Pandemic InfluenzaPhase 3NCT00971100
Immunogenicity, Safety and Tolerability of Two Doses of Adjuvanted and Non-adjuvanted Swine Origin A/H1N1 Monovalent Influenza Vaccine in Healthy Subjects From 6 Months to 17 Years of Age
A Phase 3 study testing Monovalent A/H1N1 influenza vaccine in people with Pandemic Influenza, run by Novartis Vaccines at 3 sites in 3 countries.
Trial summary
The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and adolescents. Read more about this study
- Who is it for?
- Ages 6 months to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Pandemic Influenza
- What is being tested?
- Monovalent A/H1N1 influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 752 participants
- Where
- 3 sitesin 3 countries
- Study dates
- Aug 2009to Aug 2011
- Phase
- Phase 3
- 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
- Males and females 6 months of age to 17 years of age on the day of enrollment;
- Subject's parents or legal guardians who have given written consent and the subjects has given assent consent, if applicable;
- Individuals in good health;
- Subjects, subject's parents or legal guardians that are able to comply with all study procedures;
- Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Who cannot join
- Subject's parents or legal guardians who are not able to comprehend and to follow all required study procedures;
- Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- Individuals with any serious chronic or progressive disease according to judgment of the investigator;
- History of any anaphylaxis, serious vaccine reactions to any excipients and to eggs (including ovalbumin) and chicken protein;
- Individuals who have had adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1.
- Receipt of another investigational agent within 4 weeks prior to enrollment or before completion of the safety follow-up period in this or in another study, unwilling to refuse a participation in another clinical study through the end of this study;
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- Individuals who receive any other vaccine 4 weeks prior to enrolment in this study or who are planning to receive any vaccine within four weeks from the study vaccines; the only exception being plain seasonal influenza vaccines which are allowed until one week prior to and after one week study vaccinations;
- Individuals who have received blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 12 weeks;
- Individuals with axillary temperature ≥ 38.0 degrees Celsius within 3 days of intended study vaccination;
- Known or suspected alteration of immune function;
- History of progressive or severe neurologic disorder;
- Surgery planned during the study period that in the Investigator's opinion would interfere with the study visits schedule;
- If female, of childbearing potential, and has not used any of the "acceptable contraceptive methods" for at least 2 months prior to study entry;
- Females who are pregnant or nursing (breastfeeding) mothers, or females of childbearing potential do not plan to use acceptable birth control measures during the first 3 weeks after vaccination;
- Members of research staff or their relatives.
Trial locations and contacts
3 sites in 3 countries.
3 sites in 3 countries
Germany1 site
Wurzburg, Fulda, Neumunster, Balve, Leipzig, Rostock, Detmold
Mainz
About this study
Official title: A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Cell-derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects From 6 Months to 17 Years of Age
The present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and adolescents. A booster dose will be administered 12 months after the first vaccination.
- Conditions
- Pandemic Influenza
- Being tested
- Monovalent A/H1N1 influenza vaccine
- Keywords
- Pandemic influenza, Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Monovalent A/H1N1 influenza vaccineBiological
This trial will be performed at multiple study sites in a population of healthy children and adolescent. Subjects will be randomized to receive 2 IM injections of low dose of antigen \& adjuvant, or high dose of antigen \& adjuvant, or high dose of antigen, according to the study groups.
| Study group | Role | What they receive |
|---|---|---|
| low dose of antigen + low dose of adjuvant | Experimental | Not described Receives: Biological: Monovalent A/H1N1 influenza vaccine |
| high dose of antigen + high dose of adjuvant | Experimental | Not described Receives: Biological: Monovalent A/H1N1 influenza vaccine |
| high dose of antigen | Experimental | Not described Receives: Biological: Monovalent A/H1N1 influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To identify the preferred vaccine formulation dosage (antigen & adjuvant) and schedule (one or two administrations) of the H1N1sw monovalent vaccine in children and adolescents
Measured: 43 days after first vaccination
Secondary outcomes (1)
To evaluate immunogenicity against A/California H1N1sw strain after booster dose of egg-derived seasonal trivalent, MF59 adjuvanted vaccine Fluad, recommended for 2010/2011 season, administered 12 months after primary course according to CHMP criteria.
Measured: 3 weeks after booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2009 (estimated)
- Study startAug 2009
- Primary completionMar 2010
- Study completionAug 2011
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 Pandemic 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 752 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis Vaccines
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00971100
- Sponsor's protocol ID
- V110_04
- Other IDs
- 2009-013640-37, 2009
- Status last verified
- Oct 2011
- First submitted
- 2 Sep 2009
- Last updated
- 1 Dec 2016
- Results posted
- No
Publications
Knuf M, Leroux-Roels G, Rumke H, Rivera L, Pedotti P, Arora AK, Lattanzi M, Kieninger D, Cioppa GD. Immunogenicity and safety of cell-derived MF59(R)-adjuvanted A/H1N1 influenza vaccine for children. Hum Vaccin Immunother. 2015;11(2):358-76. doi: 10.4161/21645515.2014.987014.
