InfluenzaPhase 2NCT00952419

A Study of Different Formulations of an A/H1N1 Pandemic Vaccine in Healthy Children Aged 6 Months to 9 Years

A Phase 2 study testing Monovalent Subvirion A/H1N1 Influenza vaccine in people with Influenza and Swine-origin A/H1N1 Influenza, run by Sanofi Pasteur, a Sanofi Company at 20 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children. Primary Objectives: To describe the immunogenicity of the candidate vaccines after each injection. To describe the safety of the candidate vaccines after each injection. Read more about this study

Who is it for?: Ages 6 months to 9 yearsHealthy volunteers can take part
Conditions the study is for: Influenza, Swine-origin A/H1N1 Influenza
What is being tested?: Monovalent Subvirion A/H1N1 Influenza vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 474 participants
Where: 20 sitesUnited States
Study dates: Aug 2009to Jun 2010
Phase: Phase 2
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 6 months to 9 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

All subjects:
Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 7 to 9 years
Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
Subjects aged 3 to 9 years:
Healthy children aged 3 to 9 years on the day of inclusion
Subjects aged 6 to 35 months:
Healthy infants and toddlers aged 6 to 35 months on the day of inclusion
Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

Who cannot join

Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Receipt of any vaccine in the 4 weeks preceding the trial vaccination
Planned receipt of any vaccine prior to the Day 42 blood sample
Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response
Known or suspected congenital or acquired immunodeficiency, immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy within the preceding 6 months, or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)

Show all 19Show fewer

Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B surface antigen, or Hepatitis C
Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
Self reported thrombocytopenia contraindicating intramuscular (IM) vaccination
Bleeding disorder or receipt of anticoagulants in the 3 weeks preceding inclusion contraindicating IM vaccination
Deprived of freedom by an administrative or court order, or in an emergency setting, or hospitalized involuntarily
Chronic illness that in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
Employees of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator.
Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
Personal or family history of Guillain-Barré syndrome
Active neoplastic disease or a history of any hematologic malignancy
Known seizure/epilepsy history and/or taking anti-seizure medication
Receipt of psychiatric drugs. Subjects receiving a single antidepressant drug and stable for at least 3 months prior to enrollment, without decompensating symptoms will be allowed to enroll in the study
Febrile illness (temperature ≥ 100.4°F [≥ 38.0°C]) or moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination

Trial locations and contacts

20 sites in 1 country.

City, postcode or hospital

20 sites in 1 country

United States20 sites

Study site
Austin, Texas, 78705
Study site
Barnwell, South Carolina, 29812
Study site
Cranston, Rhode Island, O2920
Study site
Crestview Hills, Kentucky, 41017
Study site
Fort Worth, Texas, 76135
Study site
Hermitage, Pennsylvania, 16148
Study site
Las Vegas, Nevada, 89104
Study site
Louisville, Kentucky, 40291
Study site
Maddisonville, Kentucky, 42431
Study site
Marietta, Georgia, 30062
Study site
Metairie, Louisiana, 70006
Study site
Miami Beach, Florida, 33141
Study site
Orem, Utah, 84057
Study site
Pittsburgh, Pennsylvania, 15237
Study site
Pittsburgh, Pennsylvania, 15241
Study site
Rochester, New York, 14609
Study site
San Angelo, Texas, 76904
Study site
South Jordan, Utah, 84095
Study site
Springville, Utah, 84663
Study site
Woodstock, Georgia, 30189

Other trials in United States

About this study

Official title: Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Subjects Aged 6 Months to 9 Years

The purpose of the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children.

Primary Objectives:

To describe the immunogenicity of the candidate vaccines after each injection.
To describe the safety of the candidate vaccines after each injection.

Read the detailed description

Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

Conditions: Influenza, Swine-origin A/H1N1 Influenza
Being tested: Monovalent Subvirion A/H1N1 Influenza vaccine, Normal saline solution (placebo)
Keywords: Influenza, Pandemic Flu, Swine-origin A/H1N1 Influenza, Children
Medical subject headings: Influenza, Human

What participants receive

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

Monovalent Subvirion A/H1N1 Influenza vaccineBiological
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)
Monovalent Subvirion A/H1N1 Influenza vaccineBiological
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)
Normal saline solution (placebo)Biological
0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)

Study groups in NCT00952419
Study group	Role	What they receive
A/H1N1 Vaccine Group 1	Experimental	Participants will receive A/H1N1 vaccine formulation 1 Receives: Biological: Monovalent Subvirion A/H1N1 Influenza vaccine
A/H1N1 Vaccine Group 2	Experimental	Participants will receive A/H1N1 vaccine formulation 2 Receives: Biological: Monovalent Subvirion A/H1N1 Influenza vaccine
Placebo Group	Placebo comparator	Participants will receive a placebo vaccine Receives: Biological: Normal saline solution (placebo)

