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	https://doi.org/10.1186/ISRCTN18107202
Protocol serial number	RPC236
Sponsor	World Health Organization (WHO) (Switzerland)
Funders	World Health Organization (WHO) (Switzerland), Gates Foundation (USA), International Financing Facility for Immunisations (IFFIm) (UK)

Submission date: 15/11/2007
Registration date: 15/11/2007
Last edited: 21/02/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Roland Sutter
Scientific

World Health Organization
Avenue Appia 20
Geneva-27
CH-1211
Switzerland

Phone	+41 (0)22 791 4682
Email	sutterr@who.int

Study information

Primary study design	Interventional
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.
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	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.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Monovalent type 1 Oral Poliovirus Vaccine (mOPV1), monovalent type 3 Oral Poliovirus Vaccine (mOPV3), trivalent Oral Poliovirus Vaccine (tOPV)
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
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	15/11/2009

Eligibility

Participant type(s)	Patient
Age group	Neonate
Sex	All
Target sample size at registration	800
Key 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)
Key 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.
Date of first enrolment	15/11/2007
Date of final enrolment	15/11/2009

Locations

Countries of recruitment

South Africa
Switzerland

Study participating centre

World Health Organization

Geneva-27
CH-1211
Switzerland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	15/01/2012		Yes	No