InfluenzaPhase 2FluMistNCT00192179
A Phase II, Trial to Assess the Safety and Tolerability of Influenza Virus Vaccine, CAIV-T in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.
A Phase 2 study testing Cold-adapted influenza vaccine trivalent (CAIV-T) in people with Influenza, run by MedImmune LLC at 6 sites in 3 countries.
Trial summary
A safety study to compare, over a 7 day period, the fever rates following one dose of either Influenza Virus Vaccine or placebo administered outside the influenza season to healthy children and adolescents aged 6 to less than 18 years. Read more about this study
- Who is it for?
- Ages 6 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Cold-adapted influenza vaccine trivalent (CAIV-T)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 6 sitesin 3 countries
- Study dates
- Jun 2003to Jul 2003
- 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 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- who are aged 6 to less than 18 years at the time of enrolment
- who, if female and is of child bearing potential is using reliable method of hormonal and/or non-hormonal contraception (which includes cervical cap, diaphragm, condoms, with spermicide or IUD) during sexual intercourse throughout the entire study period; has provided a negative pregnancy test (with detection limit of less than or equal to 25mL/ml) no more than 24 hours prior to the study vaccine administration and agreed to avoid pregnancy during participation in the study.
- N.B.lactating females are excluded from the study.
- who are in good health as determined by medical history, physical examination and clinical judgement
- whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained
- who, along with their parent(s)/legal guardian(s) will be available until completion of the study
- whose parent(s)/legal guardian(s), can be reached by study staff for the post vaccination contacts(telephone, clinic or home visit)
Who cannot join
- who along with their parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period
- with any serious chronic disease (e.g. with signs of cardiac or renal failure or severe malnutrition) including progressive neurological disease
- with Down's syndrome or other known cytogenetic disorders
- with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents
- who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study
- have an immunosuppressed or an immunocompromised individual living in the same household
Show all 15Show fewer
- with a documented history of hypersensitivity to egg or egg protein or any other components of CAIV-T or placebo
- who have a history of Guillain-Barre Syndrome (GBS)
- for whom there is intent to administer any other investigational vaccine or agent from one month prior to enrollment through to the conclusion of the study
- who, in the two weeks prior to entry into the study, received a dose of influenza treatment (commercial or investigational)
- who received aspirin (acetylsalicylic acid) or aspirin-containing products in the two weeks prior to enrollment or for which use is anticipated during the study
- who, at anytime prior to study enrollment, received any influenza vaccine (commercial or investigational)
- with asthma requiring regular medical follow up or hospitalization during the preceding year
- with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results
- Note: Pregnancy in any person who has regular contact with the subjects is not a contraindication to enrollment or ongoing participation of the subject in the study.
Trial locations and contacts
6 sites in 3 countries.
6 sites in 3 countries
Belgium3 sites
Catholic University Leuven
Leuven
Zamenhoflaan 12
Schoten
Universiteit Antwerpen
Wilrijk
United Kingdom2 sites
The Gables Medicentre
Coventry, CV 6 4DD
Townhead Surgery
Irvine, Ayshire, KA 12 OAY
About this study
Official title: A Phase II, Prospective, Randomized, Double-Blind, Placebo, Controlled Trial, to Assess the Safety and Tolerability of Influenza Virus Vaccine, Trivalent, Types A & B Live Cold-Adapted Liquid Formulation (CAIV-T) in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.
A safety study to compare, over a 7 day period, the fever rates following one dose of either Influenza Virus Vaccine or placebo administered outside the influenza season to healthy children and adolescents aged 6 to less than 18 years.
Read the detailed description
This was a prospective, randomized, double-blind, placebo-controlled, study. Subjects were randomized to receive either CAIV-T or Placebo. All subjects were healthy children and adolescents aged at least 6 years of age and less than 18 years of age at the time of enrollment.
- Conditions
- Influenza
- Being tested
- Cold-adapted influenza vaccine trivalent (CAIV-T), Placebo
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cold-adapted influenza vaccine trivalent (CAIV-T)Biological
The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 ml into each nostril). Each dose of CAIV-T used in this study contained approximately 10^7+/-0.5 fluorescent focus units (FFU) (equivalent to 10^7+/-0.5 TCID50) of each of the following three influenza virus strains: Influenza Cold Adapted Virus Type H1N1, strain A/New Caledonia/20/99; Influenza Cold Adapted Virus Type H3N2, strain A/ Panama/2007/99; Influenza Cold Adapted Virus Type B, strain B/Hong Kong/ 330/01.
PlaceboBiological
The placebo consisted of physiologic normal saline.
| Study group | Role | What they receive |
|---|---|---|
| CAIV-T | Experimental | The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). Receives: Biological: Cold-adapted influenza vaccine trivalent (CAIV-T) |
| Placebo | Placebo comparator | The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of subjects with fever greater than or equal to 39.1C oral
Measured: Days 0-7
Secondary outcomes (3)
Number of subjects with any reactogenicity
Following vaccination the following reactions were reported daily: runny nose/nasal congestion, sore throat, cough, vomiting, decreased activity level, decreased appetite, irritability, abdominal pain together with oral temperature were referred to as prompted systemic reactions.
