Multicenter prospective cohort study of vaccine safety for infants with tuberous sclerosis during evelolimus treatment

Multicenter prospective cohort study of vaccine safety for infants with tuberous sclerosis during evelolimus treatment - VaSITE study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000047238

Enrollment

Registered

2022-05-01

Start date

2022-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

tuberous sclerosis

Interventions

live attenuated vaccine

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Tuberous sclerosis infants under two years of age who full filled either one of (1)(2)(3) and (4), and who will have everolimus and vaccine. (1) subependymal giant cell astrocytoma (2) cardiac rhabdomyoma (3) paroxysmal EEG abnormalities (4) written informed consent form the parents

Exclusion criteria

Exclusion criteria: (1) Interstitial shadows on the chest X-ray (2) infected patients (3) Liver dysfunction with 100 IU/L < of AST or ALT. (4) Patients who were judged inadequet for registration by a doctor -in-charge.

Design outcomes

Primary

Measure	Time frame
Rate of seroconversion for Rota virus, pertussis, measles, rubella, and varicella virus at two years of age	—

Secondary

Measure	Time frame
Adverse events	—

Countries

Japan

Contacts

Public ContactNoriko Obuchi

Saga University Faculty of Medicine, Department of Pediatrics

obuchin@cc.saga-u.ac.jp0952242314

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026