Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Safety and Immunogenicity Study of Rotavirus Vaccine Simultaneously Vaccinated With MR or MMR Vaccine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02153866
Recruitment Status : Unknown
Verified May 2014 by Sichuan Center for Disease Control and Prevention.
Recruitment status was:  Enrolling by invitation
First Posted : June 3, 2014
Last Update Posted : June 3, 2014
Sponsor:
Collaborator:
China National Biotec Group Company Limited
Information provided by (Responsible Party):
Sichuan Center for Disease Control and Prevention

Tracking Information
First Submitted Date  ICMJE May 26, 2014
First Posted Date  ICMJE June 3, 2014
Last Update Posted Date June 3, 2014
Study Start Date  ICMJE December 2013
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
the occurrence rate of general reaction of different vaccination groups [ Time Frame: 1 months after vaccination ]
general reaction includes fever (axillary temperature> 3.85℃), local injection-site reaction (diameter> 2.5 cm) etc.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: June 2, 2014)
  • the occurrence rate of severe adverse event of different vaccination groups [ Time Frame: 1 month after vaccination ]
    severe reaction include: anaphylaxis, angioedema, purpura, an Arthus reaction, febrile convulsion, seizure, polyneuritis, other adverse events cause fatal, result in disability or clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine)
  • The variation of antibody Geometric Mean Titer compared between before and after vaccination [ Time Frame: 1 month after vaccination ]
    this measure is used to assess the immunogenicity of different groups
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Safety and Immunogenicity Study of Rotavirus Vaccine Simultaneously Vaccinated With MR or MMR Vaccine
Official Title  ICMJE The Safety and Immunogenicity Study of Rotavirus Vaccine Simultaneously Vaccinated With MR or MMR Vaccine
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.

Detailed Description
  1. Quality control plan:

    1. All vaccinators should get professional training held by local Health Bureau, and be qualified by local Health Bureau.
    2. All the clinical trial related staffs are trained by provincial or prefectural Center for Disease Control and prevention (CDC) at the beginning.
    3. Provincial and prefectural CDCs conduct supervision at each step, especially during field vaccination and Adverse Events Following Immunization (AEFI) investigation.
    4. Data valid check is designed to work in the database inputting, double entry and validation is also required.
    5. The field works are conduct under SOP (Standard Operating Procedures), The SOP for vaccination procedures which include vaccinee recruitment and vaccination practice etc. is 'Immunization Work Specification' issued by China Ministry of Health in 2005. The SOP for AEFI surveillance is 'AEFI surveillance guideline' issued by China Ministry of Health in 2010.
  2. Statistical plan

    1. Safety evaluation The analytic data include all reactions or events within 30 days after vaccination, compare the incidence of reactions among different vaccines, the statistical method is chi-square.
    2. Immunogenicity evaluation Compare the antibody positive rate and Geometric Mean Concentration between pre-vaccination and post-vaccination, and among different vaccine combinations.
  3. safety evaluation method

    At the time of vaccination, vaccinees were instructed to report any adverse event to physicians or vaccination providers. Adverse events that were fatal or that resulted in disability and clusters of events (i.e., notably high numbers of similar adverse events related to a certain vaccine) were required to be reported within 2 hours after their occurrence. The following adverse events were required to be reported within 2 days after their occurrence: anaphylaxis or other allergic reactions occurring within 24 hours after vaccination; fever (axillary temperature, >38.5°C), angioedema, or a local injection-site reaction (diameter, >2.5 cm) occurring within 5 days after vaccination; purpura, an Arthus reaction, febrile convulsion, seizure, or polyneuritis occurring within 15 days after vaccination. Other reactions that were common and minor (e.g., mild pain and fatigue) were not required to be reported.

  4. Immunogenicity evaluation

Enzyme-linked immunosorbent assay (abbreviated as ELSIA) is used to quantitatively test immunoglobulin G (IgG) of measles, rubella, mumps, test kit is provided by Virion\Serion company. Rotavirus Immunoglobulin A (RV-IgA) is used to test the antibody of rotavirus.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Rotavirus
Intervention  ICMJE
  • Biological: rotavirus vaccine
    3ml/dose, oral
  • Biological: measles-rubella vaccine
    0.5ml per dose, subcutaneous injection
    Other Name: measles-rubella live attenuated vaccine
  • Biological: measles-mumps-rubella vaccine
    0.5ml per dose, subcutaneous injection
    Other Name: measles-mumps-rubella live attenuated vaccine
Study Arms  ICMJE
  • Placebo Comparator: rotavirus
    vaccinate one dose rotavirus vaccine for each of 700 participants aged 8~9months
    Intervention: Biological: rotavirus vaccine
  • Placebo Comparator: measles-rubella
    vaccinate one dose measles-rubella vaccine for each of 350 participants aged 8~9 months.
    Intervention: Biological: measles-rubella vaccine
  • Placebo Comparator: measles-mumps-rubella
    vaccinate one dose measles-mumps-rubella vaccine for each of 350 participants aged 8~9 months.
    Intervention: Biological: measles-mumps-rubella vaccine
  • Experimental: rotavirus, measles-rubella
    simultaneously vaccinate one dose rotavirus vaccine and one dose measles-rubella vaccine for each of 700 participants aged 8~9 months.
    Interventions:
    • Biological: rotavirus vaccine
    • Biological: measles-rubella vaccine
  • Experimental: rotavirus, measles-mumps-rubella
    simultaneously vaccinate one dose rotavirus vaccine and one dose measles-mumps-rubella vaccine for each of 700 participants aged 8~9 months.
    Interventions:
    • Biological: rotavirus vaccine
    • Biological: measles-mumps-rubella vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 2, 2014)
2800
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2014
Actual Primary Completion Date May 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 8 Months to 9 Months   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02153866
Other Study ID Numbers  ICMJE cnbg-001
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sichuan Center for Disease Control and Prevention
Study Sponsor  ICMJE Sichuan Center for Disease Control and Prevention
Collaborators  ICMJE China National Biotec Group Company Limited
Investigators  ICMJE
Study Director: rui ao, Master Sichuan provincial center for disease control and prevention
PRS Account Sichuan Center for Disease Control and Prevention
Verification Date May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP