Comparative evaluation of immunogenicity of monovalent type 1 oral poliovirus vaccine (mOPV1) versus trivalent OPV (tOPV): a randomised double-blind trial set in Egypt
| ISRCTN | ISRCTN76316509 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN76316509 |
| Secondary identifying numbers | RPC 127 |
- Submission date
- 12/09/2005
- Registration date
- 01/02/2006
- Last edited
- 17/10/2008
- 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
Ms Anna-Lea Jenny Kahn
Scientific
Scientific
World Health Organization
20, Avenue Appia
Geneva-27
CH 1211
Switzerland
| Phone | +41 (0)22 791 3135 |
|---|---|
| kahna@who.int |
Study information
| Study design | Clinical trial, evaluation based, randomised double blind trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study objectives | One dose of monovalent oral poliovirus vaccine induces higher levels of seroconversion against poliovirus type 1 when compared to trivalent oral poliovirus vaccine. Please note that as of 18/10/2007 the anticipated start and end dates of this trial were modified, the initial trial dates were as follows: Anticipated start date: 15/07/2005 Anticipated end date: 31/07/2006 |
| Ethics approval(s) | Ethics approval received on the 28th June 2005. |
| Health condition(s) or problem(s) studied | Polio |
| Intervention | One dose of monovalent oral poliovirus vaccine compared to trivalent oral poliovirus vaccine. Measurements: 1. Cord blood will be collected immediately after birth 2. 30 days after birth, second sample of blood collected by heel stick method and a stool sample taken 3. Four additional stool samples collected on a weekly basis at 7, 14, 21, and 28 days after birth 4. 60 days after birth, third sample of blood collected by heel stick method |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oral poliovirus |
| Primary outcome measure | To demonstrate the superiority of one dose of mOPV1 compared with tOPV by assessing: 1. Humoral Immunity - one dose of mOPV1 induces significantly higher levels of seroconversion against poliovirus type 1 than does one dose of tOPV 2. Mucosal Immunity - one dose of mOPV1 significantly reduces excretion of poliovirus type 1 after a mOVP1 challenge than following one dose of tOPV |
| Secondary outcome measures | The secondary endpoint is prevalence of excretion of poliovirus type 1 in stool specimens 7 days post-challenge with mOPV1 at age 30 days + 7 days. Additional endpoints will be prevalence of excretion in 4 weeks after mOPV1 challenge by vaccination group; and seroconversion at 60 days after 2 doses of mOPV1 (no control available). |
| Overall study start date | 15/07/2005 |
| Completion date | 31/07/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | 1. Infants born healthy (greater than or equal to 2.75 kg, apgar score greater than or equal to 9 at five minutes) at the study site(s) (large maternity hospitals) 2. Residing within a relatively short and easily accessible distance (less than 30 km) in the same governorate as the study site 3. Not planning to travel away during entire the study period (birth to two months) |
| Key exclusion criteria | 1. High-risk newborns will be excluded 2. Newborns requiring hospitalisation 3. Birth weight below 2.75 kg 4. Apgar score less than 9 at five minutes 5. Residence greater than 30 km from study site (or residing in another governorate) 6. Family is planning to be absent during the 60-day study period 7. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the newborn ineligible for the study |
| Date of first enrolment | 15/07/2005 |
| Date of final enrolment | 31/07/2005 |
Locations
Countries of recruitment
- Egypt
- Switzerland
Study participating centre
World Health Organization
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
| Phone | +41 (0)22 791 3135 |
|---|---|
| sutterr@who.int | |
| Website | http://www.who.int |
"ROR" |
https://ror.org/01f80g185 |
Funders
Funder type
Charity
Gates Foundation (USA)
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 | 16/10/2008 | Yes | No |
