Serological Evaluation of Varicella and Hepatitis A Vaccines Using Injector Delivery - Full Text View

Sponsored by:	University of Sao Paulo General Hospital
Information provided by:	University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier:	NCT00926419

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 II Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Single Blind (Outcomes Assessor), Dose Comparison, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Chickenpox Childhood Immunization Hepatitis Hepatitis A Shingles

Drug Information available for: Hepatitis A Vaccines Chickenpox Vaccine

U.S. FDA Resources

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
Varicella (1/5 dose) - ID - Injector: Experimental 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)
Varicella (1/5 dose) - ID - Syringe: Experimental 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)
Varicella (2/5 dose) - ID - Injector: Experimental 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)
Varicella (2/5 dose) - ID - Syringe: Experimental 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)
Varicella (full dose) - SC - Injector: Active Comparator 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)
Varicella (full dose) - SC - Syringe: Active Comparator 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)
Hepatitis A (1/5 dose) ID - Injector: Experimental 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
Hepatitis A (1/5 dose) ID - Syringe: Experimental 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
Hepatitis A (full dose) IM - Injector: Active Comparator 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
Hepatitis A (full dose) IM - Syringe: Active Comparator 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

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

Locations

Brazil, SP
Disciplina de Immunologia Clínica e Alergia do HC- FMUSP
São Paulo, SP, Brazil, 05403-010

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:	Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo ( Glacus de Souza Brito )
Study ID Numbers:	CAPPesq 0911/08
Study First Received:	June 19, 2009
Last Updated:	June 22, 2009
ClinicalTrials.gov Identifier:	NCT00926419 History of Changes
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

Study placed in the following topic categories:

Virus Diseases
Hepatitis
Herpes Zoster
Liver Diseases
Digestive System Diseases
Picornaviridae Infections

Hepatitis, Viral, Human
Chickenpox
Hepatitis A
DNA Virus Infections
Enterovirus Infections
Herpesviridae Infections

Additional relevant MeSH terms:

Herpes Zoster
Liver Diseases
RNA Virus Infections
Chickenpox
Hepatitis, Viral, Human
Picornaviridae Infections
Herpesviridae Infections

Hepatitis
Virus Diseases
Digestive System Diseases
Hepatitis A
DNA Virus Infections
Enterovirus Infections

ClinicalTrials.gov processed this record on September 09, 2009