InfluenzaPhase 2NCT02100436
Safety and Immunogenicity of a Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine in Pediatric Populations
A Phase 2 study testing Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 sites in United States.
Trial summary
This is a Phase II open-label study in approximately 240, and up to 400, healthy males and non-pregnant females, aged 6 months to 17 years. This study is designed to assess the safety, reactogenicity, and immunogenicity of two doses administered intramuscularly approximately 21 days apart of an unadjuvanted subvirion… Read more about this study
- Who is it for?
- Ages 6 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Jun 2014to 20 Mar 2015
- Phase
- Phase 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 6 months to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 1. Parent(s)/legal guardian(s) must provide written informed consent (parental permission) and subjects must provide written assent as appropriate for age per local IRB and 45 CFR 46 requirements prior to initiation of any study procedures. 2. Parent(s)/legal guardian(s) and subjects as appropriate must be willing and able to comply with planned study procedures and be available for all study visits. 3. Are males or non-pregnant females aged 6 months to 17 years old, inclusive. 4. Are in good health, as determined by medical history and targeted physical examination based on medical history. 5. Axillary temperature is less than 100°F, or oral temperature is less than 101°F. 6. Females of childbearing potential (status as determined by local IRB guidelines for minimum age requirements, and/or by occurrence of menarche and not having reached menopause >/=1 year or not having been surgically sterilized via tubal ligation, bilateral oophorectomy or hysterectomy) must agree to practice adequate contraception (abstinence from sexual intercourse with males, monogamous relationship with a vasectomized partner who was vasectomized at least 6 months prior to the subject receiving the first H3N2v vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices (IUDs), NuvaRing®, successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented confirmation test at least 3 months after the procedure, licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill"), and any other Food and Drug Administration (FDA) approved birth control method) for at least 30 days prior to the first H3N2v vaccination through at least 30 days after the last H3N2v vaccination. Method of contraception will be captured on the appropriate data collection form. 7. Females of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each H3N2v vaccination.
Who cannot join
- 1. Have an acute illness, including an axillary temperature greater than or equal to 100°F or an oral temperature greater than or equal to 101°F, within 3 days prior to each H3N2v vaccination. 2. Have any condition that, in the opinion of the site principal investigator or appropriate sub-investigator, would place the subject at an unacceptable risk of injury, render them unable to meet the requirements of the protocol or confound the interpretation of results. 3. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. 4. Have known active neoplastic disease or a history of any hematologic malignancy. 5. Have known HIV, hepatitis B, or hepatitis C infection. 6. Have a known allergy to eggs, egg or chicken protein, or other components of the H3N2v MIV (including octylphenol ethoxylate (Triton® X-100), gelatin, formaldehyde, and phosphate buffered saline). 7. Have a history of severe reactions following previous immunization with licensed influenza virus vaccines. 8. Have a history of Guillain-Barré Syndrome. 9. Have a history of alcohol or drug abuse in the past 5 years. 10. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other major psychiatric diagnosis or a static or progressive neurodevelopmental disorder (e.g. Cerebral palsy with mental retardation). 11. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years. 12. Have taken oral or parenteral corticosteroids of any dose within the past 4 weeks. 13. Have taken high-dose inhaled corticosteroids within the past 4 weeks. High dose defined as >840mcg/day (children 12-17 years of age) or >672mcg/day (children <12 years of age) of beclomethasone dipropionate CFC or equivalent. 14. Have used any topical steroid daily for more than 3 weeks within the past 3 months. 15. Received any licensed live vaccine within 4 weeks or any licensed inactivated vaccine within 2 weeks prior to the first H3N2v vaccination or planned receipt of any vaccine within 42 days after the first H3N2v vaccination. This is inclusive of licensed seasonal influenza vaccines and routine childhood immunizations provided outside the scope of this study.The initiation of this protocol does not take precedence over routine childhood immunizations. 16. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 3 months prior to each H3N2v vaccination. 17. Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to the first H3N2v vaccination. 18. Are participating or plan to participate in another clinical trial with an interventional agent (licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) during the 7-month study period. 19. Are enrolled or plan to enroll in another clinical trial that has a study intervention such as a drug, biologic, device, blood product, or medication that could interfere with the safety assessment of the investigational product at any time during the 7-month study period. 