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A Phase II, Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years. (FluMist)

Primary Purpose

Influenza

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Cold-adapted influenza vaccine trivalent (CAIV-T)
Placebo
Sponsored by
MedImmune LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Influenza

Eligibility Criteria

6 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: who are aged 6 to less than 18 years at the time of enrolment who, if female and is of child bearing potential is using reliable method of hormonal and/or non-hormonal contraception (which includes cervical cap, diaphragm, condoms, with spermicide or IUD) during sexual intercourse throughout the entire study period; has provided a negative pregnancy test (with detection limit of less than or equal to 25mL/ml) no more than 24 hours prior to the study vaccine administration and agreed to avoid pregnancy during participation in the study. N.B.lactating females are excluded from the study. who are in good health as determined by medical history, physical examination and clinical judgement whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained who, along with their parent(s)/legal guardian(s) will be available until completion of the study whose parent(s)/legal guardian(s), can be reached by study staff for the post vaccination contacts(telephone, clinic or home visit) Exclusion Criteria: who along with their parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period with any serious chronic disease (e.g. with signs of cardiac or renal failure or severe malnutrition) including progressive neurological disease with Down's syndrome or other known cytogenetic disorders with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study have an immunosuppressed or an immunocompromised individual living in the same household with a documented history of hypersensitivity to egg or egg protein or any other components of CAIV-T or placebo who have a history of Guillain-Barre Syndrome (GBS) for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study who, in the two weeks prior to entry into the study, received a dose of influenza treatment (commercial or investigational) who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study who, at anytime prior to study enrollment, received any influenza vaccine (commercial or investigational) with asthma requiring regular medical follow up or hospitalization during the preceding year with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results Note: Pregnancy in any person who has regular contact with the subjects is not a contraindication to enrollment or ongoing participation of the subject in the study.

Sites / Locations

  • Catholic University Leuven
  • Zamenhoflaan 12
  • Universiteit Antwerpen
  • Oddzial Dzieciecy Szpitala Powiatowete im
  • The Gables Medicentre
  • Townhead Surgery

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CAIV-T

Placebo

Arm Description

The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).

The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).

Outcomes

Primary Outcome Measures

Number of subjects with fever greater than or equal to 39.1C oral

Secondary Outcome Measures

Number of subjects with any reactogenicity
Following vaccination the following reactions were reported daily: runny nose/nasal congestion, sore throat, cough, vomiting, decreased activity level, decreased appetite, irritability, abdominal pain together with oral temperature were referred to as prompted systemic reactions.
Number of subjects with any adverse events
Adverse events were defined as any untoward, undesired or unexpected clinical event in the form of signs, symptoms, disease or laboratory or physiological observations that occurred in a temporal relationship to the use of a WVR product, regardless of causal relationship.
Number of subjects with any serious adverse events
A Serious AE was an AE that occurred after any dose that: resulted in death, regardless of cause; was life-threatening; required in-patient hospitalization or prolonged an existing hospitalization; resulted in a persistent or significant disability or incapacity; resulted in cancer; resulted in a congenital anomaly or birth defect (in the offspring of a vaccine recipient, where applicable).

