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VaricellaPhase 2/3InjHepAVarNCT00926419

Serological Evaluation of Varicella and Hepatitis A Vaccines Using Injector Delivery

A Phase 2/3 study testing Varicella Vaccine and Hepatitis A Vaccine in people with Varicella and Hepatitis A, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 30 monthsHealthy volunteers can take part
Conditions the study is for
Varicella, Hepatitis A
What is being tested?
Varicella Vaccine and Hepatitis A Vaccine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
1 siteBrazil
Study dates
Jun 2009to May 2010
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 30 months
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.
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  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Disciplina de Immunologia Clínica e Alergia do HC- FMUSP

    São Paulo, São Paulo, 05403-010

    Glacus S Brito, MD, +55(11)30696225, glacus@usp.br

Other trials in Brazil

About this study

Official title: Serological Evaluation of Chickenpox (Varicella) and Hepatitis A Vaccines Using Disposable Needle-Free Syringe Jet Injector (DSJI) Delivery

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.

Read the 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.

Being tested
Varicella Vaccine, Hepatitis A Vaccine
Keywords
Varicella, Hepatitis A, Vaccine, Injector, Fractional dose, Intradermal, Children
Medical subject headings
Chickenpox, Hepatitis A

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Varicella VaccineBiological

    Also called PharmaJet

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

  • Hepatitis A VaccineBiological

    Hepatitis A virus vaccine, inactivated, Single dose

Study groups in NCT00926419
Study groupRoleWhat they receive
Varicella (1/5 dose) - ID - InjectorExperimentalLyophilized 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
Receives: Biological: Varicella Vaccine
Varicella (1/5 dose) - ID - SyringeExperimentalLyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
Receives: Biological: Varicella Vaccine
Varicella (2/5 dose) - ID - InjectorExperimentalLyophilized 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
Receives: Biological: Varicella Vaccine
Varicella (2/5 dose) - ID - SyringeExperimentalLyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.25 ml, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
Receives: Biological: Varicella Vaccine
Varicella (full dose) - SC - InjectorActive comparatorLyophilized 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
Receives: Biological: Varicella Vaccine
Varicella (full dose) - SC - SyringeActive comparatorLyophilized Varicella virus vaccine, live, attenuated (Oka-strain) reconstituted in 0.5 ml, Single dose, 0.5 ml Subcutaneous administration with Disposable Needle Syringe
Receives: Biological: Varicella Vaccine
Hepatitis A (1/5 dose) ID - InjectorExperimentalHepatitis A virus vaccine, inactivated, Single dose, 0.1 ml Intradermal administration with Disposable Needle-free Syringe Jet Injector
Receives: Biological: Hepatitis A Vaccine
Hepatitis A (1/5 dose) ID - SyringeExperimentalHepatitis A virus vaccine, inactivated, Single dose, 0.1 ml Intradermal administration with Disposable Needle Syringe
Receives: Biological: Hepatitis A Vaccine
Hepatitis A (full dose) IM - InjectorActive comparatorHepatitis A virus vaccine, inactivated, Single dose, 0.5 ml Intramuscular administration with Disposable Needle-free Syringe Jet Injector
Receives: Biological: Hepatitis A Vaccine
Hepatitis A (full dose) IM - SyringeActive comparatorHepatitis A virus vaccine, inactivated, Single dose, 0.5 ml Intramuscular administration with Disposable Needle Syringe
Receives: Biological: Hepatitis A Vaccine

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 45 days after immunization

Secondary outcomes (5)

  1. Degree and duration of local and systemic adverse events after immunization according to the Brighton Collaboration Group recommendations.

    Measured: 45 days after immunization

  2. 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

    Measured: 45 days after immunization

  3. Actual volume administered intradermally according to the delivery system (needle-free injector or syringe with needle) for each fractional dose tested

    Measured: At immunization

  4. Participants' parents or legal guardians acceptability according to the delivery system (needle-free injector or syringe with needle) for each dose tested

    Measured: 45 days after immunization

  5. Distribution of vaccine jet evaluated through ultrasound for the needle-free injector group

    Measured: 5 minutes after immunization

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jun 2009 (estimated)
  2. Study startJun 2009
  3. Primary completionNov 2009 (estimated)
  4. Study completionMay 2010 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
600 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00926419
Sponsor's protocol ID
CAPPesq 0911/08
Acronym
InjHepAVar
Status last verified
May 2009
First submitted
19 Jun 2009
Last updated
23 Jun 2009
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Varicella Vaccine and Hepatitis A Vaccine in people with Varicella and Hepatitis A, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00926419.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jun 2009.

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