Comparative evaluation of immunogenicity of Monovalent Type 1 Oral Poliovirus Vaccine (mOPV1) versus trivalent OPV (tOPV): a randomised double-blind trial set in India (Panacea Biotec Ltd mOPV1 study)
| ISRCTN | ISRCTN80143849 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN80143849 |
| Secondary identifying numbers | RPC133/Panbio/CR/0982004/CT |
- Submission date
- 01/02/2006
- Registration date
- 01/02/2006
- Last edited
- 17/01/2012
- 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 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) | Hospital |
| Study type | Prevention |
| Scientific title | |
| Study objectives | One dose of mOPV1 induces significantly higher levels of seroconversion against poliovirus type 1 among Indian children in Indore and Hyderabad compared to tOPV. Please note that as of 18/10/2007 the anticipated end date of this trial was updated from the 31st December 2006 to 28th March 2006. |
| Ethics approval(s) | Ethics approval received on the 20th October 2005. |
| Health condition(s) or problem(s) studied | Polio |
| Intervention | Monovalent Type 1 Oral Poliovirus Vaccine (mOPV1) versus Trivalent OPV (tOPV). Measurements: 1. Cord blood will be collected immediately after birth 2. Blood collection at 30 days of age and stool collection taken 3. During one week follow-up, stool sample collected at day 7 |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Monovalent Type 1 Oral Poliovirus Vaccine (mOPV1), Trivalent OPV (tOPV). |
| Primary outcome measure | Seroconversion after 30 days of a single dose of tOPV or mOPV1 produced for Biofarma bulk. |
| Secondary outcome measures | 1. Prevalence of excretion of Poliovirus type 1 in stool specimens 7 days post-challenge with mOPV1 (age: 30 days + 7 days) 2. Comparison of mOPV1 produced by Biofarma bulk with the mOPV1 produced by Sanofi Pasteur bulk |
| Overall study start date | 25/10/2005 |
| Completion date | 28/03/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 600 |
| Key inclusion criteria | 1. Healthy newborns (greater than or equal to 2.75 kg birth weight, apgar score at 5 minutes, greater than or equal to 9) at the study site(s) (large maternity hospitals) 2. Residing within a relatively short and easily accessible distance (less than 30 km) 3. Not planning to travel away during entire the study period (birth - 2 months) |
| Key exclusion criteria | 1. Newborns requiring hospitalisation 2. Birth weight below 2.75 kg 3. Apgar score at 5 minutes less than 9 4. Residence greater than 30 km from study site 5. Families expecting to be absent during the 60-day study period 6. 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 | 25/10/2005 |
| Date of final enrolment | 28/03/2006 |
Locations
Countries of recruitment
- India
- Switzerland
Study participating centre
World Health Organization
Geneva-27
CH 1211
Switzerland
CH 1211
Switzerland
Sponsor information
Panacea Biotec Ltd (India)
Industry
Industry
B-1 Extn. A-27
Mohan Co-op Industrial Estate
Mathura Road
New Delhi
110044
India
| arani@pblintranet.com | |
| Website | http://www.panacea-biotec.com/ |
"ROR" |
https://ror.org/01ew11x49 |
Funders
Funder type
Research organisation
Gates Foundation (USA) - grant received for a World Health Organization (WHO) Polio Eradication Initiative
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 | 05/08/2011 | Yes | No |
