Trials / Terminated
TerminatedNCT00316680
Immuno & Safety Study With 2 Formulations of DTPw-HBV/HIB When Given at Birth With Hepatitis B at 2, 4 and 6 Mths.Age.
Study to Assess Immunogenicity and Safety of GlaxoSmithKline Biologicals' Kft's DTPw-HBV/Hib vs DTPwCSL-HBV/Hib Kft and vs Concomitant Administration of CSL's Triple Antigen and GlaxoSmithKline Biologicals' Hiberix, to Infants at 2, 4, 6 Months of Age, After a Birth Dose of Hepatitis B
- Status
- Terminated
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 288 (planned)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 6 Weeks – 12 Weeks
- Healthy volunteers
- Accepted
Summary
A trial to characterize the immunogenicity of 2 different formulations of a vaccine from GSK Biologicals, including the following five antigens: diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type b. A vaccine from Commonwealth Serum Laboratories (diphtheria, tetanus, pertussis) which is co-administered with Haemophilus influenzae type b vaccine will also be used as a comparator. Reactogenicity and safety of all vaccines will be assessed as well.
Detailed description
"The study will be carried out in a partially double blind manner (i.e. double blind with respect to DTPwGöd-HBV/Hib Kft and DTPwCSL-HBV/Hib Kft groups and open with respect to CSL's Triple Antigen \& Hib group). Subjects will be randomly allocated to one of the three following groups to receive: * GSK Biologicals Kft's combined DTPwGöd-HBV/Hib Kft vaccine. * GSK Biologicals Kft's combined DTPwCSL-HBV/Hib Kft vaccine. * CSL's Triple Antigen + GSK Biologicals' Hib vaccines. There will be a specific follow-up of solicited local and general symptoms during 4 days after each vaccination and of unsolicited symptoms for 31 days after each vaccination. Serious adverse events reported during the study period will be recorded. "
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Diphtheria, tetanus, pertussis, hepatitis B, Hib vaccine |
Timeline
- Start date
- 2006-03-01
- Completion
- 2006-11-01
- First posted
- 2006-04-21
- Last updated
- 2016-10-07
Locations
1 site across 1 country: Dominican Republic
Source: ClinicalTrials.gov record NCT00316680. Inclusion in this directory is not an endorsement.