NCT02153866

Brief Summary

Nowadays these are some vaccines being vaccinated simultaneously, and a doubt is aroused if the safety and immunogenicity are same between inoculating several vaccines simultaneously and inoculating individually. So we carry out this study. The purpose of this study is to evaluate the difference of safety and immunogenicity on vaccinating rotavirus vaccine simultaneously with measles-rubella vaccine(MR) or measles-mumps-rubella vaccine(MMR) compared to vaccinating rotavirus vaccine, MR or MMR individually.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
2,800

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_4

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2014

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 3, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2014

Completed
Last Updated

June 3, 2014

Status Verified

May 1, 2014

Enrollment Period

5 months

First QC Date

May 26, 2014

Last Update Submit

June 2, 2014

Conditions

Rotavirus

Keywords

rotavirus vaccine

Outcome Measures

Primary Outcomes (1)

  • the occurrence rate of general reaction of different vaccination groups

    general reaction includes fever (axillary temperature\> 3.85℃), local injection-site reaction (diameter\> 2.5 cm) etc.

    1 months after vaccination

Secondary Outcomes (2)

  • the occurrence rate of severe adverse event of different vaccination groups

    1 month after vaccination

  • The variation of antibody Geometric Mean Titer compared between before and after vaccination

    1 month after vaccination

Study Arms (5)

rotavirus

PLACEBO COMPARATOR

vaccinate one dose rotavirus vaccine for each of 700 participants aged 8\~9months

Biological: rotavirus vaccine

measles-rubella

PLACEBO COMPARATOR

vaccinate one dose measles-rubella vaccine for each of 350 participants aged 8\~9 months.

Biological: measles-rubella vaccine

measles-mumps-rubella

PLACEBO COMPARATOR

vaccinate one dose measles-mumps-rubella vaccine for each of 350 participants aged 8\~9 months.

Biological: measles-mumps-rubella vaccine

rotavirus, measles-rubella

EXPERIMENTAL

simultaneously vaccinate one dose rotavirus vaccine and one dose measles-rubella vaccine for each of 700 participants aged 8\~9 months.

Biological: rotavirus vaccineBiological: measles-rubella vaccine

rotavirus, measles-mumps-rubella

EXPERIMENTAL

simultaneously vaccinate one dose rotavirus vaccine and one dose measles-mumps-rubella vaccine for each of 700 participants aged 8\~9 months.

Biological: rotavirus vaccineBiological: measles-mumps-rubella vaccine

Interventions

rotavirus vaccineBIOLOGICAL

3ml/dose, oral

rotavirusrotavirus, measles-mumps-rubellarotavirus, measles-rubella
measles-rubella vaccineBIOLOGICAL

0.5ml per dose, subcutaneous injection

Also known as: measles-rubella live attenuated vaccine
measles-rubellarotavirus, measles-rubella
measles-mumps-rubella vaccineBIOLOGICAL

0.5ml per dose, subcutaneous injection

Also known as: measles-mumps-rubella live attenuated vaccine
measles-mumps-rubellarotavirus, measles-mumps-rubella

Eligibility Criteria

Age8 Months - 9 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Aged 8\~9 months healthy child
  • Subjects or guardians who can and will comply with the requirements of the protocol
  • Without vaccination history of rotavirus vaccine, measles-rubella vaccine and measles-mumps-rubella vaccine.
  • Axillary temperature is under 37.0℃.
  • Accord with the requirement of drug manual of rotavirus vaccine,measles-rubella vaccine and measles-mumps-rubella vaccine.

You may not qualify if:

  • Allergic to any component of the vaccines.
  • Women of pregnancy, lactation or about to be pregnant in 60 days.
  • Infected by some rash disease within one month.
  • Known severe immunodeficiency (e.g., from hematologic and solid tumors, receipt of chemotherapy, congenital immunodeficiency, or long-term immunosuppressive therapy or patients with HIV infection who are severely immunocompromised).
  • Any prior administration of immunoglobulins, any other vaccines or experimental drugs in the last 4 weeks.
  • Family history of seizures or progressive neurological disease.
  • Diarrheal caused by rotavirus or lasting for 3 or more days.
  • Any condition that in the opinion of the investigator, may interfere with the evaluation of study objectives.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Rotavirus VaccinesMeasles-Mumps-Rubella Vaccine

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesVaccines, CombinedMeasles VaccineMumps VaccineRubella Vaccine

Study Officials

  • rui ao, Master

    Sichuan Provincial Center for Disease Control and Prevention

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2014

First Posted

June 3, 2014

Study Start

December 1, 2013

Primary Completion

May 1, 2014

Study Completion

August 1, 2014

Last Updated

June 3, 2014

Record last verified: 2014-05