Influenza Clinical Trial
Official title:
Trial to Assess Safety, Efficacy, Tolerability and Immunogenicity of Influenza Virus Vaccine, Administered Concomitantly With a Combination Live, Attenuated, Mumps, Measles, and Rubella Vaccine in Healthy Children Aged 11 - 24 Months
Verified date | December 2008 |
Source | MedImmune LLC |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
- The primary objective of the study was to determine if intranasally administered influenza virus vaccine, CAIV-T), when administered concomitantly with a subcutaneously administered combination live, attenuated mumps, measles, and rubella (MMR) virus vaccine to children interferes with the immune responses.
Status | Completed |
Enrollment | 1200 |
Est. completion date | May 2003 |
Est. primary completion date | March 2003 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 11 Months to 24 Months |
Eligibility |
Inclusion Criteria: - who were at least 11 months of age and less than 24 months of age at the time of first vaccination - who were due to receive their first dose of combined measles, mumps, and rubella vaccine (MMR) - who were in good health as determined by medical history, physical examination and clinical judgment - whose parent(s)/legal guardian(s) provided written informed consent after the nature of the study was explained - who, along with their parent(s)/legal guardian(s), were available for duration of the trial (approximately 8 months) - whose parent(s)/legal guardian(s), could be reached by study staff for the post-vaccination contact (telephone, clinic or home visit) Exclusion Criteria: - whose parent(s)/legal guardian(s) were perceived to be unavailable or difficult to contact for evaluation or study visits during the study period - who had any serious chronic disease (eg, with signs of cardiac or renal failure or severe malnutrition), including progressive neurological disease - who had Down's syndrome or other known cytogenetic disorders who had a known or suspected disease of the immune system or those who received immunosuppressive therapy, including systemic corticosteroids. Subjects receiving high doses of systemic corticosteroids given daily or on alternate days, for 14 days or more, were excluded from vaccination until corticosteroid therapy was discontinued for at least one month. High doses were defined as 2 mg/kg/day or more of prednisolone or its equivalent, or 20 mg/day or more for children who weighed more than 10 kg.38 - who received, or were anticipated to receive, any blood products, including immunoglobulin, in the period from 6 months prior to vaccination through to the conclusion of the study - for whom there was intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study had an immunosuppressed or an immunocompromised individual living in the same household - who, at any time prior to entry into this study, received a dose of any influenza vaccine (commercial or investigational) - who, at any time prior to entry into this study, received a dose of MMR vaccine or any of the individual components of the MMR vaccine (commercial or investigational) - who were anticipated to receive a subsequent dose of MMR within 1 month after receipt of the second dose of CAIV-T or placebo - with a documented history of hypersensitivity to egg or egg protein or any other components of CAIV-T or MMR - who received aspirin (acetylsalicylic acid) or aspirin-containing products in the 2 weeks prior to vaccination or for which use is anticipated during the study - with any medical conditions that in the opinion of the Investigator might have interfered with interpretation of the study results Note: Pregnancy in any person who had regular contact with the subject was not a contraindication to the enrollment or ongoing participation of the subject in the study. |
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Singapore | Respiratory Medicine Service | Singapore |
Lead Sponsor | Collaborator |
---|---|
MedImmune LLC | Wyeth is now a wholly owned subsidiary of Pfizer |
Singapore,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | All episodes of AOM, occurring during the influenza season, associated with a positive culture for influenza virus antigenically similar to those contained in the vaccine. | |||
Secondary | The first episode during the influenza season of AOM associated with a positive culture for influenza virus; all episodes during the influenza season of AOM; all during the influenza season, of AOM associated with fever. |
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 |
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 |
NCT00971425 -
Evaluation of the Immune Response and the Safety of a Pandemic Influenza Candidate Vaccine (H1N1)
|
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 |
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 |
NCT03888989 -
Response to Influenza Vaccine During Pregnancy
|
Phase 1 | |
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 |