InfluenzaPhase 1NCT01164553
Comparison of Flu Vaccine Doses in Children
A Phase 1 study testing Trivalent Inactivated Influenza Vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 sites in United States.
Trial summary
The purpose of this study is to evaluate the possibility that giving an increased dose of flu vaccine to children 6 through 35 months of age will improve protection against influenza without increasing side effects. Investigators will evaluate the body's response to the vaccine. 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?
- Trivalent Inactivated Influenza Vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 7 sitesUnited States
- Study dates
- Oct 2010to Oct 2012
- Phase
- Phase 1
- 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 6 to 35 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- All Subjects
- Healthy children 6-35 months of age (naïve cohort) or 12-35 months of age (fully primed cohort)
- Free of obvious health problems as established by medical history and clinical examination before entering the study
- Parent/legal guardian willing and capable of signing written informed consent
- Parent/legal guardian expected to be available for entire study
- Parent/legal guardian can be reached by telephone
- Fully Primed Cohort
- -Have received two doses of 2009-2010 H1N1 and two doses of trivalent inactivated influenza vaccine (TIV) at anytime in the past as defined for the purpose of this study.
Who cannot join
- All Subjects:
- Have known allergy to eggs or other components of the vaccine. *Refer to the Fluzone package insert for a list of vaccine components.
- Known or suspected latex allergy.
- Former premature infants (<32 weeks).
- History of bronchodilator use more than 2 times per week within 28 days of vaccination.
- Significant underlying chronic illness (e.g., congenital heart disease, bronchopulmonary dysplasia).
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- Immunodeficiency disease or use of immunosuppressive therapy by the participant, including perinatal exposure to or infection with human immunodeficiency virus (HIV), or known infection with hepatitis B or hepatitis C.
- Any other condition that, in the clinical judgment of the investigator, may interfere with vaccine evaluation. Children receiving antibiotics are eligible for enrollment.
- Have long term use of glucocorticoids including oral, parenteral or high-dose inhaled steroids (>800 mcg/day of beclomethasone dipropionate or equivalent) within the preceding 6 months. (Nasal and topical steroids are allowed.)
- Previous, exposure to an investigational drug or investigational vaccine within 28 days prior to vaccination in this trial.
- Plans for participation in another clinical trial with an investigational drug or investigational vaccine for the duration of this study.
- History of Guillain-Barré syndrome or any other neuromuscular disease.
- History of seizures (including febrile seizures).
- Naïve Cohort:
- Any prior influenza vaccination.
- History of documented laboratory-confirmed influenza infection.
- Fully primed Cohort:
- Have not received two doses of 2009-2010 H1N1 and two doses of trivalent inactivated influenza vaccine (TIV) at anytime in the past as defined for the purpose of this study.
- Allergic response to prior receipt of influenza vaccine.
- Criteria for temporarily delaying vaccine administration for both groups:
- The following conditions are temporary or self-limiting and a subject may be included in the study once the condition(s) has/have resolved, provided that the subject is otherwise eligible:
- Receipt of blood products in the previous 90 days
- Fever (axillary temperature > 100.0 degrees Fahrenheit/37.8 degrees Celsius), or an acute illness within 48 hours of enrollment.
- Receipt of any live vaccines within four weeks or any inactivated vaccines within two weeks of study vaccination.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
United States7 sites
Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, 30322-1014
Emory University School of Medicine - Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, 30322
University of Maryland School of Medicine - Center for Vaccine Development - Baltimore
Baltimore, Maryland, 21201-1509
Cincinnati Children's Hospital Medical Center - Infectious Diseases
Cincinnati, Ohio, 45231
University of Iowa - Infectious Disease Clinic
Iowa City, Iowa, 52242-1009
Vanderbilt University - Pediatric - Infectious Diseases
Nashville, Tennessee, 37232
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, 63104-1015
About this study
Official title: A Randomized, Double-Blind, Phase I Study Comparing an Increased Dose(s) (0.5 ml) of Trivalent Inactivated Influenza Vaccine (TIV) With Standard Dose(s) (0.25 ml) TIV in Children 6-35 Months of Age
The purpose of this study is to evaluate the possibility that giving an increased dose of flu vaccine to children 6 through 35 months of age will improve protection against influenza without increasing side effects. Investigators will evaluate the body's response to the vaccine. Male and female participants' ages 6-35 months, who have never received flu vaccine, and those ages 12-35 months, who have been previously vaccinated, will participate in the study for about 7 months. Vaccine naïve study participants will receive two doses of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Previously vaccinated subjects will receive one dose of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Study procedures include physical examination, memory aids, blood sampling and a follow-up phone call about 6 months after the last vaccine dose.
