Serological Evaluation of Varicella and Hepatitis A Vaccines Using Injector Delivery

NCT00926419 | Unknown Phase 2

• 1 other identifier: CAPPesq 0911/08
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Varicella; Hepatitis A

Keywords

Varicella; Hepatitis A; Vaccine; Injector; Fractional dose; Intradermal; Children

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

  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

Study Arms (10)

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

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

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

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

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

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

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 (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 (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 (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

Interventions

Varicella Vaccine BIOLOGICAL

Lyophilized Varicella virus vaccine, live, attenuated (Oka-strain)

Also known as: PharmaJet

Varicella (1/5 dose) - ID - Injector; Varicella (1/5 dose) - ID - Syringe; Varicella (2/5 dose) - ID - Injector; Varicella (2/5 dose) - ID - Syringe; Varicella (full dose) - SC - Injector; Varicella (full dose) - SC - Syringe

Hepatitis A Vaccine BIOLOGICAL

Hepatitis A virus vaccine, inactivated, Single dose

Hepatitis A (1/5 dose) ID - Injector; Hepatitis A (1/5 dose) ID - Syringe; Hepatitis A (full dose) IM - Injector; Hepatitis A (full dose) IM - Syringe

Eligibility Criteria

• Age: 13 Months - 30 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Disciplina de Immunologia Clínica e Alergia do HC- FMUSP

São Paulo, São Paulo, 05403-010, Brazil

Location

MeSH Terms

Conditions

Chickenpox; Hepatitis A

Interventions

Chickenpox Vaccine; Hepatitis A Vaccines

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Hepatitis, Viral, Human; Enterovirus Infections; Picornaviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Herpesvirus Vaccines; Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Viral Hepatitis Vaccines

Study Officials

• Glacus S Brito, MD

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 19, 2009
• First Posted: June 23, 2009
• Study Start: June 1, 2009
• Primary Completion: November 1, 2009
• Study Completion: May 1, 2010
• Last Updated: June 23, 2009

Record last verified: 2009-05

Locations

BR (1)