Trial to Assess Safety, Tolerability, and Immunogenicity of Influenza Virus Vaccine, Trivalent, Types A and B, Live Cold-adapted (CAIV-T) in Healthy Children

NCT00192270 | Completed Phase 2

• 1 other identifier: D153-P503
• Study Type: interventional
• Target: 498
• Locations: 2 countries
• Sites: 3

Brief Summary

The study was designed to determine the number of doses of CAIV-T required to effectively immunize children and adolescents in the 6 to 17 year age group.

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

• The number of subjects achieving strain-specific hemagglutination inhibition (HAI) antibody seroconversion post Dose 1

  Immunogenicity was evaluated by comparison of pre and post-vaccination strain-specific titers of serum HAI antibody. Seroconversion was defined as a four-fold or greater rise in serum HAI antibody titer.

  Day 0, Day 35 post Dose 1

Secondary Outcomes (4)

• The number of subjects achieving strain-specific HAI antibody seroconversion post Dose 1

  Day 0, Day 35 post Dose 2

• The number of subjects reporting any reactogenicity event post dose

  Days 0-10

• The number of subjects reporting any adverse event post dose

  Days 0-10

• The number of subjects reporting serious adverse events post dose

  Days 0-42

Study Arms (1)

Cold-adapted influenza vaccine trivalent (CAIV-T)

EXPERIMENTAL

All subjects were scheduled to receive 2 doses of CAIV-T.The total volume of 0.2 mL was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril).

Biological: CAIV-T

Interventions

CAIV-T BIOLOGICAL

Each dose of the vaccine was formulated to contain approximately 1 x 10\^7 TCID50 of each of three (two subtype A and one subtype B) reassortant 6:2 influenza strains, as described above, for a total of \~3 x 10\^7 TCID50 per dose.

Also known as: FluMist

Cold-adapted influenza vaccine trivalent (CAIV-T)

Eligibility Criteria

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

You may qualify if:

• who are at least 6 years and not more than 17 years of age at the time of enrollment;
• who, if female and is post-menarche, has provided a negative pregnancy test; · who are in good health as determined by medical history, physical examination and clinical judgement;
• who have provided written informed consent (as appropriate and according to national guidelines) and whose parent(s) or legal guardian(s) have provided written informed consent after the nature of the study has been explained; 13 who, along with their parent(s) or legal guardian(s), will be available for duration of the study (approximately three months);
• who, together with their parent(s) or legal guardian(s), can be reached by study staff for the post-vaccination contacts \[telephone, clinic visit or home visit\].

You may not qualify if:

• who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period and whose parent(s) or legal guardian(s) are perceived to be unreliable 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;
• 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 immuno-compromised 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)
• who, in the two weeks prior to entry into this study, received a dose of any influenza treatment (commercial or investigational)
• with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine;
• with a clinically confirmed respiratory illness with wheezing within two weeks prior to enrollment;
• who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study;
• who were administered any live virus vaccine within one month prior to enrollment or expect receipt of another live virus vaccine within one month of vaccination in this 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: A pregnant household member is not considered a contraindication to enrollment.

Sponsors & Collaborators

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

Study Sites (3)

University of Antwerp

Antwerp, 2610, Belgium

Location

Dienst Jeugdgezondheidszorg

Leuven, 3000, Belgium

Location

Oulu University Hospital

Oulu, 90220, Finland

Location

MeSH Terms

Interventions

FluMist

Study Officials

• Raburn Mallory, MD

  MedImmune LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 19, 2005
• Study Start: October 1, 2000
• Primary Completion: January 1, 2001
• Study Completion: January 1, 2001
• Last Updated: March 6, 2012

Record last verified: 2012-03

Locations

FI (1); BE (2)