A phase-IV randomised, double blind comparative evaluation of immunogenicity of Monovalent Type 1 Oral Poliomyelitis Vaccine (mOPV1) versus trivalent OPV (tOPV): four-armed study
| ISRCTN | ISRCTN54186735 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54186735 |
| Protocol serial number | RPC241 |
| Sponsor | Panacea Biotec Limited (India) |
| Funders | Panacea Biotec Limited (India), Gates Foundation (USA), World Health Organization (WHO) Polio Eradication Initiative |
- Submission date
- 07/09/2007
- Registration date
- 07/09/2007
- Last edited
- 28/09/2012
- 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 Roland Sutter
Scientific
Scientific
World Health Organization
20 Avenue Appia
Geneva 27
CH-1211
Switzerland
| Phone | +41 (0)22 791 4682 |
|---|---|
| sutterr@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Clinical trial, interventional, randomised, double blind four-armed comparative study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | This study aims to demonstrate the superiority of one dose of Monovalent Type 1 Oral Poliomyelitis Vaccine (mOPV1) compared to trivalent Oral Poliomyelitis Vaccine (tOPV). |
| Ethics approval(s) | Ethics approval received from: 1. World Health Organization Research Ethics Review Committee (WHO ERC) on the 3rd September 2007 (ref: RPC241) 2. MGM Medical College and Associated Hospital Society Indore on the 7th August 2007 3. Osmania Medical College Koti, Hyderabad on the 10th August 2007 |
| Health condition(s) or problem(s) studied | Polio |
| Intervention | Control group: 2 drops (approximately 0.1 ml) standard dose tOPV manufactured by Panacea at birth and 30 days of age Intervention group 1: 2 drops (approximately 0.1 ml) standard potency mOPV1 manufactured by Panacea at birth and 30 days of age Intervention group 2: 2 drops (approximately 0.1 ml) higher potency mOPV1 manufactured by Panacea at birth and 30 days of age Intervention group 3: 2 drops (approximately 0.1 ml) standard dose mOPV1 manufactured by Sanofi Pasteur at birth and 30 days of age Blood collection at birth (cord blood), further venipuncture blood collection at 30 days and at 60 days. Contact details for Principal Investigator: Dr T Jacob John 439 Civil Supplies Godown Lane Kamalakshipuram, Vellore Tamil Nadu, 632002 India Tel: +91 (0)41 6226 7364 Fax: +91 (0)41 6223 2035 (courtesy of CMC Hospital) Email: vlr_tjjohn@sancharnet.in |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Monovalent Type 1 Oral Poliomyelitis Vaccine (mOPV1), trivalent Oral Poliomyelitis Vaccine (tOPV). |
| Primary outcome measure(s) |
Seroconversion 30 days after a single dose of tOPV or mOPV1. |
| Key secondary outcome measure(s) |
Seroconversion after two doses of vaccine (one of three mOPV1 vaccines and tOPV). |
| Completion date | 08/03/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | All |
| Target sample size at registration | 720 |
| Key inclusion criteria | 1. Healthy infants (greater than or equal to 2.5 kg birth weight, apgar score at 5 minutes greater than or equal to 9) 2. Born at study sites (maternity hospitals) 3. Residing less than 30 km away from study site 4. Not planning to travel during entire study period (birth to 2 months) |
| Key exclusion criteria | 1. Newborns requiring hospitalisation 2. Birth weight less than 2.5 kg 3. Apgar score at 5 minutes less than 9 4. Residence greater than 30 km from study sites 5. Families expecting to be absent during the 60 day study period 6. A diagnosis or suspicion of immunodeficiency disorder (either in participant or immediate family member) |
| Date of first enrolment | 08/09/2007 |
| Date of final enrolment | 08/03/2008 |
Locations
Countries of recruitment
- India
- Switzerland
Study participating centre
World Health Organization
Geneva 27
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
