InfluenzaPhase 2NCT00988143

A Study of Influenza Virus Vaccines in Children and Adults

A Phase 2 study testing 2009-2010 Trivalent Influenza Virus Vaccine, 2008-2009 Trivalent Influenza Virus Vaccine and Quadrivalent Influenza Virus Vaccine in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 4 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 is to describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among children and adults. Read more about this study

Who is it for?: Ages 6 months and olderHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: 2009-2010 Trivalent Influenza Virus Vaccine, 2008-2009 Trivalent Influenza Virus Vaccine and Quadrivalent Influenza Virus Vaccine
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 600 participants
Where: 4 sitesUnited States
Study dates: Oct 2009to Mar 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 and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Subject is ≥ 6 months to < 5 years of age or 18 years of age or older on the day of inclusion.
Parent/legal guardian (if the subject is ≥ 6 months to < 5 years of age) or adult subject (if 18 years of age or older) is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
Subject in reasonably good health as assessed by the Investigator.
Parent/legal guardian (if the subject is ≥ 6 months to < 5 years of age) or adult subject (if 18 years of age or older) is willing and able to give informed consent.
For subjects ≥ 6 months to < 5 years of age: subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).
For a woman, inability to bear a child or negative serum/urine pregnancy test, if applicable.

Who cannot join

For all subjects:
History of allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
History of serious adverse reaction to any influenza vaccine.
Laboratory-confirmed influenza infection or vaccination against influenza in the six months preceding enrollment in the study.
Any vaccination scheduled between Visit 1 and Visit 2 or Visit 3.
Participation in any other interventional drug or vaccine trial during participation in this study.

Show all 27Show fewer

Thrombocytopenia or bleeding disorder contraindicating intramuscular vaccination.
Any condition that in the opinion of the Investigator would pose a health risk to the subject if enrolled or could interfere with the evaluation of the vaccine.
Prior personal history of Guillain-Barré syndrome.
For subjects > 6 months to < 5 years of age:
Known or suspected impairment of immunologic function or receipt of immunosuppressive therapy or immunoglobulin since birth.
Personal or immediate family history of congenital immune deficiency.
Developmental delay, neurologic disorder, or seizure disorder.
Chronic medical, congenital, or developmental disorder.
Known HIV-positive mother.
For subjects 18 years of age and older:
Immunocompromising condition; immunosuppressive therapy (including systemic steroid use for two weeks or more); cancer chemotherapy or radiation therapy at the time of enrollment, planned during the period of this study, or at any time within the past six months.
Diabetes mellitus requiring pharmacological control.
Person deprived of freedom by an administrative or court order (having legal or medical guardian).
For women of childbearing potential, a positive urine pregnancy test, breast feeding, or not using a medically approved and reliable form of contraception (oral contraceptives or double barrier method) for the duration of the trial.
Current use of alcohol or recreational drugs that may interfere with the subject's ability to comply with trial procedures.
Any subject with the following conditions is not eligible for enrollment. However, the subject may be enrolled subsequently if the condition has resolved and enrollment is still ongoing and the subject meets all other inclusion/exclusion criteria:
An acute illness with or without fever in the 72 hours preceding enrollment in the trial.
Clinically significant findings in vital signs or review of systems (Investigator judgment).
Received any vaccinations within the preceding 14 days.
Participation in any other interventional clinical trial within 30 days prior to enrollment.
Receipt of blood or blood products within the three months preceding enrollment in the study.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Study site
Cincinnati, Ohio, 45249
Study site
Durham, North Carolina, 27704
Study site
Jefferson Hills, Pennsylvania, 15025
Study site
Norfolk, Virginia, 23507

Other trials in United States

About this study

Official title: Immunogenicity and Safety Among Children and Adults of the 2009-2010 Trivalent Influenza Vaccine, 2008-2009 Trivalent Influenza Vaccine, and Quadrivalent Influenza Vaccine (Intramuscular Route)

Primary Objective:

To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults.

