Design and initiation of a study to assess the direct and indirect effects of influenza vaccine given to children in rural India

University of Alabama Birmingham, Birmingham, AL, USA.
Vaccine (Impact Factor: 3.62). 06/2012; 30(35):5235-9. DOI: 10.1016/j.vaccine.2012.06.002
Source: PubMed


The burden of disease due to influenza is not well characterized for children in developing countries and the effectiveness of available influenza vaccines in lower resource settings has not been established. We initiated a prospective, longitudinal, phase IV, household-randomized, controlled, observer-blinded three year study (2009-2011) in a rural community of India to measure the total and indirect household protective effects of immunizing children ages 6 months through 10 years with seasonal inactivated trivalent influenza vaccine (TIV) or a control vaccine (n=3697). Active weekly surveillance was conducted year round with home visits for identification of febrile acute respiratory illness (FARI) conducted for all vaccine recipients and household members (n=18,220). Nasal and throat swabs were collected from each FARI episode for influenza detection by real-time reverse transcription polymerase chain reaction. The primary outcome was reduction in laboratory confirmed influenza infections in the influenza vaccine versus control vaccine group, with secondary outcome assessing indirect effects among the entire study population. This report describes the study site, cluster study design, choice of study and control vaccines, and the initial enrollment in the study.

Download full-text


Available from: Vivek Gupta
  • [Show abstract] [Hide abstract]
    ABSTRACT: Healthy children are high transmitters of influenza and can experience poor influenza outcomes. Many questions remain about the efficacy and impect of preventive measures because most existing studies report imprecise proxies of influenza incidence, do not follow subjects throughout the entire influenza season and across multiple influenza seasons, or do not control for important factors such as timing of implementation and social contact patterns. Modeling and simulation are key methodologies to answer questions regarding influenza prevention. While vaccination may be the most efficacious existing intervention, variations in circulating strains and children's immune systems keep current vaccines from being fully protective, necessitating further clinical and economic studies and technology improvements. Hand hygiene appears to be an important adjunct but improving compliance, standardizing regimens and quantifying its impact remain challenging. Future studies should help better define the specific indications and circumstances for antiviral use and the role of nutritional supplements and nonpharmaceutical interventions.
    No preview · Article · Oct 2012 · Expert Review of Anti-infective Therapy
  • Source
    [Show abstract] [Hide abstract]
    ABSTRACT: The Ballabgarh Health and Demographic Surveillance System (HDSS), also known as the Comprehensive Rural Health Services Project (CRHSP) Ballabgarh, is located in north Indiaand was established in 1961 to develop a model for rural health-care practice in India. In addition to demographic surveillance and communitybased research, CRHSP Ballabgarh provides preventive, health-promotion, and curative services to its surrounding population. The population served by CRHSP Ballabgarh in 2011 was about 90 000. The system collects data for the entire population through fortnightly visits by health workers (HWs). The system's data base is updated once every month and further updated with missing data and special morbidity surveillance data during the annual census. Since 1961, CRHSP Ballabgarh has collected demographic data, reproductive data, and health data about mothers and their children. More recently, the project began collecting data on diseases such as tuberculosis, and because of changes in life style it recently began collecting data about non-communicable diseases (NCD) and risk factors for NCDs. Nonetheless, an adverse sex ratio, with more boys than girls, and a stagnant neonatal mortality rate, remain major challenges in the population served by CRHSP Ballabgarh. The project shares data with different agencies for health-management purposes, which can be made available to bona fide researchers on receipt of a proposal (enquiries should be directed to: [email protected] /* */); collaboration requests are welcome
    Full-text · Article · Apr 2013 · International Journal of Epidemiology
  • [Show abstract] [Hide abstract]
    ABSTRACT: Data on influenza illness rates with population denominators are needed to quantify overall morbidity and to prioritize public health intervention strategies. The rates of influenza A(H1N1)pdm09 infection during pandemic phases were determined in a longitudinal community cohort study as part of an influenza vaccine study in a rural community of North India. During the 711 731 person-weeks of surveillance, a total of 1410/7571 (19%) febrile acute respiratory illness cases were positive for influenza. Of these, 749 (53%) were influenza A(H1N1)pdm09, 643 (46%) influenza B, and 18 (1%) influenza A (H3N2). The overall incidence rate of influenza-associated febrile acute respiratory illness was 128/1000 person-years. The incidence rates of influenza A(H1N1)pdm09 were high during both the pandemic phase (179/1000 person-years; November 2009 to January 2010) and post-pandemic phase (156/1000 person-years; August to October 2010), with children <18 years of age being at the greatest risk of influenza infection in the community. These findings provide important information for planning clinical and public health intervention strategies to mitigate the impact of influenza epidemics.
    No preview · Article · Sep 2013 · International journal of infectious diseases: IJID: official publication of the International Society for Infectious Diseases
Show more