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Trial details imported from ClinicalTrials.gov
Ethics application status
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine,(CAIV-T)
A Randomized, Double-Blind, Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent Types A & B, Live Cold Adapted (CAIV-T) in Healthy Adults Aged 18 and Older
Universal Trial Number (UTN)
Description of intervention(s) / exposure
Other interventions - CAIV-T
Other interventions: CAIV-T
Intervention code 
Comparator / control treatment
Primary outcome 
The safety objective was to assess the safety and tolerability of CAIV-T vaccine.
Key inclusion criteria
- Healthy adults aged 18 to 59 years or > 60 years.
- Female subjects of childbearing potential who had a negative urine pregnancy test
result prior to study vaccination. Females who were surgically sterilized or
post-menopausal did not require pregnancy testing.
- Adults who were determined by medical history, physical examination and clinical
judgment eligible for this study. Subjects with stable pre-existing disease, defined
as disease not requiring change in therapy or hospitalization within 12 weeks before
receipt of study vaccination, were eligible.
- Subjects who provided written informed consent after the nature of the study was
- Subjects who were available for the duration of the study (from enrollment to study
- Subjects who could be reached by study staff for the post-vaccination contact [via
telephone, clinic or home visit].
Both males and females
Can healthy volunteers participate?
Key exclusion criteria
- Subjects who resided in a nursing home or long-term care facility or other institution
receiving skilled or semi-skilled nursing care. An ambulatory subject who resided in a
retirement home or village was eligible for participation.
- Subjects with evidence of dementia or other severe cognitive impairment based on Mini
Mental State Examination (MMSE) score of 22 or greater. Note: Administration of MMSE
was performed only if clinically indicated.
For all study subjects:
- Subjects who were perceived to be unavailable or difficult to contact for evaluation
of study visits during the study period.
- Subjects with a known or suspected disease of the immune system or those receiving
immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents.
- Subjects who received any blood products, including immunoglobulin, in the period from
six months prior to vaccination through to the conclusion of the study.
- Subjects who resided in the same household as an immunosuppressed or immunocompromised
- Subjects with a documented history of hypersensitivity to egg or egg protein or any
other component of the study vaccine or placebo.
- Subjects who were administered any live virus vaccine within one month prior to
- Subjects for whom there was intent to administer any other investigational vaccine or
agent from one month prior to enrollment through the conclusion of the study.
- Subjects who received a dose of influenza treatment (commercial or investigational)
one month prior to enrollment. Prophylactic use of influenza antivirals was not
- Subjects who received any influenza vaccine in the six months prior to enrollment, or
nonstudy influenza vaccine since enrollment.
- Subjects with any medical conditions that in the opinion of the investigator might
interfere with the interpretation of the study results.
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment
Methods used to generate the sequence in which subjects will be randomised (sequence
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
Statistical methods / analysis
Reason for early stopping/withdrawal
Accrual to date
Recruitment hospital 
Austin & Repatriation Medical Centre - Heidelburg
Recruitment postcode(s) 
Primary sponsor type
Other collaborator category 
Wyeth is now a wholly owned subsidiary of Pfizer
Ethics application status
The primary objective of this study was to perform a variety of immunological assays on
blood, serum, nasal wash samples, and cells obtained from healthy adult subjects for the
purpose of developing assays for application in the further investigation of immune responses
generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid
Trial related presentations / publications