Condition category
Infections and Infestations
Date applied
26/11/2008
Date assigned
26/11/2008
Last edited
08/05/2012
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.panacea-biotec.com/

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

Results - basic reporting

Publication summary

1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22071249

Publication citations

  1. 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.

Additional files

Editorial Notes