Condition category
Infections and Infestations
Date applied
15/11/2007
Date assigned
15/11/2007
Last edited
21/02/2012
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
Avenue Appia 20
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 4682
sutterr@who.int

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

RPC236

Study information

Scientific title

Acronym

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.

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.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Poliomyelitis

Intervention

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

Intervention type

Drug

Phase

Not Specified

Drug names

Monovalent type 1 Oral Poliovirus Vaccine (mOPV1), monovalent type 3 Oral Poliovirus Vaccine (mOPV3), trivalent Oral Poliovirus Vaccine (tOPV)

Primary outcome measures

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 measures

No secondary outcome measures

Overall trial start date

15/11/2007

Overall trial end date

15/11/2009

Reason abandoned

Eligibility

Participant 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)

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

800

Participant 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.

Recruitment start date

15/11/2007

Recruitment end date

15/11/2009

Locations

Countries of recruitment

South Africa

Trial participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

Organisation

World Health Organization (WHO) (Switzerland)

Sponsor details

Avenue Appia 20
Geneva-27
CH-1211
Switzerland
+41 (0)22 791 4682
sutterr@who.int

Sponsor type

Research organisation

Website

http://www.who.int/en/

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

Funder name

Gates Foundation (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

International Financing Facility for Immunisations (IFFIm) (UK)

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. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22158680

Publication citations

  1. Results

    Waggie Z, Geldenhuys H, Sutter RW, Jacks M, Mulenga H, Mahomed H, De Kock M, Hanekom W, Pallansch MA, Kahn AL, Burton AH, Sreevatsava M, Hussey G, Randomized trial of type 1 and type 3 oral monovalent poliovirus vaccines in newborns in Africa., J. Infect. Dis., 2012, 205, 2, 228-236, doi: 10.1093/infdis/jir721.

Additional files

Editorial Notes