InfluenzaPhase 1/2NCT00133536
A/H5N1 Vaccine in Healthy Children Aged 2-9 Years
A Phase 1/2 study testing Influenza A/H5N1 Vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 sites in United States.
Trial summary
The purposes of this study are: to make sure that there are no serious side effects of an experimental inactivated influenza A/H5N1 vaccine in children; and to see how the body's immune system reacts to the vaccine. To look at the side effects, researchers will follow children closely after vaccination. Read more about this study
- Who is it for?
- Ages 2 to 9 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza A/H5N1 Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2006to Apr 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 9 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- The subject must be male or female, aged 2 through 9 years at enrollment.
- 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 must be able to understand and comply with planned study procedures and be available for all study visits.
- Parents or guardians 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.
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- The subject must not have received any other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrollment 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 100 degrees F, within 3 days prior to vaccination.
- The subject must not have received an experimental vaccine or medication within one 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.
- History of Guillain-Barré syndrome.
- The subject must not be participating concurrently in another clinical trial (either in active phase or in follow-up phase).
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of Maryland Baltimore
Baltimore, Maryland, 21201
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229-3039
Saint Louis University
St Louis, Missouri, 63104
UCLA Center For Vaccine Research
Torrance, California, 90502
About this study
Official title: 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
The purposes of this study are: to make sure that there are no serious side effects of an experimental inactivated influenza A/H5N1 vaccine in children; and to see how the body's immune system reacts to the vaccine. To look at the side effects, researchers will follow children closely after vaccination. To look at immune system responses, researchers will test the children's blood before and a number of times after vaccination. Participants will include up to 130 healthy children ages 2-9 years. Participants will be assigned to receive 2, up to 3 doses of vaccine, or placebo (inactive substance). Subjects will receive at least 2 doses of vaccine approximately 28 days apart. If data shows an enhanced immune response from a third vaccination, children will be offered a third dose of the vaccine. Participants will be involved in study related procedures for up to 13 months, including up to 6 study visits, plus a number of telephone calls.
Read the detailed description
The goals of this study are to assess the safety, reactogenicity, and immunogenicity of 45-microgram dosage level of monovalent subvirion influenza A/H5N1 virus vaccine administered by intramuscular (IM) route to healthy children. The primary goal of this study is to determine if this dosage level of H5N1 will result in an acceptable proportion of children achieving a potentially protective post vaccination antibody titer (provisionally assigned as a serum neutralizing titer of 1:40, based on studies conducted in Hong Kong during the 1997 H5N1 outbreak). Approximately 130 healthy children, aged 2 through 9 years, will be enrolled in this multicenter, randomized, double-blinded, placebo-controlled, clinical trial to receive at least 2 and up to 3 doses of an inactivated influenza A/H5N1 vaccine at a 45-microgram dose. One hundred subjects will be enrolled and randomly assigned into the influenza A/H5N1 vaccine dose group and 20 subjects into the placebo group (in 5:1 ratio). Subjects will be stratified into 2 age groups (2 to 5 years old and 6 to 9 years old). Vaccine or placebo will be administered into the deltoid. Subjects randomized to receive vaccine will receive 2 doses of the vaccine approximately 28 days apart. At approximately month 5, subjects' parent(s) or guardian(s) will be called to remind them of the 6-month follow-up visit. At the 6-month visit, subjects will be assessed for serious adverse events (SAEs) and the randomization assignment, ie, to vaccine or placebo, will be unmasked to the subject and parent(s) or guardian(s). Should data evaluating a third dose of the influenza A/H5N1 vaccine in adults show enhanced immunogenicity, parents or guardians of subjects who received vaccine will be offered a third dose, with an additional blood draw immediately prior to the third dose and 28 days and 6 months thereafter. The 6-month post-Dose 3 blood draw is optional. For subjects assigned to placebo, the parents or guardians will be offered the opportunity to enroll the subject into a separate open-label protocol if the 2 dose regimen administered to the vaccine recipients is found to be safe and immunogenic. The primary endpoints of the study include: adverse event (AE) and SAE information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments, as indicated); proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of second dose of vaccine (approximately Day 56); and geometric mean titer (GMT) and the frequency of 4-fold or greater increases in hemagglutination inhibition and neutralizing antibody titers 28 days after receipt of second dose of vaccine (approximately Day 56). The secondary endpoints of the study include: proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus 1 and 6 months after receipt of first and third doses (if third dose will be administered [see study design]) of vaccine; GMT and the frequency of 4-fold or greater increases in serum hemagglutination inhibition antibody titer 1 and 6 months after receipt of first and third (if third dose will be administered [see study design]) doses of vaccine; and development of serum antibody responses against antigenically drifted variants of influenza H5N1 virus. This study is linked to protocol 06-0072.
