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Study of effect of adding IPV and fIPV to routine immunization program on sero-immunity and antibody titer.

Study of effect of adding IPV and fIPV to routine immunization program on sero-immunity and antibody titer.

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT2017082327144N2
Enrollment
660
Registered
2017-10-13
Start date
2017-09-20
Completion date
Unknown
Last updated
2018-02-22

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

Conditions

Immunogenicity of fIPV against the usual IM injection of IPV. Need for immunization against poliomyelitis

Interventions

Intervention 1: First Intervention group:Inoculation of 0.1 ml of fIPV subcutaneously at 2nd and 4th months of life, in addition to the routine immunization schedule. Intervention 2: Control Group: On
Treatment - Drugs
First Intervention group:Inoculation of 0.1 ml of fIPV subcutaneously at 2nd and 4th months of life, in addition to the routine immunization schedule.
Control Group: Only routine immunization schedule.
Second Intervention group: Inoculation of 0.5 ml of intramuscular IPV at 4th month of life, in addition to routine immunization schedule.

Sponsors

Vaccin Preventable Diseases Department; Ministry of Heath; I.R. Iran
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Months to 2 Months

Inclusion criteria

Inclusion criteria: Inclusion criteria: Consent of parents for taking part of their infants; Completeness of all vaccines that an infant have had to receive within the first two months of life; Absence of any contraindication for receiving all the vaccines which are in common use in the national immunization system of I. R . Iran.; Residence up to the end of age 8 months of the participants in the study region; nationality should be Iran.

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Appearence of anti-Polio antibodies against Poliovirus types 1 and 3. Timepoint: end of 7th month of age. Method of measurement: Measurement of antibody levels using ELISA methods.

Secondary

MeasureTime frame
The most common vaccination complications. Timepoint: Up to the 7th months of age. Method of measurement: Monitoring of signs and sypmtoms.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactShahrokh Izadi

Zahedan University of Medical Sciences

izadish@yahoo.com+98 54 3329 5838

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026