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Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine

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ClinicalTrials.gov Identifier: NCT02146469
Recruitment Status : Unknown
Verified May 2014 by Shanghai Municipal Center for Disease Control and Prevention.
Recruitment status was:  Enrolling by invitation
First Posted : May 23, 2014
Last Update Posted : May 23, 2014
Sponsor:
Collaborator:
Shanghai Institute Of Biological Products
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Varicella 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: A second dose with an 5 year interval Biological: 1 dose Varicella vaccine and 1 dose MMR given at the same time Biological: 1 dose MMR Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Study on Effectiveness of 2-dose Live Attenuated Varicella Vaccine
Study Start Date : December 2012
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Chickenpox Shingles

Arm Intervention/treatment
Experimental: None varicella vaccine history
2 doses with an 3 months interval
Biological: 2 doses with an 3 months interval
varicella vaccination

Experimental: 1 year after first dose
A second dose with an 1 year interval
Biological: A second dose with an 1 year interval
varicella vaccine

Experimental: 3 years after first dose
A second dose with an 3 year interval
Biological: A second dose with an 3 year interval
varicella vaccine

Experimental: 5 years after first dose
A second dose with an 5 year interval
Biological: A second dose with an 5 year interval
varicella vaccine

Experimental: Testing group for conbined immunization
1 dose Varicella vaccine and 1 dose MMR given at the same time
Biological: 1 dose Varicella vaccine and 1 dose MMR given at the same time
varicella vaccine and MMR

Placebo Comparator: Control group for conbined immunization
1 dose MMR
Biological: 1 dose MMR
MMR




Primary Outcome Measures :
  1. Seroconversion rate and GMCs after varicella vaccination [ Time Frame: 35-42 days after each dose vaccination ]

Secondary Outcome Measures :
  1. The incidence of Adverse Events Following Immunization [ Time Frame: 30 days after each dose vaccination ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

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): NCT02146469


Locations
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China, Shanghai
Shanghai municipal center for disease control and prevention
Shanghai, Shanghai, China, 021
Sponsors and Collaborators
Shanghai Municipal Center for Disease Control and Prevention
Shanghai Institute Of Biological Products
Investigators
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Study Director: Xiaodong Sun Shanghai Municipal Center for Disease Control and Prevention

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Responsible Party: Shanghai Municipal Center for Disease Control and Prevention
ClinicalTrials.gov Identifier: NCT02146469     History of Changes
Other Study ID Numbers: SH2012VAR
First Posted: May 23, 2014    Key Record Dates
Last Update Posted: May 23, 2014
Last Verified: May 2014
Keywords provided by Shanghai Municipal Center for Disease Control and Prevention:
varicella vaccination
Additional relevant MeSH terms:
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Chickenpox
Herpes Zoster
Varicella Zoster Virus Infection
Herpesviridae Infections
DNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs