In order to reduce the amount of thiomersal in its vaccines, GSK Biologicals has developed a DTPw-HBV vaccine with low thiomersal content (Tritanrix™- HepB low thio). This vaccine is to be used in combination with a Hib low dose vaccine containing 2.5µg of PRP antigen (Hib 2.5). The purpose of this study is to generate clinical data with Tritanrix™-HepB low thio vaccine when extemporaneously mixed with Hib 2.5 vaccine. The control group will receive Tritanrix™-HepB/Hiberix™. Subjects received primary vaccination in study 208108/091 (double blind). Of these subjects 50% were randomised to participate in the PRP challenge study (208108/092) (open), and all subjects will be invited to participate in a booster study DTPWHBV=HIB2.5-093 (101477).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
192
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
One dose as intramuscular injection at 6, 10 and 14 weeks of age.
One dose as intramuscular injection at 10 months of age
GSK Investigational Site
City of Muntinlupa, Philippines
anti-PRP antibody concentration above a protocol defined cut-off value.
Time frame: One month after the third dose of the primary vaccination course.
anti-HBs antibody concentration
Time frame: One month after the third dose of the primary vaccination course
anti-PRP antibody concentration
Time frame: One month after the third dose of the primary vaccination course
anti-tetanus antibody concentration
Time frame: One month after the third dose of the primary vaccination course
anti-diphtheria antibody concentration
Time frame: One month after the third dose of the primary vaccination course
anti-Bordetella pertussis (BPT) antibody concentration
Time frame: One month after the third dose of the primary vaccination course
Vaccine response to Bordetella pertussis antigen.
Time frame: One month after the third dose of the primary vaccination course
Seropositivity/seroprotection rates and GMCs for antibodies against all vaccine antigens
Time frame: Before the first dose of the primary vaccination course
anti-PRP antibody concentration
Time frame: Before and one month after the plain PRP challenge dose.
Occurrence of solicited symptoms
Time frame: During the 4-day follow-up period after each dose
Occurrence of unsolicited symptoms
Time frame: During the 31-day follow-up period after each dose
Occurrence of serious adverse events
Time frame: Over the full course of the study
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