Evaluation of humoral immune response induced by a supplemental dose of inactivated poliovirus vaccine (IPV) administered intradermally or intramuscularly versus a dose of monovalent type 1 oral poliovirus vaccine
| ISRCTN | ISRCTN90744784 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN90744784 |
| Secondary identifying numbers | RPC300 |
- Submission date
- 26/11/2008
- Registration date
- 26/11/2008
- Last edited
- 08/05/2012
- 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
CH-1211
Switzerland
| Phone | +41 (0)22 791 4682 |
|---|---|
| sutterr@who.int |
Study information
| Study design | Randomised controlled unblinded 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 | Determine if there is a greater than or equal to 4-fold rise in antibody titres measured by neutralisation assay, 28 days after a single dose of intramuscular full-dose IPV GSK or intramuscular full-dose IPV panacea or intradermal fractional-dose IPV or mOPV1 higher potency (Sanofi Pasteur) or mOPV1 lower potency (panacea). |
| Ethics approval(s) | Sanchetana IEC pending approval as of 26/11/2008 |
| Health condition(s) or problem(s) studied | Poliomyelitis |
| Intervention | 1. Intervention group one: one fractional dose of IPV by GSK (0.1 ml or 1/5 of a dose) 2. Control group one: a full dose of IPV (0.5 ml) by GSK 3. Control group two: a full dose of IPV (0.5 ml) by Panacea 4. Control group three: one dose of mOPV type 1 by Panacea (potency 10^6.15 TCID50 in 0.1 ml) 5. Control group four: one dose of mOPV type 1 (potency 10^6.8 TCID50 in 0.1 ml) by Sanofi Pasteur Contact details of Principal Investigator: Dr Jacob John 439 Civil Supplies Godown Lane Kamalakshipuram Vellore 632 002 India Tel: +91 (0)416 226 7364 Fax: +91 (0)416 223 2035 Email: vlr_tjjohn@sancharnet.in |
| Intervention type | Drug |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | Poliovirus vaccine |
| Primary outcome measure | 1. To evaluate whether intradermal administration of one-fifth of the standard IPV dose provides seroconversion rates and titres against all 3 serotypes comparable with the full 0.5 ml IPV dose administered intramuscularly 2. To determine whether IPV induces higher seroconversion rates and antibody titres (significant booster effect) to type 1 poliovirus compared to mOPV 1 in infants 6 - 9 months of age who have been exposed to several OPV doses 3. To characterise the immune response of the trial vaccination as primary (priming) or secondary (boosting), through measurement of antibody titres reached at 7 days and through determination of immunoglobulin A and M by ELISA |
| Secondary outcome measures | 1. To assess whether one dose of IPV manufactured by Panacea administered intramuscularly elicits the same immune response as one dose of IPV manufactured by GlaxoSmithKline (both with 40-8-32 D antigen potency) 2. To assess whether Sanofi-Pasteur mOPV1, with 4-fold higher vaccine virus dosage compared to Panacea mOPV1, induces higher seroconversion rates and antibody titres to poliovirus type 1 than Panacea mOPV1 |
| Overall study start date | 10/01/2009 |
| Completion date | 10/02/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 6 Months |
| Upper age limit | 9 Months |
| Sex | Both |
| Target number of participants | 1000 |
| Key inclusion criteria | 1. Healthy children in the target group (6 - 9 months at baseline, either sex) 2. Resident in Moradabad district, Uttar Pradesh, India |
| Key exclusion criteria | Children with chronic illness |
| Date of first enrolment | 10/01/2009 |
| Date of final enrolment | 10/02/2009 |
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 Dehli
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
Research organisation
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 | 01/02/2012 | Yes | No |
