A clinical study to assess the safety and overall immune response of Serum Institute of India s 21-valent Pneumococcal Conjugate Vaccine when administered as single dose in healthy Indian Adult participants

A Phase 1, Prospective, Randomized, Two-Arm, Active-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability and Immunogenicity of Serum Institute of India s 21-valent Pneumococcal Conjugate Vaccine (SIIPCV21) in Healthy Indian Adults. - NA

Status

Recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/09/094840

Enrollment

Registered

2025-09-16

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-17

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 Polysaccharide Conjugate Vaccine (Adsorbed) (21-Valent) SIIPCV21: 0.5 mL IM, non-dominant upper arm, single administration Control Intervention1: Pneumococcal 20-valent (

Eligibility

Inclusion criteria

Inclusion criteria: 1. Pneumococcal vaccine naive adult who is 18 49 years of age (both inclusive). 2. Healthy as judged by medical history, physical and other examination or investigations and in the clinical opinion of the Investigator may affect the safety of the participant or the trial endpoints. 3. Participant should be capable and willing to give voluntary written informed consent prior to inclusion in the trial. 4. Able to comprehend and comply with trial requirements and procedures and be able and willing to complete participant diary. 5. Male participants who are sexually active or married and female participants who are sexually active or married and are of childbearing potential should be willing to follow effective birth control methods for duration of the trial.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
Safety and Tolerability following IM injection of SIILPCV21 vaccine versus Active Comparator for occurrence, severity, and relationship to vaccination of solicited, unsolicited Adverse Events, SAEs.Timepoint: Solicited adverse events (local and systemic) during the 7 day follow-up period post vaccination. Unsolicited adverse events up to 28-Day follow-up period post vaccination. SAEs during the entire trial period.	—

Measure

Time frame

Safety and Tolerability following IM injection of SIILPCV21 vaccine versus Active Comparator for occurrence, severity, and relationship to vaccination of solicited, unsolicited Adverse Events, SAEs.Timepoint: Solicited adverse events (local and systemic) during the 7 day follow-up period post vaccination. Unsolicited adverse events up to 28-Day follow-up period post vaccination. SAEs during the entire trial period.

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Secondary

Measure	Time frame
Functional antibodies will be measured by OPA & IgG conc. by ELISA will be evaluated for all serotypes contained in SIIPCV21.Timepoint: Immunogenicity: Serotype-specific OPA GMTs measured 28 days post vaccination Percentage of participants with serotype-specific serum OPA titers greater than or equal to 1:8 measured 28 days post vaccination Serotype-specific IgG GMCs measured 28 days post vaccination	—

Measure

Time frame

Functional antibodies will be measured by OPA & IgG conc. by ELISA will be evaluated for all serotypes contained in SIIPCV21.Timepoint: Immunogenicity: Serotype-specific OPA GMTs measured 28 days post vaccination Percentage of participants with serotype-specific serum OPA titers greater than or equal to 1:8 measured 28 days post vaccination Serotype-specific IgG GMCs measured 28 days post vaccination

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Countries

India

Contacts

Public ContactDr Vistasp J Sethna

Serum Institute of India Pvt Ltd

vistasp.sethna@seruminstitute.com02026602506

Outcome results