20. Participated in an influenza A/H3N2v vaccine study in the past in a group receiving vaccine (does not apply to documented placebo recipients) or have a history of A/H3N2v infection prior to enrollment. 21. Plan to travel outside the US (continental US, Hawaii and Alaska) in the time between the first H3N2v vaccination and 42 days after the first H3N2v vaccination. 22. Females who are breastfeeding or plan to breastfeed at any given time during the 7-month st udy period. 23. Occupational exposure to or substantial direct physical contact with pigs in the past year or during the 42 days after the first H3N2v vaccination. Casual contact with pigs at petting zoos or county or state fairs, for example,does not exclude subjects from study participation.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Emory Children's Center - Pediatric Infectious Diseases
Atlanta, Georgia, 30322-1014
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, 45229-3039
Duke Health Center at Roxboro
Durham, North Carolina, 27704-2120
Baylor College of Medicine - Molecular Virology and Microbiology
Houston, Texas, 77030-3411
Children's Mercy Hospital and Clinics - Infectious Diseases
Kansas City, Missouri, 64108-4619
Vanderbilt University - Pediatric - Vanderbilt Vaccine Research Center
Nashville, Tennessee, 37232-2573
Saint Louis University - Center for Vaccine Development
St Louis, Missouri, 63104-1015
About this study
Official title: A Phase II Open-Label Study in Healthy Pediatric Populations to Assess the Safety, Reactogenicity, and Immunogenicity of an Intramuscular Unadjuvanted Subvirion Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine
This is a Phase II open-label study in approximately 240, and up to 400, healthy males and non-pregnant females, aged 6 months to 17 years. This study is designed to assess the safety, reactogenicity, and immunogenicity of two doses administered intramuscularly approximately 21 days apart of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine manufactured by sanofi pasteur. Subjects will be stratified by age (approximately 60-100 subjects 6-35 months old, approximately 60-100 subjects 3-8 years old and approximately 60-100 subjects 9-17 years old) to receive 2 doses of vaccine, administered intramuscularly as 15mcg HA/0.5mL dose, approximately 21 days apart. In addition, approximately 60-100 subjects 6-35 months old will receive 2 doses of vaccine, administered intramuscularly as 7.5mcg HA/0.5mL dose, approximately 21 days apart. The duration of the study for each subject will be approximately 7 months.
Read the detailed description
This is a Phase II open-label study in approximately 240 (up to 400) healthy males and non-pregnant females, 6 months to 17 years old, inclusive. This study is designed to assess the safety, reactogenicity, and immunogenicity of two doses administered intramuscularly approximately 21 days apart of an unadjuvanted subvirion monovalent inactivated influenza H3N2 variant (H3N2v) vaccine (MIV) manufactured by sanofi pasteur. Subjects will be stratified by age (approximately 120 (up to 200) subjects 6-35 months old, approximately 60 (up to 100) subjects 3-8 years old, and approximately 60 (up to 100) subjects 9-17 years old). Subjects in the 6-35 months old cohort will be randomized to receive either two doses of H3N2v MIV, administered intramuscularly as 7.5 micrograms (mcg) of hemagglutinin (HA)/0.25 milliliter (mL) dose (approximately 60 (up to 100) subjects), approximately 21 days apart, or two doses of H3N2v MIV, administered intramuscularly as 15mcg HA/0.5mL dose (approximately 60 (up to 100) subjects), approximately 21 days apart. All subjects in the 3-8 years old cohort and 9-17 years old cohort will receive two doses of H3N2v MIV, delivered intramuscularly as 15mcg HA/0.5mL dose, approximately 21 days apart. Subjects may receive licensed seasonal influenza vaccine prior to (>2 weeks if given the inactivated vaccine or >4 weeks if given the live, attenuated vaccine) the first H3N2v vaccination. Alternatively, subjects may receive licensed seasonal influenza vaccine at any time after completion of Visit 05 or following an early termination visit. Safety will be measured by the occurrence of solicited injection site and systemic reactogenicity from the time of each H3N2v vaccination through 7 days after each H3N2v vaccination. Unsolicited non-serious adverse events (AEs) will be collected from the time of the H3N2V vaccination (Day 0 (Visit 01)) through approximately 21 days after the last H3N2v vaccination (approximately Day 42 (Visit 05) for subjects who receive two H3N2v vaccinations; approximately Day 21 (Visit 03) for subjects who receive only one H3N2v vaccination). After approximately 21 days after the last H3N2v vaccination, non-serious AEs will be limited to new-onset chronic medical conditions, which will be documented through approximately 7 months after the first H3N2v vaccination (Visit 08). Serious adverse events (SAEs) will be collected from the time of the first H3N2v vaccination (Day 0 (Visit 01)) through approximately 7 months after the first H3N2v vaccination (Visit 08). Immunogenicity testing will include performing hemagglutination inhibition (HAI) and neutralizing (Neut) antibody assays on serum obtained prior to each H3N2v vaccination (Day 0 (Visit 01) and approximately Day 21 (Visit03)) and approximately 21 days after the second H3N2v vaccination (Visit 05).
