2009 H1N1 InfluenzaPhase 4H1N1ChildrenNCT01097941

Effect of Age and Prior Immunity on Response to H1N1 Vaccines in Children

A Phase 4 study testing Live Attenuated H1N1 Influenza Vaccine, Influenza A (H1N1) 2009 Monovalent Vaccine and Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine Live in people with 2009 H1N1 Influenza, run by University of Rochester at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

Who is it for?: Ages 4 to 9 yearsHealthy volunteers can take part
Conditions the study is for: 2009 H1N1 Influenza
What is being tested?: Live Attenuated H1N1 Influenza Vaccine, Influenza A (H1N1) 2009 Monovalent Vaccine and Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine Live
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: 1 siteUnited States
Study dates: Mar 2010to Sep 2010
Phase: Phase 4
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 4 to 9 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Aged between 4 and 9 years, inclusive.
Pre-vaccination serum HAI titer to A/California/07/09 of 8 or less
No prior history of laboratory documented infection with novel H1N1 virus or immunization with novel H1N1 vaccine.
in good health, as determined by: vital signs (heart rate <140 bpm; blood pressure: systolic ≥ 90 mm Hg and ≤140 mm Hg; diastolic ≤ 90 mm Hg; oral temperature <100.0ºF); medical history; and targeted physical examination, when necessary, based on medical history. Stable medical condition is defined as: no recent increase in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months.
subject/parents are able to understand and comply with the planned study procedures, including being available for all study visits.
subject/parents have provided informed consent prior to any study procedures. (An assent will be obtained for all children 6 years and older)

Who cannot join

a previous history of vaccination against novel H1N1 virus or a laboratory documented history of previous novel H1N1 infection.
History of egg allergy or allergy to other components of vaccine.
History of wheezing.
immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
has an active neoplastic disease.
has long-term (greater than 2 weeks) use of oral or parenteral steroids, or high-dose inhaled steroids (>800 mg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months (nasal and topical steroids are allowed).

Show all 15Show fewer

received immunoglobulin or another blood product within the 3 months prior to enrollment in this study.
has received an inactivated vaccine within the 2 weeks or a live vaccine within the 4 weeks prior to enrollment in this study or plans to receive another vaccine within the next 28 days (or 56 days for vaccine naïve recipients).
has an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses. These conditions include chronic conditions recognized as risk factors for influenza complications or as contraindications for live vaccination, including chronic cardiac (exclusive of hypertension) or pulmonary conditions (including asthma), diabetes mellitus, or renal impairment.
has an acute illness or an oral temperature greater than 99.9 degrees F (37.7 degrees C) within 3 days prior to enrollment or vaccination. Subjects who had an acute illness that was treated symptoms resolved are eligible to enroll as long as treatment is completed and symptoms resolve > 3 days prior to enrollment.
is currently participating or plans to participate in a study that involves an experimental agent (vaccine, drug, biologic, device, blood product, or medication) or has received an experimental agent within 1 month prior to enrollment in this study, or expects to receive another experimental agent during participation in this study, or intends to donate blood during the study period.
has any condition that would, in the opinion of the site investigator, place the subject at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
has a known human immunodeficiency virus, hepatitis B, or hepatitis C infection.
has a previous history of Guillain-Barré syndrome within 6 weeks of receipt of influenza vaccination.
has any condition that the principal investigator (PI) believes may interfere with successful completion of the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester Medical Center, Vaccine Research Unit Room 3-5000
Rochester, New York, 14642

Other trials in United States

About this study

Official title: Evaluation of the Effect of Age and Prior Immunity on the Response to Live or Inactivated A/California/07/09 H1N1 Influenza Vaccines in Children

A total of 51 children between the ages of 4 and 9 will be randomized to receive a two dose schedule of either licensed live attenuated A/California/07/09 influenza vaccine (LAIV) or licensed inactivated A/California/07/09 influenza vaccine (IIV) or IIV followed by LAIV separated by 28 days. Children with prior vaccination or natural infection with novel H1N1 influenza will be excluded. Randomization will be stratified by pre-existing HAI titers to the previous winter's seasonal H1N1 A/Brisbane/57/07 reference virus.

