Inactivated Influenza VaccinePhase 2/3GRC28NCT00242424
Safety and Immunogenicity of Inactivated Influenza Virus Vaccine Among Healthy Children 6-12 Weeks of Age
A Phase 2/3 study testing 2005-2006 trivalent inactivated influenza vaccine in people with Inactivated Influenza Vaccine, run by Seattle Children's Hospital at 1 site in United States.
Trial summary
Study of the safety and immunogenicity (antibody producing capability) comparing inactivated influenza vaccine to placebo given to infants at 2 and 3 months of age. Infants will receive inactivated influenza vaccine at the same time as other vaccines on the routine immunization schedule. Read more about this study
- Who is it for?
- Ages 42 to 84 daysHealthy volunteers can take part
- Conditions the study is for
- Inactivated Influenza Vaccine
- What is being tested?
- 2005-2006 trivalent inactivated influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,375 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2005to Sep 2007
- Phase
- Phase 2/3
- 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 42 to 84 days
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Age 42 to 84 days on the day of inclusion
- Full term (born at >=36 weeks with birth weight >=2.5 kg
- Considered to be in good health
- Parental consent obtained and available
- Available for the study duration (6 months)
Who cannot join
- Reported allergy to egg proteins, chicken proteins
- Previous history of influenza vaccination or disease
- Receipt of any vaccine other than Hepatitis B prior to enrollment
- Acute illness with rectal temperature >= 38.0 (defer enrollment)
- Known bleeding disorder
- Participation in other interventional clinical trial within 30 days prior to enrollment
Trial locations and contacts
1 site in 1 country.
United States1 site
Seattle Children's Hospital and Regional Medical Center
Seattle, Washington, 98105
About this study
Official title: Safety and Immunogenicity of Fluzone Influenza Virus Vaccine (2005-2006 Formulation) Among Healthy Children 6 to 12 Weeks of Age
Study of the safety and immunogenicity (antibody producing capability) comparing inactivated influenza vaccine to placebo given to infants at 2 and 3 months of age. Infants will receive inactivated influenza vaccine at the same time as other vaccines on the routine immunization schedule. Infants will be randomized at enrollment to receive inactivated influenza vaccine or placebo at a 2:1 ratio. This study is double-blind, randomized, and placebo-controlled.
Read the detailed description
Methods: A double-blind, randomized, placebo-controlled trial was conducted in 1375 healthy US infants 6-12 weeks of age. Subjects received either 2 doses of trivalent inactivated influenza vaccine (TIV, Fluzone®, sanofi pasteur 2005-6 pediatric formulation) (N=915) or placebo (N=460) 1 month apart, along with indicated concomitant vaccines. Solicited adverse events were collected for 7 days following each vaccination, unsolicited adverse events for 28 days, and serious adverse events for 6 months. Hemagglutination inhibition antibodies to all 3 vaccine strains were measured following the second TIV/placebo dose.
Results: No significant differences were seen between TIV and placebo groups for any safety outcomes. Fever ≥38oC rectal within 3 days of vaccination was seen in 11.2% vs 11.7% of TIV vs placebo recipients. Serious adverse events within 28 days of vaccine/placebo were reported in 1.9% of TIV and 1.5% of placebo recipients; only one (hypersensitivity reaction in a TIV recipient) was considered vaccine-related. Significantly increased antibody responses (p<0.001) were seen against all 3 strains in TIV recipients by titer ≥ 1:40 or geometric mean titer (GMT) (p<0.001). Altogether, 50% of infants had antibody titers ≥ 1:40 for H1N1, 86% for H3N2, and 11% for B compared with 7%, 10%, and 0.3% in the placebo group. The reciprocal GMT for influenza recipients was 33, 95, and 11 for H1N1, H3N2, and B vs. 7, 9, and 5 for placebo recipients. Over 90% of infants who received TIV had antibody ≥ 1:40 for at least one vaccine strain and 49.6% for 2 strains, vs. 16.4% and 0.9% in the placebo group.
Conclusions: TIV administered to young infants beginning at 6-12 weeks of age is safe and immunogenic.
- Conditions
- Inactivated Influenza Vaccine
- Being tested
- 2005-2006 trivalent inactivated influenza vaccine
- Keywords
- influenza vaccine, infants, safety, immunogenicity
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2005-2006 trivalent inactivated influenza vaccineBiological
Children enrolled at 6-12 weeks to receive first dose, 0.25 ml of trivalent inactivated influenza vaccine, 2005-6 pediatric Fluzone formulation (sanofi pastuer), with concomitant routine pediatric vaccines. Second dose administered 4 weeks later.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Placebo comparator | 0.25 ml normal saline placebo given as injection to infants at 2 and 3 months of age Receives: Biological: 2005-2006 trivalent inactivated influenza vaccine |
| 2 | Experimental | 2005-6 Fluzone, pediatric formulation of trivalent inactivated influenza vaccine (sanofi pasteur) administered to infants at 2 and 3 months of age Receives: Biological: 2005-2006 trivalent inactivated influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the safety of Fluzone vaccine administered to 2-month old children
Measured: within 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2005 (estimated)
- Study startSep 2005
- Primary completionSep 2006
- Study completionSep 2007
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 Inactivated Influenza VaccineStudies of the same condition, open and under way.
