Immune response of fractional doses of Inactivated Poliovirus Vaccine (IPV) administered intradermally in the Sultanate of Oman

• Register: ISRCTN
• Last refreshed on: 26 January 2010
• Main ID: ISRCTN17418767
• Date of registration: 15/08/2007
• Primary sponsor: World Health Organization (WHO) (Switzerland)
• Public title: Immune response of fractional doses of Inactivated Poliovirus Vaccine (IPV) administered intradermally in the Sultanate of Oman N/A
• Date of first enrolment: Feb 15 2007
• Target sample size: 400
• Recruitment status: Completed/Not recruiting
• URL: http://isrctn.org/ISRCTN17418767
• Study type: Interventional
• Study design: Randomised controlled clinical trial

Countries of recruitment

Oman

Contacts

• Name: Pradeep Malankar

Key inclusion & exclusion criteria

Inclusion criteria: 1. Healthy Omani newborns (greater than 2.5 kg, apgar score greater than 9 at five minutes) 2. Living within the catchment area of the participating study site 3. Newborns delivered by caesarean section
Exclusion criteria: 1. Newborns requiring hospitalisation (except if in hospital because of maternal admission) 2. Birth weight below 2.5 kg 3. Apgar score less than 9 at five minutes 4. Non-Omani 5. Residence outside the catchment area, or families expecting to move away during the study period 6. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will also render the newborn ineligible for the study

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Poliomyelitis vaccination

Intervention(s)

Patients will be randomised between: 1. A fractional dose of IPV (0.1 ml or 1/5 of a dose) administered intradermally by needle-free device - potency of IPV is 40-8-32-D antigen units 2. A full dose of IPV (0.5 ml) administered intramuscularly by needle and syringe - potency of IPV is 40-8-32-D antigen units Principal Investigator: Dr Ali Jaffer Mohammed P.O. Box 393 Muscat 113 Oman Tel: [phone] Fax: [phone] Email: [e-mail]

Primary Outcome(s)

Seroconversion after three doses of IPV (fractional or full doses).

Secondary Outcome(s)

Seroconversion after each dose of vaccine.

Secondary ID(s)

RPC189

Source(s) of Monetary Support

World Health Organization (WHO)/Polio Eradication Initiative (POL) (Switzerland)

Secondary Sponsor(s)

N/A