Phase 4
N=179
Tick-Borne Encephalitis (TBE) Seropersistence After First Booster and Response to a Second Booster in Children, Adolescents and Young Adults (Follow-Up to Study 700401)
Encephalitis, Tick-Borne
Bottom Line
View on ClinicalTrials.gov: NCT00894686 ↗Enrolled (actual)
179
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcome: Primary: Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 — 100.0 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- FSME-IMMUN 0.25 mL Junior (1.2 µg TBE antigen/0.25 mL) or FSME-IMMUN 0.5 mL (2.4µg TBE antigen/0.5 mL) (Biological)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Pfizer
- Primary completion
- May 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 |
100.0 | — |
| PRIMARY Seropositivity Rate Measured by Neutralization Test (NT) at 38 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 |
100.0 | — |
| PRIMARY Seropositivity Rate Measured by Neutralization Test (NT) at 46 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 |
100.0 | — |
| PRIMARY Seropositivity Rate Measured by Neutralization Test (NT) at 58 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 |
99.4 | — |
| PRIMARY Seropositivity Rate Measured by Neutralization Test (NT) at 70 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 |
98.1 | — |
| PRIMARY Seropositivity Rate Measured by Neutralization Test (NT) at 82 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 |
96.8 | — |
| PRIMARY Seropositivity Rate Measured by Neutralization Test (NT) at 94 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 |
95.5 | — |
| PRIMARY Seropositivity Rate Measured by Neutralization Test (NT) at 106 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 |
94.9 | — |
| PRIMARY Seropositivity Rate Measured by Neutralization Test (NT) at 118 Months After the First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 |
90.3 | — |
| PRIMARY Seropositivity Rate Measured by Neutralization Test (NT) at 21-35 Days After the Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 |
100.0 | — |
| SECONDARY Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at Each Available Time Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 |
98.8; 97.0; 100.0; 97.5; 96.8; 96.2 | — |
| SECONDARY Seropositivity Rate Measured by Enzyme-Linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 |
100.0 | — |
| SECONDARY Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at Each Available Time-Point After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 |
4368.2; 1081.5; 1212.1; 1005.1; 883.4; 728.6 | — |
| SECONDARY Geometric Mean Concentration Measured by Enzyme-linked Immunosorbent Assay (ELISA) at 21-35 Days After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 |
1844.1 | — |
| SECONDARY Geometric Mean Titer Measured by Neutralization Test (NT) Each Available Time-Point Blood Draw After First Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700401 |
380.7; 162.1; 108.1; 111.3; 123.4; 122.3 | — |
| SECONDARY Geometric Mean Titer Measured by Neutralization Test (NT) After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 |
126.8 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) in Antibody Concentrations After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Enzyme-Linked Immunosorbent Assay (ELISA) |
8.6 | — |
| SECONDARY Geometric Mean Fold Rise (GMFR) in Antibody Titer After Second Tick-borne Encephalitis (TBE) Booster Vaccination as Compared to Before the Booster Vaccination as Measured by Neutralization Test (NT) |
5.2 | — |
| SECONDARY Number of Participants With Injection Site Reactions and Systemic Reactions After Second Tick-borne Encephalitis (TBE) Booster Vaccination in Study 700802 |
1; 0 | — |
Summary
The main purpose of this study is to assess the seropersistence of TBE virus antibodies in children, adolescents and young adults who received the first booster vaccination with either FSME-IMMUN 0.25 mL Junior or FSME-IMMUN 0.5 mL in precursor Study 700401.
Eligibility Criteria
Inclusion Criteria
Subjects who participated in precursor Study 700401 and meet ALL of the following criteria are eligible for participation in this study:
- Subject / parent(s) / legal guardian(s) provide(s) written informed consent (according to national law);
- Subject provides written assent to the study according to age and capacity of understanding;
- Subject received the first booster vaccination with either FSME-IMMUN 0.25 ml Junior or FSME-IMMUN 0.5 ml during the course of precursor Study 700401;
- Blood was drawn after the first booster vaccination in precursor Study 700401;
- Subject / parent(s) / legal guardian(s) understand(s) the nature of the study and is / are willing to comply with the requirements of the protocol (e.g. return for follow-up visits, completion of the Subject Diary).
Exclusion Criteria
Subjects who participated in precursor Study 700401 and meet ANY of the following criteria are not eligible for participation in this study:
- Subject received any TBE vaccination since his / her first booster vaccination in precursor Study 700401;
- Subject has a history of infection with or vaccination against other flaviviruses (e.g. Dengue fever, yellow fever, Japanese B encephalitis) since his / her first booster vaccination in precursor Study 700401;
- Subject is known to be HIV positive since his / her first booster vaccination in precursor Study 700401 (a special HIV test is not required for the purpose of the study);
- Subject received a blood product or immunoglobulins within 90 days before any blood draw or in the period between the blood draw and the booster vaccination (as applicable);
- Subject has a known or suspected problem with drug or alcohol abuse (> 4 liters of wine/week or equivalent level of other alcoholic beverages);
- Subject / parent(s) / legal guardian(s) is / are in a dependent relationship with the study investigator or with a study team member. Dependent relationship includes close relatives (i.e., children or grandchildren, partner / spouse, siblings) as well as employees of the investigator or the site conducting the study.
Data sourced from ClinicalTrials.gov (NCT00894686). 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.