A Prospective, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine,(CAIV-T) in Healthy Infants

NCT00192348 | Completed Phase 1

• 1 other identifier: D153-P518
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Trial to compare the safety and tolerability of one and two doses of influenza virus vaccine.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• - To compare the safety and tolerability of one and two doses of influenza virus vaccine, trivalent,(CAIV-T) with placebo when administered intranasally

Interventions

CAIV-T BIOLOGICAL

Eligibility Criteria

• Age: 6 Weeks - 24 Weeks
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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 \[telephone, clinic or home visit\].

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedImmune LLC: lead
• Wyeth is now a wholly owned subsidiary of Pfizer: collaborator

Study Sites (1)

University of Tampere

Tampere, 33014, Finland

Location

Related Publications (1)

• 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.

  PMID: 18299305 DERIVED

MeSH Terms

Interventions

FluMist

Study Officials

• Robert Walker, MD

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: May 1, 2002
• Study Completion: December 1, 2002
• Last Updated: September 13, 2021

Record last verified: 2006-10

Locations

FI (1)