A phase-IV randomised, double blind comparative evaluation of immunogenicity of Monovalent Type 1 Oral Poliomyelitis Vaccine (mOPV1) versus trivalent OPV (tOPV): four-armed study

ISRCTN	ISRCTN54186735
DOI	https://doi.org/10.1186/ISRCTN54186735
Secondary identifying numbers	RPC241

Submission date: 07/09/2007
Registration date: 07/09/2007
Last edited: 28/09/2012

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
20 Avenue Appia
Geneva 27
CH-1211
Switzerland

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

Study information

Study design	Clinical trial, interventional, randomised, double blind four-armed comparative study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study objectives	This study aims to demonstrate the superiority of one dose of Monovalent Type 1 Oral Poliomyelitis Vaccine (mOPV1) compared to trivalent Oral Poliomyelitis Vaccine (tOPV).
Ethics approval(s)	Ethics approval received from: 1. World Health Organization Research Ethics Review Committee (WHO ERC) on the 3rd September 2007 (ref: RPC241) 2. MGM Medical College and Associated Hospital Society Indore on the 7th August 2007 3. Osmania Medical College Koti, Hyderabad on the 10th August 2007
Health condition(s) or problem(s) studied	Polio
Intervention	Control group: 2 drops (approximately 0.1 ml) standard dose tOPV manufactured by Panacea at birth and 30 days of age Intervention group 1: 2 drops (approximately 0.1 ml) standard potency mOPV1 manufactured by Panacea at birth and 30 days of age Intervention group 2: 2 drops (approximately 0.1 ml) higher potency mOPV1 manufactured by Panacea at birth and 30 days of age Intervention group 3: 2 drops (approximately 0.1 ml) standard dose mOPV1 manufactured by Sanofi Pasteur at birth and 30 days of age Blood collection at birth (cord blood), further venipuncture blood collection at 30 days and at 60 days. Contact details for Principal Investigator: Dr T Jacob John 439 Civil Supplies Godown Lane Kamalakshipuram, Vellore Tamil Nadu, 632002 India Tel: +91 (0)41 6226 7364 Fax: +91 (0)41 6223 2035 (courtesy of CMC Hospital) Email: vlr_tjjohn@sancharnet.in
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Phase IV
Drug / device / biological / vaccine name(s)	Monovalent Type 1 Oral Poliomyelitis Vaccine (mOPV1), trivalent Oral Poliomyelitis Vaccine (tOPV).
Primary outcome measure	Seroconversion 30 days after a single dose of tOPV or mOPV1.
Secondary outcome measures	Seroconversion after two doses of vaccine (one of three mOPV1 vaccines and tOPV).
Overall study start date	08/09/2007
Completion date	08/03/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Sex	Both
Target number of participants	720
Key inclusion criteria	1. Healthy infants (greater than or equal to 2.5 kg birth weight, apgar score at 5 minutes greater than or equal to 9) 2. Born at study sites (maternity hospitals) 3. Residing less than 30 km away from study site 4. Not planning to travel during entire study period (birth to 2 months)
Key exclusion criteria	1. Newborns requiring hospitalisation 2. Birth weight less than 2.5 kg 3. Apgar score at 5 minutes less than 9 4. Residence greater than 30 km from study sites 5. Families expecting to be absent during the 60 day study period 6. A diagnosis or suspicion of immunodeficiency disorder (either in participant or immediate family member)
Date of first enrolment	08/09/2007
Date of final enrolment	08/03/2008

Locations

Countries of recruitment

India
Switzerland

Study participating centre

World Health Organization

Geneva 27
CH-1211
Switzerland

Sponsor information

Panacea Biotec Limited (India)
Industry

c/o Dr Arani Chatterjee
B-1 Extn/G-3
Mohan Co-op Indl. Estate
Mathura Road
New Delhi
110044
India

Phone	+91 (0)11 4167 8000 or 4167 9000
Email	aranichatterjee@panaceabiotec.com
Website	http://www.panacea-biotec.com/
"ROR"	https://ror.org/01ew11x49

Funders

Funder type

Industry

Panacea Biotec Limited (India)

No information available

Gates Foundation (USA)

No information available

World Health Organization (WHO) Polio Eradication Initiative

No information available

Results and Publications

Intention to publish date
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?
Results article	results	05/08/2011		Yes	No