InfluenzaPhase 4MI-CP217NCT00946101

A Study to Evaluate the Safety of HIN1 Monovalent Vaccine (MEDI3414) in Children 2 to 17 Years of Age

A Phase 4 study testing MEDI3414 [Influenza A(H1N1) live attenuated, intranasal] in people with Influenza, run by MedImmune LLC at 16 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy children. Read more about this study

Who is it for?: Ages 2 to 17 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]
Type of treatment: Vaccines
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 326 participants
Where: 16 sitesUnited States
Study dates: Aug 2009to Mar 2010
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

Male or female, 2 to 17 years of age (not yet reached their 18th birthday) at the time of randomization
Healthy by medical history and physical exam
Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU and written informed assent) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
Females of child-bearing potential, (ie, unless premenarchal, surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male partner, or practices abstinence) must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of investigational product, and must agree to continue using such precautions for 60 days after the second dose of investigational product. In addition, the subject must also have a negative urine or blood pregnancy test at screening and, if screening and Day 1 do not occur on the same day, on the day of vaccination prior to randomization. Investigator judgment is required to assess the childbearing potential of a pre-adolescent or adolescent girl.
Males, unless not sexually active, must use an effective method of birth control with a female partner and must agree to continue using such contraceptive precautions for at least 30 days after the second dose of investigational product (from Day 1 through Day 59 of the study)
Subject's legal representative available by telephone
Subject/subject's legal representative is able to understand and comply with the requirements of the protocol, as judged by the investigator
Ability to complete follow-up period of 180 days after Dose 2 as required by the protocol

Who cannot join

History of hypersensitivity to any component of the investigational product including egg or egg protein, gelatin or arginine, or serious, life-threatening, or severe reactions to previous influenza vaccinations
History of hypersensitivity to gentamicin
Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (eg, asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
Acute febrile (> 100.0°F oral or equivalent) and/or clinically significant respiratory illness (eg, cough or sore throat) within 14 days prior to randomization
History of asthma, or in children < 5 years of age, history of recurrent wheezing
Any known immunosuppressive condition or immune deficiency disease, including human immunodeficiency virus infection, or ongoing immunosuppressive therapy

Show all 17Show fewer

History of Guillain-Barré syndrome
A household contact who is severely immunocompromised (eg, hematopoietic stem cell transplant recipient, during those periods in which the immunocompromised individual requires care in a protective environment); subject should additionally avoid close contact with severely immunocompromised individuals for at least 21 days after receipt of investigational product
Receipt of any investigational agent within 30 days prior to randomization, or expected receipt through 30 days after the second dose of investigational product (use of licensed agents for indications not listed in the package insert is permitted)
Use of aspirin or salicylate-containing products within 30 days prior to randomization or expected receipt through 30 days after final vaccination
Expected receipt of antipyretic or analgesic medication (non-salicylate-containing) on a daily or every other day basis from randomization through 14 days after receipt of each dose of investigational product
Administration of intranasal medications within 14 days prior to randomization, or expected receipt through 14 days after administration of each dose of investigational product
Receipt of any nonstudy vaccine within 30 days before or after Dose 1 or expected receipt of any nonstudy vaccine within 30 days before or after Dose 2
Known or suspected mitochondrial encephalomyopathy
Adolescent subject is pregnant or a nursing mother
Any condition (eg, chronic cough, allergic rhinitis) that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results
Subject, legal representative, or immediate family member of subject is an employee of the clinical study site or is otherwise in involved with the conduct of the study

Trial locations and contacts

16 sites in 1 country.

City, postcode or hospital

16 sites in 1 country

United States16 sites

Benchmark Research
Austin, Texas, 78705
Kentucky Pediatric Research Center
Bardstown, Kentucky, 40004
Benchmark Research Ft. Worth
Fort Worth, Texas, 76135
Clinical Research Center of Nevada
Henderson, Nevada, 89105
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, 40509
Coastal Clinic Research, Inc.
Mobile, Alabama, 36608
Meridian Clinical Research
Omaha, Nebraska, 68134
Primary Physicians Research, Inc.
Pittsburgh, Pennsylvania, 15241
Rochester Clinical Research Inc.
Rochester, New York, 14069
Benchmark Research
Sacramento, California, 95816
Benchmark Research San Angelo
San Angelo, Texas, 76904
California Research Foundation
San Diego, California, 92103-6204
Benchmark Research
San Francisco, California, 94102
Spartanburg Medical Research
Spartanburg, South Carolina, 29303
Sundance Clinical Research
St Louis, Missouri, 63141
Omega Medical Research
Warwick, Rhode Island, 02886

Other trials in United States

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Children

The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy children.

