Trial to Investigate Viral Shedding in Healthy Children Vaccinated With Vaccine Virus Liquid (CAIV-T)
NCT00192387
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- children at least 6 months of age and less than or equal to 18 months of age at the time of enrollment, and in good health as determined by medical history, physical examination, and clinical judgment;
- whose parent/legal guardian has provided written informed consent after the nature of the study has been explained;
- who, along with their parent or legal guardian, will be available for the two month duration of the trial (from enrollment to study completion).
- whose parents or legal guardians 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; intranasal steroids or
cytotoxic agents;
- 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
component of the study vaccine or placebo;
- who, at anytime prior to study enrollment, receives any influenza vaccine (commercial
or investigational);
- with any medical conditions that in the opinion of the investigator might interfere
with interpretation of the study results.
Note: A pregnant household member is not considered a contraindication to enrollment.
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Descriptive Information | ||||
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Brief Title ICMJE | Trial to Investigate Viral Shedding in Healthy Children Vaccinated With Vaccine Virus Liquid (CAIV-T) | |||
Official Title ICMJE | A Randomized, Double-Blinded, Placebo-Controlled Trial to Investigate Viral Shedding in Healthy Children (6 Mos and Less Than or Equal to 18 Months of Age) Vaccinated With Two Doses of Liquid Formulation of Influenza Virus Vaccine, Live Cold Adapted (CAIV-T) | |||
Brief Summary | The primary objective of this study was to determine the proportion of subjects, seronegative to all three strains of influenza, as defined by a serum hemagglutination inhibition antibodies (HAI) antibody titer of <1:10, who shed each vaccine virus strain following a single dose of CAIV-T. | |||
Detailed Description | Not Provided | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 2 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Influenza | |||
Intervention ICMJE | Biological: CAIV-T, Liquid | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Enrollment ICMJE | 60 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | December 2001 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Note: A pregnant household member is not considered a contraindication to enrollment. | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 6 Months to 18 Months (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00192387 | |||
Other Study ID Numbers ICMJE | D153-P005 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement ICMJE | Not Provided | |||
Responsible Party | Not Provided | |||
Study Sponsor ICMJE | MedImmune LLC | |||
Collaborators ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Investigators ICMJE |
| |||
PRS Account | MedImmune LLC | |||
Verification Date | December 2006 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |