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A Phase III, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Vaccine Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Invasive Solid Tumors


Phase 3
2 Years
70 Years
Not Enrolling
Both
H1N1 Influenza Virus, Invasive Solid Tumors

Thank you

Trial Information

A Phase III, Randomized, Controlled, Open Label Study to Evaluate the Immunogenicity, Safety, and Tolerability of an Adjuvanted A(H1N1) Vaccine Versus Non-Adjuvanted Vaccines Against Novel H1N1 Virus in Patients With Invasive Solid Tumors


Inclusion Criteria:



For Invasive Solid Tumor Subjects:

- Subjects between 2 and 70 years of age (inclusive)

- Any sex or ethnicity

- Confirmed diagnosis of Invasive Solid Tumor or hematological malignancies in complete
remission for at least 3 months and not more than 18 months after the last
neo-adjuvant and/or adjuvant chemotherapy cycle according to investigators assessment
and the subjects medical records

- Previous use of neo-adjuvant and/or adjuvant chemotherapy for the treatment on an
invasive solid tumor

- Life expectancy of at least 12 months

- Karnofsky Performance Scale > 40%

- Childbearing potential women must be willing to use an acceptable contraceptive
method. Acceptable contraceptive methods are defined as one or more of the following:

1. Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous
implant, cervical ring)

2. Barrier (condom with spermicide or diaphragm with spermicide) at each
intercourse and during the whole intercourse

3. Intra-uterine device (IUD)

4. Monogamous relation with vasectomized partner (must have been vasectomized at
least six months before the volunteer entered the study).

- Subjects capable of following all the study procedures and available for all visits
scheduled to the investigation site

- Subjects capable of understanding the nature and risk of the study proposed and sign
the consent form

- In case of children and adolescents (below 18 years of age): Subjects capable of
understanding the nature of the study and whose legal guardian understands the
nature and risk of the study proposed and signs the consent form

- The study subjects may have other underlying chronic diseases that do not involve
immunosuppression (e.g. osteoarticular diseases, cardiorespiratory diseases,
metabolic diseases, stable, non progressive, non-severe neurologic disorders without
cognitive impairment, ophthalmologic diseases, etc.), but their symptoms/signs must
be under control through medical follow-ups and drug therapy

For Healthy Subjects:

- Subjects between 2 and 70 years of age (inclusive)

- Any sex and ethnicity

- Subjects with good health as determined by medical history, physical evaluation, and
investigator's clinical opinion

- Childbearing potential women must be willing to use an acceptable contraceptive
method. Acceptable contraceptive methods are defined as one or more of the following:

1. Hormone contraceptive (such as oral, injectable, transdermal patch, subcutaneous
implant, cervical ring)

2. Barrier (condom with spermicide or diaphragm with spermicide) at each
intercourse and during the whole sexual intercourse

3. Intra-uterine device (IUD)

4. Monogamous relation with vasectomized partner (must have been vasectomized for
at least six months before the volunteer entered the study).

- Subjects capable of respecting all the study procedures and available for all the
visits scheduled at the investigation site

- Subjects capable of understanding the nature and risk of the study proposed and sign
the consent form

- In case of children and adolescents (below 18 years of age): Subjects capable of
understanding the nature of the study and whose legal guardian understands the
nature and risk of the study proposed and signs the consent form

Exclusion Criteria:

For Invasive Solid Tumor Subjects:

- Previous laboratory confirmed diagnosis of an infection by the novel H1N1 virus

- Administration of other vaccine against the novel H1N1 virus within 3 months prior to
inclusion in the study

- Any recent vaccine given within the last 21 days (inclusive)

- History of allergic reaction to an influenza vaccine in the past, or a current or
previous occurrence of allergy to egg or egg protein, kanamycin, and neomycin sulfate

- Acute febrile disease (vaccination may be delayed up to 3 days after the resolution
of the symptoms)

- Presence of other diseases, not related to cancer with confirmed immunosuppression

- Chemotherapy, biologic therapy or radiation within 3 months prior to inclusion in the
study

- History of chronic hepatic or renal disease

- History of cognitive disorders

- History of progressive or severe neurological disorders, including Guillain-Barré
Syndrome

- Pregnancy or breast-feeding

- Use of immunomodulatory therapy, including cyclosporin, interleukins, and
interferons, within 3 months prior to inclusion in the study

- Receipt of parenteral immunoglobulin, hemotherapy, and/or plasma derivatives within 3
months prior to inclusion in the study

- Receipt of any investigational product within 12 months prior to inclusion in the
study

For Healthy Subjects:

- Previous laboratory confirmed diagnosis of an infection by the new virus H1N1

- Receipt of another vaccine against the new virus H1N1 within 3 months prior to
inclusion in the study

- Any recent vaccine given within the last 21 days (inclusive)

- History of allergic reaction to influenza vaccine in the past, or a current or
previous allergy to egg or egg protein, kanamycin, and neomycin sulfate;

- Acute febrile disease (the vaccination may be delayed up to 3 days after symptoms
resolution)

- Pregnancy or breast-feeding

- Receipt of parenteral immunoglobulin, hemotherapy, and/or plasma derivatives within 3
months prior to inclusion in the study;

- Receipt of any investigational product within 12 months prior to inclusion in the
study

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Outcome Measure:

The primary objective of this study is to determine the optimal influenza vaccination strategy in patients with invasive solid tumors

Outcome Time Frame:

3 months

Safety Issue:

No

Authority:

Brazil: National Health Surveillance Agency

Study ID:

V111_15TP

NCT ID:

NCT01031719

Start Date:

August 2010

Completion Date:

July 2012

Related Keywords:

  • H1N1 Influenza Virus
  • Invasive Solid Tumors
  • Influenza A Virus
  • Virus Diseases
  • Influenza, Human
  • H1N1
  • Immunogenicity
  • safety
  • tolerability
  • tumors
  • oncology
  • Influenza, Human
  • Neoplasms

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