Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older Against Culture-confirmed Influenza

NCT ID: NCT00192413

Last Updated: 2012-03-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 3009 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2002-03-31
• Study Completion Date: 2002-11-30

Brief Summary

To demonstrate that the efficacy over a defined surveillance period against culture-confirmed influenza-illness caused by community-acquired subtypes antigenically similar to those contained in the vaccine, in adults aged at least 60 years at enrollment, of a single intranasally (IN) -administered dose of a liquid formulation of influenza virus vaccine,(CAIV-T) is non inferior compared with that of a single dose of commercially available influenza vaccine inactivated (TIV) administered intramuscularly (IM) prior to the anticipated commencement of the influenza season.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Cold-adapted influenza vaccine trivalent (CAIV-T)

A single 0.2 mL dose of 10\^7 fluorescent focus units was administered intranasally.

Group Type: EXPERIMENTAL

Cold-adapted influenza vaccine trivalent (CAIV-T)

Intervention Type: BIOLOGICAL

Liquid CAIV-T vaccine for this study consisted of 3 cold-adapted, attenuated, reassortant strains, representing the HA and NA antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Victoria/504/2000 influenza strains. The vaccine contained no preservatives and had a pH of 7.2 ± 0.5.

Trivalent Inactivated Vaccine (TIV)

A single dose was administered by intramuscular injection.

Group Type: ACTIVE_COMPARATOR

Trivalent Inactivated Vaccine (TIV)

Intervention Type: BIOLOGICAL

Commercially available TIV, inactivated influenza vaccine (Split Virion) BP (Aventis Pasteur MSD, Lyon, France) was administered IM according to the manufacturer's dosing instructions (one 0.5-mL IM dose for adults).

Interventions

Cold-adapted influenza vaccine trivalent (CAIV-T)

Liquid CAIV-T vaccine for this study consisted of 3 cold-adapted, attenuated, reassortant strains, representing the HA and NA antigens of the A/New Caledonia/20/99 (H1N1), A/Panama/2007/99 (H3N2), and B/Victoria/504/2000 influenza strains. The vaccine contained no preservatives and had a pH of 7.2 ± 0.5.

Intervention Type: BIOLOGICAL

Trivalent Inactivated Vaccine (TIV)

Commercially available TIV, inactivated influenza vaccine (Split Virion) BP (Aventis Pasteur MSD, Lyon, France) was administered IM according to the manufacturer's dosing instructions (one 0.5-mL IM dose for adults).

Intervention Type: BIOLOGICAL

Other Intervention Names

FluMist

Eligibility Criteria

Inclusion Criteria

• who are aged at least 60 years or older at the time of enrollment;
• who are determined by medical history, physical examination and clinical judgement to be eligible for this study;
• who have provided written informed consent after the nature of the study has been explained;
• who will be available for duration of the trial (from enrollment to November 30th, 2003);
• who can be reached by study staff for the post-vaccination and weekly surveillance contacts [telephone, clinic or home visit].

Exclusion Criteria

• who are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period;
• who are a resident of a nursing home or long-term care facility or other institution receiving skilled or semi-skilled nursing care (refer to Influenza study specific manual). An ambulatory subject who is a resident of a retirement home or village is eligible for the trial;
• with any signs of renal insufficiency requiring supportive therapy or progressive neurological disease. (Subjects with other stable pre-existing disease, defined as disease not requiring change in therapy or hospitalization within 12 weeks before receipt of study vaccination will be eligible).
• with evidence of dementia or other severe cognitive impairment based on Mini Mental State Examination (MMSE) scores (refer to Influenza study specific manual);
• 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 six months prior to vaccination through to the conclusion of the study;
• have 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 CAIV-T or TIV vaccine;
• who were administered any live virus vaccine within one month prior to vaccination or expected to receive another live virus vaccine within one month of vaccination in this 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;
• who received a dose of influenza treatment (commercial or investigational) one month prior to enrollment. The prophylactic use of influenza antivirals is not permitted.
• who receive any influenza vaccine in the 6 months prior to enrollment, or intend to receive a non-study influenza vaccine after enrollment;
• with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results; Note: A pregnant household member is not considered a contraindication to enrollment.

• Minimum Eligible Age: 60 Years
• 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

Principal Investigators

Robert Walker, MD

Role: STUDY_DIRECTOR

MedImmune LLC

Locations

Docnor House

Durban North, Dwazulu Natal, South Africa

Hazelmed Family Practice

Hazelwood, Pretoria, South Africa

Jansen van Rensburg

eManzimtoti, , South Africa

Christiaan Tertius de Villiers

Scottburgh South, , South Africa

Countries

South Africa

References

Forrest BD, Steele AD, Hiemstra L, Rappaport R, Ambrose CS, Gruber WC. A prospective, randomized, open-label trial comparing the safety and efficacy of trivalent live attenuated and inactivated influenza vaccines in adults 60 years of age and older. Vaccine. 2011 May 9;29(20):3633-9. doi: 10.1016/j.vaccine.2011.03.029. Epub 2011 Apr 5.

Reference Type: RESULT

PMID: 21440036 (View on PubMed)

Other Identifiers

D153-P516

Identifier Type: -

Identifier Source: org_study_id