Condition category
Infections and Infestations
Date applied
07/09/2007
Date assigned
07/09/2007
Last edited
28/09/2012
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 27
CH-1211
Switzerland
+41 (0)22 791 4682
sutterr@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC241

Study information

Scientific title

Acronym

Study hypothesis

This study aims to demonstrate the superiority of one dose of Monovalent Type 1 Oral Poliomyelitis Vaccine (mOPV1) compared to trivalent Oral Poliomyelitis Vaccine (tOPV).

Ethics approval

Ethics approval received from:
1. World Health Organization Research Ethics Review Committee (WHO ERC) on the 3rd September 2007 (ref: RPC241)
2. MGM Medical College and Associated Hospital Society Indore on the 7th August 2007
3. Osmania Medical College Koti, Hyderabad on the 10th August 2007

Study design

Clinical trial, interventional, randomised, double blind four-armed comparative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Polio

Intervention

Control group: 2 drops (approximately 0.1 ml) standard dose tOPV manufactured by Panacea at birth and 30 days of age
Intervention group 1: 2 drops (approximately 0.1 ml) standard potency mOPV1 manufactured by Panacea at birth and 30 days of age
Intervention group 2: 2 drops (approximately 0.1 ml) higher potency mOPV1 manufactured by Panacea at birth and 30 days of age
Intervention group 3: 2 drops (approximately 0.1 ml) standard dose mOPV1 manufactured by Sanofi Pasteur at birth and 30 days of age

Blood collection at birth (cord blood), further venipuncture blood collection at 30 days and at 60 days.

Contact details for Principal Investigator:
Dr T Jacob John
439 Civil Supplies Godown Lane
Kamalakshipuram, Vellore
Tamil Nadu, 632002
India
Tel: +91 (0)41 6226 7364
Fax: +91 (0)41 6223 2035 (courtesy of CMC Hospital)
Email: vlr_tjjohn@sancharnet.in

Intervention type

Drug

Phase

Phase IV

Drug names

Monovalent Type 1 Oral Poliomyelitis Vaccine (mOPV1), trivalent Oral Poliomyelitis Vaccine (tOPV).

Primary outcome measures

Seroconversion 30 days after a single dose of tOPV or mOPV1.

Secondary outcome measures

Seroconversion after two doses of vaccine (one of three mOPV1 vaccines and tOPV).

Overall trial start date

08/09/2007

Overall trial end date

08/03/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. Healthy infants (greater than or equal to 2.5 kg birth weight, apgar score at 5 minutes greater than or equal to 9)
2. Born at study sites (maternity hospitals)
3. Residing less than 30 km away from study site
4. Not planning to travel during entire study period (birth to 2 months)

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

720

Participant exclusion criteria

1. Newborns requiring hospitalisation
2. Birth weight less than 2.5 kg
3. Apgar score at 5 minutes less than 9
4. Residence greater than 30 km from study sites
5. Families expecting to be absent during the 60 day study period
6. A diagnosis or suspicion of immunodeficiency disorder (either in participant or immediate family member)

Recruitment start date

08/09/2007

Recruitment end date

08/03/2008

Locations

Countries of recruitment

India

Trial participating centre

World Health Organization
Geneva 27
CH-1211
Switzerland

Sponsor information

Organisation

Panacea Biotec Limited (India)

Sponsor details

c/o Dr Arani Chatterjee
B-1 Extn/G-3
Mohan Co-op Indl. Estate
Mathura Road
New Delhi
110044
India
+91 (0)11 4167 8000 or 4167 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

Gates Foundation (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

World Health Organization (WHO) Polio Eradication Initiative

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21641951

Publication citations

  1. Results

    John TJ, Jain H, Ravishankar K, Amaresh A, Verma H, Deshpande J, Pallansch MA, Singh AP, Sreevatsava M, Burton A, Malankar P, Chatterjee A, Sutter RW, Monovalent type 1 oral poliovirus vaccine among infants in India: report of two randomized double-blind controlled clinical trials., Vaccine, 2011, 29, 34, 5793-5801, doi: 10.1016/j.vaccine.2011.04.133.

Additional files

Editorial Notes