Phase 4 N=205 Prevention

Study to Evaluate Long Term Immunogenicity up to 10 Years After the First Booster Immunization With Tick Borne Encephalitis Vaccine in Adults Who Received 1 of 3 Different Primary Vaccination Schedules

Tick Borne Encephalitis · Virus Diseases

Bottom Line

View on ClinicalTrials.gov: NCT01562444 ↗

Enrolled (actual)

205

Serious AEs

—

Results posted

Aug 2018

Primary outcome: Primary: Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2 — 95.83; 100.0; 97.17 Percentage of subjects

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Blood draw (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: GlaxoSmithKline
Primary completion: Sep 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers Greater Than or Equal to (≥) 2	95.83; 100.0; 97.17	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2	89.58; 96.08; 93.40	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2	89.58; 96.08; 93.40	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2	89.58; 96.08; 93.40	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2	89.58; 96.08; 93.40	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10	89.58; 94.12; 93.40	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10	89.58; 94.12; 93.40	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10	89.58; 94.12; 93.40	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10	89.58; 94.12; 93.40	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10	89.58; 94.12; 93.40	—
PRIMARY Evaluation of Geometric Mean Antibody Titers (GMTs)	76; 228; 228; 467; 1135; 985	—
PRIMARY Evaluation of GMTs	76; 228; 228; 467; 1135; 985	—
PRIMARY Evaluation of GMTs	76; 228; 228; 467; 1135; 985	—
PRIMARY Evaluation of GMTs	76; 228; 228; 467; 1135; 985	—
PRIMARY Evaluation of GMTs	76; 228; 228; 467; 1135; 985	—
PRIMARY Geometric Mean Ratios (GMRs) Calculated to Pre Booster Baselines	6.73; 1.28; 0.99	—
PRIMARY GMRs Calculated to Pre Booster Baselines	0.76; 1.08; 0.8	—
PRIMARY GMRs Calculated to Pre Booster Baselines	0.76; 1.08; 0.8	—
PRIMARY GMRs Calculated to Pre Booster Baselines	0.76; 1.08; 0.8	—
PRIMARY GMRs Calculated to Pre Booster Baselines	0.76; 1.08; 0.8	—
PRIMARY GMRs Calculated to Post Booster Baselines	0.36; 0.22; 0.18	—
PRIMARY GMRs Calculated to Post Booster Baselines	0.36; 0.22; 0.18	—
PRIMARY GMRs Calculated to Post Booster Baselines	0.36; 0.22; 0.18	—
PRIMARY GMRs Calculated to Post Booster Baselines	0.36; 0.22; 0.18	—
PRIMARY GMRs Calculated to Post Booster Baselines	0.36; 0.22; 0.18	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups	88.57; 94.87; 92.59; 92.31; 100.0; 96.00	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups	88.57; 94.87; 92.59; 92.31; 100.0; 96.00	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups	88.57; 94.87; 92.59; 92.31; 100.0; 96.00	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups	88.57; 94.87; 92.59; 92.31; 100.0; 96.00	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 2 by Age Groups	88.57; 94.87; 92.59; 92.31; 100.0; 96.00	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups	88.57; 94.87; 92.59; 92.31; 91.67; 96.00	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups	88.57; 94.87; 92.59; 92.31; 91.67; 96.00	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups	88.57; 94.87; 92.59; 92.31; 91.67; 96.00	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups	88.57; 94.87; 92.59; 92.31; 91.67; 96.00	—
PRIMARY Percentage of Subjects With Detectable TBE Antibody Titers ≥ 10 by Age Groups	88.57; 94.87; 92.59; 92.31; 91.67; 96.00	—
PRIMARY Evaluation of GMTs in the Age Group of 15-49 Years	76; 253; 263; 638; 1299; 1008	—
PRIMARY Evaluation of GMTs in the Age Group of 15-49 Years	76; 253; 263; 638; 1299; 1008	—
PRIMARY Evaluation of GMTs in the Age Group of 15-49 Years	76; 253; 263; 638; 1299; 1008	—
PRIMARY Evaluation of GMTs in the Age Group of 15-49 Years	76; 253; 263; 638; 1299; 1008	—
PRIMARY Evaluation of GMTs in the Age Group of 15-49 Years	76; 253; 263; 638; 1299; 1008	—
PRIMARY Evaluation of GMTs in the Age Group of ≥ 50 Years	163; 145; 201; 733; 914; 119	—
PRIMARY Evaluation of GMTs in the Age Group of ≥ 50 Years	163; 145; 201; 733; 914; 119	—
PRIMARY Evaluation of GMTs in the Age Group of ≥ 50 Years	163; 145; 201; 733; 914; 119	—
PRIMARY Evaluation of GMTs in the Age Group of ≥ 50 Years	163; 145; 201; 733; 914; 119	—
PRIMARY Evaluation of GMTs in the Age Group of ≥ 50 Years	163; 145; 201; 733; 914; 119	—
PRIMARY Evaluation of GMTs in the Age Group of ≥ 60 Years	64; 69; 173; 573; 498; 181	—
PRIMARY Evaluation of GMTs in the Age Group of ≥ 60 Years	64; 69; 173; 573; 498; 181	—
PRIMARY Evaluation of GMTs in the Age Group of ≥ 60 Years	64; 69; 173; 573; 498; 181	—
PRIMARY Evaluation of GMTs in the Age Group of ≥ 60 Years	64; 69; 173; 573; 498; 181	—
PRIMARY Evaluation of GMTs in the Age Group of ≥ 60 Years	64; 69; 173; 573; 498; 181	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years	0.76; 1.05; 0.78	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years	0.76; 1.05; 0.78	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years	0.76; 1.05; 0.78	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years	0.76; 1.05; 0.78	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of 15-49 Years	0.76; 1.05; 0.78	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years	1.16; 0.89	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years	1.16; 0.89	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years	1.16; 0.89	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years	1.16; 0.89	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 50 Years	1.16; 0.89	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years	0.89; 1.04	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years	0.89; 1.04	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years	0.89; 1.04	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years	0.89; 1.04	—
PRIMARY GMRs Calculated to Pre Booster Baselines in the Age Group of ≥ 60 Years	0.89; 1.04	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years	0.29; 0.2; 0.2	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years	0.29; 0.2; 0.2	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years	0.29; 0.2; 0.2	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years	0.29; 0.2; 0.2	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of 15-49 Years	0.29; 0.2; 0.2	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years	0.59; 0.26; 0.14	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years	0.59; 0.26; 0.14	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years	0.59; 0.26; 0.14	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years	0.59; 0.26; 0.14	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 50 Years	0.59; 0.26; 0.14	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years	1.05; 0.1; 0.14	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years	1.05; 0.1; 0.14	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years	1.05; 0.1; 0.14	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years	1.05; 0.1; 0.14	—
PRIMARY GMRs Calculated to Post Booster Baselines in the Age Group of ≥ 60 Years	1.05; 0.1; 0.14	—

Summary

The aim of this study is to investigate the immunogenicity response in adults up to 10 years after one booster dose. Data collected from this study will allow for greater information to prescribers who administer TBE vaccine, so that they can appropriately time the administration of booster vaccinations to individuals who received different vaccination schedules and who live in tick borne encephalitis endemic regions.

Eligibility Criteria

Inclusion Criteria

Subjects who have completed prior study - V48P7E1.

Exclusion Criteria

Subjects whose antibody responses to booster vaccine received in the parent study fell below protective levels, subjects who have been exposed to TBE or flavivirus vaccine, subjects with immunosuppression.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01562444). 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.