InfluenzaPhase 4NCT01680679
Influenza Immunization of Children in India
A Phase 4 study testing Inactivated Trivalent Influenza Vaccine (TIV) and Inactivated poliovirus vaccine (IPV), trivalent in people with Influenza, run by University of Colorado, Denver at 1 site in India.
Trial summary
Influenza viruses are significant causes of human illness and death in developed and developing countries. This study will measure the ability of influenza vaccine given to children in India to protect both the children and unimmunized persons around them from influenza. Read more about this study
- Who is it for?
- Ages 6 months to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Inactivated Trivalent Influenza Vaccine (TIV) and Inactivated poliovirus vaccine (IPV), trivalent
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18,163 participants
- Where
- 1 siteIndia
- Study dates
- May 2012to May 2014
- Phase
- Phase 4
- 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 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Inclusion in either vaccine group (TIV or IPV) will require ages 6 months through 10 years of age.
- All individuals in enrolled households will be eligible for enrollment into surveillance arm.
Who cannot join
- Exclusion criteria from the vaccine groups includes known allergy to eggs, or hypersensitivity to other components of the vaccines.
Trial locations and contacts
1 site in 1 country.
About this study
Influenza viruses are significant causes of human illness and death in developed and developing countries. This study will measure the ability of influenza vaccine given to children in India to protect both the children and unimmunized persons around them from influenza. It will also determine whether the best time to immunize in a country like India that has both summer and winter outbreaks of influenza is in the fall, as is done now, or whether immunization should be in the spring to protect against influenza infections in the summer.
Read the detailed description
Although influenza vaccines are used routinely in the United States, including in young children, influenza vaccines have not seen widespread use in India. This is likely contributed to by the lack of information from India about disease burden due to influenza and because influenza vaccines have not been tested for efficacy in India. In addition, because young children are thought to be important in the spread of influenza in families, it is possible immunization of children against influenza will reduce influenza infections among older children and adults in the home. The study described here is an extension of an earlier study (ClinicalTrials.gov NCT00934245) that tested the use of immunization against influenza in the fall. The current study will administer influenza vaccine in the spring prior to the summer monsoon rains that are associated with peaks of influenza activity in parts of India. Reduction of influenza infections among the influenza immunized children and their household members will be compared to the children and household members in the control vaccine group.
- Conditions
- Influenza
- Being tested
- Inactivated Trivalent Influenza Vaccine (TIV), Inactivated poliovirus vaccine (IPV), trivalent
- Keywords
- Influenza, India, Children, Trivalent Influenza Vaccine (TIV), Inactivated poliovirus vaccine (IPV), Direct influenza vaccine effectiveness, Total influenza vaccine effectiveness, Indirect influenza vaccine effectiveness
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated Trivalent Influenza Vaccine (TIV)Biological
Inactivated poliovirus vaccine (IPV), trivalentBiological
| Study group | Role | What they receive |
|---|---|---|
| Inactivated Trivalent Influenza Vaccine | Experimental | Inactivated trivalent influenza vaccine (TIV), split virion Receives: Biological: Inactivated Trivalent Influenza Vaccine (TIV) |
| Inactivated Polio Vaccine | Placebo comparator | Inactivated poliovirus vaccine (IPV), trivalent Receives: Biological: Inactivated poliovirus vaccine (IPV), trivalent |
| Surveillance arm | No intervention | Those ineligible for vaccination will be enrolled for febrile acute respiratory illness (FARI) surveillance to assess indirect effects of vaccination in household members. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Laboratory-confirmed influenza infection in vaccinated child
Measured: 1 year
Secondary outcomes (1)
Laboratory-confirmed influenza infection in household member of a vaccinated child.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2012 (estimated)
- Study startMay 2012
- Primary completionMay 2014
- Study completionMay 2014
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.
