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Effect of vaccination against common respiratory infections on hospital admission and death in elderly aged more than 60 yrs

Evaluation of the effect of influenza and pneumococcal vaccination on mortality and hospitalizations in the elderly-a randomized controlled trial - NONE

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/06/088350
Enrollment
6568
Registered
2025-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Intervention1: Pneumococcal conjugate vaccine and seasonal influenzae vaccine for 2 years: At enrolment: PCV-20 0.5 mL IM with seasonal influenza vaccine 0.5 mL IM One year post enrolment: 0.5 mL IM

Sponsors

Indian Council of Medical Research
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Individuals aged 60 years and above, Reside in an area where follow-up is feasible.

Exclusion criteria

Exclusion criteria: Have planned to move out of study sites during the follow-up of 2 years, Individuals who have already taken any of the study vaccines (in the last 5 years for tetanus vaccine), Intend to take the study vaccines independent of the study, Individuals with history of adverse reaction to vaccines.

Design outcomes

Primary

MeasureTime frame
The primary outcome will be a composite outcome consisting of events of (i) the first episode of hospitalization or (ii) deaths, due to any causeTimepoint: The primary outcome will be a composite outcome consisting of events of (i) the first episode of hospitalization or (ii) deaths, due to any cause—

Secondary

MeasureTime frame
Days of antibiotic use as a proportion of total follow up days in each arm of the studyTimepoint: 36 months;Number of episodes of illness where antibiotics were used in each arm of the studyTimepoint: 36 months;Respiratory mortality and hospitalization as a composite outcome consisting of events of deaths and the first episode of hospitalization due to any respiratory causeTimepoint: 36 months;Clinical or lab-confirmed influenza like disease episodesTimepoint: 36 months;Pneumonia and invasive pneumococcal disease episodesTimepoint: 36 months;Proportions who are nucleic acid test positive for Pneumococcal carriage (Vaccine Type (VT)) in each group at each time pointTimepoint: Baseline 6 months 12 months;Incremental cost effectiveness ratioTimepoint: 36 months—

Countries

India

Contacts

Public ContactDr Kamini Walia

Indian Council of Medical Research

waliakamini@gmail.com9899897978

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026