subjects with New Onset of Chronic illnesses (NOCIs)
Timeframe: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Number of subjects with rash
Timeframe: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Number of subjects with Adverse Events resulting in Emergency Room (ER) visits
Timeframe: From fourth dose through the end of the 6-month safety follow-up of the fourth dose phase (from study Month 10-13 up to study Month 16-19)
Secondary outcomes:
Not applicable
Interventions:
Biological/vaccine: GSK Biologicals’ Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine combined (792014)
Biological/vaccine: PedvaxHIB
Biological/vaccine: Prevnar
Biological/vaccine: M-M-R II
Biological/vaccine: Varivax
Enrollment:
4021
Observational study model:
Not applicable
Primary completion date:
2008-02-09
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Haemophilus influenzae type b, Neisseria Meningitidis
Product
SB792014
Collaborators
Not applicable
Study date(s)
July 2007 to November 2008
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 15 months
Accepts healthy volunteers
Yes
- Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study
- Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:
- History of measles, mumps, rubella or varicella.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects enrolled in the primary study (NCT00345579) are eligible for participating in the booster study
Exclusion criteria:
- Subjects should not be administered M-M-R II and Varivax if any of these criteria apply:
- History of measles, mumps, rubella or varicella.
- Previous vaccination against measles, mumps, rubella or varicella.
- Hypersensitivity to any component of the vaccines, including gelatin or neomycin.
- Patients receiving immunosuppressive therapy.
- Individuals with blood dyscrasias, leukemia, lymphomas of any type, or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- Individuals with primary and acquired immunodeficiency states.
- Individuals with a family history of congenital or hereditary immunodeficiency, until the immune competence of the potential vaccine recipient is demonstrated.
- Individuals with active tuberculosis.
- Acute disease at time of booster vaccination
Trial location(s)
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35205
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15241
Status
Study Complete
Location
GSK Investigational Site
Wexford, Pennsylvania, United States, 15090
Status
Study Complete
Location
GSK Investigational Site
South Euclid, Ohio, United States, 44121
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15227
Status
Study Complete
Location
GSK Investigational Site
North Canton, Ohio, United States, 44720
Status
Study Complete
Location
GSK Investigational Site
Benton, Arkansas, United States, 72015
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15220
Status
Study Complete
Location
GSK Investigational Site
Boulder, Colorado, United States, 80303
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84121
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15217
Status
Study Complete
Location
GSK Investigational Site
Pleasant Gorve, Utah, United States, 84062
Status
Study Complete
Location
GSK Investigational Site
Greenville, Pennsylvania, United States, 16125
Status
Study Complete
Location
GSK Investigational Site
Syracuse, New York, United States, 13210
Status
Study Complete
Location
GSK Investigational Site
Erie, Pennsylvania, United States, 16505
Status
Study Complete
Location
GSK Investigational Site
West Jordan, Utah, United States, 84088
Status
Study Complete
Location
GSK Investigational Site
Salt Lake City, Utah, United States, 84109
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93710
Status
Study Complete
Location
GSK Investigational Site
Stevensville, Michigan, United States, 49127
Status
Study Complete
Location
GSK Investigational Site
Charleston, South Carolina, United States, 29406
Status
Study Complete
Location
GSK Investigational Site
Fountain Valley, California, United States, 92708
Status
Study Complete
Location
GSK Investigational Site
Boston, Massachusetts, United States, 02130
Status
Study Complete
Location
GSK Investigational Site
Ithaca, New York, United States, 14850
Status
Study Complete
Location
GSK Investigational Site
Las Vegas, Nevada, United States, 89104
Status
Study Complete
Location
GSK Investigational Site
Lexington, Kentucky, United States, 40503
Status
Study Complete
Location
GSK Investigational Site
Little Rock, Arkansas, United States, 72205
Status
Study Complete
Location
GSK Investigational Site
Portage, Michigan, United States, 49024
Status
Study Complete
Location
GSK Investigational Site
Birmingham, Alabama, United States, 35244
Status
Study Complete
Location
GSK Investigational Site
New Hartford, New York, United States, 13413
Status
Study Complete
Location
GSK Investigational Site
Bossier City, Louisiana, United States, 71111
Status
Study Complete
Location
GSK Investigational Site
Jonesboro, Arkansas, United States, 72401
Status
Study Complete
Location
GSK Investigational Site
Fresno, California, United States, 93726
Status
Study Complete
Location
GSK Investigational Site
Slinas, California, United States, 93901
Status
Study Complete
Location
GSK Investigational Site
Bardstown, Kentucky, United States, 40004
Status
Study Complete
Location
GSK Investigational Site
Plantation, Florida, United States, 33324
Status
Study Complete
Location
GSK Investigational Site
Madison, Wisconsin, United States, 53792
Status
Study Complete
Location
GSK Investigational Site
Marshfield, Wisconsin, United States, 54449
Status
Study Complete
Location
GSK Investigational Site
Longmont, Colorado, United States, 80501
Status
Study Complete
Location
GSK Investigational Site
Kingsport, Tennessee, United States, 37660
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15236
Status
Study Complete
Location
GSK Investigational Site
Madera, California, United States, 93637
Status
Study Complete
Location
GSK Investigational Site
Nampa, Idaho, United States, 208 463 3126
Status
Study Complete
Location
GSK Investigational Site
South Jordan, Utah, United States, 84095
Status
Study Complete
Location
GSK Investigational Site
West Covina, California, United States, 91790
Status
Study Complete
Location
GSK Investigational Site
West Desmoines, Iowa, United States, 50266
Status
Study Complete
Location
GSK Investigational Site
St. Paul, Minnesota, United States, 55108
Status
Study Complete
Location
GSK Investigational Site
Raleigh, North Carolina, United States, 27609
Status
Study Complete
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2008-02-09
Actual study completion date
2008-12-11
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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Additional information
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