Phase 3
N=745
Immune Memory of DTPw-HBV/Hib Vaccine Following Primary Vaccination, Immuno & Reacto of a Booster Dose Given in Infants
Whole Cell Pertussis · Diphtheria · Hepatitis B · Tetanus · Haemophilus Influenzae Type b
Bottom Line
View on ClinicalTrials.gov: NCT00169442 ↗Enrolled (actual)
745
Serious AEs
0.1%
Results posted
Feb 2017
Primary outcome: Primary: Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL — 39; 41; 37; 39 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Tritanrix™-HepB/Hiberix™ Kft. (Biological); Tritanrix™-HepB/Hiberix™ (Biological); Hiberix™ (Biological); Polyribosil-Ribitol-Phosphate (PRP) vaccine (Biological); Tritanrix™-HepB Kft (Biological)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- GlaxoSmithKline
- Primary completion
- Mar 2006
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL |
37; 41; 32; 34 | — |
| PRIMARY Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. |
74; 69; 84; 72; 53; 62 | — |
| PRIMARY Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) |
74; 68; 88; 73; 77; 71 | — |
| PRIMARY Seroprotection Rates for Anti-D Antibodies |
85.7; 71.6; 95.5; 85.1 | — |
| PRIMARY Number of Seroprotected Subjects Against Hepatitis B Surface Antigen (HBs) |
74; 69; 84; 72 | — |
| PRIMARY Number of Seroprotected Subjects Against Bordetella Pertussis (BPT) |
74; 65; 85; 69 | — |
| PRIMARY Number of Subjects With Booster Response to BPT Antigen |
70; 64; 79; 67 | — |
| PRIMARY Anti-PRP Antibody Concentrations |
33.190; 22.727 | — |
| PRIMARY Anti-PRP Antibody Concentrations. |
56.670; 81.681; 58.669; 113.073 | — |
| PRIMARY Anti-D and Anti-T Antibody Concentrations |
3.087; 1.812; 3.452; 3.128; 13.371; 12.181 | — |
| PRIMARY Anti-HBs Antibody Concentrations |
2400.0; 1628.3; 2467.9; 2465.1 | — |
| PRIMARY Anti-BPT Antibody Concentrations |
91.3; 118.8; 97.6; 93.5 | — |
| SECONDARY Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL |
37; 41; 32; 34 | — |
| SECONDARY Number of Subjects With Anti-PRP Antibody Concentrations ≥ 0.15 μg/mL and ≥ 1.0 μg/mL. |
74; 69; 84; 72; 53; 62 | — |
| SECONDARY Number of Subjects With Anti-D and Anti-T Antibody Concentrations ≥ the Cut-off Value |
45; 24; 58; 46; 72; 67 | — |
| SECONDARY Seroprotection Rates for Anti-D Antibodies |
85.7; 71.6; 95.5; 85.1 | — |
| SECONDARY Number of Subjects With Anti-HBs Antibody Concentrations ≥ the Cut-off Value |
56; 44; 69; 56 | — |
| SECONDARY Number of Subjects With Anti-BPT Antibody Concentrations ≥ the Cut-off Value |
23; 21; 33; 27 | — |
| SECONDARY Anti- PRP Antibody Concentrations |
4.683; 4.507 | — |
| SECONDARY Anti- PRP Antibody Concentrations. |
2.703; 5.312; 2.837; 2.904 | — |
| SECONDARY Anti-D and Anti-T Antibody Concentrations. |
0.117; 0.077; 0.162; 0.145; 0.397; 0.512 | — |
| SECONDARY Anti-HBs Antibody Concentrations. |
43.6; 26.1; 70.5; 43.6 | — |
| SECONDARY Anti-BPT Antibody Concentrations. |
10.6; 10.7; 12.8; 11.9 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
13; 12; 0; 0; 11; 15 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
6; 10; 0; 0; 6; 10 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms. |
56; 303; 181; 11; 57; 34 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms. |
34; 174; 105; 1; 11; 4 | — |
| SECONDARY Number of Subjects With Unsolicited Adverse Events (AEs) |
22; 27; 14 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
1; 0; 0 | — |
Summary
To assess the immune memory following primary vaccination of DTPw-HBV/Hib vaccine and to assess immunogenicity and reactogenicity of a booster dose given at 15 - 18 months of age.
Eligibility Criteria
Inclusion criteria
For subjects receiving Plain PRP followed by DTPw-HBV:
Male or female infant, 10 to 11 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.
For subjects receiving DTPw-HBV/Hib or DTPw-HBV + Hib:
Male or female infant, 15-18 months of age, who previously completed the three-dose primary vaccination course with the DTPw-HBV/Hib vaccine.
For all subjects:
- Subjects who the investigator believes that their parent/guardian can and will comply with the requirements of the protocol.
- Free of obvious health problems as established by medical history and clinical examination
Exclusion criteria
- Use of any investigational or non-registered product other than the study vaccine(s) within 30 days preceding administration of the study vaccine, or planned use during the study period.
- Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to administration of the study vaccine.
- Planned administration/administration of a vaccine not foreseen by the study protocol starting 30 days before and ending 30 days after administration of the study vaccine with the exception of oral polio vaccine.
Data sourced from ClinicalTrials.gov (NCT00169442). 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.