PubMed 25621884
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Single-blind, Dose-Ranging Study to Evaluate Immunogenicity, Safety and Tolerability of Different Formulations of Adjuvanted and Non Adjuvanted Cell-derived, Inactivated Novel Swine Origin A/H1N1 Monovalent Subunit Influenza Virus Vaccine in Healthy Subjects From 6 Months to 17 Years of Age
- ClinicalTrials.gov ID
- NCT00971100
- Acronym / sponsor ID
- V110_04
- Conditions
- Pandemic Influenza
- Keywords
- Pandemic influenza, Vaccine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 752 participants (actual)
- Lead sponsor
- Novartis VaccinesIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 3 Sep 2009 (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 present study, randomized, single-blind, dose-ranging, multicenter study, will evaluate immunogenicity, safety and tolerability of two doses of adjuvanted and not-adjuvanted new swine-origin influenza A/H1N1 virus monovalent subunit vaccine in healthy children and adolescents. A booster dose will be administered 12 months after the first vaccination.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose of antigen + low dose of adjuvant | Experimental | Biological: Monovalent A/H1N1 influenza vaccine |
| high dose of antigen + high dose of adjuvant | Experimental | Biological: Monovalent A/H1N1 influenza vaccine |
| high dose of antigen | Experimental | Biological: Monovalent A/H1N1 influenza vaccine |
Who may qualify
- Ages
- 6 months to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males and females 6 months of age to 17 years of age on the day of enrollment;
- Subject's parents or legal guardians who have given written consent and the subjects has given assent consent, if applicable;
- Individuals in good health;
- Subjects, subject's parents or legal guardians that are able to comply with all study procedures;
- Willingness to allow for serum samples to be stored beyond the study period, for potential additional future testing to better characterize immune response.
Key exclusion criteria (15 listed)
- Subject's parents or legal guardians who are not able to comprehend and to follow all required study procedures;
- Individuals with history or any illness that, in the opinion of the investigator, might interfere with the results of the study or pose additional risk to the subjects due to participation in the study;
- Individuals with any serious chronic or progressive disease according to judgment of the investigator;
- History of any anaphylaxis, serious vaccine reactions to any excipients and to eggs (including ovalbumin) and chicken protein;
- Individuals who have had adjuvanted influenza vaccine or documented confirmed or suspected influenza disease within 3 months prior to Day 1.
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 |
|---|---|---|
| Monovalent A/H1N1 influenza vaccineThis trial will be performed at multiple study sites in a population of healthy children and adolescent. Subjects will be randomized to receive 2 IM injections of low dose of antigen \& adjuvant, or high dose of antigen \& adjuvant, or high dose of antigen, according to the study groups. | Biological | high dose of antigen, high dose of antigen + high dose of adjuvant, low dose of antigen + low dose of adjuvant |
Primary outcome
To identify the preferred vaccine formulation dosage (antigen & adjuvant) and schedule (one or two administrations) of the H1N1sw monovalent vaccine in children and adolescents
Time frame: 43 days after first vaccination
1 secondary outcome
To evaluate immunogenicity against A/California H1N1sw strain after booster dose of egg-derived seasonal trivalent, MF59 adjuvanted vaccine Fluad, recommended for 2010/2011 season, administered 12 months after primary course according to CHMP criteria.
Time frame: 3 weeks after booster vaccination
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 1 Dec 2016.
- Results publication: PubMed 25621884Knuf M, Leroux-Roels G, Rumke H, Rivera L, Pedotti P, Arora AK, Lattanzi M, Kieninger D, Cioppa GD. Immunogenicity and safety of cell-derived MF59(R)-adjuvanted A/H1N1 influenza vaccine for children. Hum Vaccin Immunother. 2015;11(2):358-76. doi: 10.4161/21645515.2014.987014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Monovalent A/H1N1 influenza vaccine in people with Pandemic Influenza, run by Novartis Vaccines at 3 sites in 3 countries.
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 15 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 1 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Belgium, Dominican Republic, Germany. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
To identify the preferred vaccine formulation dosage (antigen & adjuvant) and schedule (one or two administrations) of the H1N1sw monovalent vaccine in children and adolescents (time frame: 43 days after first vaccination). 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 NCT00971100, 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 1 Dec 2016.