- Conditions
- Influenza
- Being tested
- Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203
- Keywords
- children, H3N2, H3N2v, influenza, pediatric, unadjuvanted, 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.
Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203Biological
A unadjuvanted subvirion monovalent inactivated split influenza virus vaccine (H3N2v MIV) produced in eggs. Subjects are enrolled in 3 cohorts stratified by age. 6-35 month old subjects receive 2 doses of H3N2v MIV, intramuscularly (IM) as 7.5 micrograms (mcg) of hemagglutinin (HA)/0.25 milliliter (mL) dose, 21 days apart, or 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. 3-8 year old subjects and 9-17 year old subjects receive 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart.
| Study group | Role | What they receive |
|---|---|---|
| Cohort 3-8 years old | Experimental | up to 100 subjects receive 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. Receives: Biological: Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203 |
| Cohort 6-35 months old | Experimental | up to 100 subjects receive 2 doses of H3N2v MIV, intramuscularly (IM) as 7.5 micrograms (mcg) of hemagglutinin (HA)/0.25 milliliter (mL) dose, 21 days apart. up to 100 subjects receive 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. Receives: Biological: Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203 |
| Cohort 9-17 years old | Experimental | up tp 100 subjects receive 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. Receives: Biological: Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of H3N2v MIV-related serious adverse events from the time of the first H3N2v vaccination through approximately 7 months after the first H3N2v vaccination.
Measured: First vaccination (Day 0) through 7 months.
Occurrence of solicited injection site and systemic reactogenicity from the time of each H3N2v vaccination through 7 days after each H3N2v vaccination.
Measured: Through 7 days after each H3N2v vaccination.
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H3N2v antigen contained in the H3N2v MIV following receipt of first dose of H3N2v MIV.
Measured: 6-35 months old and 3-8 year old cohorts, approximately 42 days. 9-17 years old cohort, approximately 21 days.
Percentage of subjects achieving seroconversion (defined as either pre-vacc. HAI titer < 1:10 and post-vacc. HAI titer >/=1:40 or pre-vacc. HAI titer >/=1:10 and minimum 4 fold rise in post-vacc. HAI antibody titer) following first dose of H3N2v MIV.
Measured: 6-35 months old and 3-8 years old cohorts, approximately 42 days. 9-17 years old cohort, approximately 21 days.
Secondary outcomes (5)
Geometric Mean Titers of serum HAI and Neut antibody following receipt of each dose of H3N2v.
Measured: Baseline and approximately 21 days following receipt of each dose.
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H3N2v antigen contained in the H3N2v MIV following receipt of the first dose of H3N2v MIV.
Measured: 6-35 months old and 3-8 years old cohorts, baseline and approximately 21 days. 9-17 years old cohort, baseline and approximately 42 days.
Percentage of subjects achieving a serum Neut antibody titer of 1:40 or greater against the H3N2v antigen contained in the H3N2v MIV following receipt of each dose of H3N2v MIV.
