Phase 3
Completed N=1,718
Immunogenicity, Safety of GSKs Tdap Vaccine Boostrix When Coadministered With GSKs Influenza Vaccine Fluarix in Adults
Acellular Pertussis · Diphtheria · Tetanus
Source: ClinicalTrials.gov NCT00385255 ↗
Enrolled (actual)
1,718
Serious AEs
0.6%
Results posted
Sep 2018
Primary outcomePrimary: Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens — 677; 614; 93; 79 Participants
Summary
The current study will provide information for the use of Boostrix concomitantly with influenza vaccine in adults aged 19-64 years. This study will also provide safety and immunogenicity data in a cohort of adults aged greater than or equal to 65 years.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Seroprotected Subjects Against Diphteria (D) and Tetanus (T) Toxoid Antigens |
677; 614; 93; 79; 700; 653 | — |
| PRIMARY Number of Subjects With Anti-T Antibody Concentrations ≥ the Assay Cut-off Value |
687; 621; 94; 84 | — |
| PRIMARY Antibody Concentrations Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens |
57.5; 76.9; 51.2; 59.3; 467.6; 663.3 | — |
| PRIMARY Number of Subjects With Serum Haemagglutinin Inhibition (HI) Titers Against 3 Strains of Influenza |
669; 643; 92; 88; 694; 663 | — |
| PRIMARY Number of Seroconverted Subjects Against Influenza Antigens H1N1, H3N2, and B |
414; 377; 37; 32; 560; 494 | — |
| SECONDARY Number of Seropositive Subjects With Anti-D Antibody Concentrations Above the Cut-off Value |
579; 528; 55; 49 | — |
| SECONDARY Antibody Concentrations for Diphteria Toxoid (D) and Tetanus Toxoid (T) |
0.4; 0.4; 0.2; 0.2; 3.1; 3.4 | — |
| SECONDARY Antibody Concentrations for Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) |
6.4; 6.5; 8.0; 8.0; 57.5; 76.9 | — |
| SECONDARY Number of Subjects With Booster Response Against Diphteria Toxoid (D) and Tetanus Toxoid (T) Antigens |
487; 459; 61; 48; 293; 320 | — |
| SECONDARY Number of Subjects With Booster Response Against Pertussis Toxoid (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN) Antigens |
514; 530; 71; 68; 651; 621 | — |
| SECONDARY Anti-H1N1, Anti-H3N2 and Anti-B Antibody Titers |
189.1; 181.6; 79.9; 89.3; 368.7; 337.3 | — |
| SECONDARY Number of Subjects With Any and Grade 3 Solicited Local Symptoms |
467; 315; 41; 25; 28; 7 | — |
| SECONDARY Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms |
220; 165; 20; 18; 22; 15 | — |
| SECONDARY Number of Subjects With Any Unsolicited Adverse Events (AEs) |
161; 205; 22; 21 | — |
| SECONDARY Number of Subjects With Serious Adverse Events (SAEs) |
2; 7; 1; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Healthy male or female adults aged between 19 to 64 years, inclusive for the primary cohort), or aged 65 years or older (for the exploratory cohort), at the time of vaccination.
Exclusion Criteria
- Administration of an influenza vaccine within six months prior to study entry
- Administration of a diphtheria-tetanus (Td) booster within the previous 5 years.
- Administration of a Tdap vaccine at any time prior to study entry.
- Administration of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding vaccination, or planned use during the entire study period.
- History of diphtheria and/or tetanus and/or pertussis disease.
- History of serious allergic reaction (e.g. anaphylaxis) following any other tetanus toxoid, diphtheria toxoid or pertussis-containing vaccine or influenza vaccine or any component of the study vaccines.
Data sourced from ClinicalTrials.gov (NCT00385255). 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.