Influenza Clinical Trial
Official 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
NCT number | NCT00192231 |
Other study ID # | D153 P510 |
Secondary ID | |
Status | Completed |
Phase | Phase 3 |
First received | |
Last updated | |
Start date | April 2001 |
Est. completion date | June 2001 |
Verified date | October 2006 |
Source | MedImmune LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 CAIV-T).
Status | Completed |
Enrollment | 120 |
Est. completion date | June 2001 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 explained. - Subjects who were available for the duration of the study (from enrollment to study completion). - Subjects who could be reached by study staff for the post-vaccination contact [via telephone, clinic or home visit]. 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 individual. - 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 enrollment. - 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 permitted. - 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. |
Country | Name | City | State |
---|---|---|---|
Australia | Austin & Repatriation Medical Centre | Heidelburg | Victoria |
Lead Sponsor | Collaborator |
---|---|
MedImmune LLC | Wyeth is now a wholly owned subsidiary of Pfizer |
Australia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The safety objective was to assess the safety and tolerability of CAIV-T vaccine. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05523089 -
The Effectiveness of CD388 to Prevent Flu in an Influenza Challenge Model in Healthy Adults
|
Phase 2 | |
Completed |
NCT05009251 -
Using Explainable AI Risk Predictions to Nudge Influenza Vaccine Uptake
|
N/A | |
Completed |
NCT03282240 -
Safety and Immunogenicity of High-Dose Quadrivalent Influenza Vaccine in Participants ≥65 Years in the US
|
Phase 3 | |
Completed |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
Phase 3 | |
Completed |
NCT00968526 -
Study to Evaluate Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT00968539 -
Study to Evaluate the Immunogenicity & Safety of an Investigational Influenza Vaccine (H1N1) in Adults
|
Phase 3 | |
Completed |
NCT05525494 -
Patient Portal Flu Vaccine Reminders (5)
|
N/A | |
Completed |
NCT04074928 -
Safety and Immunogenicity Study of QIVc in Healthy Pediatric Subjects
|
Phase 3 | |
Completed |
NCT04695717 -
This Study Was Conducted to Evaluate the Safety and Immunogenicity of IVACFLU-S Produced in Children From 6 Months to Under 18 Years Old and the Elderly Over 60 Years Old in Vietnam
|
Phase 3 | |
Completed |
NCT05012163 -
Lottery Incentive Nudges to Increase Influenza Vaccinations
|
N/A | |
Completed |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
Completed |
NCT04109222 -
Collection of Serum Samples From Children and Older Adults Receiving the 2019-2020 Formulations of Fluzone® Quadrivalent and Fluzone® High-Dose Influenza Vaccines, Respectively
|
Phase 4 | |
Completed |
NCT02587221 -
Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of an MF59-Adjuvanted Quadrivalent Influenza Vaccine Compared to Non-influenza Vaccine Comparator in Adults ≥ 65 Years of Age
|
Phase 3 | |
Completed |
NCT03453801 -
The Role of CD4+ Memory Phenotype, Memory, and Effector T Cells in Vaccination and Infection
|
Phase 1 | |
Completed |
NCT01440387 -
A Study of Immunogenicity and Safety of GSK Biologicals' Influenza Vaccine FLU-Q-QIV in Adults Aged 18 Years and Older
|
Phase 3 | |
Terminated |
NCT01195779 -
Trial to Evaluate Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2584786A in Healthy Children
|
Phase 2 | |
Completed |
NCT03321968 -
Lot-to-lot Consistency of a Plant-Derived Quadrivalent Virus-Like Particles Influenza Vaccine in Healthy Adults
|
Phase 3 | |
Completed |
NCT00972517 -
Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine (H1N1) in Children
|
Phase 3 | |
Completed |
NCT04570904 -
Broadening Our Understanding of Early Versus Late Influenza Vaccine Effectiveness
|
||
Recruiting |
NCT03331991 -
Prevention of Influenza and Other Wintertime Respiratory Viruses Among Healthcare Professionals in Israel
|
N/A |