Influenza Vaccine EffectivenessICICLENCT01997450
A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age
An observational study of Influenza Vaccine Effectiveness, run by MedImmune LLC at 12 sites in 2 countries.
Trial summary
This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza Vaccine (IIV) and No Vaccine in subjects 2-17 years of age. Read more about this study
- Who is it for?
- Ages 2 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza Vaccine Effectiveness
- Type of treatment
- Vaccines
- How many people
- 4,121 participants
- Where
- 12 sitesin 2 countries
- Study dates
- 2 Dec 2013to 15 Apr 2016
- Phase
- Observational
- 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 2 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Subjects 2 to 17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness.
Who may be able to join
- Community-dwelling children and adolescents 2 to 17 years of age.
- Written Informed Consent or Assent.
- Acute respiratory illness documented at study visit or at home with fever (oral temperature ≥ 100.0° Fahrenheit at study visit, or history of fever reported by parents, or use of antipyretic prior to study visit)
- Symptom onset less than 5 days prior to study visit.
- Subject and/or subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator.
Who cannot join
- Treatment with an antiviral drug for influenza (oseltamivir or Tamiflu®, zanamivir or Relenza®) during the 14 days before enrollment
- Any condition that, in the opinion of the investigator, would interfere with interpretation of subject safety or study results
- Concurrent enrollment in another clinical study
- Patient already enrolled during this influenza season
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
Trial locations and contacts
12 sites in 2 countries.
12 sites in 2 countries
United States8 sites
Research Site
Akron, Ohio, 44308-1063
Research Site
Bloomington, Minnesota, 55440
Research Site
Gainesville, Florida, 32608
Research Site
Marshfield, Wisconsin, 54449
Research Site
Nashville, Tennessee, 37212
Research Site
Portland, Oregon, 97227
Research Site
Temple, Texas, 76508
Research Site
Winston-Salem, North Carolina, 27157
United Kingdom4 sites
Research Site
Bristol, BS2 8AE
Research Site
Oxford, OX3 7EJ
Research Site
Southampton, SO16 6YD
Research Site
Tooting, SW17 0QT
About this study
This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza Vaccine (IIV) and No Vaccine in subjects 2-17 years of age.
Read the detailed description
This post-marketing study will enroll approximately 5,200 subjects 2-17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness. This study will begin in the fall of 2013 and will be completed after 4 influenza seasons (i.e.after the 2016-2017 influenza season). No investigational product will be administered in this study. A nasal swab will be obtained and tested for the presence of influenza virus and other viral pathogens. This study will be conducted at 4 sites in the United States of America. The duration of study participation for each subject is one day.
- Conditions
- Influenza Vaccine Effectiveness
- Keywords
- Q/LAIV/FluMist® Quadrivalent Vaccine, Inactivated Influenza Vaccine (IIV), Effectiveness, Influenza
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Q/LAIV | FluMist Quadrivalent | |
| Inactivated Influenza Vaccine | Inactivated Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of cases positive for wild-type influenza with an end-point PCR genotyping assay.
Vaccine Effectiveness is defined as 100 x (1-odds ratio), where the odds ratio is the odds of exposures (Q/LAIV versus Inactivated Influenza Vaccine or no vaccine) among laboratory confirmed cases of flu versus controls. Effectiveness will be monitored by flu season, class of age and by influenza strain.
Measured: Up to 6 months for each individual flu season
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2013 (estimated)
- Study start2 Dec 2013
- Primary completion15 Apr 2016
- Study completion15 Apr 2016
Why it stopped: FDA did not require the fourth season of recruitment as planned originally. Study closed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Influenza Vaccine EffectivenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 4,121 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Responsible party
- Sponsor
- Investigators
- Herve Caspard, MD, Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01997450
- Sponsor's protocol ID
- MA-VA-MEDI3250-1116
- Acronym
- ICICLE
- Status last verified
- Feb 2025
- First submitted
- 6 Nov 2013
- Last updated
- 10 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Publications
Poehling KA, Caspard H, Peters TR, Belongia EA, Congeni B, Gaglani M, Griffin MR, Irving SA, Kavathekar PK, McLean HQ, Naleway AL, Ryan K, Talbot HK, Ambrose CS. 2015-2016 Vaccine Effectiveness of Live Attenuated and Inactivated Influenza Vaccines in Children in the United States. Clin Infect Dis. 2018 Feb 10;66(5):665-672. doi: 10.1093/cid/cix869.
PubMed 29029064McLean HQ, Caspard H, Griffin MR, Poehling KA, Gaglani M, Belongia EA, Talbot HK, Peters TR, Murthy K, Ambrose CS. Effectiveness of live attenuated influenza vaccine and inactivated influenza vaccine in children during the 2014-2015 season. Vaccine. 2017 May 9;35(20):2685-2693. doi: 10.1016/j.vaccine.2017.03.085. Epub 2017 Apr 10.
PubMed 28408121Caspard H, Coelingh KL, Mallory RM, Ambrose CS. Association of vaccine handling conditions with effectiveness of live attenuated influenza vaccine against H1N1pdm09 viruses in the United States. Vaccine. 2016 Sep 30;34(42):5066-5072. doi: 10.1016/j.vaccine.2016.08.079. Epub 2016 Sep 6.
