InfluenzaPhase 2CAIVTNCT00192322
Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine (CAIV-T) in Healthy Children
A Phase 2 study testing CAIV-T 10^7, CAIVT 10^5 and TIV in people with Influenza, run by MedImmune LLC at 2 sites in United States.
Trial summary
To perform a variety of assays on blood, nasal washes, and cells obtained from healthy children for the purposes of further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA). Read more about this study
- Who is it for?
- Ages 6 to 36 monthsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- CAIV-T 10^7, CAIVT 10^5 and TIV
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 173 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2001to Dec 2001
- 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 36 months
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- children at least 6 months of age and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination and clinical judgement;
- whose parent/legal guardian has provided written informed consent after the nature of the study has been explained;
- who, along with their parent or guardian, will be available for the one month duration of the trial (from enrollment to study completion);
Who cannot join
- whose parents or guardians 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 (see Section 4.2.2);
- have an immunosuppressed or an immunocompromised individual living in the same household;
- with a documented history of hypersensitivity to egg or egg protein or any other component of the study vaccine, placebo or TIV;
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- who, at anytime prior to study enrollment, receives any influenza vaccine (commercial or investigational);
- with any medical conditions that in the opinion of the investigator might interfere with interpretation of the study results.
- Note: A pregnant household member is not considered a contraindication to enrollment.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Suncoast Clinical Research, Inc.
New Port Richey, Florida, 34652
Division of Allergy Immunology and Infectious Disease
Pittsburgh, Pennsylvania, 15213
About this study
Official title: A Randomized, Partially-Blinded, Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent,Types A & B, Live Cold Adapted (CAIV-T) in Healthy Children Aged 6 to Less Than 36 Months
To perform a variety of assays on blood, nasal washes, and cells obtained from healthy children for the purposes of further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA).
- To assess nasal swab specimens to detect vaccine virus shedding.
Read the detailed description
This was a phase II, prospective, randomized, partially-blinded, placebo-controlled, outpatient study conducted at multiple sites throughout the US in healthy children aged 6 months to less than 36 months. Parents/guardians of subjects were asked to read and sign the informed consent before any study-related procedures were performed. Subjects at each study site were sequentially assigned to 1 of 2 separate blood sample groups referred to as "cellular immunity" or "antibody secreting cell". Subjects within each blood sample group were then randomized 1:1:1:1 to receive a single intranasal dose of CAIV-T 10^7 FFU per dose, CAIV-T 10^5 FFU per dose, placebo or a commercially-available injectable trivalent influenza vaccine (TIV).
- Conditions
- Influenza
- Being tested
- CAIV-T 10^7, CAIVT 10^5, Placebo, TIV
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAIV-T 10^7Biological
a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril)
CAIVT 10^5Biological
a single intranasal 0.2 mL dose of CAIV-T <10^5
PlaceboBiological
a single intranasal 0.2 mL dose of placebo
TIVBiological
commercially available TIV injected intramuscularly
| Study group | Role | What they receive |
|---|---|---|
| CAIV-T 10^5 | Experimental | a single intranasal 0.2 mL dose of liquid CAIV-T 10^5 (approximately 0.1 mL into each nostril) Receives: Biological: CAIVT 10^5 |
| CAIVT 10^7 | Experimental | A single intranasal 0.2 mL dose of liquid CAIV-T 10^7 (approximately 0.1 mL into each nostril) Receives: Biological: CAIV-T 10^7 |
| Placebo | Placebo comparator | A single intranasal 0.2 mL dose of placebo Receives: Biological: Placebo |
| Trivalent inactivated vaccine (TIV) | Active comparator | A single intramuscular injection of commercially available vaccine Receives: Biological: TIV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurement of influenza-specific immune response following receipt of CAIV-T.
The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples.
Measured: Day 0 and Day 27
Secondary outcomes (4)
Vaccine virus shedding
The number of subjects who shed influenza virus vaccine subtypes following vaccination.
Measured: Days 2, 6, and 13
Measurement of influenza-specific immune response following receipt of CAIVT.
The immune responses were evaluated by mucosal IgA ELISA on nasal wash samples.
Measured: Day 0 and Day 27
Measurement of influenza-specific immune responses following receipt of CAIVT
The immune responses were evaluated by assays of cellular immunity (IFN-gamma ELISPOT) and assays that measured the number of antibody secreting cells (B-cell ELISPOT).
Measured: Day 0, Day 6, and Day 13
Assess the safety and tolerability of CAIV-T vaccine in healthy children.
Adverse events and serious adverse events were collect from Day 0 till the end of the study Day 27.
Measured: Day 0-27
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 startSep 2001
- Primary completionDec 2001
- Study completionDec 2001
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.
- 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
- 173 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
- Robert Walker, MD, Principal investigator, MedImmune LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00192322
- Sponsor's protocol ID
- D153-P002
- Acronym
- CAIVT
- Status last verified
- Feb 2012
- First submitted
- 12 Sep 2005
- Last updated
- 17 Feb 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Mendelman PM, Rappaport R, Cho I, Block S, Gruber W, August M, Dawson D, Cordova J, Kemble G, Mahmood K, Palladino G, Lee MS, Razmpour A, Stoddard J, Forrest BD. Live attenuated influenza vaccine induces cross-reactive antibody responses in children against an a/Fujian/411/2002-like H3N2 antigenic variant strain. Pediatr Infect Dis J. 2004 Nov;23(11):1053-5. doi: 10.1097/01.inf.0000143643.44463.b1.
