Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12612000276853
Ethics application status
Approved
Date submitted
29/02/2012
Date registered
8/03/2012
Date last updated
18/04/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparing immune response to oral polio vaccine administered at short intervals with vaccine administered at standard intervals in healthy newborns in Pakistan
Scientific title
Comparison of Immunogenicity Of Type 1 Monovalent Oral Polio Vaccine (mOPVl) Administered at Short Intervals with Type 1 Monovalent (mOPVl) And Type 1&3 Bivalent (bOPV1&3) Oral Polio Vaccine Given At Standard Intervals in Healthy Newborns in Pakistan: A Randomized Trial; Aga Khan University, Karachi
Secondary ID [1] 280060 0
None known
Universal Trial Number (UTN)
U1111-1128-7348
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
poliomyelitis 285970 0
Condition category
Condition code
Infection 286156 286156 0 0
Other infectious diseases
Public Health 286157 286157 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Three intervention arms:
1) Birth tOPV; day 42 mOPV1, day 49 mOPV1, day 79 tOPV, day 107 tOPV
2) Birth tOPV; day 42 mOPV1, day 56 mOPV1, day 86 tOPV, day 114 tOPV
3) Birth tOPV; day 42 mOPV1, day 72 mOPV1, day 102 tOPV, day 130 tOPV

tOPV: trivalent oral polio vaccine; mOPV1: monovalent type 1 oral polio vaccine
Dose for all oral polio vaccines: two drops
Intervention code [1] 284383 0
Prevention
Comparator / control treatment
One control comparator:
Birth tOPV; day 42 bOPV, day 72 bOPV, day 102 tOPV, day 130 tOPV

bOPV: bivalent oral polio vaccine type 1 and 3 (two drops administered orally)
Control group
Active

Outcomes
Primary outcome [1] 286630 0
A schedule of two doses of mOPV1 administered at a 7 or 14 day interval following a previous mOPV1 dose administered at 42 days induces comparable levels of seroconversion against poliovirus type 1 compared to a schedule of two doses of mOPV1 given at a standard interval of 30 days apart
Timepoint [1] 286630 0
102 days after study enrollment
Secondary outcome [1] 296327 0
A schedule of two doses of mOPV1 administered at a 7 or 14 day interval following a previous mOPV1 dose administered at 42 days induces comparable levels of seroconversion against poliovirus type 1 compared to a schedule of two doses of bOPV1&3 administered at a standard interval of 30 days apart.
Timepoint [1] 296327 0
102 days after study enrollment

Eligibility
Key inclusion criteria
Infants born healthy (> 2.5 kg birth weight, immediate cry, no neonatal IMCI danger signs) at the study sites (home or health facility births assisted by study-Trained Birth Attendants/other health personnel) and not planning to travel away during entire the study period (birth-102 days).
Minimum age
0 Days
Maximum age
0 Days
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
High-risk newborns will be excluded, as well as newborns requiring hospitalization, birth weight below 2.5 kg, cry >2 minutes, and with any neonatal IMNCI danger signs, residence >30 km from study site, or family is planning to be absent during the birth - 102 day study period. A diagnosis or suspicion of immunodeficiency disorder (either in the participant or in a member of the immediate family - e.g. several early infant deaths, household member on chemotherapy) will render the newborn ineligible for the study.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
15/03/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
800
Accrual to date
Final
Recruitment outside Australia
Country [1] 4180 0
Pakistan
State/province [1] 4180 0

Funding & Sponsors
Funding source category [1] 284812 0
Other
Name [1] 284812 0
World Health Organization
Country [1] 284812 0
Switzerland
Primary sponsor type
Other
Name
WHO
Address
World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse
Country
Switzerland
Secondary sponsor category [1] 283693 0
None
Name [1] 283693 0
Address [1] 283693 0
Country [1] 283693 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286802 0
WHO ERC
Ethics committee address [1] 286802 0
World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse
Ethics committee country [1] 286802 0
Switzerland
Date submitted for ethics approval [1] 286802 0
Approval date [1] 286802 0
25/08/2011
Ethics approval number [1] 286802 0
RPC 454

Summary
Brief summary
In order to generate data on 2-dose seroconversion with short interval monovalent OPV1 administration, and standard interval monovalent OPV1 and bivalent OPV (1&3) administration, we will assess additional programmatic options for short-interval SIA rounds in Pakistan and conduct a clinical trial in Karachi, Pakistan where immunogenicity of supplemental mOPV doses in a naive population (newborns) needs objective evaluation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33856 0
Address 33856 0
Country 33856 0
Phone 33856 0
Fax 33856 0
Email 33856 0
Contact person for public queries
Name 17103 0
Ondrej Mach
Address 17103 0
World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse
Country 17103 0
Switzerland
Phone 17103 0
+41227911863
Fax 17103 0
Email 17103 0
macho@who.int
Contact person for scientific queries
Name 8031 0
Ondrej Mach
Address 8031 0
World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse
Country 8031 0
Switzerland
Phone 8031 0
+41227911863
Fax 8031 0
Email 8031 0
macho@who.int

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
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