InfluenzaPhase 4NCT00934245
Direct and Indirect Protection by Influenza Vaccine Given to Children in India
A Phase 4 study testing Inactivated Trivalent Influenza Vaccine and Inactivated polio vaccine (IPV) in people with Influenza, run by Wayne Sullender, M.D. at 1 site in India.
Trial summary
The study described here will immunize children with trivalent influenza vaccine (TIV) and determine whether this reduces influenza illness among the immunized children and their older family members. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Inactivated Trivalent Influenza Vaccine and Inactivated polio vaccine (IPV)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,598 participants
- Where
- 1 siteIndia
- Study dates
- Sep 2009to Jul 2012
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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 a vaccine (streptomycin, neomycin, and polymyxin B)
Trial locations and contacts
1 site in 1 country.
India1 site
Comprehensive Rural Health Services Project (CRHSP)
Ballabgarh, Haryana
About this study
The study described here will immunize children with trivalent influenza vaccine (TIV) and determine whether this reduces influenza illness among the immunized children and their older family members. The comparison or control group for the children receiving influenza vaccine will be children immunized with inactivated poliovirus vaccine (IPV). The study will also provide information on the amount of disease produced by influenza in the study population.
Read the detailed description
Influenza is an important cause of illness among children and adults in the United States. Influenza is likely also an important cause of illness in India, but published data on influenza infections in India are limited, especially for children. 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 due to the lack of information from India about disease burden due to influenza and because the influenza vaccines have never 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.
- Conditions
- Influenza
- Being tested
- Inactivated Trivalent Influenza Vaccine, Inactivated polio vaccine (IPV)
- Keywords
- Influenza, India, Children, Trivalent Influenza Vaccine (TIV), Inactivated poliovirus vaccine (IPV), Direct vaccine effectiveness, Indirect 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 VaccineBiological
Also called split virion trivalent influenza vaccine, Vaxigrip
Vaccine administration will occur twice, one month apart, in the first year of participation in the study. This will occur as TIV vaccine becomes available in India, in the early autumn. Subsequent years will provide one immunization. Due to the inclusion of the pandemic 2009 influenza A H1N1 virus in the 2010-2011 northern hemisphere vaccine formulation and recommendations that children should receive 2 doses of this vaccine this study will administer 2 doses of vaccine in the second year of the study.
Inactivated polio vaccine (IPV)Biological
Also called Imovax
Vaccine administration will occur twice, one month apart, in the first year of participation in the study to parallel administration of TIV (experimental intervention). Subsequent years will provide one immunization except 2011 schedule modified to accommodate changes in TIV schedule as per above..
| Study group | Role | What they receive |
|---|---|---|
| Inactivated Polio Vaccine (IPV) | Active comparator | Inactivated trivalent poliovirus vaccine (IPV) age Dose # doses/year 1 # doses year 2 and 3 6 mo -8y 0.5 ml 2 1 9-10 y 0.5 ml 1 1 Receives: Biological: Inactivated polio vaccine (IPV) |
| Inactivated Trivalent Influenza Vaccine | Experimental | Inactivated split virion trivalent influenza vaccine (TIV) age Dose # doses year 1 # doses year 2 and 3 6-35 mo 0.25 ml 2 1 3-8 y 0.5 ml 2 1 9-10 y 0.5 ml 1 1 Receives: Biological: Inactivated Trivalent Influenza Vaccine |
| 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 posted8 Jul 2009 (estimated)
- Study startSep 2009
- Primary completionJul 2012
- Study completionJul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,598 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wayne Sullender, M.D.
- Sponsor type
- University, hospital or other
- Collaborators
- All India Institute of Medical Sciences, Centers for Disease Control and Prevention
- Responsible party
- Sponsor-investigator, Wayne Sullender, M.D., University of Alabama at Birmingham
- Investigators
- Wayne Sullender, MD, Principal investigator, University of Alabama at BirminghamShobha Broor, MD, Principal investigator, All India Institute of Medical SciencesAnand Krishnan, MD, Principal investigator, All India Institute of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00934245
- Sponsor's protocol ID
- F090422004
- Other IDs
- U01/IP000117-02
- Status last verified
- Feb 2013
- First submitted
- 6 Jul 2009
- Last updated
- 22 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sullender W, Fowler K, Krishnan A, Gupta V, Moulton LH, Lafond K, Widdowson MA, Lal RB, Broor S. Design and initiation of a study to assess the direct and indirect effects of influenza vaccine given to children in rural India. Vaccine. 2012 Jul 27;30(35):5235-9. doi: 10.1016/j.vaccine.2012.06.002. Epub 2012 Jun 16.
PubMed 22709952Mir MA, Lal RB, Sullender W, Singh Y, Garten R, Krishnan A, Broor S. Genetic diversity of HA1 domain of hemagglutinin gene of pandemic influenza H1N1pdm09 viruses in New Delhi, India. J Med Virol. 2012 Mar;84(3):386-93. doi: 10.1002/jmv.23205.
