InfluenzaPhase 4NCT00372255

Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years

A Phase 4 study testing Influsplit SSW® 2005/2006 in people with Influenza, run by GlaxoSmithKline at 18 sites in Germany.

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 study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old. Read more about this study

Who is it for?: Ages 6 to 13 yearsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Influsplit SSW® 2005/2006
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 240 participants
Where: 18 sitesGermany
Study dates: 17 Nov 2005to 28 Mar 2006
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 6 to 13 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy children or children with an increased health risk due to an underlying chronic disease-such as chronic airways diseases (including asthma), chronic cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic diseases-aged between 6 and 13 years.
All subjects must not have received a prior influenza vaccination.
All subjects must not have had a prior influenza disease.

Who cannot join

Use of any study or unlicensed medications/ vaccine other than the study vaccine within 30 days of the vaccination and/or during the study period.
Acute illness at the start of the study.
Acute, clinically significant pulmonary, cardiovascular abnormalities or abnormalities of the hepatic or renal function.
Known allergic reactions which might be caused by the ingredients of the vaccine.
Girls post-menarche: pregnancy or positive pregnancy-test
Multiple sclerosis or congenital or acquired immunodeficiencies.

Trial locations and contacts

18 sites in 1 country.

City, postcode or hospital

18 sites in 1 country

Germany18 sites

GSK Investigational Site
Berlin, 10315
GSK Investigational Site
Berlin, 10999
GSK Investigational Site
Berlin, 13055
GSK Investigational Site
Bischofswerda, Saxony, 01877
GSK Investigational Site
Bredstedt, Schleswig-Holstein, 25821
GSK Investigational Site
Bützow, Mecklenburg-Vorpommern, 18246
GSK Investigational Site
Dresden, Saxony, 01067
GSK Investigational Site
Dresden, Saxony, 01159
GSK Investigational Site
Dresden, Saxony, 01169
GSK Investigational Site
Flensburg, Schleswig-Holstein, 24937
GSK Investigational Site
Husum, Schleswig-Holstein, 25813
GSK Investigational Site
Leipzig, Saxony, 04178
GSK Investigational Site
Leipzig, Saxony, 04317
GSK Investigational Site
Niebüll, Schleswig-Holstein, 25899
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18106
GSK Investigational Site
Rostock, Mecklenburg-Vorpommern, 18109
GSK Investigational Site
Würzburg, Bavaria, 97070
GSK Investigational Site
Wurzen, Saxony, 04808

Other trials in Germany

About this study

Official title: An Open, Phase IV Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years

The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.

Conditions: Influenza
Being tested: Influsplit SSW® 2005/2006
Medical subject headings: Influenza, Human

What participants receive

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

Influsplit SSW® 2005/2006Biological
Study influenza vaccine was administered intramuscularly in the non-dominant arm

Study groups in NCT00372255
Study group	Role	What they receive
Influsplit SSW® 2005/2006 6-9 years Group	Experimental	Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW® 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2). Receives: Biological: Influsplit SSW® 2005/2006
Influsplit SSW® 2005/2006 10-13 years Group	Active comparator	Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW® 2005/2006 vaccine at Day 0. Receives: Biological: Influsplit SSW® 2005/2006

What is being measured

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

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Measured: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Measured: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Measured: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)

Secondary outcomes (9)

Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Measured: 21 days post-vaccination (Day 21)
SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0.The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Measured: 21 days post-vaccination (Day 21)
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Measured: 21 days post-vaccination (Day 21)
Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years
Seroprotection power (SPP) was defined as the proportion of the subjects unprotected before vaccination (titre < 40) who were protected after vaccination (titer ≥ 40). The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Measured: 21 days post-vaccination (Day 21)
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Measured: 21 days post-vaccination (Day 21)
Number of Subjects With Solicited Local Symptoms
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 50 millimeters (mm) of injection site.
Measured: During the 4-day (Day 0-3) post-vaccination period following each dose and across doses
Number of Subjects With Solicited General Symptoms
Assessed solicited general symptoms were Arthralgia, Fatigue, Fever, Headache, Myalgia, Shivering and Sweating. Any= occurrence of the symptom regardless of intensity grade. Grade 3 fever = Grade 3 symptoms greater than (>) 39.0 °C. Related = symptoms considered by the investigator to have a causal relationship to study vaccination.
Measured: During the 4-day (Day 0-3) post-vaccination period following each dose and across doses
Number of Subjects With Unsolicited Adverse Events.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Measured: During 31 days after the study vaccine dose (Day 0-30)
Number of Subjects With Serious Adverse Events (SAEs)
SAEs assessed include medical occurrences that result in death, are life-threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Measured: During the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group