Read the detailed description
Influenza is an important cause of morbidity and mortality among both children and adults. Influenza A and/or B viruses cause yearly epidemics in the United States with an average of 36,000 deaths and 114,000 hospitalizations annually. Children have the highest rates of infection. Influenza is also associated with substantial numbers of hospitalizations among young infants. Because of the limited data available and the variability of reported seroresponses to doses of 0.25 ml in children 6-35 months of age, investigators hypothesize that a higher dose will be more consistently immunogenic. In addition, since currently licensed trivalent inactivated influenza (TIV) vaccines are well tolerated with minimal systemic and local adverse events, investigators hypothesize that administering a higher dose of 0.5 ml to this age group will be well-tolerated. Therefore, investigators propose to compare the safety and immunogenicity of 0.25 ml doses of TIV to that of 0.5 ml doses of TIV when administered to children 6-35 months of age. The proposed study is a phase I, two-arm, 1:2 randomized, double-blinded trial comparing the safety and immunogenicity of increased dose(s) (0.5 ml) with standard dose (0.25 ml) of TIV in children 6-35 months of age with and without a history of previous TIV vaccination. The population will include a Naïve Cohort: 270 healthy male and female children who are 6-35 months of age and have never received an influenza vaccination; and a Fully Primed Cohort: 60 healthy male and female children who are 12-35 months of age and have received two doses of 2009-2010 H1N1 and two doses of TIV at anytime in the past as defined for purposes of this study. Either a standard pediatric dose (0.25 ml) or a larger dose (0.5 ml) of TIV will be administered intramuscularly in the anterolateral thigh with a 25 gauge 1" needle. The primary objective is to evaluate the safety of administering an increased dose(s) (0.5 ml) of TIV to children 6-35 months of age as compared to standard dose(s) (0.25 ml) of TIV. The secondary objective is to compare the humoral immune responses to TIV antigens in children 6-35 months of age who receive the increased dose(s) of TIV to those who receive the standard dose(s) of TIV.
- Conditions
- Influenza
- Being tested
- Trivalent Inactivated Influenza Vaccine
- Keywords
- influenza, pediatric, vaccine
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trivalent Inactivated Influenza VaccineBiological
Either a standard pediatric dose (0.25 ml) or a larger dose (0.5 ml) of Trivalent Inactivated Influenza Vaccine (TIV) (Fluzone®) administered intramuscularly (IM) in the thigh with a 25 gauge 1 inch needle. Naive cohort (enrolled over two influenza seasons (2010-11 and 2011-12)) will receive vaccine in two IM doses 28-42 days apart, Fully Primed cohort (enrolled in one influenza season (2010-11)) will receive vaccine in one IM dose.
| Study group | Role | What they receive |
|---|---|---|
| Group 2, 0.5 mL TIV | Experimental | Naive cohort participants (n=180) receive 0.25 mLTrivalent Inactivated Vaccine (TIV) in two intramuscular doses 28-42 days apart. Fully Primed cohort participants (previously vaccinated) (n=40) will receive 0.5 mL Trivalent Inactivated Influenza Vaccine (TIV) in one intramuscular dose. Receives: Biological: Trivalent Inactivated Influenza Vaccine |
| Group 1, 0.25 mL TIV | Active comparator | Naive cohort participants (n=90) receive 0.25 mLTrivalent Inactivated Vaccine (TIV) in two intramuscular doses 28-42 days apart. Fully Primed cohort participants (previously vaccinated) (n=20) will receive 0.25 mL Trivalent Inactivated Influenza Vaccine (TIV) in one intramuscular dose Receives: Biological: Trivalent Inactivated Influenza Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of local and systemic side effects in children receiving the standard dose (0.25ml) or increased dose (0.5 ml) of Trivalent Inactivated Influenza Vaccine.
