Status:
COMPLETED
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.
Lead Sponsor:
MedImmune LLC
Collaborating Sponsors:
Wyeth is now a wholly owned subsidiary of Pfizer
Conditions:
Influenza
Eligibility:
All Genders
6-17 years
Phase:
PHASE2
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 adoles...
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 le...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2003
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT00192179
Start Date
June 1 2003
End Date
July 1 2003
Last Update
March 2 2012
Active Locations (6)
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1
Catholic University Leuven
Leuven, Belgium
2
Zamenhoflaan 12
Schoten, Belgium
3
Universiteit Antwerpen
Wilrijk, Belgium
4
Oddzial Dzieciecy Szpitala Powiatowete im
Trzebnica, Poland