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

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.


Condition or disease Intervention/treatment Phase
Rotavirus Biological: rotavirus vaccine Biological: measles-rubella vaccine Biological: measles-mumps-rubella vaccine Phase 4

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2800 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Safety and Immunogenicity Study of Rotavirus Vaccine Simultaneously Vaccinated With MR or MMR Vaccine
Study Start Date : December 2013
Actual Primary Completion Date : May 2014
Estimated Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Measles Mumps Rubella

Arm Intervention/treatment
Placebo Comparator: rotavirus
vaccinate one dose rotavirus vaccine for each of 700 participants aged 8~9months
Biological: rotavirus vaccine
3ml/dose, oral

Placebo Comparator: measles-rubella
vaccinate one dose measles-rubella vaccine for each of 350 participants aged 8~9 months.
Biological: measles-rubella vaccine
0.5ml per dose, subcutaneous injection
Other Name: measles-rubella live attenuated vaccine

Placebo Comparator: measles-mumps-rubella
vaccinate one dose measles-mumps-rubella vaccine for each of 350 participants aged 8~9 months.
Biological: measles-mumps-rubella vaccine
0.5ml per dose, subcutaneous injection
Other Name: measles-mumps-rubella live attenuated 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.
Biological: rotavirus vaccine
3ml/dose, oral

Biological: measles-rubella vaccine
0.5ml per dose, subcutaneous injection
Other Name: measles-rubella live attenuated 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.
Biological: rotavirus vaccine
3ml/dose, oral

Biological: measles-mumps-rubella vaccine
0.5ml per dose, subcutaneous injection
Other Name: measles-mumps-rubella live attenuated vaccine




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   8 Months to 9 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02153866


Sponsors and Collaborators
Sichuan Center for Disease Control and Prevention
China National Biotec Group Company Limited
Investigators
Layout table for investigator information
Study Director: rui ao, Master Sichuan provincial center for disease control and prevention

Layout table for additonal information
Responsible Party: Sichuan Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02153866     History of Changes
Other Study ID Numbers: cnbg-001
First Posted: June 3, 2014    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: May 2014
Keywords provided by Sichuan Center for Disease Control and Prevention:
rotavirus vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
Vaccines
Immunologic Factors
Physiological Effects of Drugs