Clinical trial NCT00192179: 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.
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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Influenza
Lead sponsor: MedImmune LLC
Sponsor class: INDUSTRY
Collaborators: name: Wyeth is now a wholly owned subsidiary of Pfizer
First posted: 2005-09-19
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Number of subjects with fever greater than or equal to 39.1C oral
timeFrame: Days 0-7
Secondary outcomes:
measure: Number of subjects with any reactogenicity
timeFrame: Day 0-7
measure: Number of subjects with any adverse events
timeFrame: Days 0-7
measure: Number of subjects with any serious adverse events
timeFrame: Days 0-21
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: Catholic University Leuven
city: Schoten
country: Belgium
facility: Zamenhoflaan 12
city: Wilrijk
country: Belgium
facility: Universiteit Antwerpen
city: Trzebnica
country: Poland
facility: Oddzial Dzieciecy Szpitala Powiatowete im
city: Coventry
country: United Kingdom
facility: The Gables Medicentre
city: Irvine, Ayshire
country: United Kingdom
facility: Townhead Surgery
Study officials:
affiliation: MedImmune LLC
name: Raburn Mallory, M.D.
role: STUDY_DIRECTOR
References: