InfluenzaPhase 1/2NCT00402649
Open-Label Study of H5 Vaccine in Participants of Protocol 04-077
A Phase 1/2 study testing Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites in United States.
Trial summary
This study may provide safety information on a flu vaccine given to children and may provide immunogenicity information to add to what was collected in a previous flu vaccine study. Read more about this study
- Who is it for?
- Ages 2 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 3 sitesUnited States
- Study dates
- Feb 2007to Dec 2007
- Phase
- Phase 1/2
- 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 2 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The subject must be male or female, aged 2 through 10 years at enrollment, and must have participated in protocol 04-077 as a placebo recipient or a subject at the UCLA site.
- The subject must be in good health (and not on any chronic medications), as determined by medical history and a history-directed targeted physical examination.
- Parents or guardians of the subject must be able to understand and comply with planned study procedures and be available for all study visits.
- Parents or guardians of the subject must provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.
Who cannot join
- The subject must not have a known allergy to eggs or other components of the vaccine or sensitivity or allergy to latex.
- The subject must not have a history of asthma or recurrent wheezing.
- The subject must not be undergoing immunosuppression as a result of an underlying illness or treatment.
- The subject must not have an active neoplastic disease or a history of any hematologic malignancy.
- The subject must not be using oral or parenteral steroids, inhaled steroids, or other immunosuppressive or cytotoxic drugs. Note: Subjects on nasal or topical steroids will be allowed to enroll in this study.
- The subject must not have a history of receiving immunoglobulin or other blood product within the 3 months prior to enrollment in this study.
Show all 14Show fewer
- The subject must not receive any other inactivated vaccines within 2 weeks before or after any study vaccine or any other live vaccines within 4 weeks before or after any study vaccine in this study.
- The subject must not have an acute or chronic medical condition that, in the opinion of the investigator, would render vaccination unsafe or would interfere with the evaluation of responses (these conditions include, but are not limited to, known chronic liver disease, significant renal disease, unstable or progressive neurological disorders, diabetes mellitus, and transplant recipients).
- The subject must not have a history of severe reactions following immunization with contemporary influenza virus vaccines.
- The subject must not have an acute illness, including an axillary temperature greater than or equal to 100 degrees F or an oral temperature greater than or equal to 101 degrees F within 3 days prior to vaccination.
- The subject must not have received an experimental vaccine or medication within 1 month prior to enrollment in this study, or expect to receive an experimental vaccine, medication, or blood product during the 13-month study period.
- The subject must not have any condition that would, in the opinion of the investigator, place them at an unacceptable risk of injury or render the subject unable to meet the requirements of the protocol.
- The subject must not have a history of Guillain-Barré syndrome.
- The subject must not be participating concurrently in another clinical trial aside from DMID 04-077 (either in active phase or in follow-up phase).
Trial locations and contacts
3 sites in 1 country.
United States3 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
Saint Louis University
St Louis, Missouri, 63104
UCLA Center For Vaccine Research
Torrance, California, 90502
About this study
Official title: Open-Label Study of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Children Aged 2 Years to 10 Years
This study may provide safety information on a flu vaccine given to children and may provide immunogenicity information to add to what was collected in a previous flu vaccine study. Participants will include 55 healthy children, ages 2-10, who participated in 04-077 and received a placebo injection instead of the flu vaccine or were incompletely immunized. The study has 2 purposes: to make sure there are no serious side effects in children and to see how the immune systems react to the vaccine. Study procedures include up to 4 study visits, up to 9 follow-up phone calls, 2 blood samples to be collected during visits 1 and 3, and up to 3 vaccine injections in the arm or thigh muscle. Parents will be given a memory aid card to record side effects, temperatures, and medications. Parents will have the option for the child to receive a 3rd dose of vaccine if offered, at month 6. This booster shot will require a 6-month visit and participation for an additional 6 months.
Read the detailed description
The recent emergence of novel influenza virus strains in human populations has encouraged efforts to develop vaccines for a potential pandemic. The objectives of this study are to evaluate the safety of intramuscular (IM) subvirion inactivated H5N1 vaccine in healthy children aged 2 through 10 years and to determine the immunogenicity profile of IM subvirion inactivated H5N1 vaccine in healthy children approximately 1 month following receipt of the second of 2 doses of vaccine. Study endpoints include: adverse event (AE) and serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments, as indicated); proportion of subjects achieving a serum hemagglutination inhibition antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of second dose of vaccine (approximately Day 56); geometric mean titer and the frequency of 4-fold or greater increases in hemagglutination inhibition antibody titers 28 days after receipt of second dose of vaccine (approximately Day 56); and development of serum antibody responses against antigenically drifted variants of influenza H5N1 virus. This study is linked to DMID protocol 06-0072. Up to 55 healthy children, aged 2 through 10 years, who previously participated in DMID 04-077, will be eligible for enrollment in this multimember, open-label, phase I/II clinical trial to receive at least 2 and up to 3 doses of an inactivated influenza A/H5N1 vaccine at a 45-micrograms dose. The vaccine dosage level that will be used in this study was chosen based upon safety and immunogenicity data collected previously in adults and children. The injection volume of the 90-micrograms dose is 1 mL for the vaccine being used in this study, but this is considered unacceptable in this age group. Therefore, the 45-micrograms dose (0.5 ml volume) has been selected. Twenty three subjects who were previously enrolled and assigned to placebo in the DMID 04-077 study (A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Children Aged 2 Years Through 9 Years) along with up to 32 subjects from a single site who were incompletely immunized are eligible for enrollment in this study. Vaccine will be administered into the deltoid or (if age appropriate) thigh muscle. All subjects will receive 2 doses of the vaccine approximately 28 days apart. At month 6, subjects' parent(s) or guardian(s) will be called to assess the subjects for serious adverse events. Blood collection for immunogenicity studies will be at the discretion of the parent(s) or legal guardian(s). Should data evaluating a third dose of the influenza A/H5N1 vaccine show enhanced immunogenicity in pediatric subjects participating in DMID 04-077, parents/guardians of subjects who received vaccine will be offered the possibility of a third dose for their participating children.
- Conditions
- Influenza
- Being tested
- Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)
- Keywords
- influenza, A/H5N1, avian influenza, vaccine
- Medical subject headings
- Influenza, Human, Influenza in Birds
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)Biological
Inactivated influenza A/H5N1 vaccine administered via intramuscular (IM) injection; dosage 45-mcg.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart. Receives: Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Solicited Adverse Events Among All Subjects
Number of subjects reporting solicited Adverse Events collected on Memory Aid for Days 0-7 post each vaccination for all subjects (systematic assessment), for any and severe severities.
Measured: Days 0-7 post each vaccination
Occurrence of the Solicited Adverse Event of Body Aches, Solicited Only From Children Age 6-10
Number of subjects reporting solicited Adverse Event of Body Aches, collected on Memory Aid for Days 0-7 post each vaccination for children age 6-10 only (systematic assessment), of any and severe severities.
Measured: Days 0-7 post each vaccination
Occurrence of Unsolicited Adverse Events
Number of subjects with spontaneous reports of Adverse Events of any and severe severities. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.
Measured: Through Day 28 after second vaccination
Occurrence of Serious Adverse Events
Number of subjects with Serious Adverse Events during the 6 months after the first vaccination.
Measured: 6 months after the first vaccination
Secondary outcomes (3)
Number of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Titers of 1:40 or Greater
Number of subjects achieving serum hemagglutination inhibition antibody titer of 1:40 or greater against the influenza A/H5N1 virus after receipt of two doses of vaccine.
Measured: Day 28 after second vaccination
Geometric Mean Titer of Hemagglutination Inhibition Antibody Titers
Geometric mean titer of hemagglutination inhibition antibody titers after receipt of two doses of vaccine.
Measured: Day 28 after second vaccination
Number of Participants With a Four-fold or Greater Increase in Hemagglutination Inhibition Antibody Titers
Number of subjects with a 4-fold or greater increase, relative to baseline, in hemagglutination inhibition antibody titers after receipt of two doses of vaccine.
Measured: Day 28 after second vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2006 (estimated)
- Study startFeb 2007
- Primary completionOct 2007
- Study completionDec 2007
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 National Institute of Allergy and Infectious Diseases (NIAID)The 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 1/2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00402649
- Sponsor's protocol ID
- 06-0072
- Status last verified
- May 2008
- First submitted
- 21 Nov 2006
- Last updated
- 13 Jun 2011
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Children Aged 2 Years to 10 Years
- ClinicalTrials.gov ID
- NCT00402649
- Acronym / sponsor ID
- 06-0072
- Conditions
- Influenza
- Keywords
- influenza, A/H5N1, avian influenza, vaccine
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Feb 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 22 Nov 2006 (estimated)
- Results
- Posted 24 Nov 2008
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study may provide safety information on a flu vaccine given to children and may provide immunogenicity information to add to what was collected in a previous flu vaccine study. Participants will include 55 healthy children, ages 2-10, who participated in 04-077 and received a placebo injection instead of the flu vaccine or were incompletely immunized. The study has 2 purposes: to make sure there are no serious side effects in children and to see how the immune systems react to the vaccine. Study procedures include up to 4 study visits, up to 9 follow-up phone calls, 2 blood samples to be collected during visits 1 and 3, and up to 3 vaccine injections in the arm or thigh muscle. Parents will be given a memory aid card to record side effects, temperatures, and medications. Parents will have the option for the child to receive a 3rd dose of vaccine if offered, at month 6. This booster shot will require a 6-month visit and participation for an additional 6 months.
Detailed description
The recent emergence of novel influenza virus strains in human populations has encouraged efforts to develop vaccines for a potential pandemic. The objectives of this study are to evaluate the safety of intramuscular (IM) subvirion inactivated H5N1 vaccine in healthy children aged 2 through 10 years and to determine the immunogenicity profile of IM subvirion inactivated H5N1 vaccine in healthy children approximately 1 month following receipt of the second of 2 doses of vaccine. Study endpoints include: adverse event (AE) and serious adverse event (SAE) information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments, as indicated); proportion of subjects achieving a serum hemagglutination inhibition antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of second dose of vaccine (approximately Day 56); geometric mean titer and the frequency of 4-fold or greater increases in hemagglutination inhibition antibody titers 28 days after receipt of second dose of vaccine (approximately Day 56); and development of serum antibody responses against antigenically drifted variants of influenza H5N1 virus. This study is linked to DMID protocol 06-0072. Up to 55 healthy children, aged 2 through 10 years, who previously participated in DMID 04-077, will be eligible for enrollment in this multimember, open-label, phase I/II clinical trial to receive at least 2 and up to 3 doses of an inactivated influenza A/H5N1 vaccine at a 45-micrograms dose. The vaccine dosage level that will be used in this study was chosen based upon safety and immunogenicity data collected previously in adults and children. The injection volume of the 90-micrograms dose is 1 mL for the vaccine being used in this study, but this is considered unacceptable in this age group. Therefore, the 45-micrograms dose (0.5 ml volume) has been selected. Twenty three subjects who were previously enrolled and assigned to placebo in the DMID 04-077 study (A Randomized, Double-Blinded, Placebo-Controlled, Phase I/II, Study of the Safety, Reactogenicity, and Immunogenicity of Intramuscular Inactivated Influenza A/H5N1 Vaccine in Healthy Children Aged 2 Years Through 9 Years) along with up to 32 subjects from a single site who were incompletely immunized are eligible for enrollment in this study. Vaccine will be administered into the deltoid or (if age appropriate) thigh muscle. All subjects will receive 2 doses of the vaccine approximately 28 days apart. At month 6, subjects' parent(s) or guardian(s) will be called to assess the subjects for serious adverse events. Blood collection for immunogenicity studies will be at the discretion of the parent(s) or legal guardian(s). Should data evaluating a third dose of the influenza A/H5N1 vaccine show enhanced immunogenicity in pediatric subjects participating in DMID 04-077, parents/guardians of subjects who received vaccine will be offered the possibility of a third dose for their participating children.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)All subjects will receive at least 2 and up to 3 doses of the vaccine approximately 28 days apart. |
Who may qualify
- Ages
- 2 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The subject must be male or female, aged 2 through 10 years at enrollment, and must have participated in protocol 04-077 as a placebo recipient or a subject at the UCLA site.
- The subject must be in good health (and not on any chronic medications), as determined by medical history and a history-directed targeted physical examination.
- Parents or guardians of the subject must be able to understand and comply with planned study procedures and be available for all study visits.
- Parents or guardians of the subject must provide written consent prior to initiation of any study procedures, and subject may provide written assent as appropriate.
Key exclusion criteria (14 listed)
- The subject must not have a known allergy to eggs or other components of the vaccine or sensitivity or allergy to latex.
- The subject must not have a history of asthma or recurrent wheezing.
- The subject must not be undergoing immunosuppression as a result of an underlying illness or treatment.
- The subject must not have an active neoplastic disease or a history of any hematologic malignancy.
- The subject must not be using oral or parenteral steroids, inhaled steroids, or other immunosuppressive or cytotoxic drugs. Note: Subjects on nasal or topical steroids will be allowed to enroll in this 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 |
|---|---|---|
| Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur)Inactivated influenza A/H5N1 vaccine administered via intramuscular (IM) injection; dosage 45-mcg. | Biological | 1 |
Primary outcome
Occurrence of Solicited Adverse Events Among All Subjects
Time frame: Days 0-7 post each vaccination
Number of subjects reporting solicited Adverse Events collected on Memory Aid for Days 0-7 post each vaccination for all subjects (systematic assessment), for any and severe severities.
Occurrence of the Solicited Adverse Event of Body Aches, Solicited Only From Children Age 6-10
Time frame: Days 0-7 post each vaccination
Number of subjects reporting solicited Adverse Event of Body Aches, collected on Memory Aid for Days 0-7 post each vaccination for children age 6-10 only (systematic assessment), of any and severe severities.
Occurrence of Unsolicited Adverse Events
Time frame: Through Day 28 after second vaccination
Number of subjects with spontaneous reports of Adverse Events of any and severe severities. Events reported by more than 5.6% of subjects in any group are reported by MedDRA Preferred Term.
Occurrence of Serious Adverse Events
Time frame: 6 months after the first vaccination
Number of subjects with Serious Adverse Events during the 6 months after the first vaccination.
3 secondary outcomes
Number of Participants With Serum Hemagglutination Inhibition (HAI) Antibody Titers of 1:40 or Greater
Time frame: Day 28 after second vaccination
Geometric Mean Titer of Hemagglutination Inhibition Antibody Titers
Time frame: Day 28 after second vaccination
Number of Participants With a Four-fold or Greater Increase in Hemagglutination Inhibition Antibody Titers
Time frame: Day 28 after second vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2011.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Inactivated Influenza A/H5N1 Vaccine (sanofi pasteur) in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 3 sites 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 4 inclusion and 14 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 13 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 24 Nov 2008). 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?
Occurrence of Solicited Adverse Events Among All Subjects (time frame: Days 0-7 post each vaccination). The study lists 4 primary outcomes in all. 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 13 Jun 2011.