The primary phase of this study is evaluating the safety of Hib-MenCY-TT vaccine compared to a control group receiving licensed Hib conjugate vaccine, when each are co-administered with Pediarix® to healthy infants at 2, 4, and 6 months of age. This protocol posting deals with objectives \& outcome measures of the primary phase of the study. The objectives \& outcome measures of the Booster phase are presented in a separate protocol posting (NCT number = 00345683). The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007
Pediarix/Infanrix Penta and Prevnar should be co-administered to all subjects in all study groups according to a 2, 4, and 6 month schedule concomitantly with study vaccines.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
4,432
3-dose intramuscular injection
3-dose intramuscular injection
3-dose intramuscular injection
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Benton, Arkansas, United States
GSK Investigational Site
Fayetteville, Arkansas, United States
GSK Investigational Site
Hot Springs, Arkansas, United States
Number of Subjects Reporting Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Number of Subjects Reporting New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Number of Subjects Reporting Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae.
Time frame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Number of Subjects Reporting Adverse Events Resulting in Emergency Room (ER)
Time frame: From Dose 1 up to Day 30 after Dose 3 (from study Month 0 up to study Month 5)
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that results in death, are life threatening, require hospitalization or prolongation of hospitalization, results in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subjects.
Time frame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Number of Subjects With New Onset of Chronic Illnesses (NOCIs)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Number of Subjects With Rash
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Time frame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
Number of Subjects With Adverse Events Resulting in Emergency Room (ER)
Time frame: From Dose 1 through but excluding the fourth dose (from study Month 0 up to the booster vaccination at 12-15 months of age)
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GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Little Rock, Arkansas, United States
GSK Investigational Site
Fountain Valley, California, United States
GSK Investigational Site
Fresno, California, United States
...and 53 more locations