Seasonal InfluenzaPhase 2NCT01072799
Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine
A Phase 2 study testing A/H1N1 2009 Influenza VLP Vaccine in people with Seasonal Influenza, run by Novavax at 1 site in Mexico.
Trial summary
This is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of three dose levels (5µg, 15µg and 45µg HA) of the novel A (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults (18 to 64 years of age). Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Seasonal Influenza
- What is being tested?
- A/H1N1 2009 Influenza VLP Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,560 participants
- Where
- 1 siteMexico
- Study dates
- Oct 2009to Mar 2012
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female 18-64 years of age at the time of the vaccination.
- Informed consent must be obtained from the subject prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol.
- Available by telephone.
- Free of obvious health problems or chronic illnesses (e.g., recent exacerbation or acute episode of chronic illness in the last 3 months) as established by medical history, review of systems, and clinical examination before entering the study. This includes any mental condition that would interfere with subject self-assessment. Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable. Stable disease is defined as no new onset of exacerbation of pre-existing chronic disease 3 months prior to study vaccine injection.
- Female of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 2 months prior to vaccination. Subject must also have a negative pregnancy test at study entry then at Day 22 and must agree to continue to use adequate contraceptive precautions for three months after vaccination.
Who cannot join
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 201 follow-up call - 180 days after the second vaccination).
- Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the second vaccination.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. The use of topical, inhaled and nasal steroids will be permitted.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
- Administration of immunoglobulins and/or any blood products within the 3 months preceding the administration of the study vaccine or during the study.
Show all 14Show fewer
- Acute disease on the day of vaccination (baseline/dose 1 or dose 2). Acute disease is defined as the presence of a moderate or severe illness with or without fever > 38 C.
- Acute clinically-significant pulmonary (including asthma), cardiovascular, hepatic or renal functional abnormality as determined by physical examination or laboratory screening tests.
- Major congenital defects that may increase the risk for complications from influenza.
- History of any neurological disorders or seizures (with the exception of febrile seizures during childhood) related to an underlying immune disease or disorder, such as but not limited to multiple sclerosis, lupus, and Guillain-Barre syndrome. Individuals with other neurological disorders that are clinically mild and stable with medication, such as mild Parkinson's disease, will not be excluded.
- Pregnant or lactating female.
- Females planning to become pregnant or planning to discontinue contraceptive precautions within 60 days of enrollment in this study.
- Any condition that in the opinion of the investigator would interfere with evaluation of the vaccine or interpretation of study results.
- Participation in a novel A (H1N1) 2009 influenza vaccine study or a known history of novel A (H1N1) 2009 influenza infection.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Specialities Hospital, National Medical Centre "Siglo XXI" Mexican Institute for Social Security (IMSS)
Mexico City, C.P 06720
About this study
Official title: A Phase 2 Study to Assess the Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine
This is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of three dose levels (5µg, 15µg and 45µg HA) of the novel A (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults (18 to 64 years of age).
Read the detailed description
The study will be conducted in two parts (A \& B) at a single center in Mexico. The purpose of Part A is to evaluate the safety of the H1N1 VLP vaccine and to evaluate immunogenicity and select a dose for Part B. In Part A, 1,000 subjects will be enrolled and randomized to a 1:1:1:1 schedule (5µg, 15µg and 45µg doses of H1N1 VLP vaccine or placebo. Subjects will receive two intramuscular (IM) injections (0.5mL/dose) of the H1N1 VLP vaccine or placebo 21 days apart. Blood for HAI assays will be collected at 3 time points (baseline, Day 14 and Day 36). Subjects will be followed for all adverse events (AEs) from the first day of the study through 21 days after the second dose (Day 36). Subjects will be followed for serious AEs and significant new medical conditions (SNMCs) to the end of the study 6 months post-dose 2 (Day 194).
Once the first 500 subjects are enrolled into Part A, enrollment will be halted until 3 days of safety follow-up data are reviewed by the study Data and Safety Monitoring Board (DSMB). A second data review will occur following Day 14 visit for Part A to select the dose to be administered in Part B.
Part B of the study will be conducted to evaluate safety and accumulate enough safety data to potentially move forward with broader use of the vaccine assuming favorable results. In Part B, a total of 3,250 - 3,750 subjects will be randomized to receive the selected dose of H1N1 VLP vaccine or placebo. A total of 3,000 H1N1 VLP vaccine recipients at the selected dose or higher, and 1,250 placebo recipients will be enrolled in Parts A and B. Following completion of Day 36 in Part A, data may be reviewed to assess 1 injection vs. 2 injections in Part B.
