# A Safety Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults, Children and Infants

> **NCT01391494** · PHASE1 · COMPLETED · sponsor: **Institute of Medical Biology, Chinese Academy of Medical Sciences** · enrollment: 288 (actual)

## Conditions studied

- Hand, Foot and Mouth Disease

## Interventions

- **BIOLOGICAL:** 160Eu/0.5ml in adults
- **BIOLOGICAL:** 320Eu/0.5ml in adults
- **BIOLOGICAL:** 640Eu/0.5ml in adults
- **BIOLOGICAL:** 1280Eu/0.5ml (without adjuvant) in 12 adults
- **BIOLOGICAL:** 0Eu/0.5ml in adults
- **BIOLOGICAL:** 160Eu/0.5ml in children
- **BIOLOGICAL:** 320Eu/0.5ml in children
- **BIOLOGICAL:** 640Eu/0.5ml in children
- **BIOLOGICAL:** 1280Eu/0.5ml (without adjuvant) in children
- **BIOLOGICAL:** 0Eu/0.5ml in children
- **BIOLOGICAL:** 160Eu/0.5ml in infants
- **BIOLOGICAL:** 320Eu/0.5ml in infants
- **BIOLOGICAL:** 640Eu/0.5ml in infants
- **BIOLOGICAL:** 1280Eu/0.5ml (without adjuvant) in infants
- **BIOLOGICAL:** 0Eu/0.5ml in infants

## Key facts

- **NCT ID:** NCT01391494
- **Lead sponsor:** Institute of Medical Biology, Chinese Academy of Medical Sciences
- **Sponsor class:** OTHER
- **Phase:** PHASE1
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-02
- **Primary completion:** 2011-06
- **Final completion:** 2011-06
- **Target enrollment:** 288 (ACTUAL)
- **Last updated:** 2023-10-11

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01391494

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01391494, "A Safety Study of Inactivated EV71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Adults, Children and Infants". Retrieved via AI Analytics 2026-06-25 from https://api.ai-analytics.org/clinical/NCT01391494. Licensed CC0.

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