Vaccination coverage and factors associated with routine childhood vaccination uptake in rural Vellore, southern India, 2017.

BACKGROUND: Vellore district in southern India was selected for intensified immunization efforts through India's Mission Indradhanush campaign based on 74% coverage in the National Family Health Survey in 2015. As rural households rely almost entirely on the Universal Immunization Program (UIP), we assessed routine immunization coverage and factors associated with vaccination status of children in rural Vellore. METHODS: We conducted a cross-sectional household survey among parents or primary caretakers of children aged 12-23 months during August-September 2017 using two-stage, EPI cluster sampling. We verified vaccination histories from vaccination cards and collected data on sociodemographic and non-socio-demographic characteristics by using mobile data capture. Associations with vaccination status were examined with univariate and multivariate logistic regression models. RESULTS: A total of 643 children were included. Coverage of BCG, third dose pentavalent/DPT, measles/MR vaccines and full vaccination (BCG, three doses of polio and pentavalent/DPT and measles/MR vaccines) among children with vaccination cards (n = 606) was 94%, 96%, 93% and 84%, respectively. Of children with vaccination cards, 70.8% had received all recommended doses according to the UIP schedule. No socio-demographic differences were identified, but parents' familiarity with the schedule (Adjusted Prevalence Odds Ratio (aPOR): 2.06, 95%CI = 1.26-3.38) and receiving information on recommended vaccinations during antenatal visits (aPOR: 2.16, 95% CI = 1.13-4.12) were significantly associated with full vaccination status of the children. CONCLUSIONS: We found higher UIP antigen coverage and proportion of fully vaccinated children than previously reported from rural Vellore. However, adherence to the recommended schedule was still not optimal. Our study highlights the potential of improving parental awareness of vaccination schedule and targeting health education interventions at pregnant women during antenatal visits to sustain and improve routine immunization coverage

Vaccination coverage and the factors influencing routine childhood vaccination uptake among communities experiencing disadvantage in Vellore, southern India : a mixed-methods study

Background: In 2015, the Vellore district in southern India was selected for intensified routine immunization, targeting children from communities experiencing disadvantage such as migrant, tribal, and other hard-to-reach groups. This mixed-methods study was conducted to assess routine immunization coverage and the factors influencing childhood vaccination uptake among these communities in Vellore. Methods: We conducted a cross-sectional household survey (n = 100) and six focus group discussions (n = 43) among parents of children aged 12–23 months from the known communities experiencing disadvantage in Vellore during 2017 and 2018. Multivariate logistic regression was conducted to examine associations between the parental characteristics and children’s vaccination status in the household survey data; the qualitative discussions were analyzed by using the (previously published) “5As” taxonomy for the determinants of vaccine uptake. Results: In the household survey, the proportions of fully vaccinated children were 65% (95% CI: 53–76%) and 77% (95% CI: 58–88%) based on information from vaccination cards or parental recall and vaccination cards alone, respectively. Children whose mothers were wage earners [Adjusted prevalence odds ratio (aPOR): 0.21, 95% CI = 0.07–0.64], or salaried/small business owners [aPOR: 0.18, 95% CI = 0.04–0.73] were less likely to be fully vaccinated than children who had homemakers mothers. In the focus group discussions, parents identified difficulties in accessing routine immunization when travelling for work and showed knowledge gaps regarding the benefits and risks of vaccination, and fears surrounding certain vaccines due to negative news reports and common side-effects following childhood vaccination. Conclusions: Vaccination coverage among children from the surveyed communities in Vellore was suboptimal. Our findings suggest the need to target children from Narikuravar families and conduct periodic community-based health education campaigns to improve parental awareness about and trust in childhood vaccines among the communities experiencing disadvantage in Vellore.publishedVersionPeer reviewe

Immunogenicity and safety of an intramuscular split-virion quadrivalent inactivated influenza vaccine in individuals aged ≥ 6 months in India

A quadrivalent split-virion inactivated influenza vaccine (IIV4; Fluzone® Quadrivalent, Sanofi Pasteur) has been available in the US since 2013 for individuals aged ≥ 6 months. Here, we describe the results of an open-label, multicenter trial (WHO Universal Trial Number U1111-1143–8370) evaluating the immunogenicity and safety of IIV4 in Indian children aged 6–35 months and 3–8 years, adolescents aged 9–17 years, and adults aged ≥ 18 years (n = 100 per group). Post-vaccination hemagglutination inhibition titers for all strains in all age groups were ≥ 8 fold higher than at baseline (range, 8–51). At least 70% of participants in all age groups seroconverted or had a significant increase in titer for each strain. The most common solicited reactions were injection-site pain and tenderness, plus fever in participants 6–23 months and myalgia in older children and adolescents. All injection-site reactions and most systemic reactions were grade 1 or 2 and resolved within 3 days. Only three vaccine-related unsolicited adverse events were reported, all of which were grade 1 or 2 and transient. No immediate adverse events, adverse events leading to study discontinuation, adverse events of special interest, or serious adverse events were reported. This study showed that IIV4 was well tolerated and highly immunogenic in all age groups. This adds important data on the safety, tolerability, and immunogenicity of influenza vaccines in India

A phase III randomized, open-label, non-inferiority clinical trial comparing liquid and lyophilized formulations of oral live attenuated human rotavirus vaccine (HRV) in Indian infants

The human rotavirus vaccine (HRV; Rotarix, GSK) is available as liquid (Liq) and lyophilized (Lyo) formulations, but only Lyo HRV is licensed in India. In this phase III, randomized, open-label trial (NCT02141204), healthy Indian infants aged 6–10 weeks received 2 doses (1 month apart) of either Liq HRV or Lyo HRV. Non-inferiority of Liq HRV compared to Lyo HRV was assessed in terms of geometric mean concentrations (GMCs) of anti-RV immunoglobulin A (IgA), 1-month post-second dose (primary objective). Reactogenicity/safety were also evaluated. Seroconversion was defined as anti-RV IgA antibody concentration ≥20 units [U]/mL in initially seronegative infants (anti-RV IgA antibody concentration <20 U/mL) or ≥2-fold increase compared with pre-vaccination concentration in initially seropositive infants. Of the 451 enrolled infants, 381 (189 in Liq HRV and 192 in Lyo HRV group) were included in the per-protocol set. The GMC ratio (Liq HRV/Lyo HRV) was 0.93 (95% confidence interval [CI]: 0.65–1.34), with the lower limit of the 95% CI reaching ≥0.5, the pre-specified statistical margin for non-inferiority. In the Liq HRV and Lyo HRV groups, 42.9% and 44.3% (baseline) and 71.4% and 73.4% (1-month post-second dose) of infants had anti-RV IgA antibody concentration ≥20 U/mL, and overall seroconversion rates were 54.5% and 50.0%. Incidences of solicited and unsolicited adverse events were similar between groups and no vaccine-related serious adverse events were reported. Liq HRV was non-inferior to Lyo HRV in terms of antibody GMCs and showed similar reactogenicity/safety profiles, supporting the use of Liq HRV in Indian infants