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 |
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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
Scientific
World Health Organization
Avenue Appia 20
Geneva-27
CH-1211
Switzerland
Phone | +41 (0)22 791 4682 |
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sutterr@who.int |
Study information
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. |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Not specified |
Study type | Treatment |
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 |
Pharmaceutical study type(s) | |
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 | 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 study start date | 15/11/2007 |
Completion date | 15/11/2009 |
Eligibility
Participant type(s) | Patient |
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Age group | Neonate |
Sex | Both |
Target number of participants | 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
CH-1211
Switzerland
Sponsor information
World Health Organization (WHO) (Switzerland)
Research organisation
Research organisation
Avenue Appia 20
Geneva-27
CH-1211
Switzerland
Phone | +41 (0)22 791 4682 |
---|---|
sutterr@who.int | |
Website | http://www.who.int/en/ |
https://ror.org/01f80g185 |
Funders
Funder type
Research organisation
World Health Organization (WHO) (Switzerland)
Private sector organisation / International organizations
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 | |
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Individual participant data (IPD) Intention to share | No |
IPD sharing plan summary | Not provided at time of registration |
Publication and dissemination plan | Not provided at time of registration |
IPD sharing plan |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
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Results article | results | 15/01/2012 | Yes | No |