Covid-19 vaccine interchangeability study

Safety, immunogenicity and efficacy after interchangeability of Covid-19 vaccines [Covishield, Covaxin and Sputnik V] among adults in North India: A Randomized Control Trial

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/06/043447

Enrollment

1542

Registered

2022-06-23

Start date

Unknown

Completion date

Unknown

Last updated

2022-06-27

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

Conditions

None listed

Interventions

Intervention1: Trial Cohorts/heterologous arms 1. Cohort 1: Covishield and Covaxin 2. Cohort 2: Covishield and Sputnik V 3. Cohort 3: Covaxin and Sputnik V : Trial Cohorts/heterologous arms 1. Cohort

Eligibility

Inclusion criteria

Inclusion criteria: healthy

Exclusion criteria

Exclusion criteria: children less than 18 years

Design outcomes

Secondary

Measure	Time frame
Neutralizing antibody and celle mediated immune response after interchangeability of covid-19 vaccinesTimepoint: at baseline, 28 days of first and second dose, 6 months and 1 year.	—

Primary

Measure	Time frame
1. Antibody titers against Spike protein after interchangeability of the study vaccines at baseline, 28 days of first and second dose, 6 months and 1 year. 2. Incidence of mild, moderate and serious adverse events rate of the Covid-19 vaccines after interchangeability 3. Breakthrough infection rate of the Covid-19 vaccines (Covishield/Covaxin/Sputnik V) after interchangeability.Timepoint: At at baseline, 28 days of first and second dose, 6 months and 1 year.	—

Measure

Time frame

1. Antibody titers against Spike protein after interchangeability of the study vaccines at baseline, 28 days of first and second dose, 6 months and 1 year. 2. Incidence of mild, moderate and serious adverse events rate of the Covid-19 vaccines after interchangeability 3. Breakthrough infection rate of the Covid-19 vaccines (Covishield/Covaxin/Sputnik V) after interchangeability.Timepoint: At at baseline, 28 days of first and second dose, 6 months and 1 year.

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Countries

India

Contacts

Public ContactDr Madhu Gupta

Post Graduate Institute of Medical Education and Research

madhugupta21@gmail.com7009769629

Outcome results