Read the detailed description

The primary objective of this study was to assess the safety and descriptive immunogenicity of a monovalent influenza virus vaccine containing a new 6:2 influenza virus reassortant in healthy children.

Conditions: Influenza
Being tested: MEDI3414 [Influenza A(H1N1) live attenuated, intranasal], Placebo
Keywords: randomized, double-blind, placebo-controlled
Medical subject headings: Influenza, Human

What participants receive

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

MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]Biological
0.5 mL: (intranasal sprayer)
PlaceboBiological
Placebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer

Study groups in NCT00946101
Study group	Role	What they receive
MEDI3414 [Influenza A (H1N1) vaccine]	Active comparator	MEDI3414- Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of influenza virus type A/California/07/2009. Receives: Biological: MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]
Placebo	Placebo comparator	Placebo - Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer Receives: Biological: Placebo

What is being measured

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

Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C).
The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference < 10%.
Measured: Days 1- 8
Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
Seroresponse is described as greater than or equal to a 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses was based on the immunogenicity population.
Measured: Day 1, Day 15
Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.
Measured: Day 1, Day 29
Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.
Measured: Day 1, Day 57

Secondary outcomes (24)

Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 1
Other solicited symptoms include fever (> 100°F [37.8°C] axillary), runny/stuffy nose, sore throat, cough, headache, generalized muscle aches, decreased activity level (lethargy) or tiredness/weakness, decreased appetite.
Measured: Days 1-8
Number of Participants Reporting Adverse Events (AEs) Within 7 Days After Vaccination With Investigational Product, Dose 1
Measured: Days 1-8
Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 1
Measured: Days 1-8
Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 1
Measured: Days 1-15
Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 1
Measured: Days 1-15
Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 1
Measured: Days 1-15
Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 2
Measured: Days 29-36
Number of Participants Reporting AEs Within 7 Days After Vaccination With Investigational Product, Dose 2
Measured: Days 29-36
Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 2
Measured: Days 29-36
Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 2
Measured: Days 29-43
Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 2
Measured: Days 29-43
Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 2
Measured: Days 29-43
Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days After Vaccination With Investigational Product, Dose 1.
An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).
Measured: Days 1-29
Number of Participants With Serious Adverse Events (SAEs) Within 28 Days After Vaccination With Investigational Product, Dose 1
SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Days 1-29
Number of Participants With NOCDs Within 28 Days After Vaccination With Investigational Product, Dose 2.
An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).
Measured: Days 29-57
Number of Participants With SAEs Within 28 Days After Vaccination With Investigational Product, Dose 2
SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Days 29-57
Number of Participants With NOCDs Within 180 Days Post Final Dose of Investigational Product.
An NOCD was a newly diagnosed medical condition that was of a chronic, ongoing nature and was assessed by the investigator as medically significant. Examples of NOCDs included, but were not limited to, diabetes, asthma, autoimmune disease (eg, lupus, rheumatoid arthritis), and neurological disease (eg, epilepsy, autism). Examples of events not considered NOCDs were mild eczema, diagnosis of a congenital anomaly present at study entry, or acute illness (eg, otitis media, bronchitis).
Measured: Days 1-209
Number of Participants With SAEs Within 180 Days Post Final Dose of Investigational Product.
SAEs were those AEs that resulted in death; were immediately life threatening; resulted in inpatient hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability or incapacity; were a congenital anomaly in the offspring of a participant; or were an important medical event that may not have resulted in death, threatened life, or required hospitalization and that, based on appropriate medical judgment, may have jeopardized the participant and may have required medical or surgical intervention to prevent one of the outcomes listed above.
Measured: Days 1-209
Number of Participants Who Achieve a Post Dose 1 (Day 15) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.
All immunogenicity analyses are based on the immunogenicity population.
Measured: Day 1, Day 15
Number of Participants Who Achieve a Post Dose 1 (Day 29) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.
All immunogenicity analyses are based on the immunogenicity population.
Measured: Day 1, Day 29
Number of Participants Who Achieve a Post Dose 2 (Day 57) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.
All immunogenicity analyses are based on the immunogenicity population.
Measured: Day 1, Day 57
Serum HAI Geometric Mean Titers (GMTs) in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 15)
All immunogenicity analyses are based on the immunogenicity population.
Measured: Day 1, Day 15
Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 29)
All immunogenicity analyses are based on the immunogenicity population.
Measured: Day 1, Day 29
Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 2 (Day 57)
All immunogenicity analyses are based on the immunogenicity population.
Measured: Day 1, Day 57