Read the detailed description

The study will be conducted as a randomized, prospective, open-label evaluation of the clinical tolerability, vaccine virus shedding, and serum and mucosal antibody response to vaccination with either live monovalent novel H1N1 influenza vaccine (LAIV) or monovalent inactivated novel H1N1 influenza vaccine (IIV) in healthy children between the ages of 4 and 9 years. Children will be screened for antibody to A/Brisbane/57/07 (H1N1) and A/California/07/09 (H1N1) prior to randomization. Children with evidence of prior exposure to the 2009 pandemic H1N1 virus will be excluded. Those with antibodies to A/Brisbane/57/07 (H1N1) will be stratified by preexisting antibody. Vaccine will be administered on days 0 and 28.

Safety of vaccination will be assessed using symptoms collected by parents for 7 days after each dose of vaccine. Serum will be obtained prior to and on day 28 following each dose of vaccine and assessed for antibody by HAI, ELISA, B-cell ELISPOT and neutralization techniques. Nasal secretions will be obtained by nasal aspiration prior to and on day 28 after each dose and assessed for HA-specific IgA antibody by ELISA. Nasal swabs will be obtained on days 2, 4, and 7 after each dose of live vaccine and assessed for the presence and magnitude of vaccine virus shedding of the live attenuated vaccine by rtRT-PCR and TCID50 on MDCK cells.

Conditions: 2009 H1N1 Influenza
Being tested: Live Attenuated H1N1 Influenza Vaccine, Influenza A (H1N1) 2009 Monovalent Vaccine, Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine Live
Keywords: Influenza, H1N1
Medical subject headings: Influenza, Human

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Live Attenuated H1N1 Influenza VaccineBiological
Also called Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal
0.2 ml dose of live monovalent vaccine delivered through nasal spray, 2 doses given 28 days apart
Influenza A (H1N1) 2009 Monovalent VaccineBiological
Also called Influenza vaccine
0.5 ml IM, 2 doses given 28 days apart
Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine LiveBiological
Also called Influenza Vaccine
0.5 ml IM given X1 with 0.1 ml intranasally given 28 days later

Study groups in NCT01097941
Study group	Role	What they receive
LAIV/LAIV	Active comparator	Not described Receives: Biological: Live Attenuated H1N1 Influenza Vaccine
IIV/IIV	Active comparator	Not described Receives: Biological: Influenza A (H1N1) 2009 Monovalent Vaccine
IIV/LAIV	Active comparator	Not described Receives: Biological: Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine Live

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C
Measured: nasal swabs obtained at days 2 post vaccination
The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C
Measured: nasal swab at 4 days post vaccination
The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C
Measured: nasal swab obtained at 7 days post vaccination

Secondary outcomes (10)

The AUC of nasopharyngeal shedding assessed by quantitative rtRT-PCR
Measured: swabs will be obtained on day 2 post vaccination
The frequency and magnitude of serum hemagglutination-inhibition (HAI), ELISA, and neutralizing antibody response to vaccine
Measured: at day 28
The frequency and magnitude of hemagglutinin-specific mucosal IgA response assessed by ELISA on nasal secretions
Measured: day 28
The frequency and magnitude of antibody secreting cell and memory B cells developing after vaccination
Measured: on day 7
Development of specific local and systemic symptoms occuring after vaccine
Measured: for 7 days post each vaccination
The AUC of nasopharyngeal shedding assessed by quantitative rtRT-PCR
Measured: swab obtained at day 4 post vaccination
The AUC of nasopharyngeal shedding assessed by quantitative rtRT-PCR
Measured: swab obtained at day 7 post vaccination
The frequency and magnitude of serum hemagglutination-inhibition (HAI), ELISA, and neutralizing antibody response to vaccine
Measured: at day 56
The frequency and magnitude of hemagglutinin-specific mucosal IgA response assessed by ELISA on nasal secretions
Measured: at day 56
The frequency and magnitude of antibody secreting cell and memory B cells developing after vaccination
Measured: on day 35

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2010Sep 2010

First posted2 Apr 2010 (estimated)
Study startMar 2010
Primary completionSep 2010
Study completionSep 2010