- Conditions
- Seasonal Influenza
- Being tested
- Placebo, A/H1N1 2009 Influenza VLP Vaccine
- Keywords
- A (H1N1)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboBiological
Two doses (Day 1 and Day 22); 0.5mL
A/H1N1 2009 Influenza VLP VaccineBiological
Two doses (Day 1 \& Day 22); 0.5mL
| Study group | Role | What they receive |
|---|---|---|
| Low dose H1N1 | Experimental | Not described Receives: Biological: A/H1N1 2009 Influenza VLP Vaccine |
| Mid dose H1N1 | Experimental | Not described Receives: Biological: A/H1N1 2009 Influenza VLP Vaccine |
| High dose H1N1 | Experimental | Not described Receives: Biological: A/H1N1 2009 Influenza VLP Vaccine |
| Placebo | Placebo comparator | Not described Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability of two injections of A (H1N1) 2009 influenza VLP vaccine
Measured: 35 days
Secondary outcomes (2)
Evaluation of immunogenicity of two injections of A (H1N1) 2009 influenza VLP vaccine by Hemagglutination Inhibition
Measured: 35 days
Long-term Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMCs)
Measured: 6 months post second dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2010 (estimated)
- Study startOct 2009
- Primary completionMar 2012
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Seasonal InfluenzaStudies of the same condition, open and under way.
- 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,560 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novavax
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Instituto Mexicano del Seguro Social
- Responsible party
- Sponsor
- Investigators
- Constantino R Lopez Macias, M.D., Principal investigator, Specialities Hospital, National Medical Centre "Siglo XXI" Mexican Institute for Social Security (IMSS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01072799
- Sponsor's protocol ID
- NVX 754 H1N1-MEX
- Status last verified
- Apr 2012
- First submitted
- 19 Feb 2010
- Last updated
- 25 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Study to Assess the Safety and Immunogenicity of an A (H1N1) 2009 Influenza Virus-like Particle (VLP) Vaccine
- ClinicalTrials.gov ID
- NCT01072799
- Acronym / sponsor ID
- NVX 754 H1N1-MEX
- Conditions
- Seasonal Influenza
- Keywords
- A (H1N1)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,560 participants (actual)
- Lead sponsor
- NovavaxIndustry (pharma, biotech, devices)
- Collaborators
- Instituto Mexicano del Seguro Social
- Study start
- Oct 2009
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 22 Feb 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.
This is a Phase 2 randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability and immunogenicity of three dose levels (5µg, 15µg and 45µg HA) of the novel A (H1N1) influenza VLP vaccine as compared with a placebo in healthy adults (18 to 64 years of age).
Detailed description
The study will be conducted in two parts (A \& B) at a single center in Mexico. The purpose of Part A is to evaluate the safety of the H1N1 VLP vaccine and to evaluate immunogenicity and select a dose for Part B. In Part A, 1,000 subjects will be enrolled and randomized to a 1:1:1:1 schedule (5µg, 15µg and 45µg doses of H1N1 VLP vaccine or placebo. Subjects will receive two intramuscular (IM) injections (0.5mL/dose) of the H1N1 VLP vaccine or placebo 21 days apart. Blood for HAI assays will be collected at 3 time points (baseline, Day 14 and Day 36). Subjects will be followed for all adverse events (AEs) from the first day of the study through 21 days after the second dose (Day 36). Subjects will be followed for serious AEs and significant new medical conditions (SNMCs) to the end of the study 6 months post-dose 2 (Day 194).
Once the first 500 subjects are enrolled into Part A, enrollment will be halted until 3 days of safety follow-up data are reviewed by the study Data and Safety Monitoring Board (DSMB). A second data review will occur following Day 14 visit for Part A to select the dose to be administered in Part B.