Timeline

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

Aug 2009Mar 2010

First posted24 Jul 2009 (estimated)
Study startAug 2009
Primary completionSep 2009
Study completionMar 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies 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: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 326 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00946101
Sponsor's protocol ID: MI-CP217
Other IDs: HHS/ASPR
Acronym: MI-CP217
Status last verified: Jul 2011
First submitted: 23 Jul 2009
Last updated: 11 Aug 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

Mallory RM, Malkin E, Ambrose CS, Bellamy T, Shi L, Yi T, Jones T, Kemble G, Dubovsky F. Safety and immunogenicity following administration of a live, attenuated monovalent 2009 H1N1 influenza vaccine to children and adults in two randomized controlled trials. PLoS One. 2010 Oct 29;5(10):e13755. doi: 10.1371/journal.pone.0013755.
PubMed 21060780

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety of MEDI3414 in Children
ClinicalTrials.gov ID: NCT00946101
Acronym / sponsor ID: MI-CP217 / MI-CP217
Conditions: Influenza
Keywords: randomized, double-blind, placebo-controlled
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 326 participants (actual)
Lead sponsor: MedImmune LLCIndustry (pharma, biotech, devices)
Collaborators: Department of Health and Human Services
Study start: Aug 2009
Primary completion: Sep 2009 (actual)
Study completion: Mar 2010 (actual)
First posted: 24 Jul 2009 (estimated)
Results: Posted 11 Aug 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this study was to determine the safety and descriptive immunogenicity of the H1N1 influenza vaccine in healthy children.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
MEDI3414 [Influenza A (H1N1) vaccine]	Active comparator	Biological: MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]MEDI3414- Monovalent vaccine was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer, egg allantoic fluid, and approximately 10^7 FFU (fluorescent focus units) of influenza virus type A/California/07/2009.
Placebo	Placebo comparator	Biological: PlaceboPlacebo - Placebo was supplied in intranasal sprayers containing a total volume of 0.5 mL of sucrose-phosphate buffer

Who may qualify

Ages: 2 to 17 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

Male or female, 2 to 17 years of age (not yet reached their 18th birthday) at the time of randomization
Healthy by medical history and physical exam
Written informed consent and any locally required authorization (eg, Health Insurance Portability and Accountability Act [HIPAA] in the United States of America [USA], European Union [EU] Data Privacy Directive in the EU and written informed assent) obtained from the subject/legal representative prior to performing any protocol-related procedures, including screening evaluations
Females of child-bearing potential, (ie, unless premenarchal, surgically sterile [eg, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy], has sterile male partner, or practices abstinence) must use an effective method of avoiding pregnancy (including oral, transdermal, or implanted contraceptives, intrauterine device, female condom with spermicide, diaphragm with spermicide, cervical cap, or use of a condom with spermicide by the sexual partner) for 30 days prior to the first dose of investigational product, and must agree to continue using such precautions for 60 days after the second dose of investigational product. In addition, the subject must also have a negative urine or blood pregnancy test at screening and, if screening and Day 1 do not occur on the same day, on the day of vaccination prior to randomization. Investigator judgment is required to assess the childbearing potential of a pre-adolescent or adolescent girl.
Males, unless not sexually active, must use an effective method of birth control with a female partner and must agree to continue using such contraceptive precautions for at least 30 days after the second dose of investigational product (from Day 1 through Day 59 of the study)

Key exclusion criteria (17 listed)

History of hypersensitivity to any component of the investigational product including egg or egg protein, gelatin or arginine, or serious, life-threatening, or severe reactions to previous influenza vaccinations
History of hypersensitivity to gentamicin
Any condition for which the inactivated influenza vaccine is indicated, including chronic disorders of the pulmonary or cardiovascular systems (eg, asthma), chronic metabolic diseases (eg, diabetes mellitus), renal dysfunction, or hemoglobinopathies that required regular medical follow-up or hospitalization during the preceding year
Acute febrile (> 100.0°F oral or equivalent) and/or clinically significant respiratory illness (eg, cough or sore throat) within 14 days prior to randomization
History of asthma, or in children < 5 years of age, history of recurrent wheezing

