InfluenzaPhase 3NCT01310400

Comparison of the Efficacy of Inflexal V With a Commercially Available Influenza Vaccine in Young Children

A Phase 3 study testing Inflexal V and Agrippal in people with Influenza, run by Crucell Holland BV at 1 site in China.

Completed

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

Trial summary

A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children. 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 and Agrippal
Type of treatment: Vaccines, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,356 participants
Where: 1 siteChina
Study dates: Oct 2009to Jan 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

≥6months to ≤35 months-old healthy children (male or female) born at term after normal pregnancy
Recording of medical history and physical examination reveal no abnormality
The parent/legal guardian of the participating child must sign the written informed consent and agree to provide a blood sample taken from the child pre- and post-immunization

Who cannot join

Hypersensitivity to eggs, chicken proteins, polymyxin B, neomycin or any component of the vaccine
Previous vaccination against influenza
At time of enrollment, presentation of clinical symptoms of active infection and/or body temperature ≥38°C
Confirmation or suspicion of immunosuppressed status (including cancer), or confirmation of immunodeficiency disease (congenital or acquired including HIV)
Medical treatment (>2 weeks) with immune suppressant or immune modulating drugs including systemic steroids during the last 3 months before immunization or at present, as follows: long-term oral prednisone or other equivalent steroid: ≥0.5mg/kg/day (note: administration of local or inhaled steroids before or during the study is allowed)
Treatment with immunoglobulins or blood products during the last 3 months before immunization or such treatment scheduled during the study

Show all 15Show fewer

Participation in other clinical trials during the last 3 months before immunization or intention to participate during this study period
At present or during the last 6 months before immunization: radiotherapy or treatment with cytotoxic drugs
Other vaccination with a killed vaccine within 14 days before immunization or with an attenuated vaccine within 28 days before immunization (note: after subject inclusion vaccines of the immunization program for children are allowed upon the physician's discretion. However, immunization on the same day must be avoided)
Family history of Guillain-Barré Syndrome
Severe congenital deficiency or disease
Antecedent of neurological disease or epileptic attack
Severe cardiopulmonary disease with possibility to influence the study result
Disturbance of coagulation or under anticoagulant treatment, likely to be contraindicated to i.m. injection
Suspected non-compliance

Trial locations and contacts

1 site in 1 country.

China1 site

Guangxi Zhuang Autonomous Region CDC
Nanning, Guangxi, 530028

Other trials in China

About this study

Official title: Observer-blind, Randomized, Controlled Study to Determine the Immunogenicity and Safety of a Two-dose Regimen of Virosomal Subunit Influenza Vaccine Inflexal V in Healthy Young Children (≥6 Months to ≤35 Months) in Comparison With the Subunit Influenza Vaccine Agrippal

A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children.

Conditions: Influenza
Being tested: Inflexal V, Agrippal
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
Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:
- 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus
- 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
- 15 µg HA antigen of B/Brisbane/60/2008-like virus
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Days 0 and 28
Inflexal VBiological
Inflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose:
- 15 µg HA antigen of A/Brisbane/59/2007 (H1N1)-like virus
- 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus
- 15 µg HA antigen of B/Brisbane/60/2008-like virus
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28
AgrippalBiological
Agrippal influenza vaccine
Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28

Study groups in NCT01310400
Study group	Role	What they receive
Inflexal 0.5 mL	Experimental	Not described Receives: Biological: Inflexal V
Inflexal 0.25 mL	Experimental	Not described Receives: Biological: Inflexal V
Agrippal 0.25 mL	Experimental	Not described Receives: Biological: Agrippal

What is being measured

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

Immunogenicity, Assessed by the Haemagglutination (HI) Test
Seroconversion rate post-immunization. Seroconversion is defined as a post-vaccination titer of ≥1:40 for those with a pre-vaccination HI titer of <1:10 and as ≥ four-fold increase in HI titer for those with a pre-vaccination HI titer of ≥1:10.
Measured: 3 weeks after the 2nd vaccination

Secondary outcomes (3)

Fold Increase in Geometric Mean Titer (GMT)
GMT-fold increase - calculated as the GMT on Day 49 divided by the baseline GMT value
Measured: 3 weeks after the 2nd vaccination
Seroprotection
Seroprotection rate, defined as a post-vaccination HI titer of 1:40.
Measured: 3 weeks after the 2nd vaccination
Safety: Incidence of Solicited and Unsolicited Adverse Events
Safety assessements were made by the investigator at baseline and on Days 28 and 49, as well as by the subjects themselves (in Subjects Diaries) for the 4-day period following each vaccination.
Measured: Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end

Timeline

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

Oct 2009Jan 2010

First posted8 Mar 2011 (estimated)
Study startOct 2009
Primary completionJan 2010
Study completionJan 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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 1,356 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01310400
Sponsor's protocol ID: TG0826INF
Status last verified: Aug 2013
First submitted: 7 Mar 2011
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: Observer-blind, Randomized, Controlled Study to Determine the Immunogenicity and Safety of a Two-dose Regimen of Virosomal Subunit Influenza Vaccine Inflexal V in Healthy Young Children (≥6 Months to ≤35 Months) in Comparison With the Subunit Influenza Vaccine Agrippal
ClinicalTrials.gov ID: NCT01310400
Acronym / sponsor ID: TG0826INF
Conditions: Influenza
Keywords: Influenza, Virus, Vaccination, Immunisation
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,356 participants (actual)
Lead sponsor: Crucell Holland BVIndustry (pharma, biotech, devices)
Study start: Oct 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 8 Mar 2011 (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.

