ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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

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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Poliomyelitis

Condition category

Condition code

Infection

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]

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]

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]

Completion of 18 week visit of participants, the fifth study visit.

Secondary outcome [1]

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]

Completion of 22 week visit of participants, the sixth and the last visit

Secondary outcome [2]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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

16/08/2016

Date of last participant enrolment

Anticipated

Actual

10/10/2016

Date of last data collection

Anticipated

Actual

10/03/2017

Sample size

Target

520

Accrual to date

Final

534

Recruitment outside Australia

Country [1]

Nigeria

State/province [1]

Enugu and Kwara

Funding & Sponsors

Funding source category [1]

Charities/Societies/Foundations

Name [1]

Rotary International PolioPlus Committee

Address [1]

Rotary International
One Rotary Center
1560 Sherman Ave.
Evanston, IL 60201-3698, USA

Country [1]

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]

Other Collaborative groups

Name [1]

World Health Organization

Address [1]

20, avenue Appia -1211 Geneva 27
Switzerland

Country [1]

Switzerland

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Research Ethics Review Committee (WHO ERC)

Ethics committee address [1]

World Health Organization,
20, avenue Appia - 1211
Geneva 27
Switzerland

Ethics committee country [1]

Switzerland

Date submitted for ethics approval [1]

01/04/2016

Approval date [1]

09/05/2016

Ethics approval number [1]

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

Dr Beckie N Tagbo

Address

Chief Consultant Paediatrician
Institute of Child Health
University of Nigeria Teaching Hospital, Enugu,
Nigeria

Country

Nigeria

Phone

+2348033096473

Fax

tagbobeckie@gmail.com

Contact person for public queries

Name

Mahmud Z Mustafa

Address

Director Logistics and Health Commodities
NPHCDA
Abuja
Nigeria

Country

Nigeria

Phone

+2348056208188

Fax

drmahmudmz@gmail.com

Contact person for scientific queries

Name

Harish Verma

Address

World Health Organization
20, avenue Appia - 1211
Geneva 27
Switzerland

Country

Switzerland

Phone

+41227913567

Fax

vermah@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

Source	Title	Year of Publication	DOI
Embase	Randomized Controlled Clinical Trial of Bivalent Oral Poliovirus Vaccine and Inactivated Poliovirus Vaccine in Nigerian Children.	2022	https://dx.doi.org/10.1093/infdis/jiaa726

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically