COVID-19 studies are our top priority.

For new and updated trial submissions, we are processing trials as quickly as possible and appreciate your patience. We recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from

For full trial details, please see the original record at

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine,(CAIV-T)
Scientific title
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
Secondary ID [1] 0 0
D153 P510
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Influenza 0 0
Condition category
Condition code

Study type
Description of intervention(s) / exposure
Other interventions - CAIV-T

Other interventions: CAIV-T

Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Primary outcome [1] 0 0
The safety objective was to assess the safety and tolerability of CAIV-T vaccine.
Timepoint [1] 0 0

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].
Minimum age
18 Years
Maximum age
No limit
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.

Study design
Purpose of the study
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

Intervention assignment
Other design features
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Austin & Repatriation Medical Centre - Heidelburg
Recruitment postcode(s) [1] 0 0
3084 - Heidelburg

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
MedImmune LLC
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Wyeth is now a wholly owned subsidiary of Pfizer
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Brief summary
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 website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Robert Walker, MD
Address 0 0
MedImmune LLC
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications