Phase 3
N=308
Immune Response Post Pry Vaccination of 2 Formulations of DTPw-HBV Vaccine Given With Rotavirus Vaccine to Infants
Hepatitis B
Bottom Line
View on ClinicalTrials.gov: NCT00158756 ↗Enrolled (actual)
308
Serious AEs
3.3%
Results posted
Jul 2017
Primary outcome: Primary: Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies — 100; 100; 100; 100 IU/mL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tritanrix™-HepB (Biological); Rotarix™ (Biological); Zilbrix™ (Biological); Triple Antigen™ (Biological); Engerix™-B (Biological); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Nov 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seroprotection Status for Anti-diphteria (Anti-DT) Antibodies |
100; 100; 100; 100; 98.9 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-DT Antibodies as Assessed by ELISA |
65; 17; 60; 17; 85 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-Hepatitis B (Anti-HBs) Antibodies |
64; 19; 58; 16; 84 | — |
| SECONDARY Number of Seropositive Subjects With Anti-Bordetella Pertussis (Anti-BPT) Antibody Concentrations ≥ the Established Cut-off Values |
67; 19; 60; 16; 79 | — |
| SECONDARY Number of Subjects With Vaccine Response to BPT Antigen |
67; 19; 60; 16; 79 | — |
| SECONDARY Number of Seropositive Subjects With Anti-rotavirus (Anti-RV) Antibodies Above the Cut-off Values |
42; 0; 41; 0 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-Tetanus (Anti-T) Antigen |
68; 20; 62; 17; 87 | — |
| SECONDARY Number of Seroprotected Subjects for Anti-Poliovirus Types 1, 2, 3 (Anti-Polio 1, 2, 3) |
54; 17; 47; 14; 72; 58 | — |
| SECONDARY Concentrations of Anti-HBs Antibodies |
600.5; 732.7; 789.8; 850.6; 578.6 | — |
| SECONDARY Concentrations of Anti-DT Antibodies |
0.667; 0.545; 0.957; 0.906; 1.096 | — |
| SECONDARY Concentrations of Anti-T Antibodies |
3.138; 3.350; 3.737; 5.323; 3.319 | — |
| SECONDARY Concentrations of Anti-BPT Antibodies |
65.7; 50.8; 40.1; 37.2; 38.0 | — |
| SECONDARY Concentrations of Anti-RV Antibodies |
96.4; 10.0; 93.1; 10.0 | — |
| SECONDARY Anti-Polio Type 1, 2, 3 Antibody Titers |
900.7; 1181.0; 877.7; 779.9; 1155.0; 811.2 | — |
| SECONDARY Number of Subjects With Solicited Local Symptoms |
40; 13; 46; 14; 51; 6 | — |
| SECONDARY Number of Subjects With Any Solicited General Symptoms |
6; 0; 5; 1; 1; 0 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
8; 6; 19; 5; 12 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
1; 0; 7; 0; 2 | — |
Summary
To compare the two formulations of GSK Biologicals' DTPw-HBV vaccine to concomitant administration of CSL's DTPw vaccine and GSK Biologicals' HBV with respect to the antibody response to the diphtheria antigen after a three-dose primary vaccination course.
Eligibility Criteria
Inclusion criteria
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
- Administration of one dose of hepatitis B vaccine at birth.
- A male or female between, and including, 11 and 17 weeks of age at the time of the first DTPw vaccination.
- Free of obvious health problems as established by medical history and clinical examination before entering into the study.
Exclusion criteria
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs since birth.
- Planned administration/ administration of a vaccine not foreseen by the study protocol within 30 days before the first vaccine dose or planned administration during the study period with the exception of oral polio vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination (no laboratory testing is required)
- Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period.
Data sourced from ClinicalTrials.gov (NCT00158756). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.