Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine

Phase 4

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

• Registration Number: NCT02146469
• Lead Sponsor: Shanghai Municipal Center for Disease Control and Prevention

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12
• Status Verified: 2014-05
• Study First Submitted: 2014-05-21
• Study First Submitted QC: 2014-05-21
• Last Update Submitted: 2014-05-21
• Study First Posted: 2014-05-23
• Last Update Posted: 2014-05-23
• Primary Completion: 2014-06
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1200

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
5 years after first dose	A second dose with an 5 year interval	A second dose with an 5 year interval
Control group for conbined immunization	1 dose MMR	1 dose MMR
None varicella vaccine history	2 doses with an 3 months interval	2 doses with an 3 months interval
1 year after first dose	A second dose with an 1 year interval	A second dose with an 1 year interval
3 years after first dose	A second dose with an 3 year interval	A second dose with an 3 year interval
Testing group for conbined immunization	1 dose Varicella vaccine and 1 dose MMR given at the same time	1 dose Varicella vaccine and 1 dose MMR given at the same time

Primary Outcome Measures

Name	Time	Method
Seroconversion rate and GMCs after varicella vaccination	35-42 days after each dose vaccination

Secondary Outcome Measures

Name	Time	Method
The incidence of Adverse Events Following Immunization	30 days after each dose vaccination

Trial Locations

Locations (1)

Shanghai municipal center for disease control and prevention; 🇨🇳 Shanghai, Shanghai, China