PubMed 27613072
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Case Control Study of the Effectiveness of Q/LAIV Versus Inactivated Influenza Vaccine and No Vaccine in Subjects 2-17 Years of Age
- ClinicalTrials.gov ID
- NCT01997450
- Acronym / sponsor ID
- ICICLE / MA-VA-MEDI3250-1116
- Conditions
- Influenza Vaccine Effectiveness
- Keywords
- Q/LAIV/FluMist® Quadrivalent Vaccine, Inactivated Influenza Vaccine (IIV), Effectiveness, Influenza
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: FDA did not require the fourth season of recruitment as planned originally. Study closed.
- Enrolment
- 4,121 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- AstraZeneca
- Study start
- 2 Dec 2013 (actual)
- Primary completion
- 15 Apr 2016 (actual)
- Study completion
- 15 Apr 2016 (actual)
- First posted
- 28 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a post-marketing case-controlled study of the effectiveness of a quadrivalent live attenuated influenza vaccine (Q/LAIV/FluMist® Quadrivalent) versus Inactivated Influenza Vaccine (IIV) and No Vaccine in subjects 2-17 years of age.
Detailed description
This post-marketing study will enroll approximately 5,200 subjects 2-17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness. This study will begin in the fall of 2013 and will be completed after 4 influenza seasons (i.e.after the 2016-2017 influenza season). No investigational product will be administered in this study. A nasal swab will be obtained and tested for the presence of influenza virus and other viral pathogens. This study will be conducted at 4 sites in the United States of America. The duration of study participation for each subject is one day.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Q/LAIV | – | –FluMist Quadrivalent |
| Inactivated Influenza Vaccine | – | –Inactivated Influenza Vaccine |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Subjects 2 to 17 years of age who are seeking care in an outpatient setting for febrile acute respiratory illness.
Key inclusion criteria (5 listed)
- Community-dwelling children and adolescents 2 to 17 years of age.
- Written Informed Consent or Assent.
- Acute respiratory illness documented at study visit or at home with fever (oral temperature ≥ 100.0° Fahrenheit at study visit, or history of fever reported by parents, or use of antipyretic prior to study visit)
- Symptom onset less than 5 days prior to study visit.
- Subject and/or subject's legal representative is able to understand and comply with the requirements of the protocol as judged by the investigator.
Key exclusion criteria (5 listed)
- Treatment with an antiviral drug for influenza (oseltamivir or Tamiflu®, zanamivir or Relenza®) during the 14 days before enrollment
- Any condition that, in the opinion of the investigator, would interfere with interpretation of subject safety or study results
- Concurrent enrollment in another clinical study
- Patient already enrolled during this influenza season
- Employees of the clinical study site or any other individuals involved with the conduct of the study, or immediate family members of such individuals.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Identification of cases positive for wild-type influenza with an end-point PCR genotyping assay.
Time frame: Up to 6 months for each individual flu season
Vaccine Effectiveness is defined as 100 x (1-odds ratio), where the odds ratio is the odds of exposures (Q/LAIV versus Inactivated Influenza Vaccine or no vaccine) among laboratory confirmed cases of flu versus controls. Effectiveness will be monitored by flu season, class of age and by influenza strain.
Results and safety
The study was stopped early (reason given: FDA did not require the fourth season of recruitment as planned originally. Study closed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2025.
- Derived from this study: PubMed 29029064Poehling KA, Caspard H, Peters TR, Belongia EA, Congeni B, Gaglani M, Griffin MR, Irving SA, Kavathekar PK, McLean HQ, Naleway AL, Ryan K, Talbot HK, Ambrose CS. 2015-2016 Vaccine Effectiveness of Live Attenuated and Inactivated Influenza Vaccines in Children in the United States. Clin Infect Dis. 2018 Feb 10;66(5):665-672. doi: 10.1093/cid/cix869.
- Derived from this study: PubMed 28408121McLean HQ, Caspard H, Griffin MR, Poehling KA, Gaglani M, Belongia EA, Talbot HK, Peters TR, Murthy K, Ambrose CS. Effectiveness of live attenuated influenza vaccine and inactivated influenza vaccine in children during the 2014-2015 season. Vaccine. 2017 May 9;35(20):2685-2693. doi: 10.1016/j.vaccine.2017.03.085. Epub 2017 Apr 10.
- Derived from this study: PubMed 27613072Caspard H, Coelingh KL, Mallory RM, Ambrose CS. Association of vaccine handling conditions with effectiveness of live attenuated influenza vaccine against H1N1pdm09 viruses in the United States. Vaccine. 2016 Sep 30;34(42):5066-5072. doi: 10.1016/j.vaccine.2016.08.079. Epub 2016 Sep 6.
- redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Herve Caspard, MD study director
MedImmune LLC
12 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza Vaccine Effectiveness, run by MedImmune LLC at 12 sites in 2 countries.
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 5 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: stopped early, as of the sponsor's last update on 10 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, United Kingdom. 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.
Are results available for this study?
The study was stopped early (reason given: FDA did not require the fourth season of recruitment as planned originally. Study closed.). Results are not available in the source record.
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?
Identification of cases positive for wild-type influenza with an end-point PCR genotyping assay. (time frame: Up to 6 months for each individual flu season). 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 NCT01997450, which also lists 3 linked publications.
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 10 Mar 2025.