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
Secondary identifying numbers RPC236
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

Study designInterventional 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 designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesThe 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) studiedPoliomyelitis
InterventionControl 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 typeDrug
Pharmaceutical study type(s)
PhaseNot 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 measureSeroconversion 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 measuresNo secondary outcome measures
Overall study start date15/11/2007
Completion date15/11/2009

Eligibility

Participant type(s)Patient
Age groupNeonate
SexBoth
Target number of participants800
Key inclusion criteria1. 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 criteria1. 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 enrolment15/11/2007
Date of final enrolment15/11/2009

Locations

Countries of recruitment

  • South Africa
  • Switzerland

Study participating centre

World Health Organization
Geneva-27
CH-1211
Switzerland

Sponsor information

World Health Organization (WHO) (Switzerland)
Research organisation

Avenue Appia 20
Geneva-27
CH-1211
Switzerland

Phone +41 (0)22 791 4682
Email sutterr@who.int
Website http://www.who.int/en/
ROR logo "ROR" https://ror.org/01f80g185

Funders

Funder type

Research organisation

World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations
Alternative name(s)
منظمة الصحة العالمية, 世界卫生组织, Всемирная организация здравоохранения, Organisation mondiale de la Santé, Organización Mundial de la Salud, WHO, 世卫组织, ВОЗ, OMS
Location
Switzerland
Gates Foundation (USA)

No information available

International Financing Facility for Immunisations (IFFIm) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

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