Measured: Baseline and approximately 21 days following receipt of each dose.
Percentage of subjects achieving seroconversion (defined as either pre-vacc. HAI titer < 1:10 and post-vacc. HAI titer >/=1:40 or pre-vacc. HAI titer >/=1:10 and a minimum 4 fold rise in post-vacc. HAI antibody titer)following first dose of H3N2v MIV.
Measured: 6-35 months old and 3-8 years old cohorts, approximately 21 days. 9-17 years old cohort, approximately 42 days.
Percentage of subjects achieving seroconversion (either pre-vacc. Neut titer < 1:10 and post-vacc. Neut titer >/=1:40 or pre-vacc. Neut titer >/=1:10 and minimum 4 fold rise in post-vacc. Neut antibody titer) following receipt of each dose of H3N2v MIV.
Measured: Approximately 21 days following receipt of each dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2014 (estimated)
- Study start11 Jun 2014
- Primary completion20 Mar 2015
- Study completion20 Mar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 270 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02100436
- Sponsor's protocol ID
- 12-0016
- Other IDs
- HHSN272200800002C
- Status last verified
- 16 Dec 2014
- First submitted
- 27 Mar 2014
- Last updated
- 6 Jul 2017
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Munoz FM, Anderson EJ, Bernstein DI, Harrison CJ, Pahud B, Anderson E, Creech CB, Berry AA, Kotloff KL, Walter EB, Atmar RL, Bellamy AR, Chang S, Keitel WA. Safety and immunogenicity of unadjuvanted subvirion monovalent inactivated influenza H3N2 variant (H3N2v) vaccine in children and adolescents. Vaccine. 2019 Aug 23;37(36):5161-5170. doi: 10.1016/j.vaccine.2019.07.085. Epub 2019 Jul 30.
PubMed 31375440
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Open-Label Study in Healthy Pediatric Populations to Assess the Safety, Reactogenicity, and Immunogenicity of an Intramuscular Unadjuvanted Subvirion Monovalent Inactivated Influenza H3N2 Variant (H3N2v) Vaccine
- ClinicalTrials.gov ID
- NCT02100436
- Acronym / sponsor ID
- 12-0016
- Conditions
- Influenza
- Keywords
- children, H3N2, H3N2v, influenza, pediatric, unadjuvanted, vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 270 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 11 Jun 2014 (actual)
- Primary completion
- 20 Mar 2015 (actual)
- Study completion
- 20 Mar 2015 (actual)
- First posted
- 1 Apr 2014 (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.
This is a Phase II open-label study in approximately 240, and up to 400, healthy males and non-pregnant females, aged 6 months to 17 years. This study is designed to assess the safety, reactogenicity, and immunogenicity of two doses administered intramuscularly approximately 21 days apart of an unadjuvanted subvirion monovalent inactivated influenza H3N2v vaccine manufactured by sanofi pasteur. Subjects will be stratified by age (approximately 60-100 subjects 6-35 months old, approximately 60-100 subjects 3-8 years old and approximately 60-100 subjects 9-17 years old) to receive 2 doses of vaccine, administered intramuscularly as 15mcg HA/0.5mL dose, approximately 21 days apart. In addition, approximately 60-100 subjects 6-35 months old will receive 2 doses of vaccine, administered intramuscularly as 7.5mcg HA/0.5mL dose, approximately 21 days apart. The duration of the study for each subject will be approximately 7 months.
