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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by University of Sao Paulo General Hospital.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:
NCT00926419
First received: June 19, 2009
Last updated: June 22, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Varicella
Hepatitis A
Biological: Varicella Vaccine
Biological: Hepatitis A Vaccine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Serological Evaluation of Chickenpox (Varicella) and Hepatitis A Vaccines Using Disposable Needle-Free Syringe Jet Injector (DSJI) Delivery

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo General Hospital:

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 [ Time Frame: 45 days after immunization ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Degree and duration of local and systemic adverse events after immunization according to the Brighton Collaboration Group recommendations. [ Time Frame: 45 days after immunization ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Distribution of vaccine jet evaluated through ultrasound for the needle-free injector group [ Time Frame: 5 minutes after immunization ] [ Designated as safety issue: No ]

Estimated Enrollment: 600
Study Start Date: June 2009
Estimated Study Completion Date: May 2010
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Biological: Varicella Vaccine
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Other Names:
  • Varicella vaccine
  • PharmaJet
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
Biological: Varicella Vaccine
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Other Names:
  • Varicella vaccine
  • PharmaJet
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
Biological: Varicella Vaccine
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Other Names:
  • Varicella vaccine
  • PharmaJet
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
Biological: Varicella Vaccine
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Other Names:
  • Varicella vaccine
  • PharmaJet
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
Biological: Varicella Vaccine
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Other Names:
  • Varicella vaccine
  • PharmaJet
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
Biological: Varicella Vaccine
Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)
Other Names:
  • Varicella vaccine
  • PharmaJet
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
Biological: Hepatitis A Vaccine
Hepatitis A virus vaccine, inactivated, Single dose
Experimental: Hepatitis A (1/5 dose) ID - Syringe
Hepatitis A virus vaccine, inactivated, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
Biological: Hepatitis A Vaccine
Hepatitis A virus vaccine, inactivated, Single dose
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
Biological: Hepatitis A Vaccine
Hepatitis A virus vaccine, inactivated, Single dose
Active Comparator: Hepatitis A (full dose) IM - Syringe
Hepatitis A virus vaccine, inactivated, Single dose, 0.5 ml Intramuscular administration with Disposable Needle Syringe
Biological: Hepatitis A Vaccine
Hepatitis A virus vaccine, inactivated, Single dose

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.

  Eligibility

Ages Eligible for Study:   13 Months to 30 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00926419

Locations
Brazil
Disciplina de Immunologia Clínica e Alergia do HC- FMUSP Not yet recruiting
São Paulo, SP, Brazil, 05403-010
Contact: Glacus S Brito, MD    +55(11)30696225    glacus@usp.br   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
Principal Investigator: Glacus S Brito, MD Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
  More Information

No publications provided

Responsible Party: Glacus de Souza Brito, Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
ClinicalTrials.gov Identifier: NCT00926419     History of Changes
Other Study ID Numbers: CAPPesq 0911/08
Study First Received: June 19, 2009
Last Updated: June 22, 2009
Health Authority: Brazil: National Health Surveillance Agency

Keywords provided by University of Sao Paulo General Hospital:
Varicella
Hepatitis A
Vaccine
Injector
Fractional dose
Intradermal
Children

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Viral, Human
Herpes Zoster
Chickenpox
Liver Diseases
Digestive System Diseases
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Herpesviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on September 30, 2014