---
title: Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine
nct_id: NCT01738074
overall_status: UNKNOWN
phase: PHASE3
sponsor: Center for Disease Control and Prevention, Henan Province
study_type: INTERVENTIONAL
primary_condition: Randomized
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01738074.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01738074"
ct_last_update_post_date: 2012-11-30
last_seen_at: "2026-05-12T06:05:21.114Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Phase Three Clinical Trials of Trivalent Rotavirus Genetic Reassortment Vaccine

**NCT ID:** [NCT01738074](https://clinicaltrials.gov/study/NCT01738074)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 10020
- **Lead Sponsor:** Center for Disease Control and Prevention, Henan Province
- **Conditions:** Randomized, Double-blind, Placebo Control Design
- **Start Date:** 2012-08
- **Completion Date:** 2014-12
- **CT.gov Last Update:** 2012-11-30

## Brief Summary

Assessment and evaluation the rotavirus gastroenteritis prevention effect and severe rotavirus diarrhea reducing effectiveness of human body, which inoculate trivalent rotavirus genetic reassortment vaccine.

## Eligibility

- **Minimum age:** 6 Weeks
- **Maximum age:** 13 Weeks
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

* 6 to 13 weeks aged healthy baby;
* Guardian volunteer to participate in the study and sign informed consent;
* have use thermometer as required and the ability to fill in the diary table;
* Subjects guardian can abide by the requirements of clinical research scheme;
* The past has not been vaccinated rotavirus vaccine;
* Normal term eutocia, birth weight up to standard;
* Axillary temperature is 37.0 ℃ or less.

Exclusion Criteria:

* With allergy, convulsion, epilepsy, encephalopathy and spirit history or the family history;
* Be allergy to any ingredients in the vaccine;
* Known immunology function damage or low person;
* Immunosuppressant therapy Accepter;
* Suffering from congenital malformation and developmental disorder;
* Known or suspected also suffer from diseases including: digestive system disease, respiratory system disease, acute infection, mother or I have HIV infection, cardiovascular diseases, malignant tumor during treatment, skin disease;
* Inoculation other vaccine within 7 days.
```

## Arms

- **trivalent rotavirus genetic reassortment vaccine** (EXPERIMENTAL) — 2ml of rotavirus genetic reassortment vaccine by mouth every month for three month
- **Placebo** (PLACEBO_COMPARATOR) — 2ml of placebo by mouth every month for three month

## Interventions

- **trivalent rotavirus genetic reassortment vaccine** (BIOLOGICAL)
- **Placebo** (BIOLOGICAL)

## Primary Outcomes

- **Antibody titer differences in serum** _(time frame: 4 weeks after full vaccination)_
- **Incidence differences of rotavirus diarrhea** _(time frame: 2 years after full vaccination.)_

## Recent Field Changes (last 30 days)

- `design.enrollmentCount` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01738074.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01738074*  
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