InfluenzaPhase 2NCT00952276

A Study of Different Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adults and the Elderly

A Phase 2 study testing Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant, Monovalent Subvirion A/H1N1 influenza vaccine and Normal saline solution in people with Influenza and Swine-origin A/H1N1 Influenza, run by Sanofi at 15 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 the study is to evaluate different doses of the Influenza A/H1N1 pandemic vaccine in adults and the elderly. Primary Objectives: To describe the immunogenicity of the candidate vaccines after a single injection. To describe the safety of the candidate vaccines after a single injection. Read more about this study

Who is it for?: Ages 18 years and olderHealthy 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 with adjuvant, Monovalent Subvirion A/H1N1 influenza vaccine and Normal saline solution
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 548 participants
Where: 15 sitesUnited States
Study dates: Oct 2009to Mar 2011
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 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Healthy adults aged 18 years or older on the day of inclusion
Informed consent has been signed and dated
Able to attend all scheduled visits and comply with all trial procedures
For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.

Who cannot join

Known pregnancy or positive urine pregnancy test
Currently breastfeeding a child
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, except for the inactivated seasonal influenza vaccine, within two weeks preceding trial vaccination
Planned receipt of any vaccine prior to the Day 42 blood sample

Show all 26Show fewer

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)
Self-reported seropositivity for Human Immunodeficiency Virus (HIV), Hepatitis B 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
Current alcohol abuse or drug addiction that may interfere with the subject's ability to comply with trial procedures
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
Previous participation in a swine-origin A/H1N1 pandemic flu trial except if performed in 1976
Any confirmed case of influenza (including swine-origin A/H1N1 Influenza) since March 2009
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
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
Any Grade 1, 2, or 3 liver function values (Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), and Alkaline phosphatase) observed in blood sample taken at Screening
Any Grade 2 or Grade 3 laboratory abnormalities in blood sample taken at Screening
Receipt of any monovalent 2009 pandemic H1N1 vaccine.

Trial locations and contacts

15 sites in 1 country.

City, postcode or hospital

15 sites in 1 country

United States15 sites

Study site
Anaheim, California, 92801
Study site
Cincinnati, Ohio, 45227
Study site
Cleveland, Ohio, 44122
Study site
Fountain Valley, California, 92708
Study site
Grove City, Pennsylvania, 16127
Study site
Jackson, Tennessee, 38305
Study site
Jefferson Hills, Pennsylvania, 15025
Study site
Raleigh, North Carolina, 27612
Study site
Rochester, New York, 14609
Study site
Salt Lake City, Utah, 84109
Study site
Salt Lake City, Utah, 84124
Study site
South Miami, Florida, 33143
Study site
Springfield, Missouri, 65802
Study site
Springville, Utah, 84663
Study site
Warwick, Rhode Island, 02886

Other trials in United States

About this study

Official title: Immunogenicity and Safety of Multiple Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects

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

Primary Objectives:

To describe the immunogenicity of the candidate vaccines after a single injection.
To describe the safety of the candidate vaccines after a single injection.

Read the detailed description

Participants will receive a single injection of their randomized vaccine on Day 0.

Conditions: Influenza, Swine-origin A/H1N1 Influenza
Being tested: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant, Monovalent Subvirion A/H1N1 influenza vaccine, Normal saline solution
Keywords: Influenza Pandemic Flu Swine-origin A/H1N1 Influenza Adults
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 vaccine with adjuvantBiological
0.5 mL, Intramuscular on Day 0
Monovalent Subvirion A/H1N1 influenza vaccine with adjuvantBiological
0.5 mL, Intramuscular on Day 0
Monovalent Subvirion A/H1N1 influenza vaccineBiological
0.5 mL, Intramuscular on Day 0
Monovalent Subvirion A/H1N1 influenza vaccineBiological
0.5 mL, Intramuscular on Day 0
Normal saline solutionBiological
0.5 mL, Intramuscular on Day 0

Study groups in NCT00952276
Study group	Role	What they receive
A/H1N1 Vaccine Group 1	Experimental	Participants will receive A/H1N1 vaccine formulation 1 (with adjuvant) Receives: Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
A/H1N1 Vaccine Group 2	Experimental	Participants will receive A/H1N1 vaccine formulation 2 (with adjuvant) Receives: Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant
A/H1N1 Vaccine Group 3	Active comparator	Participants will receive A/H1N1 vaccine formulation 3 Receives: Biological: Monovalent Subvirion A/H1N1 influenza vaccine
A/H1N1 Vaccine Group 4	Active comparator	Participants will receive A/H1N1 vaccine formulation 4 Receives: Biological: Monovalent Subvirion A/H1N1 influenza vaccine
Placebo Group 5	Placebo comparator	Participants will receive a placebo vaccine Receives: Biological: Normal saline solution