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
MEDI3414 [Influenza A(H1N1) live attenuated, intranasal]0.5 mL: (intranasal sprayer)	Biological	MEDI3414 [Influenza A (H1N1) vaccine]
PlaceboPlacebo was supplied in intranasal sprayers containing 0.5 mL of sucrose-phosphate buffer	Biological	Placebo

Primary outcome

Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C).
Time frame: Days 1- 8
The number of participants with fever between the two treatment groups was compared based on the upper limit of the two-sided 95% exact confidence intervals for the rate difference (Vaccine minus Placebo). The upper limit of the two-sided 95% confidence intervals was evaluated against the prespecified equivalence criterion of 10% which corresponded to the following hypotheses: H0 (null): rate difference ≥ 10%, HA (alternative): rate difference < 10%.
Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
Time frame: Day 1, Day 15
Seroresponse is described as greater than or equal to a 4-fold rise in hemagglutination inhibition (HAI) titer from baseline. All immunogenicity analyses was based on the immunogenicity population.
Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
Time frame: Day 1, Day 29
Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.
Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus
Time frame: Day 1, Day 57
Seroresponse is described as greater than or equal to a 4-fold rise in HAI titer from baseline. All immunogenicity analyses are based on the immunogenicity population.

24 secondary outcomes

Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 1
Time frame: Days 1-8
Number of Participants Reporting Adverse Events (AEs) Within 7 Days After Vaccination With Investigational Product, Dose 1
Time frame: Days 1-8
Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 1
Time frame: Days 1-8
Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 1
Time frame: Days 1-15
Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 1
Time frame: Days 1-15
Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 1
Time frame: Days 1-15
Number of Participants With Any Solicited Symptoms Within 7 Days After Vaccination With Investigational Product, Dose 2
Time frame: Days 29-36
Number of Participants Reporting AEs Within 7 Days After Vaccination With Investigational Product, Dose 2
Time frame: Days 29-36
Number of Participants Using Anti-pyretic and Analgesic Agents Within 7 Days After Vaccination With Investigational Product, Dose 2
Time frame: Days 29-36
Number of Participants With Any Solicited Symptoms Within 14 Days After Vaccination With Investigational Product, Dose 2
Time frame: Days 29-43
Number of Participants Reporting AEs Within 14 Days After Vaccination With Investigational Product, Dose 2
Time frame: Days 29-43
Number of Participants Using Anti-pyretic and Analgesic Agents Within 14 Days After Vaccination With Investigational Product, Dose 2
Time frame: Days 29-43
Number of Participants With New Onset Chronic Diseases (NOCDs) Within 28 Days After Vaccination With Investigational Product, Dose 1.
Time frame: Days 1-29
Number of Participants With Serious Adverse Events (SAEs) Within 28 Days After Vaccination With Investigational Product, Dose 1
Time frame: Days 1-29
Number of Participants With NOCDs Within 28 Days After Vaccination With Investigational Product, Dose 2.
Time frame: Days 29-57
Number of Participants With SAEs Within 28 Days After Vaccination With Investigational Product, Dose 2
Time frame: Days 29-57
Number of Participants With NOCDs Within 180 Days Post Final Dose of Investigational Product.
Time frame: Days 1-209
Number of Participants With SAEs Within 180 Days Post Final Dose of Investigational Product.
Time frame: Days 1-209
Number of Participants Who Achieve a Post Dose 1 (Day 15) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.
Time frame: Day 1, Day 15
Number of Participants Who Achieve a Post Dose 1 (Day 29) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.
Time frame: Day 1, Day 29
Number of Participants Who Achieve a Post Dose 2 (Day 57) HAI Titer Greater Than or Equal to 32 Against the H1N1 Strain in All Participants, Regardless of Baseline Serostatus.
Time frame: Day 1, Day 57
Serum HAI Geometric Mean Titers (GMTs) in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 15)
Time frame: Day 1, Day 15
Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 1 (Day 29)
Time frame: Day 1, Day 29
Serum HAI GMTs in All Participants, Regardless of Baseline Serostatus, Dose 2 (Day 57)
Time frame: Day 1, Day 57

Results and safety

Results posted to the registry on 11 Aug 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
H1N1 Monovalent Influenza Vaccine	261	257
Placebo	65	63

Primary outcome: Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C).

