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
Protocol serial number	RPC300
Sponsor	Panacea Biotec Limited (India)
Funder	World Health Organization (WHO) (Switzerland)

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

World Health Organization
20 Avenue Appia
Geneva
CH-1211
Switzerland

Phone	+41 (0)22 791 4682
Email	sutterr@who.int

Study information

Primary study design	Interventional
Study design	Randomised controlled unblinded trial
Secondary study design	Randomised controlled trial
Study type	Participant 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
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Poliovirus vaccine
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
Key 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
Completion date	10/02/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	9 Months
Sex	All
Target sample size at registration	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

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	01/02/2012		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes