Contact information
Type
Scientific
Primary contact
Dr Anna-Lea Jenny Kahn
ORCID ID
Contact details
World Health Organization
20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 3135
kahna@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPC133/Panbio/CR/0982004/CT
Study information
Scientific title
Acronym
Study hypothesis
One dose of mOPV1 induces significantly higher levels of seroconversion against poliovirus type 1 among Indian children in Indore and Hyderabad compared to tOPV.
Please note that as of 18/10/2007 the anticipated end date of this trial was updated from the 31st December 2006 to 28th March 2006.
Ethics approval
Ethics approval received on the 20th October 2005.
Study design
Clinical trial, evaluation based, randomised double blind trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Prevention
Patient information sheet
Condition
Polio
Intervention
Monovalent Type 1 Oral Poliovirus Vaccine (mOPV1) versus Trivalent OPV (tOPV).
Measurements:
1. Cord blood will be collected immediately after birth
2. Blood collection at 30 days of age and stool collection taken
3. During one week follow-up, stool sample collected at day 7
Intervention type
Drug
Phase
Not Specified
Drug names
Monovalent Type 1 Oral Poliovirus Vaccine (mOPV1), Trivalent OPV (tOPV).
Primary outcome measure
Seroconversion after 30 days of a single dose of tOPV or mOPV1 produced for Biofarma bulk.
Secondary outcome measures
1. Prevalence of excretion of Poliovirus type 1 in stool specimens 7 days post-challenge with mOPV1 (age: 30 days + 7 days)
2. Comparison of mOPV1 produced by Biofarma bulk with the mOPV1 produced by Sanofi Pasteur bulk
Overall trial start date
25/10/2005
Overall trial end date
28/03/2006
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Healthy newborns (greater than or equal to 2.75 kg birth weight, apgar score at 5 minutes, greater than or equal to 9) at the study site(s) (large maternity hospitals)
2. Residing within a relatively short and easily accessible distance (less than 30 km)
3. Not planning to travel away during entire the study period (birth - 2 months)
Participant type
Patient
Age group
Neonate
Gender
Both
Target number of participants
600
Participant exclusion criteria
1. Newborns requiring hospitalisation
2. Birth weight below 2.75 kg
3. Apgar score at 5 minutes less than 9
4. Residence greater than 30 km from study site
5. Families expecting to be absent during the 60-day study period
6. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family) will render the newborn ineligible for the study
Recruitment start date
25/10/2005
Recruitment end date
28/03/2006
Locations
Countries of recruitment
India
Trial participating centre
World Health Organization
Geneva-27
CH 1211
Switzerland
Sponsor information
Organisation
Panacea Biotec Ltd (India)
Sponsor details
B-1 Extn. A-27
Mohan Co-op Industrial Estate
Mathura Road
New Delhi
110044
India
arani@pblintranet.com
Sponsor type
Industry
Website
Funders
Funder type
Research organisation
Funder name
Gates Foundation (USA) - grant received for a 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.