Observational Objectives:

To describe the safety of the 2009-2010 TIV among subjects ≥6 months to <5 years, 18-60 years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age.
To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to <5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of 2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of age.

Conditions: Influenza
Being tested: 2009-2010 Trivalent Influenza Virus Vaccine, 2008-2009 Trivalent Influenza Virus Vaccine, Quadrivalent Influenza Virus Vaccine
Keywords: Influenza, Trivalent Influenza Virus Vaccine, Quadrivalent Influenza Virus Vaccine
Medical subject headings: Influenza, Human

What participants receive

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

2009-2010 Trivalent Influenza Virus VaccineBiological
Also called Fluzone®
0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular.
2008-2009 Trivalent Influenza Virus VaccineBiological
Also called Fluzone®
0.25 mL, Intramuscular; 0.5 mL, Intramuscular.
Quadrivalent Influenza Virus VaccineBiological
0.5 mL, Intramuscular

Study groups in NCT00988143
Study group	Role	What they receive
Study Group 1	Experimental	Participants will receive the 2009-2010 Trivalent Influenza Vaccine (TIV) (Pediatric dose have no preservatives) Receives: Biological: 2009-2010 Trivalent Influenza Virus Vaccine
Study Group 2	Active comparator	Participants will receive the 2008-2009 Trivalent Influenza Vaccine (TIV) Receives: Biological: 2008-2009 Trivalent Influenza Virus Vaccine
Study Group 3	Active comparator	Participants will receive the Quadrivalent Influenza Vaccine (QIV) Receives: Biological: Quadrivalent Influenza Virus Vaccine

What is being measured

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

Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.
Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: >103.1°F; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable.
(24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: >102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity.
(Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering.
Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: >10 cm; Fever >102.1°F; Headache, Malaise, Myalgia \& Shivering: Significant, prevents daily activity.
Measured: Day 0 up to 7 days post-vaccination
Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Measured: 21 Days post last vaccination
Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Measured: 21 Days post last vaccination

Timeline

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

Oct 2009Mar 2010

First posted2 Oct 2009 (estimated)
Study startOct 2009
Primary completionDec 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.
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: None (open label)
Enrolment: 600 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00988143
Sponsor's protocol ID: GRC43
Other IDs: UTN: U1111-1111-5427
Status last verified: Nov 2013
First submitted: 1 Oct 2009
Last updated: 12 Dec 2013
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 12 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Immunogenicity and Safety Among Children and Adults of the 2009-2010 Trivalent Influenza Vaccine, 2008-2009 Trivalent Influenza Vaccine, and Quadrivalent Influenza Vaccine (Intramuscular Route)
ClinicalTrials.gov ID: NCT00988143
Acronym / sponsor ID: GRC43
Conditions: Influenza
Keywords: Influenza, Trivalent Influenza Virus Vaccine, Quadrivalent Influenza Virus Vaccine
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 600 participants (actual)
Lead sponsor: Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Dec 2009 (actual)
Study completion: Mar 2010 (actual)
First posted: 2 Oct 2009 (estimated)
Results: Posted 12 Dec 2013

Clinical summary

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

Primary Objective:

To describe the immunogenicity of the prototype Quadrivalent Influenza Vaccine (QIV) compared with the 2009-2010 Trivalent Influenza Vaccine (TIV) and the 2008-2009 TIV among adults.

Observational Objectives:

To describe the safety of the 2009-2010 TIV among subjects ≥6 months to <5 years, 18-60 years, and ≥ 61 years of age, and to describe the safety of 2008-2009 TIV and prototype QIV Fluzone® vaccines among subjects 18-60 years and ≥ 61 years of age.
To describe the immunogenicity of the 2009-2010 TIV vaccine among subjects ≥6 months to <5 years, 18-60 years, and ≥61 years of age, and to describe the immunogenicity of 2008-2009 TIV and prototype QIV vaccines among subjects 18-60 years and ≥61 years of age.

