Contact information
Type
Scientific
Primary contact
Dr Roland Sutter
ORCID ID
Contact details
World Health Organization
20 Avenue Appia
Geneva
CH-1211
Switzerland
+41 (0)22 791 4682
sutterr@who.int
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RPC273
Study information
Scientific title
Acronym
Study hypothesis
To determine if one or two doses of mOPV2 or mOPV3 induces significantly higher levels of seroconversion against poliovirus types 2 or 3, respectively, than does one or two doses of tOPV to these Sabin strains and to determine if one or two doses of bOPV induces similar seroconversion to types 1 and 3, respectively, compared to one or two doses of mOPV1 or mOPV3. Additionally, at one site (Indore), to determine if one or two doses of mOPV2 or mOPV3 significantly reduces excretion of poliovirus types 2 or 3, respectively than does one or two doses of tOPV and to determine if one or two doses of bOPV significantly reduces excretion of poliovirus type 1 and type 3 than does one or two doses of tOPV.
Ethics approval
1. MGM Medical College gave approval on the 7th June 2008 (ref: PBL/CR/0042008/CT)
2. The Drug Controller General of India gave approval on the 11th June 2008 (ref: PBL/CR/0042008/CT)
Study design
Randomised double-blind clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Poliomyelitis
Intervention
1. Control: standard trivalent oral poliovirus vaccine (tOPV) - one or two doses
2. Intervention group one: monovalent type 1 oral poliovirus vaccine (mOPV1) - one or two doses
3. Intervention group two: monovalent type 2 oral poliovirus vaccine (mOPV2) - one or two doses
4. Intervention group three: monovalent type 3 oral poliovirus vaccine (mOPV3) - one or two doses
5. Intervention group four: bivalent type 1 and 3 oral poliovirus vaccine (bOPV) - one or two doses
Contact details of Principal Investigator:
Dr T Jacob John
439 Civil Supplies Godown Lane
Kamalakshipuram
Vellore 632 002
India
Tel: +91 (0)416 226 7364
Email: vlr_tjjohn@sancharnet.in
Intervention type
Drug
Phase
Not Specified
Drug names
Oral poliovirus vaccines
Primary outcome measures
Seroconversion 30 days after a single dose of mOPV2 or mOPV3 compared to tOPV or seroconversion following a single dose of bOPV compared to mOPV1.
Secondary outcome measures
1. Seroconversion of two doses of mOPV2 or mOPV3 compared to tOPV
2. Seroconversion of one or two doses of bOPV compared to mOPV1 or mOPV3
3. Prevalence of excretion of poliovirus serotypes 1, 2, and 3 at 7, 30, 37, and 60 days (at Indore site only)
Overall trial start date
13/08/2008
Overall trial end date
13/10/2008
Reason abandoned
Eligibility
Participant inclusion criteria
1. Healthy newborns (either sex) (greater than or equal to 2.50 kg birth weight, apgar score at 5 min greater than or equal to 9) at the study sites (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
900
Participant exclusion criteria
1. Newborns requiring hospitalisation
2. Birth weight below 2.50 kg
3. Apgar score at 5 min 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
13/08/2008
Recruitment end date
13/10/2008
Locations
Countries of recruitment
India
Trial participating centre
World Health Organization
Geneva
CH-1211
Switzerland
Sponsor information
Organisation
Panacea Biotec Limited (India)
Sponsor details
B-1 Extn/G-3
Mohan Co-op. Indl. Estate
Mathura Road
New Delhi
110044
India
+91 (0)11 4167 8000/9000
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
World Health Organization (WHO) (Switzerland)
Alternative name(s)
WHO
Funding Body Type
private sector organisation
Funding Body Subtype
international
Location
Switzerland
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
Results - basic reporting
Publication summary
1. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20980048
Publication citations
-
Results
Sutter RW, John TJ, Jain H, Agarkhedkar S, Ramanan PV, Verma H, Deshpande J, Singh AP, Sreevatsava M, Malankar P, Burton A, Chatterjee A, Jafari H, Aylward RB, Immunogenicity of bivalent types 1 and 3 oral poliovirus vaccine: a randomised, double-blind, controlled trial., Lancet, 2010, 376, 9753, 1682-1688, doi: 10.1016/S0140-6736(10)61230-5.