Condition category
Infections and Infestations
Date applied
14/08/2007
Date assigned
15/08/2007
Last edited
25/06/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Pradeep Malankar

ORCID ID

Contact details

Technical Officer
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 1863
malankarp@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC189

Study information

Scientific title

Acronym

Study hypothesis

1. Does a schedule of three fractional 0.1 ml IPV doses administered intradermally (intervention) provide comparable seroconversion and titre with a three-dose schedule of full 0.5 ml IPV doses (control) administered intramuscularly at 2, 4, and 6 months?
2. What is the contribution to seroconversion and titre in each group after the first, second and third dose of study vaccines?
3. What is the influence of maternally-derived antibodies on seroconversion and titre?
4. Does each study arm have comparable adverse events - systemic and local (the intervention group receives fractional doses by needle-free device, while the control group receives full doses by intramuscular injection by needle and syringe)?
5. Is resistance to excretion of poliovirus type 1 (an indication of mucosal immunity) following a challenge dose with monovalent type 1 Oral Poliovirus Vaccine (mOPV1) similar among the two study groups?

Ethics approval

Ethics approval received from:
1. World Health Organization (WHO) Research Ethics Review Committee on the 29th January 2007 (ref: RPC189)
2. Ethical Review Committee of the Ministry of Health, Muscat, Oman on the 30th August 2006 (ref: 502)

Study design

Randomised controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Poliomyelitis vaccination

Intervention

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: +968 (0)600808
Fax: +968 (0)696099
Email: alijamoh@omantel.net.om

Intervention type

Drug

Phase

Not Specified

Drug names

Inactivated Poliovirus Vaccine (IPV)

Primary outcome measures

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

Secondary outcome measures

Seroconversion after each dose of vaccine.

Overall trial start date

15/02/2007

Overall trial end date

30/10/2007

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

400

Participant 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

Recruitment start date

15/02/2007

Recruitment end date

30/10/2007

Locations

Countries of recruitment

Oman

Trial participating centre

Technical Officer
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

World Health Organization (WHO) (Switzerland)

Sponsor details

20 Avenue Appia
Geneva-27
CH-1211
Switzerland

Sponsor type

Research organisation

Website

http://www.polioeradication.org/content/fixed/opvcessation/opvcessation.asp

Funders

Funder type

Research organisation

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20573923

Publication citations

  1. Results

    Mohammed AJ, AlAwaidy S, Bawikar S, Kurup PJ, Elamir E, Shaban MM, Sharif SM, van der Avoort HG, Pallansch MA, Malankar P, Burton A, Sreevatsava M, Sutter RW, Fractional doses of inactivated poliovirus vaccine in Oman., N. Engl. J. Med., 2010, 362, 25, 2351-2359, doi: 10.1056/NEJMoa0909383.

Additional files

Editorial Notes