Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12612000259842
Ethics application status
Approved
Date submitted
29/02/2012
Date registered
2/03/2012
Date last updated
2/03/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Immune response to polio vaccine in malnourished and normally nourished Pakistani infants
Scientific title
Immunogenicity of Combined Bivalent OPV and IPV Vaccines at 9 - 12 months of Age Compared to bOPV alone in Malnourished and Non-Malnourished Pakistani Infants, Aga Khan University, Karachi Pakistan
Secondary ID [1] 280051 0
Nil known
Universal Trial Number (UTN)
U1111-1128-6674
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
polio vaccine immunogenecity 285964 0
Condition category
Condition code
Infection 286149 286149 0 0
Other infectious diseases
Public Health 286155 286155 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
inactivated (injectable) polio vaccine (0.5 ml) together with bivalent oral polio vaccine (two drops) administered once to malnourished and normally nourished children between 9-12 months of age

challenge dose with bivalent oral polio vaccine (two drops) administered one month post initial vaccine administration
Intervention code [1] 284374 0
Prevention
Comparator / control treatment
bivalent oral polio vaccine (two drops) administered once to malnourished and normally nourished children between 9-12 months of age

challenge dose with bivalent oral polio vaccine (two drops) administered one month post initial vaccine administration
Control group
Active

Outcomes
Primary outcome [1] 286622 0
Difference in seropositivity and mean geometric titers between baseline sera and post-intervention sera (after 1 month) in chronically malnourished infants 9-12 month of age who receive bivalent OPV (reference arm) compared to infants who receive single dose of IPV combined with bivalent OPV (intervention arm)
Timepoint [1] 286622 0
1 month after vaccine introduction
Secondary outcome [1] 296292 0
Difference in seropositivity and mean geometric titers between baseline sera and post-intervention sera (after 1 month) in normally nourished infants 9-12 month of age who receive bivalent OPV (reference arm) compared to infants who receive single dose of IPV combined with bivalent OPV (intervention arm)
Timepoint [1] 296292 0
1 month after vaccine introduction

Eligibility
Key inclusion criteria
Infant aged 9 - 12 months of age
Resident of the study area for last 3 month at the time of enrolment
Parent/guardian provides informed consent

Nutritional status will be assessed; chronically malnourished children and normally nourished children will be assigned to different study arms
Minimum age
9 Months
Maximum age
12 Months
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Infant already enrolled in any other polio intervention study.
Allergic to antibiotics neomycin, streptomycin or polymyxin B (as these antibiotics are the component of IPV and may lead to severe life-threatening events)
Infant found acutely ill at the time of enrolment, requiring emergent medical care
Infant with moderate and severe acute malnutrition, defined by a very low weight for height (below -2z and -3z scores of the median WHO growth standards respectively).
Refusal of blood testing
Receipt of supplementary dose of OPV within 4 weeks of first study visit
Infant with certain medical conditions i.e., cerebral palsy, syndromic infants, infants on corticosteroids because of any medical illness, thrombocytopenia (contraindication of intramuscular injections), malignancies and infant with primary immunodeficiency

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
Not yet recruiting
Date of first participant enrolment
Anticipated
15/04/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
840
Accrual to date
Final
Recruitment outside Australia
Country [1] 4179 0
Pakistan
State/province [1] 4179 0

Funding & Sponsors
Funding source category [1] 284803 0
Other
Name [1] 284803 0
World Health Organization
Country [1] 284803 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] 283699 0
None
Name [1] 283699 0
Address [1] 283699 0
Country [1] 283699 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 286792 0
WHO ERC
Ethics committee address [1] 286792 0
World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse
Ethics committee country [1] 286792 0
Switzerland
Date submitted for ethics approval [1] 286792 0
Approval date [1] 286792 0
02/02/2012
Ethics approval number [1] 286792 0
RPC492

Summary
Brief summary
Because of the questionable immunogenicity of OPV in moderate to severe chronically malnourished children in a country which is having a hard time ensuring each and every child receives more than 7 doses of OPV, a transitional strategy comprising of OPV and inactivated poliovirus vaccine (IPV) may be effective in boosting intestinal and serological immunity in selected high risk populations such as in areas with a high proportion of moderate to severe chronically malnourished children. There is limited evidence to show if OPV and IPV given together results in a sufficient antigenic load to induce enhanced immunogenicity (intestinal and serological) in moderate to severe chronically malnourished children.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 33852 0
Address 33852 0
Country 33852 0
Phone 33852 0
Fax 33852 0
Email 33852 0
Contact person for public queries
Name 17099 0
Ondrej Mach
Address 17099 0
Research and Product Development Team
Global Polio Eradication Initiative

World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse
Country 17099 0
Switzerland
Phone 17099 0
+41227911863
Fax 17099 0
Email 17099 0
[email protected]
Contact person for scientific queries
Name 8027 0
Ondrej Mach
Address 8027 0
Research and Product Development Team
Global Polio Eradication Initiative

World Health Organization
Avenue Appia 20
CH-1211 Geneve 27 Suisse
Country 8027 0
Switzerland
Phone 8027 0
+41227911863
Fax 8027 0
Email 8027 0
[email protected]

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
No additional documents have been identified.