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.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-06-30

Study Completion Date

2003-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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CAIV-T

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

Group Type EXPERIMENTAL

Cold-adapted influenza vaccine trivalent (CAIV-T)

Intervention Type BIOLOGICAL

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.

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

The placebo consisted of physiologic normal saline.

Interventions

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Cold-adapted influenza vaccine trivalent (CAIV-T)

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

Placebo

The placebo consisted of physiologic normal saline.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes