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Serological Evaluation of Varicella and Hepatitis A Vaccines Using Injector Delivery (InjHepAVar)

Primary Purpose

Varicella, Hepatitis A

Status
Unknown status
Phase
Phase 2
Locations
Brazil
Study Type
Interventional
Intervention
Varicella Vaccine
Hepatitis A Vaccine
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Varicella focused on measuring Varicella, Hepatitis A, Vaccine, Injector, Fractional dose, Intradermal, Children

Eligibility Criteria

13 Months - 30 Months (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children of both genders older than 13 months and younger than 30 months of age.
  • Available for follow-up for at least 45 days at public day care centers funded by São Paulo City local government.
  • Written informed consent signed by parents or legal guardians after reading and explanation

Exclusion Criteria:

  • Suspect/verified diagnosis of congenital or acquired immunodeficiency syndrome (AIDS)
  • Suspect/verified diagnosis of malign neoplasia
  • Children on treatment with high-dose systemic corticosteroids (equivalent to prednisone 2 mg/kg/day, for two or more weeks), or immunosuppressive therapy.
  • Received a vaccine with live attenuated strain of virus within less than 30 days
  • Suspect/verified diagnosis of chickenpox or has already been immunized against chickenpox (varicella).
  • Suspect/verified diagnosis of hypersensibility to any ingredient of the vaccine.
  • One of the parents or legal guardians of the minor does not agree with the study.
  • Any other circumstances that may potentially damage the minor or prevent procedures from being carried out according to evaluation of the research team.
  • Child shows signs or symptoms of an active intercurrent disease (e.g. fever, rash, etc.) that may interfere with the evaluation of adverse events after immunization at the research team's discretion. In this case, the participant may be reevaluated within the following three months in order to verify eligibility.

Sites / Locations

  • Disciplina de Immunologia Clínica e Alergia do HC- FMUSP

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Varicella (1/5 dose) - ID - Injector

Varicella (1/5 dose) - ID - Syringe

Varicella (2/5 dose) - ID - Injector

Varicella (2/5 dose) - ID - Syringe

Varicella (full dose) - SC - Injector

Varicella (full dose) - SC - Syringe

Hepatitis A (1/5 dose) ID - Injector

Hepatitis A (1/5 dose) ID - Syringe

Hepatitis A (full dose) IM - Injector

Hepatitis A (full dose) IM - Syringe

Arm Description

Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle-free Syringe Jet Injector

Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe

Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.25 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle-free Syringe Jet Injector

Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.25 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe

Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.5 ml Subcutaneous administration with Disposable Needle-free Syringe Jet Injector

Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.5 ml Subcutaneous administration with Disposable Needle Syringe

Hepatitis A virus vaccine, inactivated, Single dose, 0.1 ml Intradermal administration with Disposable Needle-free Syringe Jet Injector

Hepatitis A virus vaccine, inactivated, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe

Hepatitis A virus vaccine, inactivated, Single dose, 0.5 ml Intramuscular administration with Disposable Needle-free Syringe Jet Injector

Hepatitis A virus vaccine, inactivated, Single dose, 0.5 ml Intramuscular administration with Disposable Needle Syringe

Outcomes

Primary Outcome Measures

Immunogenicity: General seroconversion rate 45 days following immunization. Safety: General rate of local and systemic adverse events after immunization according to definition established by Brighton Collaboration Group

Secondary Outcome Measures

Degree and duration of local and systemic adverse events after immunization according to the Brighton Collaboration Group recommendations.
Seroconversion rates and number of local and systemic adverse events after immunization according to delivery system (needle-free injector or syringe with needle) for each dose tested
Actual volume administered intradermally according to the delivery system (needle-free injector or syringe with needle) for each fractional dose tested
Participants' parents or legal guardians acceptability according to the delivery system (needle-free injector or syringe with needle) for each dose tested
Distribution of vaccine jet evaluated through ultrasound for the needle-free injector group

