Condition category
Infections and Infestations
Date applied
26/11/2008
Date assigned
26/11/2008
Last edited
23/08/2011
Prospective/Retrospective
Retrospectively 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

RPC273

Study information

Scientific title

Acronym

Study hypothesis

To determine if one or two doses of mOPV2 or mOPV3 induces significantly higher levels of seroconversion against poliovirus types 2 or 3, respectively, than does one or two doses of tOPV to these Sabin strains and to determine if one or two doses of bOPV induces similar seroconversion to types 1 and 3, respectively, compared to one or two doses of mOPV1 or mOPV3. Additionally, at one site (Indore), to determine if one or two doses of mOPV2 or mOPV3 significantly reduces excretion of poliovirus types 2 or 3, respectively than does one or two doses of tOPV and to determine if one or two doses of bOPV significantly reduces excretion of poliovirus type 1 and type 3 than does one or two doses of tOPV.

Ethics approval

1. MGM Medical College gave approval on the 7th June 2008 (ref: PBL/CR/0042008/CT)
2. The Drug Controller General of India gave approval on the 11th June 2008 (ref: PBL/CR/0042008/CT)

Study design

Randomised double-blind clinical 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. Control: standard trivalent oral poliovirus vaccine (tOPV) - one or two doses
2. Intervention group one: monovalent type 1 oral poliovirus vaccine (mOPV1) - one or two doses
3. Intervention group two: monovalent type 2 oral poliovirus vaccine (mOPV2) - one or two doses
4. Intervention group three: monovalent type 3 oral poliovirus vaccine (mOPV3) - one or two doses
5. Intervention group four: bivalent type 1 and 3 oral poliovirus vaccine (bOPV) - one or two doses

Contact details of Principal Investigator:
Dr T Jacob John
439 Civil Supplies Godown Lane
Kamalakshipuram
Vellore 632 002
India
Tel: +91 (0)416 226 7364
Email: vlr_tjjohn@sancharnet.in

Intervention type

Drug

Phase

Not Specified

Drug names

Oral poliovirus vaccines

Primary outcome measures

Seroconversion 30 days after a single dose of mOPV2 or mOPV3 compared to tOPV or seroconversion following a single dose of bOPV compared to mOPV1.

Secondary outcome measures

1. Seroconversion of two doses of mOPV2 or mOPV3 compared to tOPV
2. Seroconversion of one or two doses of bOPV compared to mOPV1 or mOPV3
3. Prevalence of excretion of poliovirus serotypes 1, 2, and 3 at 7, 30, 37, and 60 days (at Indore site only)

Overall trial start date

13/08/2008

Overall trial end date

13/10/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy newborns (either sex) (greater than or equal to 2.50 kg birth weight, apgar score at 5 min greater than or equal to 9) at the study sites (large maternity hospitals)
2. Residing within a relatively short and easily accessible distance (less than 30 km)
3. Not planning to travel away during entire the study period (birth - 2 months)

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

900

Participant exclusion criteria

1. Newborns requiring hospitalisation
2. Birth weight below 2.50 kg
3. Apgar score at 5 min less than 9
4. Residence greater than 30 km from study site
5. Families expecting to be absent during the 60-day study period
6. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the newborn ineligible for the study

Recruitment start date

13/08/2008

Recruitment end date

13/10/2008

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 Delhi
110044
India
+91 (0)11 4167 8000/9000
aranichatterjee@panaceabiotec.com

Sponsor type

Industry

Website

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

Funders

Funder type

Industry

Funder name

Panacea Biotec Limited (India)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20980048

Publication citations

  1. Results

    Sutter RW, John TJ, Jain H, Agarkhedkar S, Ramanan PV, Verma H, Deshpande J, Singh AP, Sreevatsava M, Malankar P, Burton A, Chatterjee A, Jafari H, Aylward RB, Immunogenicity of bivalent types 1 and 3 oral poliovirus vaccine: a randomised, double-blind, controlled trial., Lancet, 2010, 376, 9753, 1682-1688, doi: 10.1016/S0140-6736(10)61230-5.

Additional files

Editorial Notes