Why it stopped: Live H1N1 vaccine expired and unable to get new supply

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (10)Papers the sponsor has linked to this study.
Other trials for 2009 H1N1 InfluenzaStudies of the same condition, open and under way.
More trials run by University of RochesterThe sponsor's other registered studies.
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: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01097941
Sponsor's protocol ID: URMC 09-007
Acronym: H1N1Children
Status last verified: Sep 2015
First submitted: 30 Mar 2010
Last updated: 24 Sep 2015
Results posted: No
Data monitoring committee: No

Publications

Hancock K, Veguilla V, Lu X, Zhong W, Butler EN, Sun H, Liu F, Dong L, DeVos JR, Gargiullo PM, Brammer TL, Cox NJ, Tumpey TM, Katz JM. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med. 2009 Nov 12;361(20):1945-52. doi: 10.1056/NEJMoa0906453. Epub 2009 Sep 10.
PubMed 19745214
Shinde V, Bridges CB, Uyeki TM, Shu B, Balish A, Xu X, Lindstrom S, Gubareva LV, Deyde V, Garten RJ, Harris M, Gerber S, Vagasky S, Smith F, Pascoe N, Martin K, Dufficy D, Ritger K, Conover C, Quinlisk P, Klimov A, Bresee JS, Finelli L. Triple-reassortant swine influenza A (H1) in humans in the United States, 2005-2009. N Engl J Med. 2009 Jun 18;360(25):2616-25. doi: 10.1056/NEJMoa0903812. Epub 2009 May 7.
PubMed 19423871
Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.
PubMed 19745216
Belshe RB, Edwards KM, Vesikari T, Black SV, Walker RE, Hultquist M, Kemble G, Connor EM; CAIV-T Comparative Efficacy Study Group. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med. 2007 Feb 15;356(7):685-96. doi: 10.1056/NEJMoa065368.
PubMed 17301299
Maassab HF. Biologic and immunologic characteristics of cold-adapted influenza virus. J Immunol. 1969 Mar;102(3):728-32. No abstract available.
PubMed 5773321
Chanock RM, Murphy BR. Use of temperature-sensitive and cold-adapted mutant viruses in immunoprophylaxis of acute respiratory tract disease. Rev Infect Dis. 1980 May-Jun;2(3):421-32. doi: 10.1093/clinids/2.3.421.
PubMed 6997969
Boyce TG, Gruber WC, Coleman-Dockery SD, Sannella EC, Reed GW, Wolff M, Wright PF. Mucosal immune response to trivalent live attenuated intranasal influenza vaccine in children. Vaccine. 1999 Aug 20;18(1-2):82-8. doi: 10.1016/s0264-410x(99)00183-8.
PubMed 10501238
Sasaki S, Jaimes MC, Holmes TH, Dekker CL, Mahmood K, Kemble GW, Arvin AM, Greenberg HB. Comparison of the influenza virus-specific effector and memory B-cell responses to immunization of children and adults with live attenuated or inactivated influenza virus vaccines. J Virol. 2007 Jan;81(1):215-28. doi: 10.1128/JVI.01957-06. Epub 2006 Oct 18.
PubMed 17050593
Cox RJ, Brokstad KA, Zuckerman MA, Wood JM, Haaheim LR, Oxford JS. An early humoral immune response in peripheral blood following parenteral inactivated influenza vaccination. Vaccine. 1994 Aug;12(11):993-9. doi: 10.1016/0264-410x(94)90334-4.
PubMed 7975853
He XS, Holmes TH, Zhang C, Mahmood K, Kemble GW, Lewis DB, Dekker CL, Greenberg HB, Arvin AM. Cellular immune responses in children and adults receiving inactivated or live attenuated influenza vaccines. J Virol. 2006 Dec;80(23):11756-66. doi: 10.1128/JVI.01460-06. Epub 2006 Sep 13.
PubMed 16971435

