Trial to Determine the Safety and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold- Adapted (CAIV-T) in Healthy Children Attending Day Care Centers

NCT ID: NCT00192283

Last Updated: 2009-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 2903 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2000-09-30
• Study Completion Date: 2002-05-31

Brief Summary

The purpose of this study is to determine the efficacy of the liquid formulation of CAIVT against culture confirmed influenza illness in healthy children aged at least 6 months and less than 36 months, attending day care centers in Europe. In addition, the trial provides the opportunity to investigate the effect of CAIV-T on acute otitis media, on healthcare resource utilization and economic resources.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

1

CAIV-T

Group Type: EXPERIMENTAL

CAIV-T

Intervention Type: BIOLOGICAL

The total single-dose volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).

2

Placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

A single dose of placebo volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).

Interventions

CAIV-T

The total single-dose volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).

Intervention Type: BIOLOGICAL

Placebo

A single dose of placebo volume of 0.2 mL was administered intranasally with the spray applicator intended for commercial use (approximately 0.1 mL into each nostril).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• who are aged at least 6 months and less than 36 months of age at the time of enrollment, attending day care for at least three days a week, four hours a day;
• 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].

Exclusion Criteria

• 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; 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);
• 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 or placebo;
• 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 expected to receive 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.

• Minimum Eligible Age: 6 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

MedImmune LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

MedImmune Inc.

Principal Investigators

Robert Walker, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Tampere University Medical School

Tampere, , Finland

Countries

Finland

Other Identifiers

D153 P502

Identifier Type: -

Identifier Source: org_study_id