Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis
Conditions
Brief summary
This study will only include infants born to mothers who are tested as seronegative for human immunodeficiency virus (HIV) & hepatitis B surface antigen (HBsAg). The purpose of this study is to demonstrate in infants who received a birth dose of hepatitis B vaccine that Tritanrix™-HepB/Hib-MenAC vaccine is at least as good as Tritanrix™-HepB/Hiberix™ with respect to immunogenicity of the hepatitis B antigen.
Detailed description
Randomized study with two groups to receive one of the following vaccination regimens: * GSK Biologicals' Tritanrix™-HepB/Hib-MenAC * GSK Biologicals' Tritanrix™-HepB/Hiberix™
Interventions
BIOLOGICALDTPw-HBV/Hib-MenAC conjugate vaccine
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Days to 10 Days
Healthy volunteers
Yes
Inclusion criteria
* Healthy infants aged 7 days +/- 3 days old born to mothers who are tested as seronegative for HIV & HBsAg, written informed consent obtained from the parents, born after a gestation period of 36 to 42 weeks.
Exclusion criteria
* Known exposure to diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b and/or meningococcal disease since birth. * Any confirmed or suspected immunosuppressive or immunodeficient condition, based on physical examination. * A family history of congenital or hereditary immunodeficiency. * Major congenital defects or serious illness. * Any neurologic disorders or seizures. * Acute disease at the time of enrolment. * Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period. * A birth dose of hepatitis B vaccine given outside the frame of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations. | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity: One month after the third dose of the primary vaccination, antibody concentrations or titres against all other vaccine antigens. | — |
| Reactogenicity and safety: after each dose: solicited (day 0-3, local & general) & unsolicited (day 0-30) symptoms. Over the full course of the study: serious adverse events (SAEs) | — |
Countries
South Africa
Outcome results
None listed