PubMed 22246823Sullender WM, Fowler KB, Gupta V, Krishnan A, Ram Purakayastha D, Srungaram Vln R, Lafond KE, Saha S, Palomeque FS, Gargiullo P, Jain S, Lal R, Widdowson MA, Broor S. Efficacy of inactivated trivalent influenza vaccine in rural India: a 3-year cluster-randomised controlled trial. Lancet Glob Health. 2019 Jul;7(7):e940-e950. doi: 10.1016/S2214-109X(19)30079-8.
PubMed 31200893
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Direct and Indirect Protection by Influenza Vaccine Given to Children in India
- ClinicalTrials.gov ID
- NCT00934245
- Acronym / sponsor ID
- F090422004
- Conditions
- Influenza
- Keywords
- Influenza, India, Children, Trivalent Influenza Vaccine (TIV), Inactivated poliovirus vaccine (IPV), Direct vaccine effectiveness, Indirect vaccine effectiveness
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,598 participants (actual)
- Lead sponsor
- Wayne Sullender, M.D.University, hospital or other
- Collaborators
- All India Institute of Medical Sciences, Centers for Disease Control and Prevention
- Study start
- Sep 2009
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 8 Jul 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 study described here will immunize children with trivalent influenza vaccine (TIV) and determine whether this reduces influenza illness among the immunized children and their older family members. The comparison or control group for the children receiving influenza vaccine will be children immunized with inactivated poliovirus vaccine (IPV). The study will also provide information on the amount of disease produced by influenza in the study population.
Detailed description
Influenza is an important cause of illness among children and adults in the United States. Influenza is likely also an important cause of illness in India, but published data on influenza infections in India are limited, especially for children. 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 due to the lack of information from India about disease burden due to influenza and because the influenza vaccines have never 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.
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 Polio Vaccine (IPV) | Active comparator | Biological: Inactivated polio vaccine (IPV)Inactivated trivalent poliovirus vaccine (IPV) age Dose # doses/year 1 # doses year 2 and 3 6 mo -8y 0.5 ml 2 1 9-10 y 0.5 ml 1 1 |
| Inactivated Trivalent Influenza Vaccine | Experimental | Biological: Inactivated Trivalent Influenza VaccineInactivated split virion trivalent influenza vaccine (TIV) age Dose # doses year 1 # doses year 2 and 3 6-35 mo 0.25 ml 2 1 3-8 y 0.5 ml 2 1 9-10 y 0.5 ml 1 1 |
| 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
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
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 a vaccine (streptomycin, neomycin, and polymyxin B)
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 VaccineAlso: split virion trivalent influenza vaccine, VaxigripVaccine administration will occur twice, one month apart, in the first year of participation in the study. This will occur as TIV vaccine becomes available in India, in the early autumn. Subsequent years will provide one immunization. Due to the inclusion of the pandemic 2009 influenza A H1N1 virus in the 2010-2011 northern hemisphere vaccine formulation and recommendations that children should receive 2 doses of this vaccine this study will administer 2 doses of vaccine in the second year of the study. | Biological | Inactivated Trivalent Influenza Vaccine |
| Inactivated polio vaccine (IPV)Also: ImovaxVaccine administration will occur twice, one month apart, in the first year of participation in the study to parallel administration of TIV (experimental intervention). Subsequent years will provide one immunization except 2011 schedule modified to accommodate changes in TIV schedule as per above.. | Biological | Inactivated Polio Vaccine (IPV) |
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 22 Feb 2013.
- Background: PubMed 22709952Sullender W, Fowler K, Krishnan A, Gupta V, Moulton LH, Lafond K, Widdowson MA, Lal RB, Broor S. Design and initiation of a study to assess the direct and indirect effects of influenza vaccine given to children in rural India. Vaccine. 2012 Jul 27;30(35):5235-9. doi: 10.1016/j.vaccine.2012.06.002. Epub 2012 Jun 16.
- Background: PubMed 22246823Mir MA, Lal RB, Sullender W, Singh Y, Garten R, Krishnan A, Broor S. Genetic diversity of HA1 domain of hemagglutinin gene of pandemic influenza H1N1pdm09 viruses in New Delhi, India. J Med Virol. 2012 Mar;84(3):386-93. doi: 10.1002/jmv.23205.
- Derived from this study: PubMed 31200893Sullender WM, Fowler KB, Gupta V, Krishnan A, Ram Purakayastha D, Srungaram Vln R, Lafond KE, Saha S, Palomeque FS, Gargiullo P, Jain S, Lal R, Widdowson MA, Broor S. Efficacy of inactivated trivalent influenza vaccine in rural India: a 3-year cluster-randomised controlled trial. Lancet Glob Health. 2019 Jul;7(7):e940-e950. doi: 10.1016/S2214-109X(19)30079-8.
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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 Alabama at Birmingham
Shobha Broor, MD principal investigator
All India Institute of Medical Sciences
Anand Krishnan, 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 and Inactivated polio vaccine (IPV) in people with Influenza, run by Wayne Sullender, M.D. 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 22 Feb 2013. 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. 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?
On the ClinicalTrials.gov record for NCT00934245, which also lists 3 linked publications.
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 22 Feb 2013.