Comparative evaluation of immunogenicity of various schedules and delivery options to provide fractional Dose Inactivated Poliovirus Vaccine in routine immunization

Comparative evaluation of immunogenicity of various schedules and delivery options to provide fractional Dose Inactivated Poliovirus Vaccine in routine immunization in the post tOPV-bOPV period: A multi-centric open label randomized controlled trialâ?? (India fractional dose IPV study) - WHO fIPV study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2017/02/007793

Enrollment

800

Registered

2017-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

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 (IPV): Full dose IPV 0.5 ml will be given as deep intramuscular (IM) in the anterolateral side of the right thigh. Fractional dose intradermal IPV 0.1 ml

Eligibility

Inclusion criteria

Inclusion criteria: 1. All infants visiting study site immunization clinic for OPV1/Penta1 immunization 2. The infant should be 6-7 completed weeks of age at OPV1/Penta1 contact 3. Infants with documentary evidence having taken birth dose of bOPV 4. Weight at enrolment visit of >= 3.2 Kgs 5. Judged to be healthy by the investigator for study participation 6. Parents judged to be able to attend all scheduled study visits and comply with the study procedures 7. Parent or Legally Acceptable Representative (LAR) provides written informed consent for the babyâ??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 birth dose of bOPV 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. The primary endpoint is the seroconversion against type 2 poliovirus, four weeks after completion of doses given in the routine immunization schedule in all the study arms.Timepoint: 6, 10 and 14 week	—

Secondary

Measure	Time frame
4. Number of adverse events (AEs) occurred during the studyTimepoint: through out the study	—

Countries

India

Contacts

Public ContactDr Lalitendu Mohanty

Indian Council of Medical Research (ICMR

deshpandejm@gmail.com7506176377

Outcome results