Contact information
Type
Scientific
Primary contact
Dr Roland Sutter
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva 27
CH-1211
Switzerland
+41 (0)22 791 4682
sutterr@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPC241
Study information
Scientific title
Acronym
Study hypothesis
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
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
Study design
Clinical trial, interventional, randomised, double blind four-armed comparative study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
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
Phase
Phase IV
Drug names
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 trial start date
08/09/2007
Overall trial end date
08/03/2008
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
720
Participant 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)
Recruitment start date
08/09/2007
Recruitment end date
08/03/2008
Locations
Countries of recruitment
India
Trial participating centre
World Health Organization
Geneva 27
CH-1211
Switzerland
Sponsor information
Organisation
Panacea Biotec Limited (India)
Sponsor details
c/o Dr Arani Chatterjee
B-1 Extn/G-3
Mohan Co-op Indl. Estate
Mathura Road
New Delhi
110044
India
+91 (0)11 4167 8000 or 4167 9000
aranichatterjee@panaceabiotec.com
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
Panacea Biotec Limited (India)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Gates Foundation (USA)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
World Health Organization (WHO) Polio Eradication Initiative
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
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21641951
Publication citations
-
Results
John TJ, Jain H, Ravishankar K, Amaresh A, Verma H, Deshpande J, Pallansch MA, Singh AP, Sreevatsava M, Burton A, Malankar P, Chatterjee A, Sutter RW, Monovalent type 1 oral poliovirus vaccine among infants in India: report of two randomized double-blind controlled clinical trials., Vaccine, 2011, 29, 34, 5793-5801, doi: 10.1016/j.vaccine.2011.04.133.