What is being measured

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

Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.
Measured: Day 0 and Day 21 post-vaccination
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Measured: Day 0 and Day 21 post-vaccination
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Measured: Day 0 and Day 21 post-vaccination
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).
Measured: Day 0 and Day 21 post-vaccination
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Measured: Day 0 and Day 21 post-vaccination
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Measured: Day 0 and Day 21 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Measured: Day 0 up to Day 7 post-vaccination
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.
Measured: Day 0 up to Day 7 post-vaccination

Timeline

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

Oct 2009Mar 2011

First posted6 Aug 2009 (estimated)
Study startOct 2009
Primary completionDec 2010
Study completionMar 2011

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.
Other trials for InfluenzaStudies of the same condition, open and under way.
More trials run by SanofiThe 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: 548 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00952276
Sponsor's protocol ID: FUF16
Other IDs: UTN: U1111-1111-4882
Status last verified: Aug 2011
First submitted: 3 Aug 2009
Last updated: 3 Oct 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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 3 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety of Multiple Formulations of an Adjuvanted A/H1N1 Pandemic Vaccine in Healthy Adult and Elderly Subjects
ClinicalTrials.gov ID: NCT00952276
Acronym / sponsor ID: FUF16
Conditions: Influenza, Swine-origin A/H1N1 Influenza
Keywords: Influenza Pandemic Flu Swine-origin A/H1N1 Influenza Adults
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 548 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Dec 2010 (actual)
Study completion: Mar 2011 (actual)
First posted: 6 Aug 2009 (estimated)
Results: Posted 3 Oct 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 adults and the elderly.

Primary Objectives:

To describe the immunogenicity of the candidate vaccines after a single injection.
To describe the safety of the candidate vaccines after a single injection.

Detailed description

Participants will receive a single injection of their randomized vaccine on Day 0.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
A/H1N1 Vaccine Group 1	Experimental	Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvantParticipants will receive A/H1N1 vaccine formulation 1 (with adjuvant)
A/H1N1 Vaccine Group 2	Experimental	Biological: Monovalent Subvirion A/H1N1 influenza vaccine with adjuvantParticipants will receive A/H1N1 vaccine formulation 2 (with adjuvant)
A/H1N1 Vaccine Group 3	Active comparator	Biological: Monovalent Subvirion A/H1N1 influenza vaccineParticipants will receive A/H1N1 vaccine formulation 3
A/H1N1 Vaccine Group 4	Active comparator	Biological: Monovalent Subvirion A/H1N1 influenza vaccineParticipants will receive A/H1N1 vaccine formulation 4
Placebo Group 5	Placebo comparator	Biological: Normal saline solutionParticipants will receive a placebo vaccine

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Healthy adults aged 18 years or older on the day of inclusion
Informed consent has been signed and dated
Able to attend all scheduled visits and comply with all trial procedures
For a woman of child-bearing potential, use of an effective method of contraception or abstinence from at least 4 weeks prior to the first vaccination, until at least 4 weeks after last vaccination.

Key exclusion criteria (26 listed)

Known pregnancy or positive urine pregnancy test
Currently breastfeeding a child
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, except for the inactivated seasonal influenza vaccine, within two weeks preceding trial vaccination

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 vaccine with adjuvant0.5 mL, Intramuscular on Day 0	Biological	A/H1N1 Vaccine Group 1
Monovalent Subvirion A/H1N1 influenza vaccine with adjuvant0.5 mL, Intramuscular on Day 0	Biological	A/H1N1 Vaccine Group 2
Monovalent Subvirion A/H1N1 influenza vaccine0.5 mL, Intramuscular on Day 0	Biological	A/H1N1 Vaccine Group 3
Monovalent Subvirion A/H1N1 influenza vaccine0.5 mL, Intramuscular on Day 0	Biological	A/H1N1 Vaccine Group 4
Normal saline solution0.5 mL, Intramuscular on Day 0	Biological	Placebo Group 5

