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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 10.1186/ISRCTN90744784
ClinicalTrials.gov identifier
EudraCT number
Public title 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
Scientific title
Acronym N/A
Serial number at source RPC300
Study hypothesis 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).
Lay summary Not provided at time of registration
Ethics approval Sanchetana IEC pending approval as of 26/11/2008
Study design Randomised controlled unblinded trial
Countries of recruitment India
Disease/condition/study domain Poliomyelitis
Participants - inclusion criteria 1. Healthy children in the target group (6 - 9 months at baseline, either sex)
2. Resident in Moradabad district, Uttar Pradesh, India
Participants - exclusion criteria Children with chronic illness
Anticipated start date 10/01/2009
Anticipated end date 10/02/2009
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 1000
Interventions 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
Primary outcome measure(s) 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 measure(s) 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
Sources of funding World Health Organization (WHO) (Switzerland)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22071249
Contact name Dr  Roland  Sutter
  Address World Health Organization
20 Avenue Appia
  City/town Geneva
  Zip/Postcode CH-1211
  Country Switzerland
  Tel +41 (0)22 791 4682
  Email sutterr@who.int
Sponsor Panacea Biotec Limited (India)
  Address B-1 Extn/G-3
Mohan Co-op. Indl. Estate
Mathura Road
  City/town New Dehli
  Zip/Postcode 110044
  Country India
  Tel +91 (0)11 4167 8000/9000
  Fax +91 (0)11 4157 8085
  Email aranichatterjee@panaceabiotec.com
  Sponsor website: http://www.panacea-biotec.com/
Date applied 26/11/2008
Last edited 08/05/2012
Date ISRCTN assigned 26/11/2008
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