- Conditions
- Influenza
- Being tested
- Influenza A/H5N1 Vaccine, Placebo
- Keywords
- H5N1, Influenza, children
- 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.
Influenza A/H5N1 VaccineBiological
Monovalent inactivated subvirion influenza H5N1 vaccine (derived from A/Vietnam/1203/04). Packaged in single-dose vials of 90 mcg/mL (0.7 mL/vial). Dosage 45 mcg/0.5 mL administered intramuscularly.
PlaceboDrug
Normal saline administered intramuscularly.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 100 subjects 45 mcg of influenza A/H5N1. Receives: Biological: Influenza A/H5N1 Vaccine |
| 2 | Placebo comparator | 20 subjects saline placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse event (AE) and serious adverse event (SAE) information (solicited in clinic and via memory aids, concomitant medications, and periodic targeted physical assessments.)
Measured: Solicited AEs-reactogenicity following each vaccination. Unsolicited AEs-SAEs occurring during the length of the study, and nonserious events occurring 28 days after receipt of the 2nd (from enrollment) or 3rd dose of vaccine.
Proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus.
Measured: 28 days after receipt of the 2nd dose of vaccine (Day 56).
Geometric mean titer and the frequency of 4-fold or greater increases in hemagglutination inhibition and neutralizing antibody titers.
Measured: 28 days after receipt of the 2nd dose of vaccine (Day 56).
Secondary outcomes (3)
Proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus.
Measured: 1 and 6 months after receipt of first and third doses (if third dose will be administered [see study design]) of vaccine.
Geometric mean titer and the frequency of 4-fold or greater increases in serum hemagglutination inhibition antibody titer.
Measured: 1 and 6 months after receipt of first and third (if third dose will be administered [see study design]) doses of vaccine.
Development of serum antibody responses against antigenically drifted variants of influenza H5N1 virus.
Measured: Blood samples for serum assays will be collected at day 0, approximately 1 month after each immunization, and approximately 6 months after the first immunization and third immunization (if provided).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startJan 2006
- Primary completionApr 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133536
- Sponsor's protocol ID
- 04-077
- Status last verified
- Jun 2008
- First submitted
- 19 Aug 2005
- Last updated
- 27 Aug 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00133536
- Acronym / sponsor ID
- 04-077
- Conditions
- Influenza
- Keywords
- H5N1, Influenza, children
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Jan 2006
- Primary completion
- Apr 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 23 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purposes of this study are: to make sure that there are no serious side effects of an experimental inactivated influenza A/H5N1 vaccine in children; and to see how the body's immune system reacts to the vaccine. To look at the side effects, researchers will follow children closely after vaccination. To look at immune system responses, researchers will test the children's blood before and a number of times after vaccination. Participants will include up to 130 healthy children ages 2-9 years. Participants will be assigned to receive 2, up to 3 doses of vaccine, or placebo (inactive substance). Subjects will receive at least 2 doses of vaccine approximately 28 days apart. If data shows an enhanced immune response from a third vaccination, children will be offered a third dose of the vaccine. Participants will be involved in study related procedures for up to 13 months, including up to 6 study visits, plus a number of telephone calls.