PubMed 15545863
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Partially-Blinded, Placebo-Controlled Trial to Investigate Immune Responses Elicited by a Liquid Formulation of Influenza Virus Vaccine, Trivalent,Types A & B, Live Cold Adapted (CAIV-T) in Healthy Children Aged 6 to Less Than 36 Months
- ClinicalTrials.gov ID
- NCT00192322
- Acronym / sponsor ID
- CAIVT / D153-P002
- Conditions
- Influenza
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- MedImmune LLCIndustry (pharma, biotech, devices)
- Collaborators
- Wyeth is now a wholly owned subsidiary of Pfizer
- Study start
- Sep 2001
- Primary completion
- Dec 2001 (actual)
- Study completion
- Dec 2001 (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.
To perform a variety of assays on blood, nasal washes, and cells obtained from healthy children for the purposes of further investigation of immune responses generated by influenza virus vaccine, trivalent, types A and B, live, cold-adapted (liquid CAIV-T; Wyeth Lederle Vaccines, Marietta, PA).
- To assess nasal swab specimens to detect vaccine virus shedding.
Detailed description
This was a phase II, prospective, randomized, partially-blinded, placebo-controlled, outpatient study conducted at multiple sites throughout the US in healthy children aged 6 months to less than 36 months. Parents/guardians of subjects were asked to read and sign the informed consent before any study-related procedures were performed. Subjects at each study site were sequentially assigned to 1 of 2 separate blood sample groups referred to as "cellular immunity" or "antibody secreting cell". Subjects within each blood sample group were then randomized 1:1:1:1 to receive a single intranasal dose of CAIV-T 10^7 FFU per dose, CAIV-T 10^5 FFU per dose, placebo or a commercially-available injectable trivalent influenza vaccine (TIV).
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 |
|---|---|---|
| CAIV-T 10^5 | Experimental | Biological: CAIVT 10^5a single intranasal 0.2 mL dose of liquid CAIV-T 10^5 (approximately 0.1 mL into each nostril) |
| CAIVT 10^7 | Experimental | Biological: CAIV-T 10^7A single intranasal 0.2 mL dose of liquid CAIV-T 10^7 (approximately 0.1 mL into each nostril) |
| Placebo | Placebo comparator | Biological: PlaceboA single intranasal 0.2 mL dose of placebo |
| Trivalent inactivated vaccine (TIV) | Active comparator | Biological: TIVA single intramuscular injection of commercially available vaccine |
Who may qualify
- Ages
- 6 to 36 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- children at least 6 months of age and less than 36 months of age at the time of enrollment, and in good health as determined by medical history, physical examination and clinical judgement;
- whose parent/legal guardian has provided written informed consent after the nature of the study has been explained;
- who, along with their parent or guardian, will be available for the one month duration of the trial (from enrollment to study completion);
Key exclusion criteria (9 listed)
- whose parents or guardians 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 (see Section 4.2.2);
- have an immunosuppressed or an immunocompromised individual living in the same household;
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 |
|---|---|---|
| CAIV-T 10^7a single intranasal 0.2 mL dose of liquid CAIV-T 107 (approximately 0.1 mL into each nostril) | Biological | CAIVT 10^7 |
| CAIVT 10^5a single intranasal 0.2 mL dose of CAIV-T <10^5 | Biological | CAIV-T 10^5 |
| Placeboa single intranasal 0.2 mL dose of placebo | Biological | Placebo |
| TIVcommercially available TIV injected intramuscularly | Biological | Trivalent inactivated vaccine (TIV) |
Primary outcome
Measurement of influenza-specific immune response following receipt of CAIV-T.
Time frame: Day 0 and Day 27
The immune responses were evaluated by hemagglutination inhibition assay (HAI) on serum samples.
4 secondary outcomes
Vaccine virus shedding
Time frame: Days 2, 6, and 13
Measurement of influenza-specific immune response following receipt of CAIVT.
Time frame: Day 0 and Day 27
Measurement of influenza-specific immune responses following receipt of CAIVT
Time frame: Day 0, Day 6, and Day 13
Assess the safety and tolerability of CAIV-T vaccine in healthy children.
Time frame: Day 0-27
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 17 Feb 2012.
- Results publication: PubMed 15545863Mendelman PM, Rappaport R, Cho I, Block S, Gruber W, August M, Dawson D, Cordova J, Kemble G, Mahmood K, Palladino G, Lee MS, Razmpour A, Stoddard J, Forrest BD. Live attenuated influenza vaccine induces cross-reactive antibody responses in children against an a/Fujian/411/2002-like H3N2 antigenic variant strain. Pediatr Infect Dis J. 2004 Nov;23(11):1053-5. doi: 10.1097/01.inf.0000143643.44463.b1.
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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.
Robert Walker, MD principal investigator
MedImmune LLC
2 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 CAIV-T 10^7, CAIVT 10^5 and TIV in people with Influenza, run by MedImmune LLC at 2 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 3 inclusion and 9 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 17 Feb 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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. 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?
Measurement of influenza-specific immune response following receipt of CAIV-T. (time frame: Day 0 and Day 27). 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 NCT00192322, 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 17 Feb 2012.