# A Phase II, Safety and Efficacy Study of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants

> **NCT01512706** · PHASE2 · COMPLETED · sponsor: **Institute of Medical Biology, Chinese Academy of Medical Sciences** · enrollment: 660 (actual)

## Conditions studied

- The Study Focused on the Safety of Inactivated EV71 Vaccine (Human Diploid Cell) Against Hand, Foot and Mouth Disease in Chinese Children and Infants

## Interventions

- **BIOLOGICAL:** 160Eu/0.5ml in infants (6-11 months old)
- **BIOLOGICAL:** 320Eu/0.5ml in infants (6-11 months old)
- **BIOLOGICAL:** 640Eu/0.5ml in infants (6-11 months old)
- **BIOLOGICAL:** 1280Eu/0.5ml (without adjuvant) in infants (6-11 months old)
- **BIOLOGICAL:** 0Eu/0.5ml in infants (6-11 months old)
- **BIOLOGICAL:** 160Eu/0.5ml in infants (12-23 months old)
- **BIOLOGICAL:** 320Eu/0.5ml in infants (12-23 months old)
- **BIOLOGICAL:** 640Eu/0.5ml in infants (12-23 months old)
- **BIOLOGICAL:** 1280Eu/0.5ml (without adjuvant) in infants (12-23 months old)
- **BIOLOGICAL:** 0Eu/0.5ml in infants (12-23 months old)
- **BIOLOGICAL:** 160Eu/0.5ml in children (24 months-5 years old)
- **BIOLOGICAL:** 320Eu/0.5ml in children (24 months-5 years old)
- **BIOLOGICAL:** 640Eu/0.5ml in children (24 months-5 years old)
- **BIOLOGICAL:** 1280Eu/0.5ml (without adjuvant) in children (24 months-5 years old)
- **BIOLOGICAL:** 0Eu/0.5ml in children (24 months-5 years old)

## Key facts

- **NCT ID:** NCT01512706
- **Lead sponsor:** Institute of Medical Biology, Chinese Academy of Medical Sciences
- **Sponsor class:** OTHER
- **Phase:** PHASE2
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2011-07
- **Primary completion:** 2012-01
- **Final completion:** 2012-02
- **Target enrollment:** 660 (ACTUAL)
- **Last updated:** 2023-10-11

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01512706

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01512706, "A Phase II, Safety and Efficacy Study of Inactivated EV 71 Vaccine (Human Diploid Cell, KMB-17) in Chinese Infants". Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/clinical/NCT01512706. Licensed CC0.

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