What is being measured

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

Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Measured: Pre-vaccination (Day 0) and 21 days post-vaccination
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Measured: Pre-vaccination (Day 0) and Day 21 post-vaccination
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Measured: Pre-vaccination (Day 0) and 21 days post-vaccination
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Measured: Pre-vaccination (Day 0) and 21 days post-vaccination
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Measured: Pre-vaccination (Day 0) and Day 21 post-vaccination
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Measured: Pre-vaccination (Day 0) and Day 21 post-vaccination
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months
Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
Measured: Days 0 to 7 post-vaccination
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
Measured: Days 0 to 7 post-vaccination
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
Measured: Days 0 to 7 post vaccination

Timeline

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

Aug 2009Jun 2010

First posted6 Aug 2009 (estimated)
Study startAug 2009
Primary completionMar 2010
Study completionJun 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 (2)Papers the sponsor has linked to this study.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by Sanofi Pasteur, a Sanofi CompanyThe 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 2
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 474 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00952419
Sponsor's protocol ID: FUF15
Other IDs: UTN: U1111-1111-4713
Status last verified: Apr 2016
First submitted: 3 Aug 2009
Last updated: 14 Apr 2016
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, Reeves-Hoche MK, Denis M. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine. 2011 Feb 11;29(8):1569-75. doi: 10.1016/j.vaccine.2010.12.116. Epub 2011 Jan 8.
PubMed 21219979
Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15.
PubMed 20018365

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?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of Multiple Formulations of an A/H1N1 Pandemic Vaccine in Healthy Subjects Aged 6 Months to 9 Years
ClinicalTrials.gov ID: NCT00952419
Acronym / sponsor ID: FUF15
Conditions: Influenza, Swine-origin A/H1N1 Influenza
Keywords: Influenza, Pandemic Flu, Swine-origin A/H1N1 Influenza, Children
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 474 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Aug 2009
Primary completion: Mar 2010 (actual)
Study completion: Jun 2010 (actual)
First posted: 6 Aug 2009 (estimated)
Results: Posted 11 Jul 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 the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in toddlers and children.

Primary Objectives:

To describe the immunogenicity of the candidate vaccines after each injection.
To describe the safety of the candidate vaccines after each injection.

Detailed description

Participants will receive two injections of their randomized vaccine on Day 0 and Day 21, respectively.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3

Arm	Type	Receives
A/H1N1 Vaccine Group 1	Experimental	Biological: Monovalent Subvirion A/H1N1 Influenza vaccineParticipants will receive A/H1N1 vaccine formulation 1
A/H1N1 Vaccine Group 2	Experimental	Biological: Monovalent Subvirion A/H1N1 Influenza vaccineParticipants will receive A/H1N1 vaccine formulation 2
Placebo Group	Placebo comparator	Biological: Normal saline solution (placebo)Participants will receive a placebo vaccine

Who may qualify

Ages: 6 months to 9 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (8 listed)

Provision of Informed Consent Form signed by the subject's parent(s)/legal representative (and by an independent witness if required by local regulations). In addition, provision of Assent Form signed by subjects aged 7 to 9 years
Subject and parent/guardian are able to attend all scheduled visits and to comply with all trial procedures
Healthy children aged 3 to 9 years on the day of inclusion
Healthy infants and toddlers aged 6 to 35 months on the day of inclusion
Born at full term of pregnancy (≥ 37 weeks) and with a birth weight ≥ 2.5 kg

Key exclusion criteria (19 listed)

Participation in another clinical trial investigating a vaccine, drug, medical device, or a medical procedure in the 4 weeks preceding the first trial vaccination
Planned participation in another clinical trial during the present trial period
Receipt of any vaccine in the 4 weeks preceding the trial vaccination
Planned receipt of any vaccine prior to the Day 42 blood sample
Receipt of blood or blood-derived products in the past 3 months which might interfere with the assessment of immune response

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
Monovalent Subvirion A/H1N1 Influenza vaccine0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on Day 0 and Day 21 (6 months to 35 Months)	Biological	A/H1N1 Vaccine Group 1
Monovalent Subvirion A/H1N1 Influenza vaccine0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)	Biological	A/H1N1 Vaccine Group 2
Normal saline solution (placebo)0.5 mL, Intramuscular Day 0 and Day 21 (3 to 9 years); 0.25 mL, Intramuscular on day 0 and Day 21 (6 months to 35 Months)	Biological	Placebo Group

Primary outcome

Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Pre- and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Time frame: Pre-vaccination (Day 0) and Day 21 post-vaccination
Seroprotection: Antibody titer of ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months
Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
Time frame: Pre-vaccination (Day 0) and Day 21 post-vaccination
Seroprotection: Antibody titer ≥ 40 1/dil. Antibody titers were determined by the hemagglutination inhibition (HAI) test.
Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years
Time frame: Pre-vaccination (Day 0) and Day 21 post-vaccination
Pre-vaccination and post-vaccination antibody titers were determined by the hemagglutination inhibition (HAI) test.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 6 to 23 Months
Time frame: Days 0 to 7 post-vaccination
Solicited Injection Site Reactions: Tenderness, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), vomiting, crying abnormal, drowsiness, appetite lost, irritability.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 24 to 35 Months
Time frame: Days 0 to 7 post-vaccination
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.
Number of Participants With At Least One Solicited Injection Site or Systemic Reaction Following Vaccination - Age 3 to 9 Years
Time frame: Days 0 to 7 post vaccination
Solicited Injection Site Reactions: Pain, erythema (redness), swelling, induration (hardening), ecchymosis (bruising). Solicited systemic reactions: Fever (temperature), headache, malaise (feeling unwell), myalgia (muscle aches and pains), shivering.

