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

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ClinicalTrials.gov Identifier: NCT00926419
Recruitment Status : Unknown
Verified May 2009 by University of Sao Paulo General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : June 23, 2009
Last Update Posted : June 23, 2009
Sponsor:
Information provided by:
University of Sao Paulo General Hospital

June 19, 2009
June 23, 2009
June 23, 2009
June 2009
November 2009   (Final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
  • Degree and duration of local and systemic adverse events after immunization according to the Brighton Collaboration Group recommendations. [ Time Frame: 45 days after immunization ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Distribution of vaccine jet evaluated through ultrasound for the needle-free injector group [ Time Frame: 5 minutes after immunization ]
Same as current
Not Provided
Not Provided
 
Serological Evaluation of Varicella and Hepatitis A Vaccines Using Injector Delivery
Serological Evaluation of Chickenpox (Varicella) and Hepatitis A Vaccines Using Disposable Needle-Free Syringe Jet Injector (DSJI) Delivery
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.
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.
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
  • Varicella
  • Hepatitis A
  • Biological: Varicella Vaccine
    Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
    Other Name: PharmaJet
  • Biological: Hepatitis A Vaccine
    Hepatitis A virus vaccine, inactivated, Single dose
  • Experimental: Varicella (1/5 dose) - ID - Injector
    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
    Intervention: Biological: Varicella Vaccine
  • Experimental: Varicella (1/5 dose) - ID - Syringe
    Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
    Intervention: Biological: Varicella Vaccine
  • Experimental: Varicella (2/5 dose) - ID - Injector
    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
    Intervention: Biological: Varicella Vaccine
  • Experimental: Varicella (2/5 dose) - ID - Syringe
    Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.25 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
    Intervention: Biological: Varicella Vaccine
  • Active Comparator: Varicella (full dose) - SC - Injector
    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
    Intervention: Biological: Varicella Vaccine
  • Active Comparator: Varicella (full dose) - SC - Syringe
    Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.5 ml Subcutaneous administration with Disposable Needle Syringe
    Intervention: Biological: Varicella Vaccine
  • Experimental: Hepatitis A (1/5 dose) ID - Injector
    Hepatitis A virus vaccine, inactivated, Single dose, 0.1 ml Intradermal administration with Disposable Needle-free Syringe Jet Injector
    Intervention: Biological: Hepatitis A Vaccine
  • Experimental: Hepatitis A (1/5 dose) ID - Syringe
    Hepatitis A virus vaccine, inactivated, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
    Intervention: Biological: Hepatitis A Vaccine
  • Active Comparator: Hepatitis A (full dose) IM - Injector
    Hepatitis A virus vaccine, inactivated, Single dose, 0.5 ml Intramuscular administration with Disposable Needle-free Syringe Jet Injector
    Intervention: Biological: Hepatitis A Vaccine
  • Active Comparator: Hepatitis A (full dose) IM - Syringe
    Hepatitis A virus vaccine, inactivated, Single dose, 0.5 ml Intramuscular administration with Disposable Needle Syringe
    Intervention: Biological: Hepatitis A Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
600
Same as current
May 2010
November 2009   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
13 Months to 30 Months   (Child)
Yes
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT00926419
CAPPesq 0911/08
No
Not Provided
Not Provided
Glacus de Souza Brito, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
University of Sao Paulo General Hospital
Not Provided
Principal Investigator: Glacus S Brito, MD University of Sao Paulo
University of Sao Paulo General Hospital
May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP