InfluenzaPhase 3NCT01229397

Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V

A Phase 3 study testing Inflexal V in people with Influenza, run by Crucell Holland BV at 2 sites in Italy.

Completed

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

Trial summary

The study aims to evaluate the immunogenicity of a single full (0.5 mL) dose and a 0.25 mL 2-dose regime of Inflexal V in unprimed children aged 6 - <36 months, using the EMA guideline for the re-registration of the seasonal influenza vaccine in adults (aged ≥18 ≤60 years) as reference. Read more about this study

Who is it for?: Ages 6 to 35 monthsHealthy volunteers can take part
Conditions the study is for: Influenza
What is being tested?: Inflexal V
Type of treatment: Vaccines
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 205 participants
Where: 2 sitesItaly
Study dates: Oct 2010to Nov 2010
Phase: Phase 3
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 35 months
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy male and female children
Aged ≥6 to <36 months on Day 1
Born at a gestational age ≥37 weeks
Written informed consent
No previous influenza vaccination

Who cannot join

Acute respiratory infection or other acute disease
Acute febrile illness (≥38.0 °C)
Past vaccination with an influenza vaccine, including vaccination against the influenza strain A/California/7/2009 (H1N1)-like virus
Laboratory-confirmed infection with any influenza strain, including the pandemic influenza strain H1N1 (A/California/7/2009 (H1N1)-like virus)
Known hypersensitivity to any vaccine component
Known history of egg protein allergy or severe atopy

Show all 15Show fewer

Known blood coagulation disorder
Chronic (longer than 14 days) administration of immunosuppressants or other immune-modifying drugs within 6 months before the first dose of the study vaccine, incl. oral corticosteroids in dosages of ≥0.5 mg/kg/d prednisolone or equivalent for ≥14 days (inhaled or topical steroids are allowed)
Known immunodeficiency (including leukemia, cancer, HIV seropositivity)
Investigational medicinal product received in the past 3 months (90 days)
Treatment with immunoglobulins or blood transfusion(s) received in the past 3 months (90 days)
Vaccination with the MMR vaccine in the past 4 weeks, or planned within the study period
Participation in another clinical trial
Child or legal charge of the investigator or an employee at the study site, or living in the same household as the investigator/employee and/or dependent on the investigator/employee
Suspected non-compliance

Trial locations and contacts

2 sites in 1 country.

Italy2 sites

Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital
Milan, 20157
Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena"
Milan, 20122

Other trials in Italy

About this study

Official title: A Phase III Open, Randomized, Parallel, Multi-center Study in Children Aged 6 - 35 Months to Compare the Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V Administered According to a 0/4 Week Schedule

Conditions: Influenza
Being tested: Inflexal V
Keywords: Influenza, Virus, Vaccination, Immunisation
Medical subject headings: Influenza, Human, Virus Diseases

What participants receive

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

Inflexal VBiological
vaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart
Inflexal VBiological
Inflexal V 0.5 mL administrated once only

Study groups in NCT01229397
Study group	Role	What they receive
Inflexal V 0.25 mL x 2	Active comparator	Not described Receives: Biological: Inflexal V
Inflexal V 0.5 mL x 1	Experimental	Not described Receives: Biological: Inflexal V

What is being measured

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

Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Seroprotection rate
Measured: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Seroconversion rate
Measured: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value
Measured: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen

Secondary outcomes (1)

Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability
Measured: Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary

Timeline

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

Oct 2010Nov 2010

First posted27 Oct 2010 (estimated)
Study startOct 2010
Primary completionNov 2010
Study completionNov 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.
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 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 205 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01229397
Sponsor's protocol ID: INF-V-A005
Status last verified: Aug 2013
First submitted: 22 Oct 2010
Last updated: 6 Feb 2014
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 6 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase III Open, Randomized, Parallel, Multi-center Study in Children Aged 6 - 35 Months to Compare the Immunogenicity and Safety of a Single 0.5 mL Dose of Inflexal V With a 0.25 mL 2-dose Regimen of Inflexal V Administered According to a 0/4 Week Schedule
ClinicalTrials.gov ID: NCT01229397
Acronym / sponsor ID: INF-V-A005
Conditions: Influenza
Keywords: Influenza, Virus, Vaccination, Immunisation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 205 participants (actual)
Lead sponsor: Crucell Holland BVIndustry (pharma, biotech, devices)
Study start: Oct 2010
Primary completion: Nov 2010 (actual)
Study completion: Nov 2010 (actual)
First posted: 27 Oct 2010 (estimated)
Results: Posted 20 May 2013

Clinical summary

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

Study design

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

Arm	Type	Receives
Inflexal V 0.25 mL x 2	Active comparator	Biological: Inflexal V
Inflexal V 0.5 mL x 1	Experimental	Biological: Inflexal V

Who may qualify

Ages: 6 to 35 months
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (5 listed)

Healthy male and female children
Aged ≥6 to <36 months on Day 1
Born at a gestational age ≥37 weeks
Written informed consent
No previous influenza vaccination

Key exclusion criteria (15 listed)

Acute respiratory infection or other acute disease
Acute febrile illness (≥38.0 °C)
Past vaccination with an influenza vaccine, including vaccination against the influenza strain A/California/7/2009 (H1N1)-like virus
Laboratory-confirmed infection with any influenza strain, including the pandemic influenza strain H1N1 (A/California/7/2009 (H1N1)-like virus)
Known hypersensitivity to any vaccine component

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
Inflexal Vvaccination with Inflexal V 0.25 mL administered twice, 4 weeks apart	Biological	Inflexal V 0.25 mL x 2
Inflexal VInflexal V 0.5 mL administrated once only	Biological	Inflexal V 0.5 mL x 1

Primary outcome

Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Time frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Seroprotection rate
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Time frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
Seroconversion rate
Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference
Time frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen
GMT-fold increase - calculated as the GMT on Day 22 divided by the baseline GMT value

1 secondary outcome

Number of Participants With Local and Systemic Adverse Events as a Measure of Safety and Tolerability
Time frame: Solicited local and systemic AEs were collected from Day 1 (day of vaccination) to Day 4 inclusive using a subject diary

Results and safety

Results posted to the registry on 20 May 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
Inflexal V 0.25 mL x 2	103	92
Inflexal V 0.5 mL x 1	102	93

Primary outcome: Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference

Time frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen. Number (95% Confidence Interval). Unit: percentage subjects

Measure	Inflexal V 0.25 mL x 2 n = 98	Inflexal V 0.5 mL x 1 n = 99
Percentage of subjects seroprotected: A/H1N1	99.0 (94.4 to 100)	98.0 (92.9 to 99.8)
Percentage of subjects seroprotected: A/H3N2	99.0 (94.4 to 100)	97.0 (91.4 to 99.4)
Percentage of subjects seroprotected: B-strain	92.2 (85.8 to 97.1)	86.9 (78.6 to 92.8)

Population analysed: Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers

Primary outcome: Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference

Time frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen. Number (95% Confidence Interval). Unit: percentage subjects

Measure	Inflexal V 0.25 mL x 2 n = 98	Inflexal V 0.5 mL x 1 n = 99
Percentage of subjects seroconverted: A/H1N1	92.9 (85.1 to 97.3)	95.5 (88.8 to 98.7)
Percentage of subjects seroconverted: A/H3N2	99.0 (94.4 to 100)	97.0 (91.4 to 99.4)
Percentage of subjects seroconverted: B-strain	92.9 (85.8 to 97.1)	86.9 (78.6 to 92.8)

Population analysed: Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers

Primary outcome: Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference

Time frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen. Number (95% Confidence Interval). Unit: Fold (ratio)

Measure	Inflexal V 0.25 mL x 2 n = 98	Inflexal V 0.5 mL x 1 n = 99
GMT fold increase from baseline: A/H1N1	25.5 (21.3 to 30.5)	19.6 (16.9 to 22.7)
GMT fold increase from baseline: A/H3N2	31.6 (26.7 to 37.3)	24.6 (20.7 to 29.3)
GMT fold increase from baseline: B-strain	12.8 (11.2 to 14.6)	14.7 (12.3 to 17.4)

Population analysed: Intention to treat population, vaccinated subjects with available pre- and post-vaccination titers

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Any AE occurring within 1 month (minimum 28 days) following vaccine administration was recorded. Any SAE occurring from study start up to 6 months (at least 180 days) following vaccine administration was recorded.. Other adverse events reported at 4% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inflexal V 0.25 mL x 2 - After 1st Vaccination	1 of 102 (1%)	51 of 102 (50%)	Not reported
Inflexal V 0.25 mL x 2 - After 2nd Vaccination	0 of 101 (0%)	48 of 101 (47.5%)	Not reported
Inflexal V 0.5 mL x 1	5 of 100 (5%)	49 of 100 (49%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Nicola Principi, Prof Dr principal investigator

Institute of Paediatrics, University of Milan, Fondazione IRCCS "Ospedale Maggiore Policlinico, Mangiagalli e Regina Elena", Via Commenda 9, 20122, Milano, Italy

Gian Vincenzo Zuccotti, Prof Dr principal investigator

Department of Pediatrics, Department of Clinical Sciences, Università di Milano, L. Sacco Hospital, 74, Via GB Grassi,

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inflexal V in people with Influenza, run by Crucell Holland BV at 2 sites in Italy.

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 5 inclusion and 15 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 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Italy. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 20 May 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?

Immunogenicity of a Single Full (0.5 mL) Dose and a 0.25 mL 2-dose Regimen of Inflexal V, Using the EMA Guideline for the Re-registration of the Seasonal Influenza Vaccine in Adults (Aged ≥18 to ≤60 Years) as Reference (time frame: This assesment was done for immunogenicity data collected at Day 29 after completion of designated vaccination regimen). 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 NCT01229397.

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 Feb 2014.