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Trial registered on ANZCTR


Registration number
ACTRN12616001272482
Ethics application status
Approved
Date submitted
12/08/2016
Date registered
9/09/2016
Date last updated
11/08/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Polio vaccines study in infants in Nigeria
Scientific title
Randomized Controlled Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children in the EPI Schedule
Secondary ID [1] 290010 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Poliomyelitis 299899 0
Condition category
Condition code
Infection 299802 299802 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Vaccines:
Bivalent oral poliovirus vaccine (bOPV) types 1 and 3
Inactivated Poliovirus Vaccine (IPV)
There are two Arms in the study, the infants in these Arms will receive bOPV and IPV both in different/reverse schedule as described below.
How many times:
Arm A - Infants will be administered 4 doses of bOPV, at birth, 6, 10 and 14 weeks age. In addition, these infants will receive 2 doses of IPV at 14 and 18 weeks age respectively
Arm B - Infants will receive 3 doses of IPV at 6, 10 and 14 weeks. In addition, they will receive a bOPV dose at 18 weeks.

Dose and route of administration:

Dose of bOPV will be the standard prescribed dose of 2 drops given orally and IPV also in the regular dose of 0.5 ml administered by intramuscular injection.

Who will administer and where:
The vaccines will be administered by experienced and trained vaccinators under the supervision of trained research physicians at four study sites in Nigeria:
1. Institute of Child Health, University of Nigeria Teaching Hospital (UNTH), Enugu,
2. Uwani Cottage Hospital Enugu,
3. Institute of Child Health, University of Ilorin Teaching Hospital and
4. Children Hospital, Ilorin.
Intervention code [1] 295608 0
Prevention
Comparator / control treatment
IPV at 6, 10 and 14 weeks age schedule (Arm B) is the comparator and bOPV at birth, 6,10 and 14 weeks schedule with an added dose of IPV at 14 weeks (Arm A) is the control treatment.
Control group
Active

Outcomes
Primary outcome [1] 299268 0
To assess seroconversion rates achieved for poliovirus types 1, 2 and 3 in bOPV-IPV schedule (Arm A) and IPV schedule (ArmB) comparing the level of neutralizing antibodies in serum samples collected at 18 weeks with the baseline samples collected at birth.
Timepoint [1] 299268 0
Completion of 18 week visit of participants, the fifth study visit.
Secondary outcome [1] 326697 0
To assess and compare seroconversion for poliovirus type 2 in the bOPV-IPV schedule with one IPV dose (Arm A) with bOPV and two dose IPV (extended Arm A) using serum samples collected at 18 and 22 weeks study visits.
Timepoint [1] 326697 0
Completion of 22 week visit of participants, the sixth and the last visit
Secondary outcome [2] 326698 0
To assess seroconversion for all three poliovirus types in two/three dose IPV schedule by comparing level of serum neutralizing antibodies in Arm B in 14 and 18 week samples
Timepoint [2] 326698 0
Completion of 18 week visit of participants

Eligibility
Key inclusion criteria
*Infants aged less than or equal to 14 days
*Subject who have not received any polio vaccine since birth
*Baby weighing greater than or equal to 2.5 Kg at the time of enrolment
*Residential address within 20 km radius of the study site
*Assessed to be available for all follow up visits
Minimum age
0 Days
Maximum age
14 Days
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
*Subjects with any major congenital abnormality, serious medical condition, contraindication for venepuncture or any other condition judged by the investigator for exclusion
*Known/suspected immunodeficiency disorder in baby or immediate family member

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
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 8093 0
Nigeria
State/province [1] 8093 0
Enugu and Kwara

Funding & Sponsors
Funding source category [1] 294294 0
Charities/Societies/Foundations
Name [1] 294294 0
Rotary International PolioPlus Committee
Address [1] 294294 0
Rotary International
One Rotary Center
1560 Sherman Ave.
Evanston, IL 60201-3698, USA
Country [1] 294294 0
United States of America
Primary sponsor type
Government body
Name
National Primary Health Care Development Agency (NPHCDA), Nigeria
Address
Plot 68/682 Port-Harcourt Crescent, Off Gimbiya Street, Area 11, Garki, Abuja, Nigeria
Country
Nigeria
Secondary sponsor category [1] 293137 0
Other Collaborative groups
Name [1] 293137 0
World Health Organization
Address [1] 293137 0
20, avenue Appia -1211 Geneva 27
Switzerland
Country [1] 293137 0
Switzerland

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295725 0
Research Ethics Review Committee (WHO ERC)
Ethics committee address [1] 295725 0
World Health Organization,
20, avenue Appia - 1211
Geneva 27
Switzerland
Ethics committee country [1] 295725 0
Switzerland
Date submitted for ethics approval [1] 295725 0
01/04/2016
Approval date [1] 295725 0
09/05/2016
Ethics approval number [1] 295725 0
ERC.0002737

Summary
Brief summary
This vaccines study has been planned to generate data on efficacy of different polio vaccines in Nigerian children. National Primary Health Care Development Agency (NPHCDA) Nigeria and Paediatric Association of Nigeria (PAN) had shown keen interest to generate data on the efficacy of vaccines currently in use and also for future informed decisions on future policy changes in vaccination against poliomyelitis in Nigeria and elsewhere. On request from NPHCDA, World Health Organization (WHO) agreed to build research capacity in Nigeria and extend technical and financial (through Rotary IPPC) support for this trial.

Primary purpose of the study is to assess and compare the efficacy of the currently in use vaccination schedule using bivalent oral polio vaccine (bOPV) and inactivated poliovirus vaccine (IPV) with IPV only schedule. The study will assess protection provided by different number of bOPV doses and IPV doses separately and also in different bOPV-IPV & IPV-bOPV combination schedules. Data from the study will provide confidence to the immunization program managers of the country in the present vaccination schedule and inputs for informed decisions in future.

Sample size of the study is 520. Two study sites each in Enugu and Ilorin states of Nigeria will enroll 260 healthy new born babies in the study. The enrolled babies will be followed up for different vaccination visits and small quantity blood collections during some of the visits up to 5 1/2 months age. The study participants mothers will be given advice on good care of babies on nutrition, growth and development. Entire vaccination requirement of babies will be taken care by the investigators including medical care when needed.

Data from the study is expected to confirm that polio vaccines are efficacious and safe in Nigerian/African children.

Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 68234 0
Dr Beckie N Tagbo
Address 68234 0
Chief Consultant Paediatrician
Institute of Child Health
University of Nigeria Teaching Hospital, Enugu,
Nigeria

Country 68234 0
Nigeria
Phone 68234 0
+2348033096473
Fax 68234 0
Email 68234 0
tagbobeckie@gmail.com
Contact person for public queries
Name 68235 0
Dr Mahmud Z Mustafa
Address 68235 0
Director Logistics and Health Commodities
NPHCDA
Abuja
Nigeria
Country 68235 0
Nigeria
Phone 68235 0
+2348056208188
Fax 68235 0
Email 68235 0
drmahmudmz@gmail.com
Contact person for scientific queries
Name 68236 0
Dr Harish Verma
Address 68236 0
World Health Organization
20, avenue Appia - 1211
Geneva 27
Switzerland
Country 68236 0
Switzerland
Phone 68236 0
+41227913567
Fax 68236 0
Email 68236 0
vermah@who.int

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary