Polio vaccines study in infants in Nigeria

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12616001272482
• Date of registration: 09/09/2016
• Prospective Registration: No
• Primary sponsor: National Primary Health Care Development Agency (NPHCDA), Nigeria
• 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
• Date of first enrolment: 16/08/2016
• Target sample size: 520
• Recruitment status: Completed
• URL: https://anzctr.org.au/ACTRN12616001272482.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial;

Countries of recruitment

Nigeria

Contacts

• Name: Dr Harish Verma

• Name: Dr Mahmud Z Mustafa

Key inclusion & exclusion criteria

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

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


Age minimum: Days
Age maximum: 14 Days
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Infection - Other infectious diseases

Poliomyelitis;
Poliomyelitis

Intervention(s)

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.

Primary Outcome(s)

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

Secondary Outcome(s)

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.[Completion of 22 week visit of participants, the sixth and the last visit]

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[Completion of 18 week visit of participants]

Secondary ID(s)

None

Source(s) of Monetary Support

Rotary International PolioPlus Committee

Secondary Sponsor(s)

World Health Organization

Ethics review

Status: Approved
Approval date:
Contact:

Research Ethics Review Committee (WHO ERC)