Full Information

First Posted
September 12, 2005
Last Updated
February 29, 2012
Sponsor
MedImmune LLC
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00192179
Brief Title
A Phase II, Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.
Acronym
FluMist
Official Title
A Phase II, Prospective, Randomized, Double-Blind, Placebo, Controlled Trial, to Assess the Safety and Tolerability of Influenza Virus Vaccine, Trivalent, Types A & B Live Cold-Adapted Liquid Formulation (CAIV-T) in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
June 2003 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
July 2003 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
MedImmune LLC
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A safety study to compare, over a 7 day period, the fever rates following one dose of either Influenza Virus Vaccine or placebo administered outside the influenza season to healthy children and adolescents aged 6 to less than 18 years.
Detailed Description
This was a prospective, randomized, double-blind, placebo-controlled, study. Subjects were randomized to receive either CAIV-T or Placebo. All subjects were healthy children and adolescents aged at least 6 years of age and less than 18 years of age at the time of enrollment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CAIV-T
Arm Type
Experimental
Arm Description
The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).
Intervention Type
Biological
Intervention Name(s)
Cold-adapted influenza vaccine trivalent (CAIV-T)
Intervention Description
The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 ml into each nostril). Each dose of CAIV-T used in this study contained approximately 10^7+/-0.5 fluorescent focus units (FFU) (equivalent to 10^7+/-0.5 TCID50) of each of the following three influenza virus strains: Influenza Cold Adapted Virus Type H1N1, strain A/New Caledonia/20/99; Influenza Cold Adapted Virus Type H3N2, strain A/ Panama/2007/99; Influenza Cold Adapted Virus Type B, strain B/Hong Kong/ 330/01.
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
The placebo consisted of physiologic normal saline.
Primary Outcome Measure Information:
Title
Number of subjects with fever greater than or equal to 39.1C oral
Time Frame
Days 0-7
Secondary Outcome Measure Information:
Title
Number of subjects with any reactogenicity
Description
Following vaccination the following reactions were reported daily: runny nose/nasal congestion, sore throat, cough, vomiting, decreased activity level, decreased appetite, irritability, abdominal pain together with oral temperature were referred to as prompted systemic reactions.
Time Frame
Day 0-7
Title
Number of subjects with any adverse events
Description
Adverse events were defined as any untoward, undesired or unexpected clinical event in the form of signs, symptoms, disease or laboratory or physiological observations that occurred in a temporal relationship to the use of a WVR product, regardless of causal relationship.
Time Frame
Days 0-7
Title
Number of subjects with any serious adverse events
Description
A Serious AE was an AE that occurred after any dose that: resulted in death, regardless of cause; was life-threatening; required in-patient hospitalization or prolonged an existing hospitalization; resulted in a persistent or significant disability or incapacity; resulted in cancer; resulted in a congenital anomaly or birth defect (in the offspring of a vaccine recipient, where applicable).
Time Frame
Days 0-21

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: who are aged 6 to less than 18 years at the time of enrolment who, if female and is of child bearing potential is using reliable method of hormonal and/or non-hormonal contraception (which includes cervical cap, diaphragm, condoms, with spermicide or IUD) during sexual intercourse throughout the entire study period; has provided a negative pregnancy test (with detection limit of less than or equal to 25mL/ml) no more than 24 hours prior to the study vaccine administration and agreed to avoid pregnancy during participation in the study. N.B.lactating females are excluded from the study. who are in good health as determined by medical history, physical examination and clinical judgement whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained who, along with their parent(s)/legal guardian(s) will be available until completion of the study whose parent(s)/legal guardian(s), can be reached by study staff for the post vaccination contacts(telephone, clinic or home visit) Exclusion Criteria: who along with their parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period with any serious chronic disease (e.g. with signs of cardiac or renal failure or severe malnutrition) including progressive neurological disease with Down's syndrome or other known cytogenetic disorders with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study have an immunosuppressed or an immunocompromised individual living in the same household with a documented history of hypersensitivity to egg or egg protein or any other components of CAIV-T or placebo who have a history of Guillain-Barre Syndrome (GBS) for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study who, in the two weeks prior to entry into the study, received a dose of influenza treatment (commercial or investigational) who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study who, at anytime prior to study enrollment, received any influenza vaccine (commercial or investigational) with asthma requiring regular medical follow up or hospitalization during the preceding year with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results Note: Pregnancy in any person who has regular contact with the subjects is not a contraindication to enrollment or ongoing participation of the subject in the study.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raburn Mallory, M.D.
Organizational Affiliation
MedImmune LLC
Official's Role
Study Director
Facility Information:
Facility Name
Catholic University Leuven
City
Leuven
Country
Belgium
Facility Name
Zamenhoflaan 12
City
Schoten
Country
Belgium
Facility Name
Universiteit Antwerpen
City
Wilrijk
Country
Belgium
Facility Name
Oddzial Dzieciecy Szpitala Powiatowete im
City
Trzebnica
Country
Poland
Facility Name
The Gables Medicentre
City
Coventry
ZIP/Postal Code
CV 6 4DD
Country
United Kingdom
Facility Name
Townhead Surgery
City
Irvine, Ayshire
ZIP/Postal Code
KA 12 OAY
Country
United Kingdom

12. IPD Sharing Statement

Learn more about this trial

A Phase II, Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.

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