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

Rotavirus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02153866
• Other study ID #: cnbg-001
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: May 26, 2014
• Last updated: June 2, 2014
• Start date: December 2013
• Est. completion date: August 2014

Study information

• Verified date: May 2014
• Source: Sichuan Center for Disease Control and Prevention
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 2800
• Est. completion date: August 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Months to 9 Months

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Rotavirus

Intervention

Biological:
• rotavirus vaccine
3ml/dose, oral
• measles-rubella vaccine
0.5ml per dose, subcutaneous injection
• measles-mumps-rubella vaccine
0.5ml per dose, subcutaneous injection

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Sichuan Center for Disease Control and Prevention	China National Biotec Group Company

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	the occurrence rate of severe adverse event of different vaccination groups	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)	1 month after vaccination	Yes
Secondary	The variation of antibody Geometric Mean Titer compared between before and after vaccination	this measure is used to assess the immunogenicity of different groups	1 month after vaccination	No