None listed
Conditions
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.
Interventions
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 we
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.
Sponsors
National Primary Health Care Development Agency (NPHCDA), Nigeria
Study design
Allocation
Randomised controlled trial
Primary purpose
Prevention
Eligibility
Sex/Gender
All
Age
0 to 14 Days
Healthy volunteers
No
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
Outcome results
None listed