Study design

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

Arm	Type	Receives
Study Group 1	Experimental	Biological: 2009-2010 Trivalent Influenza Virus VaccineParticipants will receive the 2009-2010 Trivalent Influenza Vaccine (TIV) (Pediatric dose have no preservatives)
Study Group 2	Active comparator	Biological: 2008-2009 Trivalent Influenza Virus VaccineParticipants will receive the 2008-2009 Trivalent Influenza Vaccine (TIV)
Study Group 3	Active comparator	Biological: Quadrivalent Influenza Virus VaccineParticipants will receive the Quadrivalent Influenza Vaccine (QIV)

Who may qualify

Ages: 6 months and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

Subject is ≥ 6 months to < 5 years of age or 18 years of age or older on the day of inclusion.
Parent/legal guardian (if the subject is ≥ 6 months to < 5 years of age) or adult subject (if 18 years of age or older) is willing and able to attend scheduled visits and to comply with the study procedures during the entire duration of the study.
Subject in reasonably good health as assessed by the Investigator.
Parent/legal guardian (if the subject is ≥ 6 months to < 5 years of age) or adult subject (if 18 years of age or older) is willing and able to give informed consent.
For subjects ≥ 6 months to < 5 years of age: subject was born at full term of pregnancy (≥ 37 weeks) with a birth weight ≥ 2.5 kg (5.5 lbs).

Key exclusion criteria (27 listed)

History of allergy to egg proteins, chicken proteins, or one of the constituents of the vaccine, such as thimerosal or formaldehyde.
History of serious adverse reaction to any influenza vaccine.
Laboratory-confirmed influenza infection or vaccination against influenza in the six months preceding enrollment in the study.
Any vaccination scheduled between Visit 1 and Visit 2 or Visit 3.
Participation in any other interventional drug or vaccine trial during participation in this study.

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
2009-2010 Trivalent Influenza Virus VaccineAlso: Fluzone®0.25 mL, Intramuscular (participants at 6 to 35 months of age - Pediatric Dose); Others 0.5 mL, Intramuscular.	Biological	Study Group 1
2008-2009 Trivalent Influenza Virus VaccineAlso: Fluzone®0.25 mL, Intramuscular; 0.5 mL, Intramuscular.	Biological	Study Group 2
Quadrivalent Influenza Virus Vaccine0.5 mL, Intramuscular	Biological	Study Group 3

Primary outcome

Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.
Time frame: Day 0 up to 7 days post-vaccination
Solicited injection site reactions (6-23 Months): Tenderness, Redness and Swelling; Solicited systemic reactions: Fever, Abnormal crying, Drowsiness, Loss of appetite, Vomiting and Irritability Grade 3 Tenderness: cries when injected limb is moved; Redness and Swelling: ≥5 cm; Fever: >103.1°F; Abnormal crying: >3 hours; Drowsiness: Sleeping most of the time; Loss of appetite: refuses ≥3 feeds/meals; Vomiting: ≥6 episodes/24 hours; Irritability: inconsolable. (24-59 Months): Pain, Redness and Swelling; Fever, Headache, Malaise and Myalgia. Grade 3: Pain, Incapacitating; Redness and Swelling: ≥5 cm; Fever: >102.1°F, Headache, Malaise and Myalgia: Significant, prevents daily activity. (Adults): Pain, Redness, Induration, and Ecchymosis; Fever, Headache, Malaise, Myalgia and Shivering. Grade 3: Pain: significant, prevents daily activities; Redness, Swelling, Induration and Ecchymosis: >10 cm; Fever >102.1°F; Headache, Malaise, Myalgia \& Shivering: Significant, prevents daily activity.
Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.
Time frame: 21 Days post last vaccination
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.
Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.
Time frame: 21 Days post last vaccination
Immunogenicity outcomes were assessed in serum samples by Hemagglutination inhibition (HAI) assay. The lower limit of quantitation (LLOQ) was set at the lowest dilution used in the assay, 1/10. Titers below this level were reported as <10.

Results and safety

Results posted to the registry on 12 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Study Group 1 (2009-2010 TIV)	220	220
Study Group 2 (2008-2009 TIV)	190	190
Study Group 3 (QIV)	190	190

Primary outcome: Number of Participants Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines.