Detailed description
This is a Phase II open-label study in approximately 240 (up to 400) healthy males and non-pregnant females, 6 months to 17 years old, inclusive. This study is designed to assess the safety, reactogenicity, and immunogenicity of two doses administered intramuscularly approximately 21 days apart of an unadjuvanted subvirion monovalent inactivated influenza H3N2 variant (H3N2v) vaccine (MIV) manufactured by sanofi pasteur. Subjects will be stratified by age (approximately 120 (up to 200) subjects 6-35 months old, approximately 60 (up to 100) subjects 3-8 years old, and approximately 60 (up to 100) subjects 9-17 years old). Subjects in the 6-35 months old cohort will be randomized to receive either two doses of H3N2v MIV, administered intramuscularly as 7.5 micrograms (mcg) of hemagglutinin (HA)/0.25 milliliter (mL) dose (approximately 60 (up to 100) subjects), approximately 21 days apart, or two doses of H3N2v MIV, administered intramuscularly as 15mcg HA/0.5mL dose (approximately 60 (up to 100) subjects), approximately 21 days apart. All subjects in the 3-8 years old cohort and 9-17 years old cohort will receive two doses of H3N2v MIV, delivered intramuscularly as 15mcg HA/0.5mL dose, approximately 21 days apart. Subjects may receive licensed seasonal influenza vaccine prior to (>2 weeks if given the inactivated vaccine or >4 weeks if given the live, attenuated vaccine) the first H3N2v vaccination. Alternatively, subjects may receive licensed seasonal influenza vaccine at any time after completion of Visit 05 or following an early termination visit. Safety will be measured by the occurrence of solicited injection site and systemic reactogenicity from the time of each H3N2v vaccination through 7 days after each H3N2v vaccination. Unsolicited non-serious adverse events (AEs) will be collected from the time of the H3N2V vaccination (Day 0 (Visit 01)) through approximately 21 days after the last H3N2v vaccination (approximately Day 42 (Visit 05) for subjects who receive two H3N2v vaccinations; approximately Day 21 (Visit 03) for subjects who receive only one H3N2v vaccination). After approximately 21 days after the last H3N2v vaccination, non-serious AEs will be limited to new-onset chronic medical conditions, which will be documented through approximately 7 months after the first H3N2v vaccination (Visit 08). Serious adverse events (SAEs) will be collected from the time of the first H3N2v vaccination (Day 0 (Visit 01)) through approximately 7 months after the first H3N2v vaccination (Visit 08). Immunogenicity testing will include performing hemagglutination inhibition (HAI) and neutralizing (Neut) antibody assays on serum obtained prior to each H3N2v vaccination (Day 0 (Visit 01) and approximately Day 21 (Visit03)) and approximately 21 days after the second H3N2v vaccination (Visit 05).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 3-8 years old | Experimental | Biological: Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203up to 100 subjects receive 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. |
| Cohort 6-35 months old | Experimental | Biological: Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203up to 100 subjects receive 2 doses of H3N2v MIV, intramuscularly (IM) as 7.5 micrograms (mcg) of hemagglutinin (HA)/0.25 milliliter (mL) dose, 21 days apart. up to 100 subjects receive 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. |
| Cohort 9-17 years old | Experimental | Biological: Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203up tp 100 subjects receive 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- 1. Parent(s)/legal guardian(s) must provide written informed consent (parental permission) and subjects must provide written assent as appropriate for age per local IRB and 45 CFR 46 requirements prior to initiation of any study procedures. 2. Parent(s)/legal guardian(s) and subjects as appropriate must be willing and able to comply with planned study procedures and be available for all study visits. 3. Are males or non-pregnant females aged 6 months to 17 years old, inclusive. 4. Are in good health, as determined by medical history and targeted physical examination based on medical history. 5. Axillary temperature is less than 100°F, or oral temperature is less than 101°F. 6. Females of childbearing potential (status as determined by local IRB guidelines for minimum age requirements, and/or by occurrence of menarche and not having reached menopause >/=1 year or not having been surgically sterilized via tubal ligation, bilateral oophorectomy or hysterectomy) must agree to practice adequate contraception (abstinence from sexual intercourse with males, monogamous relationship with a vasectomized partner who was vasectomized at least 6 months prior to the subject receiving the first H3N2v vaccination, barrier methods such as condoms or diaphragms with spermicide or foam, effective intrauterine devices (IUDs), NuvaRing®, successful Essure® placement (permanent, non-surgical, non-hormonal sterilization) with documented confirmation test at least 3 months after the procedure, licensed hormonal methods such as implants, injectables or oral contraceptives ("the pill"), and any other Food and Drug Administration (FDA) approved birth control method) for at least 30 days prior to the first H3N2v vaccination through at least 30 days after the last H3N2v vaccination. Method of contraception will be captured on the appropriate data collection form. 7. Females of childbearing potential must have a negative urine or serum pregnancy test within 24 hours prior to each H3N2v vaccination.
