InfluenzaPhase 4NCT00836953
Study to Collect Sera for Immunogenicity Testing in Children Vaccinated With Fluzone®
A Phase 4 study testing Influenza virus vaccine (Pediatric formulation) in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 1 site in United States.
Trial summary
To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months. Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza virus vaccine (Pediatric formulation)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2003to Jul 2004
- 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Aged ≥ 6 months to < 36 months.
- Considered to be in good health on the basis of reported medical history and limited physical examination.
- Available for the duration of the study (44 days +4 days).
- Parent/guardian is willing and able to provide informed consent.
- Parent/guardian is willing and able to meet protocol requirements.
Who cannot join
- Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
- Previous history of influenza vaccination or documented history of influenza infection.
- An acute illness with or without fever (temperature > 100.4 °F rectal) in the 72 hours preceding enrollment in the trial (defer enrollment).
- Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
- Participation in any other clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the study.
- Known or suspected impairment of immunologic function, or receipt of immunosuppressive therapy or immunoglobulin since birth.
Show all 12Show fewer
- Personal or immediate family history of congenital immune deficiency.
- Developmental delay, neurologic disorder, or seizure disorder.
- Chronic medical, congenital, or developmental disorder.
- Known human immunodeficiency virus (HIV)-positive mother.
- Prior history of Guillain-Barré syndrome.
- Any condition which, in the opinion of the investigator, would pose a health risk to the subject or interfere with the evaluation of the vaccine.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Trial for the Collection of Sera in Healthy Children Receiving Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004
To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.
To describe the immunogenicity findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months
Read the detailed description
The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.
- Conditions
- Influenza
- Being tested
- Influenza virus vaccine (Pediatric formulation)
- Keywords
- Influenza, Fluzone®, Children
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza virus vaccine (Pediatric formulation)Biological
Also called Fluzone®
0.25 mL, Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Experimental | Participants received 2 doses of Fluzone® vaccine Receives: Biological: Influenza virus vaccine (Pediatric formulation) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination
Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.
Measured: Day 0 to 3 post-vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2009 (estimated)
- Study startSep 2003
- Primary completionJan 2004
- Study completionJul 2004
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 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 4
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sanofi Pasteur, a Sanofi Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Sanofi Pasteur Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00836953
- Sponsor's protocol ID
- GRC17
- Status last verified
- Apr 2016
- First submitted
- 3 Feb 2009
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Mitchell DK, Ruben FL, Gravenstein S. Immunogenicity and safety of inactivated influenza virus vaccine in young children in 2003-2004. Pediatr Infect Dis J. 2005 Oct;24(10):925-7. doi: 10.1097/01.inf.0000180978.66362.d9.
PubMed 16220095
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial for the Collection of Sera in Healthy Children Receiving Influenza Virus Vaccine USP Trivalent Types A and B (Zonal Purified Subvirion) Fluzone® 2003/2004
- ClinicalTrials.gov ID
- NCT00836953
- Acronym / sponsor ID
- GRC17
- Conditions
- Influenza
- Keywords
- Influenza, Fluzone®, Children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2003
- Primary completion
- Jan 2004 (actual)
- Study completion
- Jul 2004 (actual)
- First posted
- 4 Feb 2009 (estimated)
- Results
- Posted 27 Aug 2009
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To describe the safety findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months.
To describe the immunogenicity findings from Days 0 to 44 following injection of the 2003-2004 pediatric formulation of the inactivated, split-virion influenza vaccine Fluzone®, given in the two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months
Detailed description
The study is to collect sera from healthy children being administered the 2003-2004 formulation of the inactivated, split-virion influenza vaccine Fluzone®.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Biological: Influenza virus vaccine (Pediatric formulation)Participants received 2 doses of Fluzone® vaccine |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged ≥ 6 months to < 36 months.
- Considered to be in good health on the basis of reported medical history and limited physical examination.
- Available for the duration of the study (44 days +4 days).
- Parent/guardian is willing and able to provide informed consent.
- Parent/guardian is willing and able to meet protocol requirements.
Key exclusion criteria (12 listed)
- Reported allergy to egg proteins, chicken proteins, or any other constituent of the vaccine.
- Previous history of influenza vaccination or documented history of influenza infection.
- An acute illness with or without fever (temperature > 100.4 °F rectal) in the 72 hours preceding enrollment in the trial (defer enrollment).
- Clinically significant findings in vital signs or review of systems (investigator judgment; defer or exclude).
- Participation in any other clinical trial within 30 days prior to enrollment up to termination of the subject's participation in the 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 |
|---|---|---|
| Influenza virus vaccine (Pediatric formulation)Also: Fluzone®0.25 mL, Intramuscular | Biological | Study Group |
Primary outcome
Number of Participants Reporting Solicited Local and Systemic Reactions After Fluzone® Vaccination
Time frame: Day 0 to 3 post-vaccination
Solicited local reactions: Erythema (redness), induration, bruising and pain at the injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting and rash.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 16220095Mitchell DK, Ruben FL, Gravenstein S. Immunogenicity and safety of inactivated influenza virus vaccine in young children in 2003-2004. Pediatr Infect Dis J. 2005 Oct;24(10):925-7. doi: 10.1097/01.inf.0000180978.66362.d9.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Influenza virus vaccine (Pediatric formulation) in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 1 site in United States.
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 12 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 14 Apr 2016. 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 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 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 27 Aug 2009). 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 Local and Systemic Reactions After Fluzone® Vaccination (time frame: Day 0 to 3 post-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 NCT00836953, 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 14 Apr 2016.