Status:
COMPLETED
Safety and Immunogenicity of a 10 Valent Pneumococcal Conjugate Vaccine (SIILPCV10) in Healthy Adults, Toddlers, Infants
Lead Sponsor:
PATH
Conditions:
Pneumococcal Disease
Eligibility:
All Genders
4-40 years
Phase:
PHASE1
PHASE2
Brief Summary
Phase 1/2, Prospective, Single Center, Randomized, ActiveControlled, Double-Blind, Age De-escalation Study to assess the safety and tolerability of SIILPCV10 administered as a single-dose regimen to h...
Detailed Description
This was a prospective, single-center, randomized, active-controlled, double-blind, age de escalation study in healthy Gambian PCV-naïve adults (18-40 years old), PCV primed toddlers (12-15 months old...
Eligibility Criteria
Inclusion
- • Healthy adults (18-40 yrs), toddlers (12-15 mo), full term infants (6-8 wks) and ≥ 3.5 kg
- Able to provide informed consent (for themselves or child)
- Willing to comply with study requirements and procedures.
- Toddlers have completed their Gambian infant EPI schedule
- Infants who have received the birth doses of BCG, HepB and OPV but who have not received any additional vaccines.
- Infants and toddlers with a weight-to-height Z score of ≥ -2.
- Subjects resident in the study area with no plans to travel outside the study area during the period of study participation.
Exclusion
- Use of any investigational medicinal product within 90 days prior to randomization and throughout the study.
- Ingestion of herbal or other traditional local medication within 14 days of randomization.
- Adults and infants who have previously been vaccinated against S. pneumoniae.
- History of S. pneumoniae infection confirmed by culture from a normally sterile site.
- History of allergic disease or history of a serious reaction to any prior vaccination or known hypersensitivity to any component of the study vaccines.
- History of anaphylactic shock.
- Screening laboratory test or vital signs outside the normal range.
- HIV-positive or HbsAg- positive based on testing during screening.
- Acute illness (moderate or severe) and/or fever (axillary temperature of ≥ 38.0°C for adults or ≥ 37.5°C for toddlers and infants).
- Use of antibiotics within 5 days of randomization (excluding treatment for malaria).
- A positive test for malaria at time of screening, which remains positive post treatment when retested at time of randomization (Day 0).
- Administration of any non-study vaccine within 30 days prior to administration of study vaccine or planned vaccination during the course of study participation.
- Chronic administration of immunosuppressant or other immune modifying drugs prior to the administration of the study. The use of topical and inhaled glucocorticoids will be permitted.
- Administration of immunoglobulins and/or any blood products within the 6 months prior to administration of the study vaccine or during the study period.
- History of known disturbance of coagulation or blood disorder that could cause anemia or excess bleeding.
- Employee of, or direct descendant of any person employed by the Sponsor, the CRO, the PI, study site personnel, or site.
- Adults only
- Recent history or signs of alcohol or substance abuse.
- History of major psychiatric disorder.
- Female adult subjects who are pregnant or breast-feeding. Infants/Toddlers only
- Family history of suspected primary immunodeficiency in first-degree relative.
- Had a sibling die suddenly and without apparent other cause or preceding illness in the first year of life.
- Evidence of a clinically significant congenital abnormality as judged by the PI.
- Evidence of fetal alcohol syndrome or maternal history of alcohol abuse during pregnancy.
- History of meningitis, seizures or any neurological disorder.
- Evidence of exposure to an HIV-positive individual through maternal fetal transmission, breast milk, or other bloodborne mechanisms
Key Trial Info
Start Date :
January 12 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 3 2016
Estimated Enrollment :
346 Patients enrolled
Trial Details
Trial ID
NCT02308540
Start Date
January 12 2015
End Date
November 3 2016
Last Update
August 2 2019
Active Locations (1)
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1
Medical Research Council (MRC) Unit, The Gambia
Fajara, The Gambia