Measured: Day 0-7
Number of subjects with any adverse events
Adverse events were defined as any untoward, undesired or unexpected clinical event in the form of signs, symptoms, disease or laboratory or physiological observations that occurred in a temporal relationship to the use of a WVR product, regardless of causal relationship.
Measured: Days 0-7
Number of subjects with any serious adverse events
A Serious AE was an AE that occurred after any dose that: resulted in death, regardless of cause; was life-threatening; required in-patient hospitalization or prolonged an existing hospitalization; resulted in a persistent or significant disability or incapacity; resulted in cancer; resulted in a congenital anomaly or birth defect (in the offspring of a vaccine recipient, where applicable).
Measured: Days 0-21
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2005 (estimated)
- Study startJun 2003
- Primary completionJul 2003
- Study completionJul 2003
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.
- 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
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedImmune LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Investigators
- Raburn Mallory, M.D., Study director, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192179
- Sponsor's protocol ID
- D153-P526
- Acronym
- FluMist
- Status last verified
- Feb 2012
- First submitted
- 12 Sep 2005
- Last updated
- 2 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Prospective, Randomized, Double-Blind, Placebo, Controlled Trial, to Assess the Safety and Tolerability of Influenza Virus Vaccine, Trivalent, Types A & B Live Cold-Adapted Liquid Formulation (CAIV-T) in Healthy Children and Adolescents Ages 6 to Less Than 18 Years.
- ClinicalTrials.gov ID
- NCT00192179
- Acronym / sponsor ID
- FluMist / D153-P526
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Jun 2003
- Primary completion
- Jul 2003 (actual)
- Study completion
- Jul 2003 (actual)
- First posted
- 19 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A safety study to compare, over a 7 day period, the fever rates following one dose of either Influenza Virus Vaccine or placebo administered outside the influenza season to healthy children and adolescents aged 6 to less than 18 years.
Detailed description
This was a prospective, randomized, double-blind, placebo-controlled, study. Subjects were randomized to receive either CAIV-T or Placebo. All subjects were healthy children and adolescents aged at least 6 years of age and less than 18 years of age at the time of enrollment.
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 |
|---|---|---|
| CAIV-T | Experimental | Biological: Cold-adapted influenza vaccine trivalent (CAIV-T)The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
| Placebo | Placebo comparator | Biological: PlaceboThe total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 mL into each nostril). |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- who are aged 6 to less than 18 years at the time of enrolment
- who, if female and is of child bearing potential is using reliable method of hormonal and/or non-hormonal contraception (which includes cervical cap, diaphragm, condoms, with spermicide or IUD) during sexual intercourse throughout the entire study period; has provided a negative pregnancy test (with detection limit of less than or equal to 25mL/ml) no more than 24 hours prior to the study vaccine administration and agreed to avoid pregnancy during participation in the study.
- N.B.lactating females are excluded from the study.
- who are in good health as determined by medical history, physical examination and clinical judgement
- whose parent(s)/legal guardian(s) have provided written informed consent after the nature of the study has been explained
Key exclusion criteria (15 listed)
- who along with their parent(s)/legal guardian(s) are perceived to be unavailable or difficult to contact for evaluation or study visits during the study period
- with any serious chronic disease (e.g. with signs of cardiac or renal failure or severe malnutrition) including progressive neurological disease
- with Down's syndrome or other known cytogenetic disorders
- with a known or suspected disease of the immune system or those receiving immunosuppressive therapy, including systemic corticosteroids; or cytotoxic agents
- who received any blood products, including immunoglobulin, in the period from six months prior to vaccination through to the conclusion of the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cold-adapted influenza vaccine trivalent (CAIV-T)The total volume of 0.2 ml was administered intranasally with a spray applicator (approximately 0.1 ml into each nostril). Each dose of CAIV-T used in this study contained approximately 10^7+/-0.5 fluorescent focus units (FFU) (equivalent to 10^7+/-0.5 TCID50) of each of the following three influenza virus strains: Influenza Cold Adapted Virus Type H1N1, strain A/New Caledonia/20/99; Influenza Cold Adapted Virus Type H3N2, strain A/ Panama/2007/99; Influenza Cold Adapted Virus Type B, strain B/Hong Kong/ 330/01. | Biological | CAIV-T |
| PlaceboThe placebo consisted of physiologic normal saline. | Biological | Placebo |
Primary outcome
Number of subjects with fever greater than or equal to 39.1C oral
Time frame: Days 0-7
3 secondary outcomes
Number of subjects with any reactogenicity
Time frame: Day 0-7
Number of subjects with any adverse events
Time frame: Days 0-7
Number of subjects with any serious adverse events
Time frame: Days 0-21
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 2 Mar 2012.
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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.
Raburn Mallory, M.D. study director
MedImmune LLC
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cold-adapted influenza vaccine trivalent (CAIV-T) in people with Influenza, run by MedImmune LLC at 6 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 7 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 2 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, United Kingdom, Poland. 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?
Number of subjects with fever greater than or equal to 39.1C oral (time frame: Days 0-7). 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 2 Mar 2012.