India f-IPV Study 2025: Comparing Immune Response to Different Dose Schedules of Inactivated Polio Vaccine in Routine Immunization.

Comparative evaluation of immunogenicity of variable dose schedules of Inactivated Poliovirus Vaccine in routine immunization: A multi-centric open label randomized controlled trial (India f-IPV study-2025) - NA

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/07/091180

Enrollment

500

Registered

2025-07-18

Start date

Unknown

Completion date

Unknown

Last updated

2025-07-21

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

Conditions

None listed

Interventions

Intervention1: Inactivated poliovirus vaccine: Enrolled infants will be randomized (1:1) into one of the two study arms (A & B). Arm A: 250 subjects will receive Fractional dose intradermal IPV (dose

Eligibility

Inclusion criteria

Inclusion criteria: 1.All infants visiting study site immunization clinic for first MR vaccine at 9 to 12 months of age. 2. Infants with documentary evidence having taken 4 bOPV doses and two f-IPV doses per the routine schedule. 3. Judged to be healthy by the investigator for study participation. 4. Parents judged to be able to attend all scheduled study visits and comply with the study procedures. 5. Parent or Legally Acceptable Representative (LAR) provides written informed consent for the baby s inclusion in the study.

Exclusion criteria

Exclusion criteria: 1. Not fulfilling any of the inclusion criteria 2. Taken any polio vaccine/s other than the national EPI schedule or Polio Immunization Campaigns. 3. Any diagnosed/suspected medical condition which requires active management or hospitalization as judged by the investigator. 4. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family). 5. Thrombocytopenia or a bleeding disorder.

Design outcomes

Primary

Measure	Time frame
1. Compare the gains in seroconversion and antibody titres against poliovirus serotype 2 after third fractional or full IPV dose given at 9-12 months age at MR vaccination visit in the routine immunization schedule.Timepoint: The primary endpoint is the seroconversion against serotype 2 poliovirus, 1 month (30 days) after IPV vaccination in the study.	—

Secondary

Measure	Time frame
1. Assess persistence of serotype 2 antibodies at enrollment after two primary fIPV doses. 2. Assessment of priming response following two primary fIPV doses. 3. To evaluate adverse events following vaccination.Timepoint: 1. Persistence of serotype 2 antibodies after two primary doses of fIPV from the baseline sample taken at enrollment. 2. Priming effect of the additional f-IPV dose 7 days (1 week) after IPV vaccination, given at 9-12 months of age. 3. The secondary endpoint is the seroconversion against polioviruses serotypes 1 & 3, 1 month (30 days) after IPV vaccination in the study. 4. Number of adverse events (AEs) causally associated to the study vaccine.	—

Measure

Time frame

1. Assess persistence of serotype 2 antibodies at enrollment after two primary fIPV doses. 2. Assessment of priming response following two primary fIPV doses. 3. To evaluate adverse events following vaccination.Timepoint: 1. Persistence of serotype 2 antibodies after two primary doses of fIPV from the baseline sample taken at enrollment. 2. Priming effect of the additional f-IPV dose 7 days (1 week) after IPV vaccination, given at 9-12 months of age. 3. The secondary endpoint is the seroconversion against polioviruses serotypes 1 & 3, 1 month (30 days) after IPV vaccination in the study. 4. Number of adverse events (AEs) causally associated to the study vaccine.

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Countries

India

Contacts

Public ContactDr Mohammad Ahmad

WHO Country Office, India, New Delhi

ahmadmoh@who.int8800495773

Outcome results