Time frame: Day 0 up to 7 days post-vaccination. Number. Unit: Participants

Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n = 220	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n = 190	Study Group 3 (Quadrivalent Influenza Vaccine) n = 190
Injection site Tenderness (15, 0, 0)	4	0 (0 to 0)	0 (0 to 0)
Grade 3 Injection site Tenderness (15, 0, 0)	0	0 (0 to 0)	0 (0 to 0)
Injection site Pain (205, 190, 190)	105	82 (0 to 0)	90 (0 to 0)
Grade 3 Injection site Pain (206, 190, 190)	1	0 (0 to 0)	1 (0 to 0)
Injection site Erythema (220, 190, 190)	7	3 (0 to 0)	2 (0 to 0)
Grade 3 Injection site Erythema (220, 190, 190)	0	0 (0 to 0)	0 (0 to 0)
Injection site Swelling (220, 190, 190)	10	2 (0 to 0)	1 (0 to 0)
Grade 3 Injection site Swelling (220, 190, 190)	0	0 (0 to 0)	0 (0 to 0)

Population analysed: Solicited injection site and systemic reactions were assessed in all randomized and vaccinated participants, safety population.

Primary outcome: Geometric Mean Titers (GMTs) Against Influenza B Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.

Time frame: 21 Days post last vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n = 187	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n = 188	Study Group 3 (Quadrivalent Influenza Vaccine) n = 190
B/Brisbane/60/2008 (187, 0, 190)	114 (97.8 to 134)	NA (NA to NA)	101 (85.6 to 120)
B/Florida/04/2006 (0, 188, 190)	NA (NA to NA)	135 (117 to 156)	155 (133 to 180)

Population analysed: Geometric mean titers to vaccine B strains were determined in randomized and vaccinated participants, per-protocol population

Primary outcome: Geometric Mean Titers (GMTs) Against Influenza A Strains After Vaccination With Fluzone® Quadrivalent Influenza Vaccine or Trivalent Influenza Vaccine in Adult Participants.

Time frame: 21 Days post last vaccination. Geometric mean (95% Confidence Interval). Unit: Titers

Measure	Study Group 1 (2009-2010 Trivalent Influenza Vaccine) n = 375	Study Group 2 (2008-2009 Trivalent Influenza Vaccine) n = 0	Study Group 3 (Quadrivalent Influenza Vaccine) n = 190
A/Brisbane/59/2007(A1N1) [N = 375, 0, 190]	151 (134 to 171)	–	161 (137 to 189)
A/Uruguay/716/2007(H3N2) [N = 375, 0, 190]	339 (239 to 392)	–	304 (249 to 370)

Population analysed: Geometric mean titers to vaccine A strains were determined in the per-protocol population. For this outcome, the data for the A/Brisbane/59/2007(A1N1) and A/Uruguay/716/2007(H3N2) antibodies were pooled for participants vaccinated with either 2009-2010 TIV or 2008-2009 TIV and presented in the column for Study Group 1 (2009-2010 TIV).

Adverse events

Time frame: Adverse events data were collected from the day of vaccination (Day 0) up to 28 days post-vaccination. Other adverse events reported at 5.00% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Study Group 1 (2009-2010 Trivalent Influenza Vaccine)	0 of 220 (0%)	105 of 220 (47.7%)	Not reported
Study Group 2 (2008-2009 Trivalent Influenza Vaccine)	0 of 190 (0%)	84 of 190 (44.2%)	Not reported
Study Group 3 (Quadrivalent Influenza Vaccine)	2 of 190 (1.1%)	91 of 190 (47.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2013.
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 Director study director

Sanofi Pasteur Inc.

4 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 6 inclusion and 27 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 12 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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. 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 12 Dec 2013). 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 Reporting Solicited Injection Site and Systemic Reactions Following Vaccination With Quadrivalent Influenza Vaccine or Fluzone® Trivalent Influenza Vaccines. (time frame: Day 0 up to 7 days post-vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00988143.

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 12 Dec 2013.