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Organization (Industry)

Serum Institute of India (India)

ClinicalTrials.gov lists Serum Institute of India (India) as lead sponsor of 25 trials. It has 27 active development programs and 2 approved assets.

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5 0 2012 2026

Trials started per year with this organization as sponsor or collaborator, 1990 onward. The series also counts trials where the organization is a collaborator; the lead-sponsor trial count does not.

2026 is partial: 3 registered with a 2026 start date. The dashed outline is the pace from the 2 registered with a start date through September, planned starts included, not adjusted; not a forecast. No forecast is made for this organization: it averages 2.4 trial starts a year over the five years to September, under the 5 a year the method needs.

This page covers Serum Institute of India (India): 25 lead-sponsored trials and 1 legal-entity registration.

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Disease areas (22)

Shown in this order: most trials first.

Disease areas
Disease area Trials
Diarrhea 3
Malaria 2
Malaria, Falciparum 2
Meningitis 2
Meningitis, Bacterial 2

Trials by start year as sponsor or collaborator (13)

Shown in this order: most recent first. 2026 is partial: trials registered with a 2026 start date so far, not a full year.

Show the table of trials by start year as sponsor or collaborator
Trials by start year as sponsor or collaborator
Year Trials started
2026 (partial year) 3
2025 5
2024 2
2023 1
2022 2
2020 2
2019 5
2018 2
2017 3
2016 1

Recruitment duration, a model prediction: 3 trials still running at the 2026-10-09 snapshot, fewer than the 5 needed for a median. Source: ClinicalTrials.gov / AACT (CTTI), public domain.

Active development programs (27)

Shown in this order: max phase, then active trials.

Active development programs
Drug Disease area Max phase Trials
Gardasil as three dose regimen Papillomavirus Infections Phase 3 1
Cervavac as three dose regimen Papillomavirus Infections Phase 3 1
Cervavac as two dose regimen Papillomavirus Infections Phase 3 1
VPM1002 Tuberculosis Phase 3 2
Menactra Meningitis Phase 3 2

Approved assets (2)

Shown in this order: max phase first.

Approved assets
Drug Trials
MMR (Measles, Mumps, and Rubella) Vaccine 1
DTP-HB-Hib vaccine 1

Sponsor delivery record (1)

Enrollment hit target: the share of this sponsor's lead-sponsored trials whose actual enrollment reached the planned enrollment. On time: the share whose actual primary completion date was no later than the planned date. Each share counts only trials where we observed an estimated figure before the actual one, and n is that number of trials. Below 5 trials the count is shown as a fraction, not a percentage.

Sponsor delivery record
Enrollment Timeline
92% hit target (n=12) 8% on time (n=12)

Journals published in (9)

Shown in this order: most published in first.

Journals published in
Journal Publications
Vaccine 10
The Lancet. Infectious diseases 6
The New England journal of medicine 5
PLoS medicine 3
BMC nutrition 1

FDA import refusals (1)

FDA import refusals
Refused import lines Latest refusal
1 2007-04-05

Manufacturing and distribution sites (15)

Shown in this order: severity rank then name.

Manufacturing and distribution sites
Facility Location Regulators Member organization
Serum Institute of India Pvt. Ltd. Hadapsar, Pune, IN Health Canada
Serum Institute of India Pvt. Ltd. Hadapsar, Pune, IN Health Canada
Serum Institute of India Pvt. Ltd. Manjari Budruk, Pune, IN Health Canada
Serum Institute of India Pvt. Ltd. Manjari Budruk, Pune, IN Health Canada
Serum Institute of India Pvt. Ltd. Hadapsar, Pune, IN Health Canada

Organization relationships (16)

Shown in this order: most evidence first.

Organization relationships
Related organization Relationship Evidence
Path Co sponsors trial with 3
Serum Life Science Europe GmbH Co sponsors trial with 2
Triclinium Clinical Trial Project Management (Pty) Ltd. Co sponsors trial with 1
VisMederi srl, Sienna, Italy Co sponsors trial with 1
Pharmassist Ltd Co sponsors trial with 1

Latest dated events (34)

Shown in this order: newest first.

Latest dated events
Date Event Source
2026-10 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2026-09-11 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2026-05-05 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2025-10-03 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))
2025-09-29 Trial started Clinical trials (ClinicalTrials.gov) (ClinicalTrials.gov, U.S. National Library of Medicine; AACT database, Clinical Trials Transformation Initiative (CTTI))

Biomarker capability evidence (14)

Shown in this order: tier desc, then gene symbol.

Biomarker capability evidence
Gene Role Evidence
CD4 Trial sponsor Named in trial inclusion criteria
CD4 Trial sponsor Named in trial inclusion criteria
IVNS1ABP Trial sponsor Named in trial inclusion criteria
IVNS1ABP Trial sponsor Named in trial inclusion criteria
CD4 Trial sponsor Exploratory endpoint in a trial

Biomarkers this organization publishes on (5)

Shown in this order: most publications first.

Biomarkers this organization publishes on
Biomarker Publications
NANP 3
CD79A 1
DNAJC5 1
GOLGB1 1
PRNP 1

Not on this page

Checked, with nothing recorded for this organization: companies grouped under this page, related companies not grouped here, us granted patents, sec-reported annual financials, financing and grant events, fda warning letters, fda untitled letters, fda inspection record, fda recalls, climate targets, as filed, workforce and board diversity, as filed, and clia clinical laboratory certificates.