Measured: In the week after each vaccination.
Incidence of adverse events in children receiving the standard dose (0.25ml) or increased dose (0.5 ml) of Trivalent Inactivated Influenza Vaccine (TIV).
Measured: In the 4 weeks after each vaccination.
Secondary outcomes (2)
Percent of children who develop hemagglutinin inhibition (HAI) antibody titers greater than or equal to 1:40 (presumed protective titers) and the percent with 4-fold rises.
Measured: Approximately 30 days after one or two standard (0.25 ml) or increased (0.5 ml) doses of Trivalent Inactivated Influenza Vaccine (TIV) in fully primed and naive children.
Geometric mean titer (GMT) of the hemagglutinin inhibition (HAI) antibody responses to each of the components of the Trivalent Inactivated Influenza Vaccine (TIV).
Measured: Approximately 30 days after one or two standard (0.25 ml) or increased (0.5 ml) doses of Trivalent Inactivated Influenza Vaccine in fully primed and naïve children.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012
- Study completionOct 2012
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
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01164553
- Sponsor's protocol ID
- 09-0018
- Other IDs
- N01AI80006C
- Status last verified
- Oct 2012
- First submitted
- 15 Jul 2010
- Last updated
- 29 Apr 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Phase I Study Comparing an Increased Dose(s) (0.5 ml) of Trivalent Inactivated Influenza Vaccine (TIV) With Standard Dose(s) (0.25 ml) TIV in Children 6-35 Months of Age
- ClinicalTrials.gov ID
- NCT01164553
- Acronym / sponsor ID
- 09-0018
- Conditions
- Influenza
- Keywords
- influenza, pediatric, vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 16 Jul 2010 (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 purpose of this study is to evaluate the possibility that giving an increased dose of flu vaccine to children 6 through 35 months of age will improve protection against influenza without increasing side effects. Investigators will evaluate the body's response to the vaccine. Male and female participants' ages 6-35 months, who have never received flu vaccine, and those ages 12-35 months, who have been previously vaccinated, will participate in the study for about 7 months. Vaccine naïve study participants will receive two doses of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Previously vaccinated subjects will receive one dose of flu vaccine, either the 0.25 mL dose (Group 1) or 0.5 mL dose (Group 2). Study procedures include physical examination, memory aids, blood sampling and a follow-up phone call about 6 months after the last vaccine dose.
Detailed description
Influenza is an important cause of morbidity and mortality among both children and adults. Influenza A and/or B viruses cause yearly epidemics in the United States with an average of 36,000 deaths and 114,000 hospitalizations annually. Children have the highest rates of infection. Influenza is also associated with substantial numbers of hospitalizations among young infants. Because of the limited data available and the variability of reported seroresponses to doses of 0.25 ml in children 6-35 months of age, investigators hypothesize that a higher dose will be more consistently immunogenic. In addition, since currently licensed trivalent inactivated influenza (TIV) vaccines are well tolerated with minimal systemic and local adverse events, investigators hypothesize that administering a higher dose of 0.5 ml to this age group will be well-tolerated. Therefore, investigators propose to compare the safety and immunogenicity of 0.25 ml doses of TIV to that of 0.5 ml doses of TIV when administered to children 6-35 months of age. The proposed study is a phase I, two-arm, 1:2 randomized, double-blinded trial comparing the safety and immunogenicity of increased dose(s) (0.5 ml) with standard dose (0.25 ml) of TIV in children 6-35 months of age with and without a history of previous TIV vaccination. The population will include a Naïve Cohort: 270 healthy male and female children who are 6-35 months of age and have never received an influenza vaccination; and a Fully Primed Cohort: 60 healthy male and female children who are 12-35 months of age and have received two doses of 2009-2010 H1N1 and two doses of TIV at anytime in the past as defined for purposes of this study. Either a standard pediatric dose (0.25 ml) or a larger dose (0.5 ml) of TIV will be administered intramuscularly in the anterolateral thigh with a 25 gauge 1" needle. The primary objective is to evaluate the safety of administering an increased dose(s) (0.5 ml) of TIV to children 6-35 months of age as compared to standard dose(s) (0.25 ml) of TIV. The secondary objective is to compare the humoral immune responses to TIV antigens in children 6-35 months of age who receive the increased dose(s) of TIV to those who receive the standard dose(s) of TIV.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2, 0.5 mL TIV | Experimental | Biological: Trivalent Inactivated Influenza VaccineNaive cohort participants (n=180) receive 0.25 mLTrivalent Inactivated Vaccine (TIV) in two intramuscular doses 28-42 days apart. Fully Primed cohort participants (previously vaccinated) (n=40) will receive 0.5 mL Trivalent Inactivated Influenza Vaccine (TIV) in one intramuscular dose. |
