Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine

Varicella Clinical Trial

Official title:

Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02146469
• Other study ID #: SH2012VAR
• Status: Enrolling by invitation
• Phase: Phase 4
• First received: May 21, 2014
• Last updated: May 21, 2014
• Start date: December 2012
• Est. completion date: December 2014

Study information

• Verified date: May 2014
• Source: Shanghai Municipal 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

The objective of the study is as follows:

1. To know the antibody level during different interval after received 1 dose varicella vaccine.

2. To know safety and effectiveness of received 2 doses varicella vaccine with different interval.

3. To know safety and effectiveness of received varicella vaccine and MMR at the same time.

To achieve that, this study selects children with specific varicella vaccine history, gives 1 or 2 doses varicella vaccine, collects blood specimens and makes a follow-up visit after vaccination.

All blood specimens will be tested by a third-party detection institution.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 1200
• Est. completion date: December 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 1 Year to 7 Years

Eligibility

Inclusion Criteria:

• Aged 1 to 7

• Without a previous history of varicella

• With an axillary temperature =37.5? at the time of vaccination

• Appropriate varicella vaccination history

• With guardian signing the informed consent and available for clinical observation

Exclusion Criteria:

• Hypersensitive to any active substance of the vaccine including excipients and antibiotics

• With acute illness, severe or acute attack of chronic illness or fever

• With immunodeficiency or weakened immune system or being treated with immunosuppressant drugs

• Suffering a brain disease, uncontrolled epilepsy or progressive nerve system disease

• With a family or personal history of seizure, chronic illness, epilepsy or allergy

• With unknown immunization history or unable to follow the immunization schedule of EPI

• Received any vaccine within 4 weeks or willing to receive any vaccine in 1 month

• With hemorrhagic tendency or prolonged period of bleeding

• Received whole blood, plasma or immunoglobulin within 5 months

• Received systemic antibiotics or antiviral treatment for acute illness within 7 days

• With an axillary temperature =38? within 3 days

• Participating in another clinical trial

• Any situation that might influence the consequence of the clinical trial

Study Design

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

Related Conditions & MeSH terms

• Chickenpox
• Herpes Zoster
• Varicella

Intervention

Biological:
• 2 doses with an 3 months interval
varicella vaccination
• A second dose with an 1 year interval
varicella vaccine
• A second dose with an 3 year interval
varicella vaccine
• A second dose with an 5 year interval
varicella vaccine
• 1 dose Varicella vaccine and 1 dose MMR given at the same time
varicella vaccine and MMR
• 1 dose MMR
MMR

Locations

Country	Name	City	State
China	Shanghai municipal center for disease control and prevention	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Shanghai Municipal Center for Disease Control and Prevention	Shanghai Institute Of Biological Products

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rate and GMCs after varicella vaccination		35-42 days after each dose vaccination	No
Secondary	The incidence of Adverse Events Following Immunization		30 days after each dose vaccination	Yes