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

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

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

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Biological: CAIV-T

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: Interventional
• Enrollment: 120
• Phase: Phase 1

Contacts and Locations

Study Locations

• Finland
  • Tampere, Finland, 33014
    • University of Tampere

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 5 months (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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].

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: Double

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: MedImmune LLC
• Collaborators: Wyeth is now a wholly owned subsidiary of Pfizer

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: May 1, 2002
• Study Completion: December 1, 2002

Study Registration Dates

• First Submitted: September 12, 2005
• First Submitted That Met QC Criteria: September 12, 2005
• First Posted (Estimate): September 19, 2005

Study Record Updates

• Last Update Posted (Actual): September 13, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: October 1, 2006

More Information

Terms related to this study

• Other Study ID Numbers: D153-P518