A real life study to determine the safety of the Fluquadri vaccine (Influenza vaacine) during routine clinical practice in children who are 6 months to 35 months of age in India

Non-Interventional post marketing enhanced passive safety surveillance of the Quadrivalent influenza vaccine (split-virion, inactivated) (FluQuadri) during routine clinical practice in participants who are 6 months to 35 months of age in India.

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2024/06/068442

Enrollment

2000

Registered

2024-06-06

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

Health Condition 1: B998- Other infectious disease

Interventions

Intervention1: Quadrivalent influenza vaccine (split-virion, inactivated): Non-interventional on the therapeutic strategy as the decision to vaccinate is part of routine care and entirely at the discr

Eligibility

Inclusion criteria

Inclusion criteria: -Participants aged 6 to 35 months, who have received either 1 or 2 doses (depending on previous influenza vaccination status) of the 0.5ml Quadrivalent Inactivated Influenza Vaccine (split virion) in routine clinical care. - Written informed consent will be taken prior to recruitment of participant.

Exclusion criteria

Exclusion criteria: None

Design outcomes

Primary

Measure	Time frame
To determine the occurrence of any adverse drug reactions (ADRs) within 4 weeks following vaccination (One to two doses of vaccine depending on previous influenza vaccination status) with Quadrivalent Inactivated Influenza Vaccine (split virion) I.P. for 0.5ml dose in the age group of 6 to 35 months.Timepoint: Data will be collected up to 4 weeks after 1st dose in previously vaccinated participants and 4 weeks after 1st and 2nd dose in previously unvaccinated participants, as appropriate	—

Measure

Time frame

To determine the occurrence of any adverse drug reactions (ADRs) within 4 weeks following vaccination (One to two doses of vaccine depending on previous influenza vaccination status) with Quadrivalent Inactivated Influenza Vaccine (split virion) I.P. for 0.5ml dose in the age group of 6 to 35 months.Timepoint: Data will be collected up to 4 weeks after 1st dose in previously vaccinated participants and 4 weeks after 1st and 2nd dose in previously unvaccinated participants, as appropriate

—

Secondary

Measure	Time frame
NATimepoint: NA	—

Countries

India

Contacts

Public ContactVijay Mandal

Sanofi Healthcare India Pvt. Ltd.

Deepa.NAIKCHODANKAR@sanofi.com9096867313

Outcome results

None listed

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