Timeline

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

17 Nov 200528 Mar 2006

First posted6 Sep 2006 (estimated)
Study start17 Nov 2005
Primary completion28 Mar 2006
Study completion28 Mar 2006

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.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 240 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00372255
Sponsor's protocol ID: 106252
Other IDs: 2005-004517-14, 2005
Status last verified: Feb 2019
First submitted: 5 Sep 2006
Last updated: 6 May 2019
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

Schmidt-Ott R, Schwarz T, Haase R, Sander H, Walther U, Fourneau M, Htun-Myint L, Sanger R, Schuster V. Immunogenicity and reactogenicity of a trivalent influenza split vaccine in previously unvaccinated children aged 6-9 and 10-13 years. Vaccine. 2007 Dec 21;26(1):32-40. doi: 10.1016/j.vaccine.2007.10.049. Epub 2007 Nov 9.
PubMed 18022736

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 6 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open, Phase IV Study on the Immunogenicity and Tolerability of Influsplit SSW® 2005/2006 in Children Aged 6 - 13 Years
ClinicalTrials.gov ID: NCT00372255
Acronym / sponsor ID: 106252
Conditions: Influenza
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 240 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 17 Nov 2005 (actual)
Primary completion: 28 Mar 2006 (actual)
Study completion: 28 Mar 2006 (actual)
First posted: 6 Sep 2006 (estimated)
Results: Posted 6 May 2019

Clinical summary

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

The study will evaluate the immune response and the tolerability of the influenza vaccine administered in children aged 6-13 years old.

Study design

Primary purpose: Prevention
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Influsplit SSW® 2005/2006 6-9 years Group	Experimental	Biological: Influsplit SSW® 2005/2006Subjects aged 6 to 9 years who received 2 doses of Influsplit SSW® 2005/2006 vaccine at an interval of 4 weeks (Day 0 and Day 28 ± 2).
Influsplit SSW® 2005/2006 10-13 years Group	Active comparator	Biological: Influsplit SSW® 2005/2006Subjects aged 10 to 13 years who received 1 dose of Influsplit SSW® 2005/2006 vaccine at Day 0.

Who may qualify

Ages: 6 to 13 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (3 listed)

Healthy children or children with an increased health risk due to an underlying chronic disease-such as chronic airways diseases (including asthma), chronic cardiovascular, hepatic and renal diseases as well as diabetes and other metabolic diseases-aged between 6 and 13 years.
All subjects must not have received a prior influenza vaccination.
All subjects must not have had a prior influenza disease.

Key exclusion criteria (6 listed)

Use of any study or unlicensed medications/ vaccine other than the study vaccine within 30 days of the vaccination and/or during the study period.
Acute illness at the start of the study.
Acute, clinically significant pulmonary, cardiovascular abnormalities or abnormalities of the hepatic or renal function.
Known allergic reactions which might be caused by the ingredients of the vaccine.
Girls post-menarche: pregnancy or positive pregnancy-test

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
Influsplit SSW® 2005/2006Study influenza vaccine was administered intramuscularly in the non-dominant arm	Biological	Influsplit SSW® 2005/2006 10-13 years Group, Influsplit SSW® 2005/2006 6-9 years Group

Primary outcome

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
Time frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Titers of serum HI antibodies are presented as geometric mean titers (GMTs) against the three influenza strains contained in the trivalent influenza vaccine Influsplit SSW 2005/2006 (GlaxoSmithKline/SSW) after a single versus after two vaccine doses of Influsplit SSW 2005/2006. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
Time frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
Seroconversion factors were defined as the fold increase in serum HI GMTs post-vaccination compared to Day 0. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years
Time frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)
A seroconverted subject was defined as a subject who was either seronegative prior to the vaccination and had a protective post-vaccination titer of greater than or equal to (≥) 1:40 or who was seropositive prior to the vaccination and had at least a 4-fold increase in the titer as the outcome of the vaccination. The three influenza strains assessed were: A/New Caledonia (H1N1), A/New York (H3N2), B/Jiangsu.