Full Information

First Posted
June 19, 2009
Last Updated
June 22, 2009
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00926419
Brief Title
Serological Evaluation of Varicella and Hepatitis A Vaccines Using Injector Delivery
Acronym
InjHepAVar
Official Title
Serological Evaluation of Chickenpox (Varicella) and Hepatitis A Vaccines Using Disposable Needle-Free Syringe Jet Injector (DSJI) Delivery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2009
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
November 2009 (Anticipated)
Study Completion Date
May 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This study aims to assess immunogenicity and safety of nd influence of the delivery system (needle-free injector or syringe with needle) of fractional doses (dose sparing) of two vaccines (Varicella and Hepatitis A vaccines) in children aged 13 to 30 months.
Detailed Description
The purpose of this study is to evaluate the immunogenicity, safety and influence of the delivery system (needle-free injector or syringe with needle) of fractional doses (dose sparing) (23,3 and 43,3 PFU - plaque-forming units - of live attenuated OKA strain of Varicella-zoster virus and 100 radioimmunoassay units HAV) of chickenpox and Hepatitis A ( vaccines, intradermally administered, compared with full dose of 103,3 PFU, subcutaneously administered, in 600 primo (first) vaccinated children aged 13 to 30 months selected at random at day care centers in São Paulo. Vaccines will be tested sequentially (Varicella on day 0 and Hepatitis A on day 45). Only 400 children will be randomized again for Hepatitis A vaccine testing, the remaining 200 children will receive the regular dose of Hepatitis A vaccine without further assessment. Doses will be administered using two systems: Disposable Needle-free Syringe Jet Injector (DSJI), compared with the conventional procedure using syringes and needles. Serial blood samples will be blindly analyzed to detect antibody seroconversion. Local and systemic adverse events will be assessed according to definition established by Brighton Collaboration Group, 24 and 72 hours, 7 days, 14 days, 21 days and 45 days after each vaccination, through clinical evaluation and telephone calls.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicella, Hepatitis A
Keywords
Varicella, Hepatitis A, Vaccine, Injector, Fractional dose, Intradermal, Children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Varicella (1/5 dose) - ID - Injector
Arm Type
Experimental
Arm Description
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle-free Syringe Jet Injector
Arm Title
Varicella (1/5 dose) - ID - Syringe
Arm Type
Experimental
Arm Description
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
Arm Title
Varicella (2/5 dose) - ID - Injector
Arm Type
Experimental
Arm Description
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.25 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle-free Syringe Jet Injector
Arm Title
Varicella (2/5 dose) - ID - Syringe
Arm Type
Experimental
Arm Description
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.25 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
Arm Title
Varicella (full dose) - SC - Injector
Arm Type
Active Comparator
Arm Description
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.5 ml Subcutaneous administration with Disposable Needle-free Syringe Jet Injector
Arm Title
Varicella (full dose) - SC - Syringe
Arm Type
Active Comparator
Arm Description
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.5 ml Subcutaneous administration with Disposable Needle Syringe
Arm Title
Hepatitis A (1/5 dose) ID - Injector
Arm Type
Experimental
Arm Description
Hepatitis A virus vaccine, inactivated, Single dose, 0.1 ml Intradermal administration with Disposable Needle-free Syringe Jet Injector
Arm Title
Hepatitis A (1/5 dose) ID - Syringe
Arm Type
Experimental
Arm Description
Hepatitis A virus vaccine, inactivated, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
Arm Title
Hepatitis A (full dose) IM - Injector
Arm Type
Active Comparator
Arm Description
Hepatitis A virus vaccine, inactivated, Single dose, 0.5 ml Intramuscular administration with Disposable Needle-free Syringe Jet Injector
Arm Title
Hepatitis A (full dose) IM - Syringe
Arm Type
Active Comparator
Arm Description
Hepatitis A virus vaccine, inactivated, Single dose, 0.5 ml Intramuscular administration with Disposable Needle Syringe
Intervention Type
Biological
Intervention Name(s)
Varicella Vaccine
Other Intervention Name(s)
PharmaJet
Intervention Description
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Intervention Type
Biological
Intervention Name(s)
Hepatitis A Vaccine
Intervention Description
Hepatitis A virus vaccine, inactivated, Single dose
Primary Outcome Measure Information:
Title
Immunogenicity: General seroconversion rate 45 days following immunization. Safety: General rate of local and systemic adverse events after immunization according to definition established by Brighton Collaboration Group
Time Frame
45 days after immunization
Secondary Outcome Measure Information:
Title
Degree and duration of local and systemic adverse events after immunization according to the Brighton Collaboration Group recommendations.
Time Frame
45 days after immunization
Title
Seroconversion rates and number of local and systemic adverse events after immunization according to delivery system (needle-free injector or syringe with needle) for each dose tested
Time Frame
45 days after immunization
Title
Actual volume administered intradermally according to the delivery system (needle-free injector or syringe with needle) for each fractional dose tested
Time Frame
At immunization
Title
Participants' parents or legal guardians acceptability according to the delivery system (needle-free injector or syringe with needle) for each dose tested
Time Frame
45 days after immunization
Title
Distribution of vaccine jet evaluated through ultrasound for the needle-free injector group
Time Frame
5 minutes after immunization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
13 Months
Maximum Age & Unit of Time
30 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children of both genders older than 13 months and younger than 30 months of age. Available for follow-up for at least 45 days at public day care centers funded by São Paulo City local government. Written informed consent signed by parents or legal guardians after reading and explanation Exclusion Criteria: Suspect/verified diagnosis of congenital or acquired immunodeficiency syndrome (AIDS) Suspect/verified diagnosis of malign neoplasia Children on treatment with high-dose systemic corticosteroids (equivalent to prednisone 2 mg/kg/day, for two or more weeks), or immunosuppressive therapy. Received a vaccine with live attenuated strain of virus within less than 30 days Suspect/verified diagnosis of chickenpox or has already been immunized against chickenpox (varicella). Suspect/verified diagnosis of hypersensibility to any ingredient of the vaccine. One of the parents or legal guardians of the minor does not agree with the study. Any other circumstances that may potentially damage the minor or prevent procedures from being carried out according to evaluation of the research team. Child shows signs or symptoms of an active intercurrent disease (e.g. fever, rash, etc.) that may interfere with the evaluation of adverse events after immunization at the research team's discretion. In this case, the participant may be reevaluated within the following three months in order to verify eligibility.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glacus S Brito, MD
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Disciplina de Immunologia Clínica e Alergia do HC- FMUSP
City
São Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Glacus S Brito, MD
Phone
+55(11)30696225
Email
glacus@usp.br

12. IPD Sharing Statement

Learn more about this trial

Serological Evaluation of Varicella and Hepatitis A Vaccines Using Injector Delivery

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