A study to assess whether the Northern Hemisphere 2009/2010 season influenza vaccine Inflexal V is as immunogenic as a locally sourced competitor vaccine in young children.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 3

Arm	Type	Receives
Inflexal 0.5 mL	Experimental	Biological: Inflexal V
Inflexal 0.25 mL	Experimental	Biological: Inflexal V
Agrippal 0.25 mL	Experimental	Biological: Agrippal

Who may qualify

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

Key inclusion criteria (3 listed)

≥6months to ≤35 months-old healthy children (male or female) born at term after normal pregnancy
Recording of medical history and physical examination reveal no abnormality
The parent/legal guardian of the participating child must sign the written informed consent and agree to provide a blood sample taken from the child pre- and post-immunization

Key exclusion criteria (15 listed)

Hypersensitivity to eggs, chicken proteins, polymyxin B, neomycin or any component of the vaccine
Previous vaccination against influenza
At time of enrollment, presentation of clinical symptoms of active infection and/or body temperature ≥38°C
Confirmation or suspicion of immunosuppressed status (including cancer), or confirmation of immunodeficiency disease (congenital or acquired including HIV)
Medical treatment (>2 weeks) with immune suppressant or immune modulating drugs including systemic steroids during the last 3 months before immunization or at present, as follows: long-term oral prednisone or other equivalent steroid: ≥0.5mg/kg/day (note: administration of local or inhaled steroids before or during the study is allowed)

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 VInflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: * 15 µg hemagglutinin (HA) antigen of A/Brisbane/59/2007 (H1N1)-like virus * 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus * 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoideus) of a single dose of 0.5 mL on Days 0 and 28	Biological	Inflexal 0.5 mL
Inflexal VInflexal V influenza vaccine, formulated for the WHO requirements of the 2009-2010 season, containing per 0.5 mL dose: * 15 µg HA antigen of A/Brisbane/59/2007 (H1N1)-like virus * 15 µg HA antigen of A/Brisbane/10/2007 (H3N2)-like virus * 15 µg HA antigen of B/Brisbane/60/2008-like virus Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28	Biological	Inflexal 0.25 mL
AgrippalAgrippal influenza vaccine Dose: intramuscular administration (M. deltoideus) of a single dose of 0.25 mL on Days 0 and 28	Biological	Agrippal 0.25 mL

Primary outcome

Immunogenicity, Assessed by the Haemagglutination (HI) Test
Time frame: 3 weeks after the 2nd vaccination
Seroconversion rate post-immunization. Seroconversion is defined as a post-vaccination titer of ≥1:40 for those with a pre-vaccination HI titer of <1:10 and as ≥ four-fold increase in HI titer for those with a pre-vaccination HI titer of ≥1:10.

3 secondary outcomes

Fold Increase in Geometric Mean Titer (GMT)
Time frame: 3 weeks after the 2nd vaccination
Seroprotection
Time frame: 3 weeks after the 2nd vaccination
Safety: Incidence of Solicited and Unsolicited Adverse Events
Time frame: Solicited AEs: Days 1-4 and 28-31, and Days 28 and 49; unsolicited AEs: until study end

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 0.5 mL	452	424
Inflexal V 0.25 mL	452	420
Agrippal 0.25 mL	452	422

Primary outcome: Immunogenicity, Assessed by the Haemagglutination (HI) Test

Time frame: 3 weeks after the 2nd vaccination. Number (95% Confidence Interval). Unit: percentage of participants

Measure	Inflexal V 0.5 mL n = 423	Inflexal V 0.25 mL n = 380	Agrippal 0.25 mL n = 384
Percentage of subjects seroconverted: A/H1N1	97.2 (95.1 to 98.5)	89.7 (86.2 to 92.6)	92.7 (89.6 to 95.1)
Percentage of subjects seroconverted: A/H3N2	90.5 (87.4 to 93.2)	83.4 (79.3 to 87.0)	82.6 (78.4 to 86.2)
Percentage of subjects seroconverted: B-strain	57.5 (52.6 to 62.2)	47.9 (42.8 to 53.1)	37.2 (32.4 to 42.3)

Inflexal V 0.5 mL vs Agrippal 0.25 mL: Difference in seroconversion rates: 4.5 (95% CI 1.4 to 7.5), p = 0.0036, Chi-squared
Inflexal V 0.25 mL vs Agrippal 0.25 mL: Difference in seroconversion rates: -3.0 (95% CI -7.0 to 1.0), p = 0.1465, Chi-squared
Inflexal V 0.5 mL vs Agrippal 0.25 mL: Difference in seroconversion rates: 8.0 (95% CI 3.3 to 12.7), p <0.001, Chi-squared

Population analysed: According-to-protocol population: subjects who received both doses of influenza vaccine, with available pre- and post-vaccination titers and without major protocol violations

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Inflexal V 0.5 mL	0 of 452 (0%)	57 of 452 (12.6%)	Not reported
Inflexal V 0.25 mL	1 of 451 (0.2%)	37 of 451 (8.2%)	Not reported
Agrippal 0.25 mL	1 of 451 (0.2%)	55 of 451 (12.2%)	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.

Rongcheng Li, MD principal investigator

Guangxi Zhuang Autonomous Region CDC

1 site 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 and Agrippal in people with Influenza, run by Crucell Holland BV at 1 site in China.

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 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 1 site in China. 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, Assessed by the Haemagglutination (HI) Test (time frame: 3 weeks after the 2nd vaccination). 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 NCT01310400.

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.