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 |
| Secondary identifying numbers | RPC273 |
- 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
| Study design | Randomised double-blind clinical trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Oral poliovirus vaccines |
| Primary outcome measure | 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. |
| Secondary outcome measures | 1. Seroconversion of two doses of mOPV2 or mOPV3 compared to tOPV 2. Seroconversion of one or two doses of bOPV compared to mOPV1 or mOPV3 3. Prevalence of excretion of poliovirus serotypes 1, 2, and 3 at 7, 30, 37, and 60 days (at Indore site only) |
| Overall study start date | 13/08/2008 |
| Completion date | 13/10/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Both |
| Target number of participants | 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
Sponsor information
Panacea Biotec Limited (India)
Industry
Industry
B-1 Extn/G-3
Mohan Co-op. Indl. Estate
Mathura Road
New Delhi
110044
India
| Phone | +91 (0)11 4167 8000/9000 |
|---|---|
| aranichatterjee@panaceabiotec.com | |
| Website | http://www.panacea-biotec.com/ |
"ROR" |
https://ror.org/01ew11x49 |
Funders
Funder type
Industry
Panacea Biotec Limited (India)
No information available
World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations
Private sector organisation / International organizations
- Alternative name(s)
- منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
- Location
- Switzerland
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 | 13/11/2010 | Yes | No |
