Hepatitis B
Conditions
Brief summary
This study will assess the immunogenicity, safety and reactogenicity of GSK Biological's DTPa-HBV-IPV/ Hib vaccine as compared to GSK's DTPa-IPV/Hib vaccine co-administered with HBV according to a three-dose immunisation course and as a booster dose in infants born to hepatitis B antigen seronegative mothers and previously primed with a birth dose of GSK's HBV vaccine.
Interventions
BIOLOGICALDTPa-HBV-IPV/Hib vaccine
Vaccination according to a 3-dose schedule at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.
BIOLOGICALDTPa-IPV/Hib vaccine
Vaccination according to a 3-dose schedule at at 1 ½, 3 ½ and 6 months of age with booster at 15-18 months of age.
BIOLOGICALEngerixTM-B
The vaccine was administered according to a 2-dose schedule at 1½ and 6 months of age with booster at 15-18 months of age.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Weeks to 8 Weeks
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria for enrolment at birth * Written informed consent obtained from the parents or guardians of the subject. * A male or female infant born after a normal gestation period (between 36 and 42 weeks). * Born to a mother seronegative for HBsAg. * Free of obvious health problems as established by clinical examination before entering into the study. Inclusion criteria for administration of the combined vaccine regimen * Between, and including, 6 and 8 weeks of age at the time of the first dose of the three-dose course of vaccination. * Free of obvious health problems as established by medical history and clinical examination before entering into this phase of the study. Inclusion criteria for administration of the booster dose * Between, and including, 15 and 18 months of age at the time of the booster vaccination. * Written informed consent obtained from the parents or guardians of the subject. * Free of obvious health problems as established by medical history and clinical examination before entering into the study. * Completion of the three-dose primary vaccination course.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Seroprotective anti-HBs antibody titres above protocol specified cut-off value | At the time of the second dose of combined vaccination, one month after the 3rd dose of combined vaccination and one month after the booster dose. |
Secondary
| Measure | Time frame |
|---|---|
| Antibody titres against all investigational vaccine antigen components | One month after first combined vaccine dose, two months after Dose 1, one month after third combined vaccine dose prior to booster vaccination and one month post-booster vaccination. |
| Occurrence of solicited symptoms | During the 4-day follow-up period after each dose |
| Occurrence of unsolicited symptoms | During the 30-day follow-up period after each dose of study vaccine |
| Occurrence of Serious Adverse Events | From the birth dose of hepatitis B vaccine and ending with the last study visit or performance of the last study procedure or a minimum of 30 days following the third dose of the mixed vaccines and from the start of booster dose and ending a minimum of 3 |
Outcome results
None listed