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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| 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 |
|
| Varicella (full dose) - SC - Injector | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Varicella Vaccine | Biological | Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 45 days after immunization |
| Measure | Description | Time Frame |
|---|---|---|
| Degree and duration of local and systemic adverse events after immunization according to the Brighton Collaboration Group recommendations. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Glacus S Brito, MD | University of Sao Paulo | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Disciplina de Immunologia ClÃnica e Alergia do HC- FMUSP | São Paulo | São Paulo | 05403-010 | Brazil |
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| ID | Term |
|---|---|
| D002644 | Chickenpox |
| D006506 | Hepatitis A |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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| ID | Term |
|---|---|
| D019433 | Chickenpox Vaccine |
| D022362 | Hepatitis A Vaccines |
| ID | Term |
|---|---|
| D022283 | Herpesvirus Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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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
|
| 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 |
|
| 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 |
|
| Hepatitis A (1/5 dose) ID - Syringe | Experimental | Hepatitis A virus vaccine, inactivated, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe |
|
| 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 |
|
| Hepatitis A (full dose) IM - Syringe | Active Comparator | Hepatitis A virus vaccine, inactivated, Single dose, 0.5 ml Intramuscular administration with Disposable Needle Syringe |
|
|
| Hepatitis A Vaccine | Biological | Hepatitis A virus vaccine, inactivated, Single dose |
|
| 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 | At immunization |
| Participants' parents or legal guardians acceptability according to the delivery system (needle-free injector or syringe with needle) for each dose tested | 45 days after immunization |
| Distribution of vaccine jet evaluated through ultrasound for the needle-free injector group | 5 minutes after immunization |
| D007239 | Infections |
| D006525 | Hepatitis, Viral, Human |
| D004769 | Enterovirus Infections |
| D010850 | Picornaviridae Infections |
| D012327 | RNA Virus Infections |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D045424 |
| Complex Mixtures |
| D014761 | Viral Hepatitis Vaccines |