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Immunogenicity and safety of an inactivated enterovirus 71 vaccine (EV71) in immunocompromised pediatric patients

Immunogenicity and safety of an inactivated enterovirus 71 vaccine (EV71) in immunocompromised pediatric patients

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
TCTR
Registry ID
TCTR20250218016
Enrollment
76
Registered
2025-02-18
Start date
2025-02-12
Completion date
Unknown
Last updated
2026-03-30

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

Conditions

Immunocompromised children age 6-71 months and immunogenicity to inactivated enterovirus 71 vaccine Immunocompromised hosts, immunocompromised patients, oncology, rheumatology, inactivated vaccine

Interventions

Inactivated enterovirus type 71 (human diploid cell) vaccine 0.5 ml Intramuscular route doses at day 0,28 The vaccine was prepared from the C4 subgenogroup of EV-A71 C4a Fy23 strain, cultured in a hum
Immunocompromised hosts,Healthy

Sponsors

Faculty of medicine Ramathibodi hospital, Mahidol university
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Months to 71 Months

Inclusion criteria

Inclusion criteria: 1. Participants aged 6-71 months 2. Being an immunocompromised host, such as patients with cancer who are undergoing chemotherapy, patients with rheumatological disease and receiving immunomodulating or immunosuppressive treatment (51 cases) or healthy (25 cases) 3. Being followed at Ramathibodi Hospital, Chakri Naruebodindra Medical Institute, and Phramongkutklao Hospital 4. No history of receiving the inactivated EV71 vaccine 5. Provide informed consent 6. Parents or LARs understand the Thai language

Exclusion criteria

Exclusion criteria: 1. Having a history of severe allergic reaction to vaccine or vaccine component 2. Having a fever > 38.3 C on a day of immunization 3. Receiving induction chemotherapy 4. Recipient of stem cell transplant within 6 months 5. Recipient of solid organ transplant within 6 months

Design outcomes

Primary

MeasureTime frame
seropositivity rate prior and at 1 month after 2nd dose of vaccine anti-EV71 neutralizing antibody level

Secondary

MeasureTime frame
seroprotective rate prior and at 1 month after 2nd dose of vaccine anti-EV71 neutralizing antibody level

Countries

Thailand

Contacts

Public ContactPornnatcha Asawakanjanakij

Department of Pediatrics,Faculty of Medicine Ramathibodi Hospital

pornnatcha.tea@gmail.com6622011774

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Apr 4, 2026