Part B of the study will be conducted to evaluate safety and accumulate enough safety data to potentially move forward with broader use of the vaccine assuming favorable results. In Part B, a total of 3,250 - 3,750 subjects will be randomized to receive the selected dose of H1N1 VLP vaccine or placebo. A total of 3,000 H1N1 VLP vaccine recipients at the selected dose or higher, and 1,250 placebo recipients will be enrolled in Parts A and B. Following completion of Day 36 in Part A, data may be reviewed to assess 1 injection vs. 2 injections in Part B.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Low dose H1N1 | Experimental | Biological: A/H1N1 2009 Influenza VLP Vaccine |
| Mid dose H1N1 | Experimental | Biological: A/H1N1 2009 Influenza VLP Vaccine |
| High dose H1N1 | Experimental | Biological: A/H1N1 2009 Influenza VLP Vaccine |
| Placebo | Placebo comparator | Biological: Placebo |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female 18-64 years of age at the time of the vaccination.
- Informed consent must be obtained from the subject prior to beginning any study specific procedures indicating that they understand the purpose of this study and are willing to adhere to the procedures described in this protocol.
- Available by telephone.
- Free of obvious health problems or chronic illnesses (e.g., recent exacerbation or acute episode of chronic illness in the last 3 months) as established by medical history, review of systems, and clinical examination before entering the study. This includes any mental condition that would interfere with subject self-assessment. Subjects with a pre-existing chronic disease will be allowed to participate if the disease is stable. Stable disease is defined as no new onset of exacerbation of pre-existing chronic disease 3 months prior to study vaccine injection.
- Female of childbearing potential, she must be abstinent or have used adequate contraceptive precautions (e.g., intrauterine contraceptive device; oral contraceptives or other equivalent hormonal contraception) for 2 months prior to vaccination. Subject must also have a negative pregnancy test at study entry then at Day 22 and must agree to continue to use adequate contraceptive precautions for three months after vaccination.
Key exclusion criteria (14 listed)
- Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
- Received an experimental agent (vaccine, drug, biologic, device, blood product, or medication) within 1 month prior to vaccination in this study or expect to receive an experimental agent during this study (prior to the Day 201 follow-up call - 180 days after the second vaccination).
- Have received any live licensed vaccines within 4 weeks or inactivated licensed vaccines within 2 weeks prior to vaccination in this study or plan receipt of such vaccines within 21 days following the second vaccination.
- Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within 6 months prior to the administration of the study vaccine. The use of topical, inhaled and nasal steroids will be permitted.
- Any medically diagnosed or suspected immunodeficient condition based on medical history and physical examination.
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 |
|---|---|---|
| PlaceboTwo doses (Day 1 and Day 22); 0.5mL | Biological | Placebo |
| A/H1N1 2009 Influenza VLP VaccineTwo doses (Day 1 \& Day 22); 0.5mL | Biological | High dose H1N1, Low dose H1N1, Mid dose H1N1 |
Primary outcome
Safety and tolerability of two injections of A (H1N1) 2009 influenza VLP vaccine
Time frame: 35 days
2 secondary outcomes
Evaluation of immunogenicity of two injections of A (H1N1) 2009 influenza VLP vaccine by Hemagglutination Inhibition
Time frame: 35 days
Long-term Serious Adverse Events (SAEs) and Significant New Medical Conditions (SNMCs)
Time frame: 6 months post second 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 25 Apr 2012.
Related trials for Seasonal Influenza
RecruitingPhase 1
A Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA-1010 in Healthy Children
Seasonal Influenza
Active, not recruitingPhase 3
A Clinical Study to Evaluate the Safety, Tolerability, and Immunogenicity of VAX-31 With Influenza Vaccine in Adults ≥ 50 Years of Age
Pneumococcal Disease
RecruitingPhase 1
Evaluating the Dose, Safety, Tolerability, and Immunogenicity of Mosaic Hexavalent Influenza Vaccine VRCFLUMOS0116-00-VP (FluMos-v2) With and Without ALFQ Adjuvant in Healthy Adults
Influenza Prevention, Seasonal Influenza
Not yet recruitingPhase 1
Phase I Clinical Trial of Trivalent Inactivated Split Influenza Virus Vaccine (MDCK Cell)
Seasonal Influenza
Not yet recruitingPhase 4
A Study of Updated mRNA Seasonal Influenza Vaccines
Seasonal Influenza
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.
Constantino R Lopez Macias, M.D. principal investigator
Specialities Hospital, National Medical Centre "Siglo XXI" Mexican Institute for Social Security (IMSS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing A/H1N1 2009 Influenza VLP Vaccine in people with Seasonal Influenza, run by Novavax at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 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 25 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. 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 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?
Safety and tolerability of two injections of A (H1N1) 2009 influenza VLP vaccine (time frame: 35 days). 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 25 Apr 2012.