Detailed description
The goals of this study are to assess the safety, reactogenicity, and immunogenicity of 45-microgram dosage level of monovalent subvirion influenza A/H5N1 virus vaccine administered by intramuscular (IM) route to healthy children. The primary goal of this study is to determine if this dosage level of H5N1 will result in an acceptable proportion of children achieving a potentially protective post vaccination antibody titer (provisionally assigned as a serum neutralizing titer of 1:40, based on studies conducted in Hong Kong during the 1997 H5N1 outbreak). Approximately 130 healthy children, aged 2 through 9 years, will be enrolled in this multicenter, randomized, double-blinded, placebo-controlled, clinical trial to receive at least 2 and up to 3 doses of an inactivated influenza A/H5N1 vaccine at a 45-microgram dose. One hundred subjects will be enrolled and randomly assigned into the influenza A/H5N1 vaccine dose group and 20 subjects into the placebo group (in 5:1 ratio). Subjects will be stratified into 2 age groups (2 to 5 years old and 6 to 9 years old). Vaccine or placebo will be administered into the deltoid. Subjects randomized to receive vaccine will receive 2 doses of the vaccine approximately 28 days apart. At approximately month 5, subjects' parent(s) or guardian(s) will be called to remind them of the 6-month follow-up visit. At the 6-month visit, subjects will be assessed for serious adverse events (SAEs) and the randomization assignment, ie, to vaccine or placebo, will be unmasked to the subject and parent(s) or guardian(s). Should data evaluating a third dose of the influenza A/H5N1 vaccine in adults show enhanced immunogenicity, parents or guardians of subjects who received vaccine will be offered a third dose, with an additional blood draw immediately prior to the third dose and 28 days and 6 months thereafter. The 6-month post-Dose 3 blood draw is optional. For subjects assigned to placebo, the parents or guardians will be offered the opportunity to enroll the subject into a separate open-label protocol if the 2 dose regimen administered to the vaccine recipients is found to be safe and immunogenic. The primary endpoints of the study include: adverse event (AE) and SAE information (solicited in-clinic and via memory aids, concomitant medications, and periodic targeted physical assessments, as indicated); proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus 28 days after receipt of second dose of vaccine (approximately Day 56); and geometric mean titer (GMT) and the frequency of 4-fold or greater increases in hemagglutination inhibition and neutralizing antibody titers 28 days after receipt of second dose of vaccine (approximately Day 56). The secondary endpoints of the study include: proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus 1 and 6 months after receipt of first and third doses (if third dose will be administered [see study design]) of vaccine; GMT and the frequency of 4-fold or greater increases in serum hemagglutination inhibition antibody titer 1 and 6 months after receipt of first and third (if third dose will be administered [see study design]) doses of vaccine; and development of serum antibody responses against antigenically drifted variants of influenza H5N1 virus. This study is linked to protocol 06-0072.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Biological: Influenza A/H5N1 Vaccine100 subjects 45 mcg of influenza A/H5N1. |
| 2 | Placebo comparator | Drug: Placebo20 subjects saline placebo. |
Who may qualify
- Ages
- 2 to 9 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- The subject must be male or female, aged 2 through 9 years at enrollment.
- 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 must be able to understand and comply with planned study procedures and be available for all study visits.
- Parents or guardians 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 |
|---|---|---|
| Influenza A/H5N1 VaccineMonovalent inactivated subvirion influenza H5N1 vaccine (derived from A/Vietnam/1203/04). Packaged in single-dose vials of 90 mcg/mL (0.7 mL/vial). Dosage 45 mcg/0.5 mL administered intramuscularly. | Biological | 1 |
| PlaceboNormal saline administered intramuscularly. | Drug | 2 |
Primary outcome
Adverse event (AE) and serious adverse event (SAE) information (solicited in clinic and via memory aids, concomitant medications, and periodic targeted physical assessments.)
Time frame: Solicited AEs-reactogenicity following each vaccination. Unsolicited AEs-SAEs occurring during the length of the study, and nonserious events occurring 28 days after receipt of the 2nd (from enrollment) or 3rd dose of vaccine.
Proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus.
Time frame: 28 days after receipt of the 2nd dose of vaccine (Day 56).
Geometric mean titer and the frequency of 4-fold or greater increases in hemagglutination inhibition and neutralizing antibody titers.
Time frame: 28 days after receipt of the 2nd dose of vaccine (Day 56).
3 secondary outcomes
Proportion of subjects achieving a serum neutralizing antibody titer of 1:40 against the influenza A/H5N1 virus.
Time frame: 1 and 6 months after receipt of first and third doses (if third dose will be administered [see study design]) of vaccine.
Geometric mean titer and the frequency of 4-fold or greater increases in serum hemagglutination inhibition antibody titer.
Time frame: 1 and 6 months after receipt of first and third (if third dose will be administered [see study design]) doses of vaccine.
Development of serum antibody responses against antigenically drifted variants of influenza H5N1 virus.
Time frame: Blood samples for serum assays will be collected at day 0, approximately 1 month after each immunization, and approximately 6 months after the first immunization and third immunization (if provided).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2010.
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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.
4 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 Influenza A/H5N1 Vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 4 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 27 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Adverse event (AE) and serious adverse event (SAE) information (solicited in clinic and via memory aids, concomitant medications, and periodic targeted physical assessments.) (time frame: Solicited AEs-reactogenicity following each vaccination. Unsolicited AEs-SAEs occurring during the length of the study, and nonserious events occurring 28 days after receipt of the 2nd (from enrollment) or 3rd dose of vaccine.). 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?
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 27 Aug 2010.