- More trials run by Seattle Children's HospitalThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 1,375 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Investigators
- Janet A Englund, MD, Study chair, Seattle Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242424
- Sponsor's protocol ID
- 05065501
- Acronym
- GRC28
- Status last verified
- Jan 2009
- First submitted
- 19 Oct 2005
- Last updated
- 28 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Englund JA, Walter EB, Black S, et al. Safety and Immunogenicity of Fluzone Trivalent Inactivated Influenza Vaccine (TIV) in Infants 6-12 Weeks of Age. Presented at Infectious Disease Society of America (IDSA), Toronto, Oct. 14, 2006
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Immunogenicity of Fluzone Influenza Virus Vaccine (2005-2006 Formulation) Among Healthy Children 6 to 12 Weeks of Age
- ClinicalTrials.gov ID
- NCT00242424
- Acronym / sponsor ID
- GRC28 / 05065501
- Conditions
- Inactivated Influenza Vaccine
- Keywords
- influenza vaccine, infants, safety, immunogenicity
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,375 participants (actual)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Sanofi Pasteur, a Sanofi Company
- Study start
- Sep 2005
- Primary completion
- Sep 2006 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 20 Oct 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.
Study of the safety and immunogenicity (antibody producing capability) comparing inactivated influenza vaccine to placebo given to infants at 2 and 3 months of age. Infants will receive inactivated influenza vaccine at the same time as other vaccines on the routine immunization schedule. Infants will be randomized at enrollment to receive inactivated influenza vaccine or placebo at a 2:1 ratio. This study is double-blind, randomized, and placebo-controlled.
Detailed description
Methods: A double-blind, randomized, placebo-controlled trial was conducted in 1375 healthy US infants 6-12 weeks of age. Subjects received either 2 doses of trivalent inactivated influenza vaccine (TIV, Fluzone®, sanofi pasteur 2005-6 pediatric formulation) (N=915) or placebo (N=460) 1 month apart, along with indicated concomitant vaccines. Solicited adverse events were collected for 7 days following each vaccination, unsolicited adverse events for 28 days, and serious adverse events for 6 months. Hemagglutination inhibition antibodies to all 3 vaccine strains were measured following the second TIV/placebo dose.
Results: No significant differences were seen between TIV and placebo groups for any safety outcomes. Fever ≥38oC rectal within 3 days of vaccination was seen in 11.2% vs 11.7% of TIV vs placebo recipients. Serious adverse events within 28 days of vaccine/placebo were reported in 1.9% of TIV and 1.5% of placebo recipients; only one (hypersensitivity reaction in a TIV recipient) was considered vaccine-related. Significantly increased antibody responses (p<0.001) were seen against all 3 strains in TIV recipients by titer ≥ 1:40 or geometric mean titer (GMT) (p<0.001). Altogether, 50% of infants had antibody titers ≥ 1:40 for H1N1, 86% for H3N2, and 11% for B compared with 7%, 10%, and 0.3% in the placebo group. The reciprocal GMT for influenza recipients was 33, 95, and 11 for H1N1, H3N2, and B vs. 7, 9, and 5 for placebo recipients. Over 90% of infants who received TIV had antibody ≥ 1:40 for at least one vaccine strain and 49.6% for 2 strains, vs. 16.4% and 0.9% in the placebo group.
Conclusions: TIV administered to young infants beginning at 6-12 weeks of age is safe and immunogenic.
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 |
|---|---|---|
| 1 | Placebo comparator | Biological: 2005-2006 trivalent inactivated influenza vaccine0.25 ml normal saline placebo given as injection to infants at 2 and 3 months of age |
| 2 | Experimental | Biological: 2005-2006 trivalent inactivated influenza vaccine2005-6 Fluzone, pediatric formulation of trivalent inactivated influenza vaccine (sanofi pasteur) administered to infants at 2 and 3 months of age |
Who may qualify
- Ages
- 42 to 84 days
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Age 42 to 84 days on the day of inclusion
- Full term (born at >=36 weeks with birth weight >=2.5 kg
- Considered to be in good health
- Parental consent obtained and available
- Available for the study duration (6 months)
Key exclusion criteria (6 listed)
- Reported allergy to egg proteins, chicken proteins
- Previous history of influenza vaccination or disease
- Receipt of any vaccine other than Hepatitis B prior to enrollment
- Acute illness with rectal temperature >= 38.0 (defer enrollment)
- Known bleeding disorder
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 |
|---|---|---|
| 2005-2006 trivalent inactivated influenza vaccineChildren enrolled at 6-12 weeks to receive first dose, 0.25 ml of trivalent inactivated influenza vaccine, 2005-6 pediatric Fluzone formulation (sanofi pastuer), with concomitant routine pediatric vaccines. Second dose administered 4 weeks later. | Biological | 1, 2 |
Primary outcome
To demonstrate the safety of Fluzone vaccine administered to 2-month old children
Time frame: within 6 months
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 28 Jan 2009.
- Results publicationEnglund JA, Walter EB, Black S, et al. Safety and Immunogenicity of Fluzone Trivalent Inactivated Influenza Vaccine (TIV) in Infants 6-12 Weeks of Age. Presented at Infectious Disease Society of America (IDSA), Toronto, Oct. 14, 2006
Related trials for Inactivated Influenza Vaccine
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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.
Janet A Englund, MD study chair
Seattle Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing 2005-2006 trivalent inactivated influenza vaccine in people with Inactivated Influenza Vaccine, run by Seattle Children's Hospital at 1 site 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 5 inclusion and 6 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 28 Jan 2009. 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 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 combined 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.
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 demonstrate the safety of Fluzone vaccine administered to 2-month old children (time frame: within 6 months). 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 NCT00242424, 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 28 Jan 2009.