A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine,(CAIV-T) in Healthy Infants
NCT00192348
ABOUT THIS STUDY
FOR MORE INFORMATION
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Pfizer Clinical Trials Contact Center
1-800-718-1021
- children at least 6 weeks of age and less than 24 weeks of age at the time of enrollment, of >37 weeks gestational age and with a birth weight of >2500 g, and in good health as determined by medical history, physical examination and clinical judgment;
- whose parent/legal guardian provided written informed consent after the nature of the study was explained;
- who, along with their parent or legal guardian, were available for the three month duration of the trial (from enrollment to study completion);
- whose parent(s)/legal guardian(s), could be reached by study staff for the post-vaccination contacts [telephone, clinic or home visit].
- whose parents or legal guardians were 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 birth
through to the conclusion of the study;
- had 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 vaccines or placebo;
- who were administered any live virus vaccine within one month prior to enrollment; or
expected to receive another live vaccine within 1 month of vaccination in the study.
- for whom there was intent to administer any other investigational vaccine or agent
from one month prior to enrollment through to the conclusion of the study;
- who received a dose of influenza treatment (commercial or investigational) two weeks
prior to enrollment. The prophylactic use of influenza antivirals was not permitted;
- who, at anytime prior to study enrollment, received any influenza vaccine (commercial
or investigational);
- with a respiratory illness with wheezing within two weeks prior to each dose of study
vaccine;
- who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two
weeks prior to enrollment or for which use was anticipated during the study;
- with any medical conditions that in the opinion of the investigator might have
interfered with interpretation of the study results.
Note: Pregnancy in any person who had regular contact with the subjects was not considered
a contraindication to enrollment.
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Descriptive Information | ||||
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Brief Title ICMJE | A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine,(CAIV-T) in Healthy Infants | |||
Official Title ICMJE | A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold Adapted (CAIV-T) in Healthy Infants | |||
Brief Summary | Trial to compare the safety and tolerability of one and two doses of influenza virus vaccine. | |||
Detailed Description | The objective of this study was to compare the safety and tolerability of one and two doses of influenza virus vaccine, trivalent, types A and B, live cold-adapted liquid (CAIV-T) with placebo when administered intranasally to healthy infants aged 6 < 24 weeks. | |||
Study Type ICMJE | Interventional | |||
Study Phase ICMJE | Phase 1 | |||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Primary Purpose: Treatment | |||
Condition ICMJE | Healthy | |||
Intervention ICMJE | Biological: CAIV-T | |||
Study Arms ICMJE | Not Provided | |||
Publications * | Vesikari T, Karvonen A, Smith HM, Dunning A, Razmpour A, Saville MK, Gruber WC, Forrest BD. Safety and tolerability of cold-adapted influenza vaccine, trivalent, in infants younger than 6 months of age. Pediatrics. 2008 Mar;121(3):e568-73. doi: 10.1542/peds.2007-1405. Epub 2008 Feb 25. | |||
* 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 | 120 | |||
Original Enrollment ICMJE | Same as current | |||
Study Completion Date ICMJE | December 2002 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
Note: Pregnancy in any person who had regular contact with the subjects was not considered a contraindication to enrollment. | |||
Sex/Gender ICMJE |
| |||
Ages ICMJE | 6 Weeks to 24 Weeks (Child) | |||
Accepts Healthy Volunteers ICMJE | Yes | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | Finland | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT00192348 | |||
Other Study ID Numbers ICMJE | D153-P518 | |||
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 |