Time frame: Days 1- 8. Number. Unit: participants

Measure	H1N1 Monovalent Influenza Vaccine n = 259	Placebo n = 65
Value	4	1

H1N1 Monovalent Influenza Vaccine vs Placebo: rate difference: 0.0 (95% CI -6.4 to 3.1), score

Population analysed: The safety population included all participants who received at least one dose of investigational product and experienced any follow-up for safety (H1N1=259; Placebo=65).

Primary outcome: Number of Participants Who Experience a Post Dose 1 (Day 15) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus

Time frame: Day 1, Day 15. Number. Unit: participants

Measure	H1N1 Monovalent Influenza Vaccine n = 129	Placebo n = 32
Value	10	2

H1N1 Monovalent Influenza Vaccine vs Placebo: rate difference: 1.5 (95% CI -12.8 to 9.8), score

Population analysed: Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65), had valid HAI measurements from blood samples obtained at baseline and post Dose 1 were included in the analysis (H1N1=129; Placebo=32).

Primary outcome: Number of Participants Who Experience a Post Dose 1 (Day 29) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus

Time frame: Day 1, Day 29. Number. Unit: participants

Measure	H1N1 Monovalent Influenza Vaccine n = 126	Placebo n = 32
Value	14	2

H1N1 Monovalent Influenza Vaccine vs Placebo: rate difference: 4.9 (95% CI -9.6 to 13.8), score

Population analysed: Participants who received Dose 1 of study vaccine (H1N1=259; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 1 (H1N1=126; Placebo=32).

Primary outcome: Number of Participants Who Experience a Post Dose 2 (Day 57) Seroresponse Against the H1N1 Strain in All Participants Regardless of Baseline Serostatus

Time frame: Day 1, Day 57. Number. Unit: participants

Measure	H1N1 Monovalent Influenza Vaccine n = 250	Placebo n = 62
Value	80	9

H1N1 Monovalent Influenza Vaccine vs Placebo: rate difference: 17.5 (95% CI 5.5 to 27.1), score

Population analysed: Participants who received 2 doses of the same study vaccine (H1N1=258; Placebo=65) and had valid HAI measurements from blood samples obtained at baseline and post Dose 2 were included in the analysis (H1N1=250; Placebo=62).

24 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse event data were collected through 14 days after each vaccination, ie, Days 1-15 and Days 29-43. Serious adverse events (SAEs) were collected through 28 days after each vaccination, ie, Days 1-28 and Days 29-57 and through 180 days post last dose.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
H1N1 Monovalent Vaccine Days 1-28	1 of 259 (0.4%)	13 of 259 (5%)	Not reported
Placebo Days 1-28	0 of 65 (0%)	2 of 65 (3.1%)	Not reported
H1N1 Monvalent Vaccine Days 29-57	0 of 255 (0%)	11 of 255 (4.3%)	Not reported
Placebo Days 29-57	0 of 63 (0%)	3 of 63 (4.8%)	Not reported
H1N1 Monovalent Vaccine Days 58-209	1 of 259 (0.4%)	0 of 255 (0%)	Not reported
Placebo Days 58-209	1 of 65 (1.5%)	0 of 63 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 21060780Mallory RM, Malkin E, Ambrose CS, Bellamy T, Shi L, Yi T, Jones T, Kemble G, Dubovsky F. Safety and immunogenicity following administration of a live, attenuated monovalent 2009 H1N1 influenza vaccine to children and adults in two randomized controlled trials. PLoS One. 2010 Oct 29;5(10):e13755. doi: 10.1371/journal.pone.0013755.

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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.

Elissa Malkin, D.O. study director

MedImmune LLC

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

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing MEDI3414 [Influenza A(H1N1) live attenuated, intranasal] in people with Influenza, run by MedImmune LLC at 16 sites in United States.

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 8 inclusion and 17 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: finished, as of the sponsor's last update on 11 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites 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. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 11 Aug 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Participants With Fever Post Dose 1 (Days 1-8), Defined as an Axillary Temperature ≥ 101°F (38.3°C). (time frame: Days 1- 8). The study lists 4 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 NCT00946101, which also lists 1 linked publication.

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 11 Aug 2011.