Key exclusion criteria (1 listed)
- 1. Have an acute illness, including an axillary temperature greater than or equal to 100°F or an oral temperature greater than or equal to 101°F, within 3 days prior to each H3N2v vaccination. 2. Have any condition that, in the opinion of the site principal investigator or appropriate sub-investigator, would place the subject at an unacceptable risk of injury, render them unable to meet the requirements of the protocol or confound the interpretation of results. 3. Have immunosuppression as a result of an underlying illness or treatment, or use of anticancer chemotherapy or radiation therapy within the preceding 36 months. 4. Have known active neoplastic disease or a history of any hematologic malignancy. 5. Have known HIV, hepatitis B, or hepatitis C infection. 6. Have a known allergy to eggs, egg or chicken protein, or other components of the H3N2v MIV (including octylphenol ethoxylate (Triton® X-100), gelatin, formaldehyde, and phosphate buffered saline). 7. Have a history of severe reactions following previous immunization with licensed influenza virus vaccines. 8. Have a history of Guillain-Barré Syndrome. 9. Have a history of alcohol or drug abuse in the past 5 years. 10. Have any diagnosis, current or past, of schizophrenia, bipolar disease, or other major psychiatric diagnosis or a static or progressive neurodevelopmental disorder (e.g. Cerebral palsy with mental retardation). 11. Have been hospitalized for psychiatric illness, history of suicide attempt, or confinement for danger to self or others, within the past 10 years. 12. Have taken oral or parenteral corticosteroids of any dose within the past 4 weeks. 13. Have taken high-dose inhaled corticosteroids within the past 4 weeks. High dose defined as >840mcg/day (children 12-17 years of age) or >672mcg/day (children <12 years of age) of beclomethasone dipropionate CFC or equivalent. 14. Have used any topical steroid daily for more than 3 weeks within the past 3 months. 15. Received any licensed live vaccine within 4 weeks or any licensed inactivated vaccine within 2 weeks prior to the first H3N2v vaccination or planned receipt of any vaccine within 42 days after the first H3N2v vaccination. This is inclusive of licensed seasonal influenza vaccines and routine childhood immunizations provided outside the scope of this study.The initiation of this protocol does not take precedence over routine childhood immunizations. 16. Received immunoglobulin or other blood products (with exception of Rho D immunoglobulin) within 3 months prior to each H3N2v vaccination. 17. Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to the first H3N2v vaccination. 18. Are participating or plan to participate in another clinical trial with an interventional agent (licensed or unlicensed vaccine, drug, biologic, device, blood product, or medication) during the 7-month study period. 19. Are enrolled or plan to enroll in another clinical trial that has a study intervention such as a drug, biologic, device, blood product, or medication that could interfere with the safety assessment of the investigational product at any time during the 7-month study period. 20. Participated in an influenza A/H3N2v vaccine study in the past in a group receiving vaccine (does not apply to documented placebo recipients) or have a history of A/H3N2v infection prior to enrollment. 21. Plan to travel outside the US (continental US, Hawaii and Alaska) in the time between the first H3N2v vaccination and 42 days after the first H3N2v vaccination. 22. Females who are breastfeeding or plan to breastfeed at any given time during the 7-month st udy period. 23. Occupational exposure to or substantial direct physical contact with pigs in the past year or during the 42 days after the first H3N2v vaccination. Casual contact with pigs at petting zoos or county or state fairs, for example,does not exclude subjects from study participation.
