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InfluenzaPhase 3FluMistNCT00192413

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

A Phase 3 study testing Cold-adapted influenza vaccine trivalent (CAIV-T) and Trivalent Inactivated Vaccine (TIV) in people with Influenza, run by MedImmune LLC at 4 sites in South Africa.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 60 years and olderHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Cold-adapted influenza vaccine trivalent (CAIV-T) and Trivalent Inactivated Vaccine (TIV)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,009 participants
Where
4 sitesSouth Africa
Study dates
Mar 2002to Nov 2002
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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].

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

4 sites in 1 country.

South Africa4 sites

  • Docnor House

    Durban North, Dwazulu Natal

  • Jansen van Rensburg

    eManzimtoti

  • Hazelmed Family Practice

    Hazelwood, Pretoria

  • Christiaan Tertius de Villiers

    Scottburgh South

Other trials in South Africa

About this study

Official title: A Prospective, Randomized, Open-Label, Controlled Trial to Compare the Safety, Tolerability, and Efficacy of Influenza Virus Vaccine, Trivalent, Types A & B, Live Cold-Adapted (CAIV-T) With Inactivated, Influenza Vaccine, Trivalent, Types A & B, in Adults Aged 60 Years and Older

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
Being tested
Cold-adapted influenza vaccine trivalent (CAIV-T), Trivalent Inactivated Vaccine (TIV)
Medical subject headings
Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cold-adapted influenza vaccine trivalent (CAIV-T)Biological

    Also called FluMist

    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)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).

Study groups in NCT00192413
Study groupRoleWhat they receive
Cold-adapted influenza vaccine trivalent (CAIV-T)ExperimentalA single 0.2 mL dose of 10^7 fluorescent focus units was administered intranasally.
Receives: Biological: Cold-adapted influenza vaccine trivalent (CAIV-T)
Trivalent Inactivated Vaccine (TIV)Active comparatorA single dose was administered by intramuscular injection.
Receives: Biological: Trivalent Inactivated Vaccine (TIV)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The first episode of a culture-confirmed influenza-illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine, which occurs at least 15 days following receipt of a dose of study vaccine.

    The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted.

    Measured: Dosing through 30Nov2002

Secondary outcomes (12)

  1. The first episode of a culture-confirmed influenza-illness, caused by any community-acquired subtype, which occurs at least 15 days following receipt of a dose of study vaccine.

    The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted.

    Measured: 15 days after dosing through 30Nov2002

  2. The first episode in a study subject of a culture-confirmed influenza illness caused by community-acquired virus of each of the subtypes antigenically similar to those contained in the vaccine

    The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted.

    Measured: 15 days after dosing through 30Nov2002

  3. The first episode in a study subject of a culture-confirmed influenza illness caused by any community-acquired virus of each of the subtypes.

    The criteria for obtaining nasal and throat swabs for viral culture were any one of the following: A feeling of "feverishness", An oral temperature ≥37.2ºC, Sore throat, New or increased cough, Malaise, Myalgia. Swabs for viral cultures were also obtained, if, in the opinion of the investigator, the symptom complex so warranted.

    Measured: 15 days after dosing through 30Nov2002

  4. The first episode of influenza-like illness

    Measured: 15 days after dosing through 30Nov2002

  5. Incidence of clinic visits

    A possibility of multiple visits per subject; each visit will be counted once in the analysis.

    Measured: 15 days after dosing through 30Nov2002

  6. Incidence of hospitalization

    Measured: 15 days after dosing through 30Nov2002

  7. Incidence of confirmed pneumonia

    Pneumonia means one or more areas of acute interstitial or alveolar infiltrates documented radiographically

    Measured: 15 days after dosing through 30Nov2002

  8. Incidence of death due to influenza-like illness

    With or without confirmation by viral culture or PCR analysis

    Measured: 15 days after dosing through 30Nov2002

  9. Incidence of seroconversion

    Seroconversion is defined as at least a 4-fold increase in titer from baseline to the sample 35 plus or minus 7 days after vaccination. all subjects were to provide serum samples at 2 time points: at study visit 1 prior to vaccination with CAIV-T or TIV, and 35 days ± 7 days following vaccination (study visit 2).

    Measured: Day 0-35

  10. Incidence of systemic reactogenicity events

    The 12 systemic reactions were fever with 3 grades defined as ≥37.2°C, ≥38.6°C, and ≥40°C based on the temperature reported on the diary card in addition to the 9 events reported on the diary card.

    Measured: Day 0-10

  11. Incidence of local reactions

    The local reactions were pain, redness (2 grades: any and significant), and swelling (also 2 grades).

    Measured: Days 0-10

  12. Incidence of adverse events

    Measured: Days 0-10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Sep 2005 (estimated)
  2. Study startMar 2002
  3. Primary completionNov 2002
  4. Study completionNov 2002

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
3,009 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00192413
Sponsor's protocol ID
D153-P516
Acronym
FluMist
Status last verified
Mar 2012
First submitted
13 Sep 2005
Last updated
14 Mar 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 21440036

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cold-adapted influenza vaccine trivalent (CAIV-T) and Trivalent Inactivated Vaccine (TIV) in people with Influenza, run by MedImmune LLC at 4 sites in South Africa.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The first episode of a culture-confirmed influenza-illness, caused by community-acquired subtypes antigenically similar to those contained in the vaccine, which occurs at least 15 days following receipt of a dose of study vaccine. (time frame: Dosing through 30Nov2002). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00192413, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Mar 2012.

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