NCT00192179

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2003

Shorter than P25 for phase_2

Geographic Reach
3 countries

6 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2003

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2003

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
Last Updated

March 2, 2012

Status Verified

February 1, 2012

Enrollment Period

1 month

First QC Date

September 12, 2005

Last Update Submit

February 29, 2012

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

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

    Days 0-7

Secondary Outcomes (3)

  • Number of subjects with any reactogenicity

    Day 0-7

  • Number of subjects with any adverse events

    Days 0-7

  • Number of subjects with any serious adverse events

    Days 0-21

Study Arms (2)

CAIV-T

EXPERIMENTAL

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

Biological: Cold-adapted influenza vaccine trivalent (CAIV-T)

Placebo

PLACEBO COMPARATOR

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

Biological: Placebo

Interventions

Cold-adapted influenza vaccine trivalent (CAIV-T)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.

CAIV-T
PlaceboBIOLOGICAL

The placebo consisted of physiologic normal saline.

Placebo

Eligibility Criteria

Age6 Years - 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Catholic University Leuven

Leuven, Belgium

Location

Zamenhoflaan 12

Schoten, Belgium

Location

Universiteit Antwerpen

Wilrijk, Belgium

Location

Oddzial Dzieciecy Szpitala Powiatowete im

Trzebnica, Poland

Location

The Gables Medicentre

Coventry, CV 6 4DD, United Kingdom

Location

Townhead Surgery

Irvine, Ayshire, KA 12 OAY, United Kingdom

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Raburn Mallory, M.D.

    MedImmune LLC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

June 1, 2003

Primary Completion

July 1, 2003

Study Completion

July 1, 2003

Last Updated

March 2, 2012

Record last verified: 2012-02

Locations

PL(1)GB(2)BE(3)