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, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203A unadjuvanted subvirion monovalent inactivated split influenza virus vaccine (H3N2v MIV) produced in eggs. Subjects are enrolled in 3 cohorts stratified by age. 6-35 month old subjects receive 2 doses of H3N2v MIV, intramuscularly (IM) as 7.5 micrograms (mcg) of hemagglutinin (HA)/0.25 milliliter (mL) dose, 21 days apart, or 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. 3-8 year old subjects and 9-17 year old subjects receive 2 doses of H3N2v MIV, IM as 15mcg HA/0.5mL dose, 21 days apart. | Biological | Cohort 3-8 years old, Cohort 6-35 months old, Cohort 9-17 years old |
Primary outcome
Occurrence of H3N2v MIV-related serious adverse events from the time of the first H3N2v vaccination through approximately 7 months after the first H3N2v vaccination.
Time frame: First vaccination (Day 0) through 7 months.
Occurrence of solicited injection site and systemic reactogenicity from the time of each H3N2v vaccination through 7 days after each H3N2v vaccination.
Time frame: Through 7 days after each H3N2v vaccination.
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H3N2v antigen contained in the H3N2v MIV following receipt of first dose of H3N2v MIV.
Time frame: 6-35 months old and 3-8 year old cohorts, approximately 42 days. 9-17 years old cohort, approximately 21 days.
Percentage of subjects achieving seroconversion (defined as either pre-vacc. HAI titer < 1:10 and post-vacc. HAI titer >/=1:40 or pre-vacc. HAI titer >/=1:10 and minimum 4 fold rise in post-vacc. HAI antibody titer) following first dose of H3N2v MIV.
Time frame: 6-35 months old and 3-8 years old cohorts, approximately 42 days. 9-17 years old cohort, approximately 21 days.
5 secondary outcomes
Geometric Mean Titers of serum HAI and Neut antibody following receipt of each dose of H3N2v.
Time frame: Baseline and approximately 21 days following receipt of each dose.
Percentage of subjects achieving a serum HAI antibody titer of 1:40 or greater against the H3N2v antigen contained in the H3N2v MIV following receipt of the first dose of H3N2v MIV.
Time frame: 6-35 months old and 3-8 years old cohorts, baseline and approximately 21 days. 9-17 years old cohort, baseline and approximately 42 days.
Percentage of subjects achieving a serum Neut antibody titer of 1:40 or greater against the H3N2v antigen contained in the H3N2v MIV following receipt of each dose of H3N2v MIV.
Time frame: Baseline and approximately 21 days following receipt of each dose.
Percentage of subjects achieving seroconversion (defined as either pre-vacc. HAI titer < 1:10 and post-vacc. HAI titer >/=1:40 or pre-vacc. HAI titer >/=1:10 and a minimum 4 fold rise in post-vacc. HAI antibody titer)following first dose of H3N2v MIV.
Time frame: 6-35 months old and 3-8 years old cohorts, approximately 21 days. 9-17 years old cohort, approximately 42 days.
Percentage of subjects achieving seroconversion (either pre-vacc. Neut titer < 1:10 and post-vacc. Neut titer >/=1:40 or pre-vacc. Neut titer >/=1:10 and minimum 4 fold rise in post-vacc. Neut antibody titer) following receipt of each dose of H3N2v MIV.
Time frame: Approximately 21 days following receipt of each dose.
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 6 Jul 2017.
- Derived from this study: PubMed 31375440Munoz FM, Anderson EJ, Bernstein DI, Harrison CJ, Pahud B, Anderson E, Creech CB, Berry AA, Kotloff KL, Walter EB, Atmar RL, Bellamy AR, Chang S, Keitel WA. Safety and immunogenicity of unadjuvanted subvirion monovalent inactivated influenza H3N2 variant (H3N2v) vaccine in children and adolescents. Vaccine. 2019 Aug 23;37(36):5161-5170. doi: 10.1016/j.vaccine.2019.07.085. Epub 2019 Jul 30.
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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.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Influenza Virus Vaccine, Monovalent A/H3N2v A/Minnesota/11/2010 NYMC X-203 in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 8 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 1 inclusion and 1 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 6 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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 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?
Occurrence of H3N2v MIV-related serious adverse events from the time of the first H3N2v vaccination through approximately 7 months after the first H3N2v vaccination. (time frame: First vaccination (Day 0) through 7 months.). 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?
On the ClinicalTrials.gov record for NCT02100436, 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 6 Jul 2017.