Contact information
Type
Scientific
Primary contact
Dr Roland Sutter
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva
CH-1211
Switzerland
+41 (0)22 791 4682
sutterr@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPC300
Study information
Scientific title
Acronym
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).
Ethics approval
Sanchetana IEC pending approval as of 26/11/2008
Study design
Randomised controlled unblinded trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Specified
Drug names
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 trial start date
10/01/2009
Overall trial end date
10/02/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy children in the target group (6 - 9 months at baseline, either sex)
2. Resident in Moradabad district, Uttar Pradesh, India
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
1000
Participant exclusion criteria
Children with chronic illness
Recruitment start date
10/01/2009
Recruitment end date
10/02/2009
Locations
Countries of recruitment
India
Trial participating centre
World Health Organization
Geneva
CH-1211
Switzerland
Sponsor information
Organisation
Panacea Biotec Limited (India)
Sponsor details
B-1 Extn/G-3
Mohan Co-op. Indl. Estate
Mathura Road
New Dehli
110044
India
+91 (0)11 4167 8000/9000
aranichatterjee@panaceabiotec.com
Sponsor type
Industry
Website
Funders
Funder type
Research organisation
Funder name
World Health Organization (WHO) (Switzerland)
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
Switzerland
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22071249
Publication citations
-
Results
Estívariz CF, Jafari H, Sutter RW, John TJ, Jain V, Agarwal A, Verma H, Pallansch MA, Singh AP, Guirguis S, Awale J, Burton A, Bahl S, Chatterjee A, Aylward RB, Immunogenicity of supplemental doses of poliovirus vaccine for children aged 6-9 months in Moradabad, India: a community-based, randomised controlled trial., Lancet Infect Dis, 2012, 12, 2, 128-135, doi: 10.1016/S1473-3099(11)70190-6.