Diphtheria; Haemophilus Influenzae Type b; Hepatitis B; Tetanus; Whole Cell Pertussis Clinical Trial
Official title:
Demonstrate Non-inferiority of GSK Biologicals' Tritanrix™-HepB/Hib-MenAC vs Tritanrix™-HepB/Hiberix™ With Respect to Anti-HBs Immune Response, When Given to Healthy Infants at 6,10 & 14 Weeks Age, After a Birth Dose of Hepatitis B Vaccine
| Verified date | September 2016 |
| Source | GlaxoSmithKline |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | South Africa: Medicines Control Council |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 192 |
| Est. completion date | July 2005 |
| Est. primary completion date | July 2005 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | N/A to 10 Days |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| South Africa | GSK Investigational Site | Brits | |
| South Africa | GSK Investigational Site | Brits | |
| South Africa | GSK Investigational Site | Centurion | |
| South Africa | GSK Investigational Site | Ga-Rankuwa |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
South Africa,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | One month after the third dose of the primary vaccination, measurement of anti-HBs antibody concentrations. | |||
| Secondary | Immunogenicity: One month after the third dose of the primary vaccination, antibody concentrations or titres against all other vaccine antigens. | |||
| Secondary | 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)" |