Phase 3
Completed N=617
Response to GSK Biologicals' Tritanrix-HepB/Hib-MenAC Vacc (4th Dose) at 15-24m & Mencevax ACWY at 24-30m
Source: ClinicalTrials.gov NCT00136604 ↗Enrolled (actual)
617
Serious AEs
1.8%
Results posted
Sep 2018
Primary outcomePrimary: Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value — 100; 100 Percentage
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of the study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of DTPw-HBV/Hib-MenAC compared to DTPw-HBV/Hib given to healthy subjects at 15 to 24 months of age primed with 3 doses of Tritanrix-HepB/Hib-MenAC in study 100480. Antibody persistence will be evaluated at 24 to 30 months. Immunogenicity, safety and reactogenicity of a dose of Mencevax ACWY given at 24 to 30 months will also be evaluated when given to subjects not boosted with a MenA conjugate and/or MenC containing vaccine.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects With Meningococcal C Serum Bactericidal Assay (SBA-MenC) Antibody Titers Above the Cut-off Value |
100; 100 | — |
| PRIMARY Percentage of Subjects With SBA-MenA Antibody Titers Above the Cut-off Value |
100; 100 | — |
| PRIMARY Percentage of Seroprotected (SPR) Subjects With Anti-Polyribosyl Ribitol Phosphate Anti-(PRP) Antibody Concentrations Above the Cut-off Value |
100; 100 | — |
| SECONDARY Percentage of SPR Subjects With Anti-(PRP) Antibody Concentrations Above Predefined Cut-off Values |
100; 99.2; 100; 100; 99.2; 100 | — |
| SECONDARY Anti-PRP Antibody Concentrations |
4.572; 4.371; 3.728; 4.498; 4.775; 85.798 | — |
| SECONDARY Percentage of Subjects With SBA-MenC Antibody Titers Above the Cut-off Values |
95.1; 10.7; 90.8; 100; 100; 100 | — |
| SECONDARY Anti-SBA-MenC Antibody Titers |
295.2; 6.3; 143.8; 4891.2; 1868.4; 8068.6 | — |
| SECONDARY Percentage of Subjects With Serum Bactericidal Assay Against Meningococcal Serogroup A Using Rabbit Complement (rSBA-MenA) Antibody Titers Above the Pre-defined Cut-off Values |
99.6; 88.6; 94.1; 100; 100; 97.4 | — |
| SECONDARY Anti-rSBA-MenA Antibody Titers |
626.2; 327.2; 468.3; 1488.8; 3429.6; 411.5 | — |
| SECONDARY Percentage of Subjects With Anti-polysaccharide C (Anti-PSC) Antibody Concentrations Above the Predefined Cut-off Values |
97.2; 3.9; 97.5; 100; 100; 100 | — |
| SECONDARY Anti-PSC Antibody Concentrations |
1.37; 0.16; 1.41; 11.71; 25.96; 31.42 | — |
| SECONDARY Percentage of Subjects With Anti-polysaccharide A (Anti-PSA) Antibody Concentrations Above the Predefined Cut-off Values |
78.9; 18.4; 7.3; 100; 100; 15.0 | — |
| SECONDARY Anti-PSA Antibody Concentrations |
0.64; 0.20; 0.17; 20.31; 14.20; 0.19 | — |
| SECONDARY Percentage of Seroprotected (SPR) Subjects With Anti-diphtheria Toxoid (Anti-DT) Antibody Concentrations Above the Predefined Cut-off Values |
99.2; 100; 100; 100; 100 | — |
| SECONDARY Anti-D Antibody Concentrations |
0.126; 0.137; 0.134; 0.124; 0.168; 4.705 | — |
| SECONDARY Percentage of Seroprotected (SPR) Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations Above the Predefined Cut-off Values |
99.2; 99.2; 97.4; 97.6; 96.6; 100 | — |
| SECONDARY Anti-TT Antibody Concentrations |
0.709; 0.648; 0.617; 0.537; 0.566; 16.313 | — |
| SECONDARY Percentage of Seroprotected (SPR) Subjects With Anti-Bordetella Pertussis Toxoid (Anti-BPT) Antibody Concentrations Above the Predefined Cut-off Value |
98.2; 100; 100; 97.4; 99.1 | — |
| SECONDARY Anti-BPT Antibody Concentrations |
11.7; 10.5; 10.6; 10.5; 11.1; 122.1 | — |
| SECONDARY Percentage of Seroprotected (SPR) Subjects With Anti-hepatitis B (Anti-HBs) Antibody Concentrations Above the Predefined Cut-off Value |
82.6; 90.8; 94.7; 90.2; 81.6; 95.8 | — |
| SECONDARY Anti-HBs Antibody Concentrations |
54.8; 91.2; 95.0; 84.4; 65.6; 3451.8 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
206; 90; 61; 31; 87; 55 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
159; 71; 46; 24; 58; 1 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
7; 4; 0; 2; 8 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
8; 0; 1; 1; 1 | — |
Eligibility Criteria
Inclusion criteria
- Healthy male or female between and including 15 and 24 months of age
- Having participated in the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480)
Exclusion criteria
- Booster vaccination against diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b (Hib) and/or meningococcal serogroups A and/or C disease not foreseen in the protocol, after the date of the study conclusion visit of the primary vaccination study DTPW-HBV=HIB-MENAC-TT-003 (eTrack No. 100480).
- History of or known exposure to diphtheria, tetanus, pertussis, hepatitis B, Hib and/or meningococcal serogroup A or C disease.
- Any confirmed or suspected immunosuppressive or immunodeficient condition.
- A family history of congenital or hereditary immunodeficiency.
- Major congenital defects or serious chronic illness.
- History of any neurologic disorders or seizures including febrile seizures (at least two events) in infancy.
Data sourced from ClinicalTrials.gov (NCT00136604). 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. Informational only — not medical advice.