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.
Hib-MenCY-TT = GSK Biologicals' Haemophilus influenzae type b and Neisseria meningitidis serogroups C and Y-tetanus toxoid conjugate vaccine. The study will be conducted in a single blind manner up to 30 days after administration of the booster dose; the extended safety follow-up after the booster dose will be conducted in an unblinded manner. All subjects will receive Prevnar, M-M-R II and Varivax as study vaccines, preferencially co-administered with the booster dose of Hib-MenCY-TT/PedvaxHIB. Note: This protocol posting deals with the objectives \& outcome measures for the booster phase of the study. The objectives \& outcome measures for the primary phase are presented in a separate protocol posting (NCT00345579)
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
4,021
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Birmingham, Alabama, United States
GSK Investigational Site
Benton, Arkansas, United States
GSK Investigational Site
Jonesboro, Arkansas, United States
GSK Investigational Site
Little Rock, 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 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)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: 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
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Time frame: 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
Time frame: 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)
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 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)
NOCIs include autoimmune disorders, asthma, type I diabetes, allergies.
Time frame: 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
Rash assessed was hives, idiopathic thrombocytopenic purpura, petechiae
Time frame: 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
Time frame: 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)
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GSK Investigational Site
Fountain Valley, California, United States
GSK Investigational Site
Fresno, California, United States
GSK Investigational Site
Fresno, California, United States
GSK Investigational Site
Madera, California, United States
GSK Investigational Site
Slinas, California, United States
...and 47 more locations