- More trials run by University of Colorado, DenverThe 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 18,163 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Sciences, International Clinical Epidemiology Network (INCLEN) TRUST, University of Alabama at Birmingham, Centers for Disease Control and Prevention
- Responsible party
- Sponsor
- Investigators
- Wayne Sullender, MD, Principal investigator, University of Colorado, DenverShobha Broor, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01680679
- Sponsor's protocol ID
- 13-0210
- Other IDs
- U01IP000475
- Status last verified
- Mar 2017
- First submitted
- 4 Sep 2012
- Last updated
- 24 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Immunization of Children in India
- ClinicalTrials.gov ID
- NCT01680679
- Acronym / sponsor ID
- 13-0210
- Conditions
- Influenza
- Keywords
- Influenza, India, Children, Trivalent Influenza Vaccine (TIV), Inactivated poliovirus vaccine (IPV), Direct influenza vaccine effectiveness, Total influenza vaccine effectiveness, Indirect influenza vaccine effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18,163 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- All India Institute of Medical Sciences, International Clinical Epidemiology Network (INCLEN) TRUST, University of Alabama at Birmingham, Centers for Disease Control and Prevention
- Study start
- May 2012
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 7 Sep 2012 (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.
Influenza viruses are significant causes of human illness and death in developed and developing countries. This study will measure the ability of influenza vaccine given to children in India to protect both the children and unimmunized persons around them from influenza. It will also determine whether the best time to immunize in a country like India that has both summer and winter outbreaks of influenza is in the fall, as is done now, or whether immunization should be in the spring to protect against influenza infections in the summer.
Detailed description
Although influenza vaccines are used routinely in the United States, including in young children, influenza vaccines have not seen widespread use in India. This is likely contributed to by the lack of information from India about disease burden due to influenza and because influenza vaccines have not been tested for efficacy in India. In addition, because young children are thought to be important in the spread of influenza in families, it is possible immunization of children against influenza will reduce influenza infections among older children and adults in the home. The study described here is an extension of an earlier study (ClinicalTrials.gov NCT00934245) that tested the use of immunization against influenza in the fall. The current study will administer influenza vaccine in the spring prior to the summer monsoon rains that are associated with peaks of influenza activity in parts of India. Reduction of influenza infections among the influenza immunized children and their household members will be compared to the children and household members in the control vaccine group.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Inactivated Trivalent Influenza Vaccine | Experimental | Biological: Inactivated Trivalent Influenza Vaccine (TIV)Inactivated trivalent influenza vaccine (TIV), split virion |
| Inactivated Polio Vaccine | Placebo comparator | Biological: Inactivated poliovirus vaccine (IPV), trivalentInactivated poliovirus vaccine (IPV), trivalent |
| Surveillance arm | No intervention | –Those ineligible for vaccination will be enrolled for febrile acute respiratory illness (FARI) surveillance to assess indirect effects of vaccination in household members. |
Who may qualify
- Ages
- 6 months to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Inclusion in either vaccine group (TIV or IPV) will require ages 6 months through 10 years of age.
- All individuals in enrolled households will be eligible for enrollment into surveillance arm.
Key exclusion criteria (1 listed)
- Exclusion criteria from the vaccine groups includes known allergy to eggs, or hypersensitivity to other components of the vaccines.
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 |
|---|---|---|
| Inactivated Trivalent Influenza Vaccine (TIV) | Biological | Inactivated Trivalent Influenza Vaccine |
| Inactivated poliovirus vaccine (IPV), trivalent | Biological | Inactivated Polio Vaccine |
Primary outcome
Laboratory-confirmed influenza infection in vaccinated child
Time frame: 1 year
1 secondary outcome
Laboratory-confirmed influenza infection in household member of a vaccinated child.
Time frame: 1 year
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 24 Mar 2017.
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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.
Wayne Sullender, MD principal investigator
University of Colorado, Denver
Shobha Broor, MD principal investigator
All India Institute of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inactivated Trivalent Influenza Vaccine (TIV) and Inactivated poliovirus vaccine (IPV), trivalent in people with Influenza, run by University of Colorado, Denver at 1 site in India.
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 2 inclusion and 1 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 24 Mar 2017. 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 India. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Laboratory-confirmed influenza infection in vaccinated child (time frame: 1 year). 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 24 Mar 2017.