drugset / Trial / NCT00934245
Direct and Indirect Protection by Influenza Vaccine Given to Children in India
Phase 4
Completed
4598 enrolled
Wayne Sullender, M.D.
All India Institute of Medical Sciences · collabCenters for Disease Control and Prevention · collab
RandomizedParallel-groupQuadruple-blindPrevention
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. 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.
Timeline
- Start
- 2009-09
- Primary completion
- 2012-07
- Completion
- 2012-07
Outcome
Met primary endpoint
paper total IIV3 vaccine efficacy 25·6% [95% CI 6·8-40·6]; p=0·010 PMID 31200893 ↗
paper vaccine efficacy 41·0% [24·1-54·1]; p<0·0001 PMID 31200893 ↗
paper vaccine efficacy 74·2% [57·8-84·3]; p<0·0001 PMID 31200893 ↗
Publications
- Background 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.
- Background Mir 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.
- Sullender 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Inactivated Polio Vaccine | Vaccine | 0.5 ml | — |
| Subject | Inactivated Trivalent Influenza Vaccine | Vaccine | 0.25 ml | Intramuscular |
| Subject | Inactivated Trivalent Influenza Vaccine | Vaccine | 0.5 ml | Intramuscular |