Immune response of fractional doses of Inactivated Poliovirus Vaccine (IPV) administered intradermally in the Sultanate of Oman
| ISRCTN | ISRCTN17418767 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17418767 |
| Secondary identifying numbers | RPC189 |
- Submission date
- 14/08/2007
- Registration date
- 15/08/2007
- Last edited
- 25/06/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Pradeep Malankar
Scientific
Scientific
Technical Officer
World Health Organization
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Phone | +41 (0)22 791 1863 |
|---|---|
| malankarp@who.int |
Study information
| Study design | Randomised controlled clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | 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) |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Inactivated Poliovirus Vaccine (IPV) |
| Primary outcome measure | Seroconversion after three doses of IPV (fractional or full doses). |
| Secondary outcome measures | Seroconversion after each dose of vaccine. |
| Overall study start date | 15/02/2007 |
| Completion date | 30/10/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 400 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 15/02/2007 |
| Date of final enrolment | 30/10/2007 |
Locations
Countries of recruitment
- Oman
- Switzerland
Study participating centre
Technical Officer
Geneva-27
CH-1211
Switzerland
CH-1211
Switzerland
Sponsor information
World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
20 Avenue Appia
Geneva-27
CH-1211
Switzerland
| Website | http://www.polioeradication.org/content/fixed/opvcessation/opvcessation.asp |
|---|---|
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
World Health Organization (WHO)/Polio Eradication Initiative (POL) (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 24/06/2010 | Yes | No |
