Comparative evaluation of immunogenicity and reactogenicity of monovalent type 2 and 3 oral poliovirus vaccines (mOPV 2 and mOPV3) versus trivalent oral poliovirus vaccine (tOPV), and bivalent oral poliovirus vaccine (bOPV) versus monovalent types 1 and 3 oral poliovirus vaccines, respectively: a randomised double-blind trial
| ISRCTN | ISRCTN64725429 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN64725429 |
| Protocol serial number | RPC273 |
| Sponsor | Panacea Biotec Limited (India) |
| Funders | Panacea Biotec Limited (India), World Health Organization (WHO) (Switzerland) |
- Submission date
- 26/11/2008
- Registration date
- 26/11/2008
- Last edited
- 23/08/2011
- 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
CH-1211
Switzerland
| Phone | +41 (0)22 791 4682 |
|---|---|
| sutterr@who.int |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised double-blind clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | To determine if one or two doses of mOPV2 or mOPV3 induces significantly higher levels of seroconversion against poliovirus types 2 or 3, respectively, than does one or two doses of tOPV to these Sabin strains and to determine if one or two doses of bOPV induces similar seroconversion to types 1 and 3, respectively, compared to one or two doses of mOPV1 or mOPV3. Additionally, at one site (Indore), to determine if one or two doses of mOPV2 or mOPV3 significantly reduces excretion of poliovirus types 2 or 3, respectively than does one or two doses of tOPV and to determine if one or two doses of bOPV significantly reduces excretion of poliovirus type 1 and type 3 than does one or two doses of tOPV. |
| Ethics approval(s) | 1. MGM Medical College gave approval on the 7th June 2008 (ref: PBL/CR/0042008/CT) 2. The Drug Controller General of India gave approval on the 11th June 2008 (ref: PBL/CR/0042008/CT) |
| Health condition(s) or problem(s) studied | Poliomyelitis |
| Intervention | 1. Control: standard trivalent oral poliovirus vaccine (tOPV) - one or two doses 2. Intervention group one: monovalent type 1 oral poliovirus vaccine (mOPV1) - one or two doses 3. Intervention group two: monovalent type 2 oral poliovirus vaccine (mOPV2) - one or two doses 4. Intervention group three: monovalent type 3 oral poliovirus vaccine (mOPV3) - one or two doses 5. Intervention group four: bivalent type 1 and 3 oral poliovirus vaccine (bOPV) - one or two doses Contact details of Principal Investigator: Dr T Jacob John 439 Civil Supplies Godown Lane Kamalakshipuram Vellore 632 002 India Tel: +91 (0)416 226 7364 Email: vlr_tjjohn@sancharnet.in |
| Intervention type | Drug |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oral poliovirus vaccines |
| Primary outcome measure(s) |
Seroconversion 30 days after a single dose of mOPV2 or mOPV3 compared to tOPV or seroconversion following a single dose of bOPV compared to mOPV1. |
| Key secondary outcome measure(s) |
1. Seroconversion of two doses of mOPV2 or mOPV3 compared to tOPV |
| Completion date | 13/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | All |
| Target sample size at registration | 900 |
| Key inclusion criteria | 1. Healthy newborns (either sex) (greater than or equal to 2.50 kg birth weight, apgar score at 5 min greater than or equal to 9) at the study sites (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 2.50 kg 3. Apgar score at 5 min 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 | 13/08/2008 |
| Date of final enrolment | 13/10/2008 |
Locations
Countries of recruitment
- India
- Switzerland
Study participating centre
World Health Organization
Geneva
CH-1211
Switzerland
CH-1211
Switzerland
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 13/11/2010 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