| Group 1, 0.25 mL TIV | Active comparator | Biological: Trivalent Inactivated Influenza VaccineNaive cohort participants (n=90) receive 0.25 mLTrivalent Inactivated Vaccine (TIV) in two intramuscular doses 28-42 days apart. Fully Primed cohort participants (previously vaccinated) (n=20) will receive 0.25 mL Trivalent Inactivated Influenza Vaccine (TIV) in one intramuscular dose |
Who may qualify
- Ages
- 6 to 35 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- All Subjects
- Healthy children 6-35 months of age (naïve cohort) or 12-35 months of age (fully primed cohort)
- Free of obvious health problems as established by medical history and clinical examination before entering the study
- Parent/legal guardian willing and capable of signing written informed consent
- Parent/legal guardian expected to be available for entire study
Key exclusion criteria (24 listed)
- Have known allergy to eggs or other components of the vaccine. *Refer to the Fluzone package insert for a list of vaccine components.
- Known or suspected latex allergy.
- Former premature infants (<32 weeks).
- History of bronchodilator use more than 2 times per week within 28 days of vaccination.
- Significant underlying chronic illness (e.g., congenital heart disease, bronchopulmonary dysplasia).
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 |
|---|---|---|
| Trivalent Inactivated Influenza VaccineEither a standard pediatric dose (0.25 ml) or a larger dose (0.5 ml) of Trivalent Inactivated Influenza Vaccine (TIV) (Fluzone®) administered intramuscularly (IM) in the thigh with a 25 gauge 1 inch needle. Naive cohort (enrolled over two influenza seasons (2010-11 and 2011-12)) will receive vaccine in two IM doses 28-42 days apart, Fully Primed cohort (enrolled in one influenza season (2010-11)) will receive vaccine in one IM dose. | Biological | Group 1, 0.25 mL TIV, Group 2, 0.5 mL TIV |
Primary outcome
Incidence of local and systemic side effects in children receiving the standard dose (0.25ml) or increased dose (0.5 ml) of Trivalent Inactivated Influenza Vaccine.
Time frame: In the week after each vaccination.
Incidence of adverse events in children receiving the standard dose (0.25ml) or increased dose (0.5 ml) of Trivalent Inactivated Influenza Vaccine (TIV).
Time frame: In the 4 weeks after each vaccination.
2 secondary outcomes
Percent of children who develop hemagglutinin inhibition (HAI) antibody titers greater than or equal to 1:40 (presumed protective titers) and the percent with 4-fold rises.
Time frame: Approximately 30 days after one or two standard (0.25 ml) or increased (0.5 ml) doses of Trivalent Inactivated Influenza Vaccine (TIV) in fully primed and naive children.
Geometric mean titer (GMT) of the hemagglutinin inhibition (HAI) antibody responses to each of the components of the Trivalent Inactivated Influenza Vaccine (TIV).
Time frame: Approximately 30 days after one or two standard (0.25 ml) or increased (0.5 ml) doses of Trivalent Inactivated Influenza Vaccine in fully primed and naïve children.
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 29 Apr 2013.
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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.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Trivalent Inactivated Influenza Vaccine in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 7 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 8 inclusion and 24 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 29 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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 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.
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?
Incidence of local and systemic side effects in children receiving the standard dose (0.25ml) or increased dose (0.5 ml) of Trivalent Inactivated Influenza Vaccine. (time frame: In the week after each vaccination.). The study lists 2 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 29 Apr 2013.