Results and safety

Results posted to the registry on 11 Jul 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
A/H1N1 Vaccine Group 1	215	209
A/H1N1 Vaccine Group 2	208	198
Placebo Group	51	51

Primary outcome: Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months

Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination. Number. Unit: Participants

Measure	A/H1N1 Vaccine Group 1 n = 92	A/H1N1 Vaccine Group 2 n = 87	Placebo Group n = 23
Pre-Vaccination 1 (Day 0) Titers at ≥ 10 1/dil	5	2	0
Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil	72	79	0
Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil	90	87	1

Population analysed: Pre- and post-vaccination antibody titers were assessed in the per-protocol population

Primary outcome: Number of Participants With Antibody Titers ≥ 40 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months

Time frame: Pre-vaccination (Day 0) and Day 21 post-vaccination. Number. Unit: Participants

Measure	A/H1N1 Vaccine Group 1 n = 92	A/H1N1 Vaccine Group 2 n = 87	Placebo Group n = 23
Pre-Vaccination 1 (Day 0) Titers at ≥ 40 1/dil	5	2	0
Post-Vaccination 1 (Day 21) Titers at ≥ 40 1/dil	43	42	0
Post-Vaccination 2 (Day 42) Titers at ≥ 40 1/dil	84	86	1

Population analysed: Antibody titers were assessed in the per-protocol population.

Primary outcome: Geometric Mean Titers (GMT) of Antibodies Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months

Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	A/H1N1 Vaccine Group 1 n = 92	A/H1N1 Vaccine Group 2 n = 87	Placebo Group n = 23
Pre-Vaccination 1 (Day 0) GMT	5.99 (5.10 to 7.04)	5.48 (4.84 to 6.20)	5.00 (5.00 to 5.00)
Post-Vaccination 1 (Day 21) GMT	33.3 (23.8 to 46.5)	45.1 (32.8 to 62.0)	5.08 (4.92 to 5.24)
Post-Vaccination 2 (Day 42) GMT	368 (271 to 500)	586 (451 to 763)	5.64 (4.39 to 7.24)

Population analysed: Antibody titers were assessed in the per-protocol population.

Primary outcome: Number of Participants With Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 3 to 9 Years

Time frame: Pre-vaccination (Day 0) and 21 days post-vaccination. Number. Unit: Participants

Measure	A/H1N1 Vaccine Group 1 n = 98	A/H1N1 Vaccine Group 2 n = 91	Placebo Group n = 24
Pre-Vaccination 1(Day 0) Titers at ≥ 10 1/dil	7	4	7
Post-Vaccination 1 (Day 21) Titers at ≥ 10 1/dil	91	88	8
Post-Vaccination 2 (Day 42) Titers at ≥ 10 1/dil	98	91	8

Population analysed: Pre- and post-vaccination antibody titers were assessed in the per-protocol population

Adverse events

Time frame: Adverse events data were collected from the day of vaccination to up to 6 months post-vaccination.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
A/H1N1 Vaccine Group 1	1 of 219 (0.5%)	110 of 219 (50.2%)	Not reported
A/H1N1 Vaccine Group 2	0 of 204 (0%)	104 of 204 (51%)	Not reported
Placebo Group	1 of 51 (2%)	27 of 51 (52.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 21219979Plennevaux E, Blatter M, Cornish MJ, Go K, Kirby D, Wali M, Reeves-Hoche MK, Denis M. Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial. Vaccine. 2011 Feb 11;29(8):1569-75. doi: 10.1016/j.vaccine.2010.12.116. Epub 2011 Jan 8.
Derived from this study: PubMed 20018365Plennevaux E, Sheldon E, Blatter M, Reeves-Hoche MK, Denis M. Immune response after a single vaccination against 2009 influenza A H1N1 in USA: a preliminary report of two randomised controlled phase 2 trials. Lancet. 2010 Jan 2;375(9708):41-8. doi: 10.1016/S0140-6736(09)62026-2. Epub 2009 Dec 15.
Related InfoLink provided by the sponsor.

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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.

Medical Monitor study director

Sanofi Pasteur Inc.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Monovalent Subvirion A/H1N1 Influenza vaccine in people with Influenza and Swine-origin A/H1N1 Influenza, run by Sanofi Pasteur, a Sanofi Company at 20 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 19 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 14 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Jul 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 Antibody Titers ≥ 10 1/Dilution (1/Dil) Against A/California (H1N1 Vaccine) Strain - Age 6 to 35 Months (time frame: Pre-vaccination (Day 0) and 21 days post-vaccination). The study lists 9 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 NCT00952419, which also lists 2 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 14 Apr 2016.