Study at a glance

From the registry record, last updated by the sponsor on 24 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of the Effect of Age and Prior Immunity on the Response to Live or Inactivated A/California/07/09 H1N1 Influenza Vaccines in Children
ClinicalTrials.gov ID: NCT01097941
Acronym / sponsor ID: H1N1Children / URMC 09-007
Conditions: 2009 H1N1 Influenza
Keywords: Influenza, H1N1
Phase: Phase 4
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Live H1N1 vaccine expired and unable to get new supply
Enrolment: 0 participants (actual)
Lead sponsor: University of RochesterUniversity, hospital or other
Collaborators: National Institutes of Health (NIH)
Study start: Mar 2010
Primary completion: Sep 2010 (actual)
Study completion: Sep 2010 (actual)
First posted: 2 Apr 2010 (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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
LAIV/LAIV	Active comparator	Biological: Live Attenuated H1N1 Influenza Vaccine
IIV/IIV	Active comparator	Biological: Influenza A (H1N1) 2009 Monovalent Vaccine
IIV/LAIV	Active comparator	Biological: Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine Live

Who may qualify

Ages: 4 to 9 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (6 listed)

Aged between 4 and 9 years, inclusive.
Pre-vaccination serum HAI titer to A/California/07/09 of 8 or less
No prior history of laboratory documented infection with novel H1N1 virus or immunization with novel H1N1 vaccine.
in good health, as determined by: vital signs (heart rate <140 bpm; blood pressure: systolic ≥ 90 mm Hg and ≤140 mm Hg; diastolic ≤ 90 mm Hg; oral temperature <100.0ºF); medical history; and targeted physical examination, when necessary, based on medical history. Stable medical condition is defined as: no recent increase in prescription medication, dose, or frequency of medication in the last 3 months and health outcomes of the specific disease are considered to be within acceptable limits in the last 6 months.
subject/parents are able to understand and comply with the planned study procedures, including being available for all study visits.

Key exclusion criteria (15 listed)

a previous history of vaccination against novel H1N1 virus or a laboratory documented history of previous novel H1N1 infection.
History of egg allergy or allergy to other components of vaccine.
History of wheezing.
immunosuppressed as a result of an underlying illness or treatment with immunosuppressive or cytotoxic drugs, or use of anticancer chemotherapy or radiation therapy.
has an active neoplastic disease.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Live Attenuated H1N1 Influenza VaccineAlso: Influenza A (H1N1) 2009 Monovalent Vaccine Live, Intranasal0.2 ml dose of live monovalent vaccine delivered through nasal spray, 2 doses given 28 days apart	Biological	LAIV/LAIV
Influenza A (H1N1) 2009 Monovalent VaccineAlso: Influenza vaccine0.5 ml IM, 2 doses given 28 days apart	Biological	IIV/IIV
Influenza A (H1N1) 2009 Monovalent Vaccine/ Influenza A (H1N1) Monovalent Vaccine LiveAlso: Influenza Vaccine0.5 ml IM given X1 with 0.1 ml intranasally given 28 days later	Biological	IIV/LAIV

Primary outcome

The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C
Time frame: nasal swabs obtained at days 2 post vaccination
The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C
Time frame: nasal swab at 4 days post vaccination
The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C
Time frame: nasal swab obtained at 7 days post vaccination

10 secondary outcomes

The AUC of nasopharyngeal shedding assessed by quantitative rtRT-PCR
Time frame: swabs will be obtained on day 2 post vaccination
The frequency and magnitude of serum hemagglutination-inhibition (HAI), ELISA, and neutralizing antibody response to vaccine
Time frame: at day 28
The frequency and magnitude of hemagglutinin-specific mucosal IgA response assessed by ELISA on nasal secretions
Time frame: day 28
The frequency and magnitude of antibody secreting cell and memory B cells developing after vaccination
Time frame: on day 7
Development of specific local and systemic symptoms occuring after vaccine
Time frame: for 7 days post each vaccination
The AUC of nasopharyngeal shedding assessed by quantitative rtRT-PCR
Time frame: swab obtained at day 4 post vaccination
The AUC of nasopharyngeal shedding assessed by quantitative rtRT-PCR
Time frame: swab obtained at day 7 post vaccination
The frequency and magnitude of serum hemagglutination-inhibition (HAI), ELISA, and neutralizing antibody response to vaccine
Time frame: at day 56
The frequency and magnitude of hemagglutinin-specific mucosal IgA response assessed by ELISA on nasal secretions
Time frame: at day 56
The frequency and magnitude of antibody secreting cell and memory B cells developing after vaccination
Time frame: on day 35

