Study to check the effect of Covovax vaccine when administered as booster dose in adults in India who have already received two doses of COVID-19 vaccines

A phase 3, observer-blind, randomized, controlled study to evaluate the safety and immunogenicity of a booster dose of COVOVAX in Indian adults who have received primary vaccination against COVID-19 - COVOVAX-Booster

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/042017

Enrollment

372

Registered

2022-04-21

Start date

Unknown

Completion date

Unknown

Last updated

2024-01-22

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

Conditions

None listed

Interventions

Intervention1: COVOVAX [SARS-CoV-2 recombinant spike protein nanoparticle vaccine (SARS-CoV-2 rS) with Matrix-M1™ adjuvant]: Single dose of 0.5 mL contains 5 µg antigen and 50 µg Matrix-M1 adjuvant.

Eligibility

Inclusion criteria

Inclusion criteria: 1. Adults aged more than or equal to 18 years of either sex 2. Written informed consent by participants 3. Those who have completed primary COVID-19 vaccination schedule with at least 6 months ago 4. Female participants of childbearing potential must have a negative urine pregnancy test within 24 hours prior to study vaccine administration

Exclusion criteria

Exclusion criteria: 1. Acute illness at the time of screening 2. History of laboratory confirmed COVID-19 3. History of allergic reactions after previous vaccinations including primary vaccination for COVID-19 4. Have any bleeding disorder which is considered as a contraindication to intramuscular injection or blood draw 5. Suspected or known current alcohol or drug dependence 6. Chronic administration of immunosuppressant or other immune-modifying drugs within three months prior to the study vaccination or planned use throughout the study period 7. Administration of blood, blood products and/or plasma derivatives or any parenteral immunoglobulin preparation in the past 3 months or planned use throughout the study period 8. Administration of any vaccine within 28 days prior to enrolment in the study or planned administration of any vaccine for until 28 days after study vaccination 9. Prior receipt of a booster dose of COVID-19 vaccine 10. Pregnant or breast-feeding 11. Acute or chronic, clinically significant systemic disorders 12. Any other condition that in the opinion of the investigator would jeopardize the safety or rights of the participant in the study or make it unlikely that the participant could complete the protocol

Design outcomes

Primary

Measure	Time frame
Anti-S IgG and Neutralizing antibodiesTimepoint: 28 days after vaccination	—

Secondary

Measure	Time frame
Anti-S IgG and Neutralizing antibodiesTimepoint: at Day 91 and Day 181;Occurrence of SAEs, and adverse events of special interest (AESI) throughout the study duration following vaccinationTimepoint: 180 Days Post Vaccination;Occurrence of solicited local and systemic adverse events (AEs) for 7 days post-vaccinationTimepoint: 7 days post-vaccination;Occurrence of unsolicited AEs for 28 days post-vaccinationTimepoint: 28 days post-vaccination	—

Measure

Time frame

Anti-S IgG and Neutralizing antibodiesTimepoint: at Day 91 and Day 181;Occurrence of SAEs, and adverse events of special interest (AESI) throughout the study duration following vaccinationTimepoint: 180 Days Post Vaccination;Occurrence of solicited local and systemic adverse events (AEs) for 7 days post-vaccinationTimepoint: 7 days post-vaccination;Occurrence of unsolicited AEs for 28 days post-vaccinationTimepoint: 28 days post-vaccination

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Countries

India

Contacts

Public ContactDr Prasad Kulkarni

Serum Institute of India Private Limited

drpsk@seruminstitute.com00912071946820

Outcome results