Condition category
Infections and Infestations
Date applied
12/09/2005
Date assigned
01/02/2006
Last edited
17/10/2008
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

Ms 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

RPC 127

Study information

Scientific title

Acronym

Study hypothesis

One dose of monovalent oral poliovirus vaccine induces higher levels of seroconversion against poliovirus type 1 when compared to trivalent oral poliovirus vaccine.

Please note that as of 18/10/2007 the anticipated start and end dates of this trial were modified, the initial trial dates were as follows:
Anticipated start date: 15/07/2005
Anticipated end date: 31/07/2006

Ethics approval

Ethics approval received on the 28th June 2005.

Study design

Clinical trial, evaluation based, randomised double blind trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Polio

Intervention

One dose of monovalent oral poliovirus vaccine compared to trivalent oral poliovirus vaccine.

Measurements:
1. Cord blood will be collected immediately after birth
2. 30 days after birth, second sample of blood collected by heel stick method and a stool sample taken
3. Four additional stool samples collected on a weekly basis at 7, 14, 21, and 28 days after birth
4. 60 days after birth, third sample of blood collected by heel stick method

Intervention type

Drug

Phase

Not Specified

Drug names

Oral poliovirus

Primary outcome measures

To demonstrate the superiority of one dose of mOPV1 compared with tOPV by assessing:
1. Humoral Immunity - one dose of mOPV1 induces significantly higher levels of seroconversion against poliovirus type 1 than does one dose of tOPV
2. Mucosal Immunity - one dose of mOPV1 significantly reduces excretion of poliovirus type 1 after a mOVP1 challenge than following one dose of tOPV

Secondary outcome measures

The secondary endpoint is prevalence of excretion of poliovirus type 1 in stool specimens 7 days post-challenge with mOPV1 at age 30 days + 7 days. Additional endpoints will be prevalence of excretion in 4 weeks after mOPV1 challenge by vaccination group; and seroconversion at 60 days after 2 doses of mOPV1 (no control available).

Overall trial start date

15/07/2005

Overall trial end date

31/07/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Infants born healthy (greater than or equal to 2.75 kg, apgar score greater than or equal to 9 at five minutes) at the study site(s) (large maternity hospitals)
2. Residing within a relatively short and easily accessible distance (less than 30 km) in the same governorate as the study site
3. Not planning to travel away during entire the study period (birth to two months)

Participant type

Patient

Age group

Neonate

Gender

Both

Target number of participants

600

Participant exclusion criteria

1. High-risk newborns will be excluded
2. Newborns requiring hospitalisation
3. Birth weight below 2.75 kg
4. Apgar score less than 9 at five minutes
5. Residence greater than 30 km from study site (or residing in another governorate)
6. Family is planning to be absent during the 60-day study period
7. 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

15/07/2005

Recruitment end date

31/07/2005

Locations

Countries of recruitment

Egypt

Trial participating centre

World Health Organization
Geneva-27
CH 1211
Switzerland

Sponsor information

Organisation

World Health Organization (WHO) (Switzerland)

Sponsor details

20
Avenue Appia
Geneva-27
CH 1211
Switzerland
+41 (0)22 791 3135
sutterr@who.int

Sponsor type

Research organisation

Website

http://www.who.int

Funders

Funder type

Charity

Funder name

Gates Foundation (USA)

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

Results http://www.ncbi.nlm.nih.gov/pubmed/18923170

Publication citations

  1. Results

    el-Sayed N, el-Gamal Y, Abbassy AA, Seoud I, Salama M, Kandeel A, Hossny E, Shawky A, Hussein HA, Pallansch MA, van der Avoort HG, Burton AH, Sreevatsava M, Malankar P, Wahdan MH, Sutter RW, Monovalent type 1 oral poliovirus vaccine in newborns., N. Engl. J. Med., 2008, 359, 16, 1655-1665, doi: 10.1056/NEJMoa0800390.

Additional files

Editorial Notes