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2015.
Background: PubMed 19745214Hancock K, Veguilla V, Lu X, Zhong W, Butler EN, Sun H, Liu F, Dong L, DeVos JR, Gargiullo PM, Brammer TL, Cox NJ, Tumpey TM, Katz JM. Cross-reactive antibody responses to the 2009 pandemic H1N1 influenza virus. N Engl J Med. 2009 Nov 12;361(20):1945-52. doi: 10.1056/NEJMoa0906453. Epub 2009 Sep 10.
Background: PubMed 19423871Shinde V, Bridges CB, Uyeki TM, Shu B, Balish A, Xu X, Lindstrom S, Gubareva LV, Deyde V, Garten RJ, Harris M, Gerber S, Vagasky S, Smith F, Pascoe N, Martin K, Dufficy D, Ritger K, Conover C, Quinlisk P, Klimov A, Bresee JS, Finelli L. Triple-reassortant swine influenza A (H1) in humans in the United States, 2005-2009. N Engl J Med. 2009 Jun 18;360(25):2616-25. doi: 10.1056/NEJMoa0903812. Epub 2009 May 7.
Background: PubMed 19745216Greenberg ME, Lai MH, Hartel GF, Wichems CH, Gittleson C, Bennet J, Dawson G, Hu W, Leggio C, Washington D, Basser RL. Response to a monovalent 2009 influenza A (H1N1) vaccine. N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.
Background: PubMed 17301299Belshe RB, Edwards KM, Vesikari T, Black SV, Walker RE, Hultquist M, Kemble G, Connor EM; CAIV-T Comparative Efficacy Study Group. Live attenuated versus inactivated influenza vaccine in infants and young children. N Engl J Med. 2007 Feb 15;356(7):685-96. doi: 10.1056/NEJMoa065368.
Background: PubMed 5773321Maassab HF. Biologic and immunologic characteristics of cold-adapted influenza virus. J Immunol. 1969 Mar;102(3):728-32. No abstract available.
Background: PubMed 6997969Chanock RM, Murphy BR. Use of temperature-sensitive and cold-adapted mutant viruses in immunoprophylaxis of acute respiratory tract disease. Rev Infect Dis. 1980 May-Jun;2(3):421-32. doi: 10.1093/clinids/2.3.421.
Background: PubMed 10501238Boyce TG, Gruber WC, Coleman-Dockery SD, Sannella EC, Reed GW, Wolff M, Wright PF. Mucosal immune response to trivalent live attenuated intranasal influenza vaccine in children. Vaccine. 1999 Aug 20;18(1-2):82-8. doi: 10.1016/s0264-410x(99)00183-8.
Background: PubMed 17050593Sasaki S, Jaimes MC, Holmes TH, Dekker CL, Mahmood K, Kemble GW, Arvin AM, Greenberg HB. Comparison of the influenza virus-specific effector and memory B-cell responses to immunization of children and adults with live attenuated or inactivated influenza virus vaccines. J Virol. 2007 Jan;81(1):215-28. doi: 10.1128/JVI.01957-06. Epub 2006 Oct 18.
Background: PubMed 7975853Cox RJ, Brokstad KA, Zuckerman MA, Wood JM, Haaheim LR, Oxford JS. An early humoral immune response in peripheral blood following parenteral inactivated influenza vaccination. Vaccine. 1994 Aug;12(11):993-9. doi: 10.1016/0264-410x(94)90334-4.
Background: PubMed 16971435He XS, Holmes TH, Zhang C, Mahmood K, Kemble GW, Lewis DB, Dekker CL, Greenberg HB, Arvin AM. Cellular immune responses in children and adults receiving inactivated or live attenuated influenza vaccines. J Virol. 2006 Dec;80(23):11756-66. doi: 10.1128/JVI.01460-06. Epub 2006 Sep 13.

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.

John J Treanor, MD principal investigator

University of Rochester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 15 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: withdrawn, as of the sponsor's last update on 24 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

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?

The primary endpoint for assessment of the live attenuated vaccine take will be the AUC of the live vaccine virus shedding determined by 50% tissue culture infectious dose (TCID ) on MDCK cells at 33 degrees C (time frame: nasal swabs obtained at days 2 post vaccination). The study lists 3 primary outcomes in all. 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 NCT01097941, which also lists 10 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 24 Sep 2015.