Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, (CAIV-T) in Healthy Children
NCT00192374
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
- •who are aged at least 6 months and less than 36 months of age at the time of first vaccination
- 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 for duration of the trial (8 months ±1 month)
- whose parent(s)/legal guardian(s), can be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].
- whose 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 (see Section 4.2.1)
- who received any blood products, including immunoglobulin, in the period from six
months prior to vaccination through to the conclusion of the study
- 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
- have an immunosuppressed or an immunocompromised individual living in the same
household
- who, at any time prior to entry into this study, received a dose of any influenza
vaccine (commercial or investigational)
- with a documented history of hypersensitivity to egg or egg protein or any other
component of the assigned study vaccine
- who received aspirin (acetylsalicylic acid) or aspirin-containing products in the
two weeks prior to vaccination or for which use is anticipated during the study
- with any medical conditions that in the opinion of the investigator might
interfere with interpretation of the study results. If any of these criteria are
met following enrolment, the subject will be excluded from subsequent vaccine
dosing.
Note: Pregnancy in a household member or any person who has regular contact with the
subject is not a contraindication to the enrollment or ongoing participation of the subject
in the study.
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Descriptive Information | |||||||
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Brief Title ICMJE | Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, (CAIV-T) in Healthy Children | ||||||
Official Title ICMJE | A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III, Multicenter Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B,Live, Cold-Adapted (CAIV-T) in Healthy Children | ||||||
Brief Summary | - Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of(CAIV-T) in Healthy Children. | ||||||
Detailed Description | - A Prospective, Randomized, Double-Blind, Placebo-Controlled, Phase III, Multicenter Trial to Compare the Safety, Tolerability, Immunogenicity and Efficacy of Three Dose Levels of a Liquid Formulation of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) in Healthy Children | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Treatment | ||||||
Condition ICMJE | Healthy | ||||||
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 | 1920 | ||||||
Original Enrollment ICMJE | Same as current | ||||||
Study Completion Date ICMJE | November 2002 | ||||||
Primary Completion Date | Not Provided | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Note: Pregnancy in a household member or any person who has regular contact with the subject is not a contraindication to the enrollment or ongoing participation of the subject in the study. | ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 6 Months to 35 Months (Child) | ||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Philippines, Thailand | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT00192374 | ||||||
Other Study ID Numbers ICMJE | D153-P513 | ||||||
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 | October 2006 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |