IPV Clinical Trial - The Gambia

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01847872
• Date of registration: 19/04/2013
• Prospective Registration: Yes
• Primary sponsor: London School of Hygiene and Tropical Medicine
• Public title: IPV Clinical Trial - The Gambia IPV
• Scientific title: A Phase 4, Randomized Trial to Assess the Safety and Immunogenicity of Inactivated Poliovirus Vaccine When Given Concomitantly With Measles and Rubella Combined Vaccine and Yellow Fever Vaccine at Nine Months and When Administered Via Different Vaccination Routes
• Date of first enrolment: July 2013
• Target sample size: 1504
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01847872
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: None (Open Label).
• Phase: Phase 4

Countries of recruitment

Gambia

Contacts

• Name: Ed Clarke, MD
• Affiliation: Medical Research Council Unit, The Gambia

Key inclusion & exclusion criteria

Inclusion Criteria:

- Nine to ten months of age inclusive

- Receipt of at least three doses of tOPV (excluding a dose given at birth) a minimum of
four weeks prior to recruitment date

- Informed consent for trial participation obtained from a parent/guardian (see section
19.1.2 for definition of guardian and section 19.1.3 for details regarding consent
procedure)

- Resident in the study area and with no plans to travel outside the study area during
the period of subject participation

- Willingness and capacity to comply with the study protocol as judged by a member of
the clinical trial team

Exclusion Criteria:

- Use of any Investigational Medicinal Product(IMP) within the 28 days preceding
enrolment

- Planned administration of any vaccine outside those defined in the study protocol at
anytime during trial participation (for procedure in the event of a national OPV
campaign see section 12.5.1.1)

- Previous receipt of a measles, rubella, yellow fever or IPV vaccine

- Bacillus Calmette-Guérin(BCG) vaccination in the month prior to recruitment

- Any suspected or confirmed congenital or acquired state of immune deficiency including
but not limited to primary immunodeficiencies including thymus disorders, HIV/AIDS,
hematological or lymphoid malignancies (blood tests will not be routinely undertaken
with this regard as part of the study)

- Any current immunosuppressive/immunomodulatory medication or treatment including, but
not limited to corticosteroids, cyclosporin, azathioprine, cyclophosphamide,
methotrexate, radiotherapy, bone marrow transplantation

- Receipt of any immunosuppressive or immunomodulatory medication or treatment within
the six months preceding trial enrolment (for corticosteroids this is defined as a
dose of prednisolone (or equivalent) of greater than 2mg/kg/day for one week or
1mg/kg/day for one month. The use of inhaled or topical corticosteroids is not an
exclusion criteria

- Receipt of pooled human immunoglobulin, other blood product or any monoclonal antibody
therapy at any point prior to recruitment or plans to receive such therapy at any
point during the trial-

- Any significant congenital defect or significant chronic health problem (e.g. chronic
hematological (including severe anemia), renal, gastrointestinal, respiratory,
neurological and cardiovascular disorders).

- A history of anaphylactic or anaphylactoid reaction to egg, chicken proteins,
neomycin, streptomycin polymyxin B, any previous vaccination or any individual
component of one of the vaccines

- Confirmed fructose intolerance

- Severe protein-energy malnutrition (weight-for-age Z-score of less than -3)

- Any clinically suspected or confirmed congenital or acquired clotting or bleeding
disorder or any mediation known to significantly interfere with clotting (e.g.
hemophilia or current anti-coagulant therapy) (blood tests will not be routinely
undertaken with this regard as part of the study)

- Any other condition which, in the opinion of the research clinician or ultimately the
PI, is likely to interfere with the assessment of the primary and secondary objectives

- Any significant signs or symptoms of an acute illness or infection including a
tympanic temperature >38.0°C or documented fever >38°C in the preceding 48 hours



Age minimum: 9 Months
Age maximum: 10 Months
Gender: All

Health Condition(s) or Problem(s) studied

Poliomyelitis

Intervention(s)

Drug: IPV IM Needle

Drug: IPV IM Device

Drug: IPV ID Device

Drug: IPV ID Needle

Primary Outcome(s)

interference and immunugenicity [Time Frame: 4 - 6 weeks after vaccination]

Safety [Time Frame: up to 10 weeks after first vaccination]

Secondary Outcome(s)

Cellular immune responses (B and T cells) to IPV vaccination [Time Frame: up to 4 - 6 weeks post vaccination]

time motion study [Time Frame: 4- 6 weeks]

Perception of devices [Time Frame: 4 to 6 weeks]

stool tOPV quantification [Time Frame: Day 14 - 21 after tOPV administration]

Secondary ID(s)

SCC 1327

Source(s) of Monetary Support

Please refer to primary and secondary sponsors