9 secondary outcomes

Titers for Serum HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
Time frame: 21 days post-vaccination (Day 21)
SCF for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
Time frame: 21 days post-vaccination (Day 21)
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
Time frame: 21 days post-vaccination (Day 21)
Number of Seroprotected Subjects Who Were Unprotected at Pre-vaccination Against 3 Influenza Strains in Children Aged Between 10 and 13 Years
Time frame: 21 days post-vaccination (Day 21)
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease in Children Aged Between 10 and 13 Years
Time frame: 21 days post-vaccination (Day 21)
Number of Subjects With Solicited Local Symptoms
Time frame: During the 4-day (Day 0-3) post-vaccination period following each dose and across doses
Number of Subjects With Solicited General Symptoms
Time frame: During the 4-day (Day 0-3) post-vaccination period following each dose and across doses
Number of Subjects With Unsolicited Adverse Events.
Time frame: During 31 days after the study vaccine dose (Day 0-30)
Number of Subjects With Serious Adverse Events (SAEs)
Time frame: During the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group

Results and safety

Results posted to the registry on 6 May 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Influsplit SSW 2005/2006 6-9 Years Group	110	108
Influsplit SSW 2005/2006 10-13 Years Group	114	113

Primary outcome: Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years

Time frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2). Geometric mean (95% Confidence Interval). Unit: Titer

Measure	Influsplit SSW 2005/2006 6-9 Years Group n = 97
A/New Caledonia (H1N1), Dose 1	290.4 (165.6 to 509.3)
A/New Caledonia (H1N1), Dose 2	719.2 (503.3 to 1027.7)
A/New York (H3N2), Dose 1	381.2 (281.3 to 516.6)
A/New York (H3N2), Dose 2	393.9 (313.5 to 494.9)
B/Jiangsu, Dose 1	97.7 (68.6 to 139.2)
B/Jiangsu, Dose 2	301.8 (246.3 to 369.9)

Population analysed: The analysis was performed on the According-to-Protocol (ATP) cohort for immunogenicity, included all evaluable subjects for whom data was available for the considered time point and assay assessed.

Primary outcome: Seroconversion Factor (SCF) for HI Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years

Time frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2). Geometric mean (95% Confidence Interval). Unit: Fold increase

Measure	Influsplit SSW 2005/2006 6-9 Years Group n = 97
A/New Caledonia (H1N1), Dose 1	16.7 (11.8 to 23.8)
A/New Caledonia (H1N1), Dose 2	40.7 (32.6 to 50.8)
A/New York (H3N2), Dose 1	14.9 (10.9 to 20.3)
A/New York (H3N2), Dose 2	15.4 (11.9 to 20.0)
B/Jiangsu, Dose 1	8.5 (6.7 to 10.7)
B/Jiangsu, Dose 2	26.1 (21.4 to 31.9)

Primary outcome: Number of Seroconverted Subjects Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years

Time frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2). Count of participants. Unit: Participants

Measure	Influsplit SSW 2005/2006 6-9 Years Group n = 97
A/New Caledonia (H1N1), Dose 1	63
A/New Caledonia (H1N1), Dose 2	93
A/New York (H3N2), Dose 1	79
A/New York (H3N2), Dose 2	80
B/Jiangsu, Dose 1	66
B/Jiangsu, Dose 2	92

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Solicited local and general: during the 4-day (Day 0-3) post-vaccination period following each dose and across doses. Unsolicited adverse events (AEs): during 31 days after the study vaccine dose (Day 0-30). SAEs: during the entire study period, from Day 0 to 58 + 5 days (30 + 5 days after the 2nd vaccine dose) for the 6-9 years Group and from Day 0 to 30 + 5 days (30 + 5 days after the vaccination) for the 10-13 years Group.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Influsplit SSW 2005/2006 6-9 Years Group	3 of 110 (2.7%)	100 of 110 (90.9%)	0 of 110
Influsplit SSW 2005/2006 10-13 Years Group	0 of 114 (0%)	90 of 114 (78.9%)	0 of 114

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18022736Schmidt-Ott R, Schwarz T, Haase R, Sander H, Walther U, Fourneau M, Htun-Myint L, Sanger R, Schuster V. Immunogenicity and reactogenicity of a trivalent influenza split vaccine in previously unvaccinated children aged 6-9 and 10-13 years. Vaccine. 2007 Dec 21;26(1):32-40. doi: 10.1016/j.vaccine.2007.10.049. Epub 2007 Nov 9.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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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.

GSK Clinical Trials study director

GlaxoSmithKline

18 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 Influsplit SSW® 2005/2006 in people with Influenza, run by GlaxoSmithKline at 18 sites in Germany.

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 3 inclusion and 6 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 6 May 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 18 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

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

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 May 2019). 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?

Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease in Children Aged Between 6 and 9 Years (time frame: 28 days after Dose 1 (Day 28) and 21 days after Dose 2 (Day 49 ± 2)). 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 NCT00372255, 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 6 May 2019.