Condition category
Infections and Infestations
Date applied
01/02/2006
Date assigned
01/02/2006
Last edited
17/01/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.panacea-biotec.com/

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

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21641951

Publication citations

  1. 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.

Additional files

Editorial Notes