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Serological Evaluation of Varicella and Hepatitis A Vaccines Using Injector Delivery

Sponsored by University of Sao Paulo General Hospital

About this trial

Last updated 16 years ago

Study ID

CAPPesq 0911/08

Status

Unknown status

Type

Interventional

Phase

Phase 2/Phase 3

Placebo

No

Accepting

18-75 Years
13 to 30 Years
All
All

Trial Timing

Ended 15 years ago

What is this trial about?

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.

What are the participation requirements?

Yes

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

No

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.

Locations

Location

Status