Primary outcome

Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Time frame: Day 0 and Day 21 post-vaccination
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti HA antibody titer was defined as titers ≥ 10 (1/dilution) on Day 0 and Day 21 post-vaccination.
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Time frame: Day 0 and Day 21 post-vaccination
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Time frame: Day 0 and Day 21 post-vaccination
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Time frame: Day 0 and Day 21 post-vaccination
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Detectable anti-HA antibody titer was defined as titers ≥ 10 (1/dil).
Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Time frame: Day 0 and Day 21 post-vaccination
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay. Seroprotection was defined as a titer ≥ 40 (1/dil).
Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Time frame: Day 0 and Day 21 post-vaccination
Antibodies to vaccine were measured using the Hemagglutinin Inhibition (HAI) assay.
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years
Time frame: Day 0 up to Day 7 post-vaccination
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering
Number of Participants Reporting a Solicited Injection Site or Systemic Reaction Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years
Time frame: Day 0 up to Day 7 post-vaccination
Solicited Injections Site Reactions: Pain, Erythema, Swelling, Induration, and Ecchymosis. Solicited Systemic Reactions: Fever (Temperature), Headache, Malaise, Myalgia, and Shivering.

Results and safety

Results posted to the registry on 3 Oct 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
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant	127	126
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant	115	115
Group 3: A/H1N1 Vaccine Formulation 3	122	122
Group 4: A/H1N1 Vaccine Formulation 4	121	120
Group 5: Placebo	63	63

Primary outcome: Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years

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

Measure	Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant n = 72	Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant n = 67	Group 3: A/H1N1 Vaccine Formulation 3 n = 72	Group 4: A/H1N1 Vaccine Formulation 4 n = 68	Group 5: Placebo n = 38
Day 0 (Pre-vaccination)	44	41	51	46	22
Day 21 (Post-vaccination)	71	67	71	68	27

Population analysed: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.

Primary outcome: Number of Participants With Seroprotection Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years

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

Measure	Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant n = 72	Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant n = 67	Group 3: A/H1N1 Vaccine Formulation 3 n = 72	Group 4: A/H1N1 Vaccine Formulation 4 n = 68	Group 5: Placebo n = 38
Day 0 (Pre-vaccination)	25	24	26	27	11
Day 21 (Post-vaccination)	71	66	67	64	13

Population analysed: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.

Primary outcome: Geometric Mean Titers (GMTs) of A/H1N1 Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years

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

Measure	Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant n = 72	Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant n = 67	Group 3: A/H1N1 Vaccine Formulation 3 n = 72	Group 4: A/H1N1 Vaccine Formulation 4 n = 68	Group 5: Placebo n = 38
Day 0 (Pre-vaccination)	23.7 (16.2 to 34.6)	21.0 (14.4 to 30.5)	23.8 (17.1 to 33.1)	27.7 (18.4 to 41.7)	20.0 (11.2 to 35.7)
Day 21 (Post-vaccination)	896 (673 to 1195)	900 (653 to 1241)	470 (314 to 705)	608 (423 to 875)	26.3 (15.0 to 46.0)

Population analysed: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 18 to 64 years.

Primary outcome: Number of Participants With Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age ≥ 65 Years

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

Measure	Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant n = 51	Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant n = 45	Group 3: A/H1N1 Vaccine Formulation 3 n = 47	Group 4: A/H1N1 Vaccine Formulation 4 n = 50	Group 5: Placebo n = 25
Day 0 (Pre-vaccination)	35	39	37	38	19
Day 21 (Post-vaccination)	50	45	46	50	18

Population analysed: Pre and post-vaccination antibody titers were assessed in the per-protocol population aged 65 years or older.

Adverse events

Time frame: Adverse events data were collected from the day of vaccination (Day 0) up to 12 months post-vaccination.. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1: A/H1N1 Vaccine Formulation 1 + Adjuvant	6 of 127 (4.7%)	77 of 127 (60.6%)	Not reported
Group 2: A/H1N1 Vaccine Formulation 2 + Adjuvant	5 of 115 (4.3%)	75 of 115 (65.2%)	Not reported
Group 3: A/H1N1 Vaccine Formulation 3	5 of 122 (4.1%)	75 of 122 (61.5%)	Not reported
Group 4: A/H1N1 Vaccine Formulation 4	4 of 121 (3.3%)	82 of 121 (67.8%)	Not reported
Group 5: Placebo	5 of 63 (7.9%)	40 of 63 (63.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

15 sites 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 4 inclusion and 26 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 3 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 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 3 Oct 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 Detectable Antibodies Before and Following Vaccination With Either Adjuvanted or Non-adjuvanted A/H1N1 Pandemic Vaccine or a Placebo: Age 18 to 64 Years (time frame: Day 0 and Day 21 post-vaccination). The study lists 8 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 NCT00952276.

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 3 Oct 2011.