InfluenzaPhase 4NCT00831675
Study of Safety and Immunogenicity of Fluzone® in Healthy Children
A Phase 4 study testing Influenza Vaccine 2004-2005 Paediatric Formulation in people with Influenza, run by Sanofi Pasteur, a Sanofi Company at 1 site in United States.
Trial summary
To describe the safety of the 2004-2005 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 35 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza Vaccine 2004-2005 Paediatric Formulation
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Apr 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 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Participant is aged ≥ 6 months to < 36 months.
- Participant is considered to be in good health on the basis of reported medical history and limited physical examination.
- Participant is available for the duration of the study.
- 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 13Show 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.
- Any vaccination in the 14 days preceding enrollment in the study or scheduled between Visit 1 and Visit 3.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005
To describe the safety of the 2004-2005 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 of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months
Read the detailed description
To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).
- Conditions
- Influenza
- Being tested
- Influenza Vaccine 2004-2005 Paediatric Formulation
- Keywords
- Influenza, Fluzone® vaccine, Infants, Toddlers
- 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 Vaccine 2004-2005 Paediatric FormulationBiological
Also called Fluzone®
0.25 mL (Day 0 and Day 28), Intramuscular
Influenza Vaccine 2004-2005 Paediatric FormulationBiological
Also called Fluzone®
0.25 mL (Day 0 and Day 28), Intramuscular
| Study group | Role | What they receive |
|---|---|---|
| Infants <12 Months | Experimental | Participants aged ≥ 6 to < 12 months at enrollment and received 2 doses of Fluzone® Vaccine Receives: Biological: Influenza Vaccine 2004-2005 Paediatric Formulation |
| Toddlers ≥12 Months | Experimental | Participants aged ≥ 12 to < 36 months at enrollment and received 2 doses of Fluzone® vaccine Receives: Biological: Influenza Vaccine 2004-2005 Paediatric Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation
Solicited local reactions: Erythema, bruising, induration, pain at injection site.
Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection.
Measured: Days 0-3 Post-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2009 (estimated)
- Study startSep 2004
- Primary completionApr 2006
- Study completionApr 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.
- 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
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 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
- NCT00831675
- Sponsor's protocol ID
- GRC21
- Status last verified
- Apr 2016
- First submitted
- 28 Jan 2009
- Last updated
- 14 Apr 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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
- Annual Study for Serum Collection and Evaluation of Safety and Immunogenicity Among Healthy Children Receiving Influenza Virus Vaccine Fluzone® 2004-2005
- ClinicalTrials.gov ID
- NCT00831675
- Acronym / sponsor ID
- GRC21
- Conditions
- Influenza
- Keywords
- Influenza, Fluzone® vaccine, Infants, Toddlers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sanofi Pasteur, a Sanofi CompanyIndustry (pharma, biotech, devices)
- Study start
- Sep 2004
- Primary completion
- Apr 2006 (actual)
- Study completion
- Apr 2006 (actual)
- First posted
- 29 Jan 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 of the 2004-2005 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 of the 2004-2005 inactivated, split-virion influenza vaccine Fluzone®, administered in a two-dose schedule in accordance with the Package Insert, in children aged ≥ 6 months to < 36 months
Detailed description
To provide the Centers for Biologic Evaluation and Research (CBER) with sera collected from healthy children receiving the 2004-2005 formulation of the inactivated, split-virion influenza vaccine Fluzone® for further study by the Food and Drug Administration (FDA), Centers for Disease Control and Prevention (CDC), and the World Health Organization (WHO).
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Infants <12 Months | Experimental | Biological: Influenza Vaccine 2004-2005 Paediatric FormulationParticipants aged ≥ 6 to < 12 months at enrollment and received 2 doses of Fluzone® Vaccine |
| Toddlers ≥12 Months | Experimental | Biological: Influenza Vaccine 2004-2005 Paediatric FormulationParticipants aged ≥ 12 to < 36 months at enrollment and received 2 doses of Fluzone® vaccine |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participant is aged ≥ 6 months to < 36 months.
- Participant is considered to be in good health on the basis of reported medical history and limited physical examination.
- Participant is available for the duration of the study.
- Parent/guardian is willing and able to provide informed consent.
- Parent/guardian is willing and able to meet protocol requirements.
Key exclusion criteria (13 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 Vaccine 2004-2005 Paediatric FormulationAlso: Fluzone®0.25 mL (Day 0 and Day 28), Intramuscular | Biological | Infants <12 Months |
| Influenza Vaccine 2004-2005 Paediatric FormulationAlso: Fluzone®0.25 mL (Day 0 and Day 28), Intramuscular | Biological | Toddlers ≥12 Months |
Primary outcome
Number of Participants With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation
Time frame: Days 0-3 Post-dose
Solicited local reactions: Erythema, bruising, induration, pain at injection site. Solicited systemic reactions: Fever (temperature), irritability, crying, lethargy, appetite decreased, diarrhea, vomiting, rash collected daily for four days after each injection.
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.
- 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 Vaccine 2004-2005 Paediatric 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 13 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 With Solicited Local and Systemic Reactions After Vaccination With Fluzone® 2004-2005 Pediatric Formulation (time frame: Days 0-3 Post-dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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.