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Comparative evaluation of Immunogenicity of monovalent type 1 Oral Poliovirus Vaccine (mOPV1) and monovalent type 3 Oral Poliovirus Vaccine (mOPV3) versus trivalent Oral Poliovirus Vaccine (tOPV): a randomised double-blind controlled trial in South Africa
ISRCTN ISRCTN18107202
DOI 10.1186/ISRCTN18107202
ClinicalTrials.gov identifier
EudraCT number
Public title Comparative evaluation of Immunogenicity of monovalent type 1 Oral Poliovirus Vaccine (mOPV1) and monovalent type 3 Oral Poliovirus Vaccine (mOPV3) versus trivalent Oral Poliovirus Vaccine (tOPV): a randomised double-blind controlled trial in South Africa
Scientific title
Acronym N/A
Serial number at source RPC236
Study hypothesis The study aims to demonstrate the superiority of one dose of monovalent type 1 Oral Poliovirus Vaccine (mOPV1) or monovalent type 3 Oral Poliovirus Vaccine (mOPV3) compared to trivalent Oral Poliovirus Vaccine (tOPV) in inducing seroconversion.
Lay summary Not provided at time of registration
Ethics approval Ethics approval received from:
1. World Health Organization (WHO) Ethics Review Committee (ERC) on the 24th October 2007 (ref: RPC236)
2. University of Cape Town's Research Ethics Committee on the 2nd October 2007 (ref: 355/2007)

Regulatory authority approval from the Medicines Control Council South Africa is still in progress.
Study design Interventional randomised double blind controlled trial for 3 arms of vaccine produced by GSK but randomised and unblinded for the mOPV1 vaccine produced by Panacea Biotec Ltd.
Countries of recruitment South Africa
Disease/condition/study domain Poliomyelitis
Participants - inclusion criteria 1. Healthy infants (birth weight greater than or equal to 2.5 kg and Apgar score greater than or equal to 9 at 5 minutes) born at study sites
2. Residing less than or equal to 50 km from study sites
3. Family is not planning on travel during the study period (birth to 1 month)
Participants - exclusion criteria 1. High risk newborns
2. Other newborns requiring hospitalisation
3. Birthweight less than 2.5 kg
4. Apgar score less than 9 at 5 minutes
5. Infants residing more than 50 km from study sites
6. Infants whose families are planning to be absent during one month study period
7. A diagnosis or suspicion of B cell immunodeficiency in participant or immediate family

The study will not collect information on acquired immunodefiency disease or Human Immunodeficiency Virus (HIV) status of mother or study subject.
Anticipated start date 15/11/2007
Anticipated end date 15/11/2009
Status of trial Completed
Patient information material
Target number of participants 800
Interventions Control group:
2 drops (approximately 0.1 ml) standard dose of tOPV manufactured by GlaxoSmithKline (GSK) at birth.

Intervention groups:
1. 2 drops (approximately 0.1 ml) of mOPV1 manufactured by GSK at birth
2. 2 drops (approximately 0.1 ml) of mOPV1 manufactured by Panacea at birth
3. 2 drops (approximately 0.1 ml) of mOPV3 manufactured by GSK at birth

Blood collection at birth (cord blood or blood from newborn) and at 30 days.

Principal Investigator:
Professor Gregory D. Hussey
Institute of Infectious Disease and Molecular Medicine
University of Cape Town
Anzio Road, Observatory
7925 Cape Town
South Africa
Tel: +27 (0)21 406 6738
Fax: +27 (0)21 406 6081
Email: Gregory.Hussey@uct.ac.za
Primary outcome measure(s) Seroconversion 30 days after a single dose of tOPV, mOPV1, or mOPV3. Measurements on humoral immunity (specific primary endpoints) as as follows:
1. One dose of mOPV1 induces significantly higher levels of seroconversion against poliovirus type 1 than one dose of tOPV
2. One dose of mOPV3 induces significantly higher levels of seroconversion against poliovirus type 3 than one dose of tOPV
Secondary outcome measure(s) No secondary outcome measures
Sources of funding 1. World Health Organization (WHO) (Switzerland)
2. Gates Foundation (USA)
3. International Financing Facility for Immunisations (IFFIm) (UK)
Trial website
Publications 1. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22158680
Contact name Dr  Roland  Sutter
  Address World Health Organization
Avenue Appia 20
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
  Tel +41 (0)22 791 4682
  Email sutterr@who.int
Sponsor World Health Organization (WHO) (Switzerland)
  Address Avenue Appia 20
  City/town Geneva-27
  Zip/Postcode CH-1211
  Country Switzerland
  Tel +41 (0)22 791 4682
  Email sutterr@who.int
  Sponsor website: http://www.who.int/en/
Date applied 15/11/2007
Last edited 21/02/2012
Date ISRCTN assigned 15/11/2007
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