Phase
Condition
Hiv Infections
Aids And Aids Related Infections
Hiv/aids
Treatment
Prevnar 13™
V114
PNEUMOVAX™23
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Male or female between the ages of 6 and 17 years (inclusive) infected with HIV andhas a Cluster of Differentiation 4+ (CD4+) T-cell count ≥200 cells/µL and plasma HIVribonucleic acid (RNA) <50,000 copies/mL
- Is Pneumococcal Conjugate Vaccine (PCV) naïve, previously vaccinated with a <13-valentPCV, partially vaccinated with Prevnar 13™, or has a history of previous Prevnar 13™vaccination ≥3 years before Visit 2 (Day 1)
- Is PnPs vaccine naïve or has a history of 1 previous PnPs vaccination ≥5 years beforeVisit 2 (Day 1)
- Female participant: not pregnant, not breastfeeding and 1) not of childbearingpotential, or 2) of childbearing potential and agrees to practice contraceptionthrough 6 weeks after administration of last dose of the study vaccine.
Exclusion
Exclusion Criteria:
- History of World Health Organization (WHO) HIV classification of clinical Stage 4disease within the past 12 months
- History of invasive pneumococcal disease
- Known hypersensitivity to any vaccine component
- Known or suspected congenital immunodeficiency (other than HIV infection), functionalor anatomic asplenia, or history of autoimmune disease
- Bleeding disorder contraindicating intramuscular vaccinations
- History of malignancy ≤5 years prior to signing informed consent/assent, except foradequately treated basal cell or squamous cell skin cancer or in situ cervical cancer
- Female participant: positive urine or serum pregnancy test
- Expect to receive any pneumococcal vaccine during the study outside of the protocol
- Receiving immunosuppressive therapy, including chemotherapeutic agents used to treatcancer or other conditions, and interventions associated with organ or bone marrowtransplantation, or autoimmune disease
- Received a blood transfusion or blood products within 6 months of enrollment
- Participated in another clinical study of an investigational product within 2 monthsof enrollment
- Current user of recreational or illicit drugs or history of drug or alcohol abuse ordependence
Study Design
Connect with a study center
Perinatal HIV Research Unit ( Site 0042)
Johannesburg, Gauteng 1864
South AfricaSite Not Available
Wits Reproductive Health and HIV Institute (WRHI) ( Site 0043)
Johannesburg, Gauteng 2001
South AfricaSite Not Available
Family Clinic Research With UBUNTU ( Site 0045)
Cape Town, Western Cape 7505
South AfricaSite Not Available
Be Part Yoluntu Centre ( Site 0041)
Paarl, Western Cape 7626
South AfricaSite Not Available
Faculty of Medicine - Khon Kaen University-Pediatrics ( Site 0063)
Amphoe Mueang, Khon Kaen 40002
ThailandSite Not Available
Chulalongkorn University-Pediatrics ( Site 0062)
Bangkok, Krung Thep Maha Nakhon 10330
ThailandSite Not Available
Faculty of Medicine Siriraj Hospital-Pediatric Infectious Diseases ( Site 0064)
Bangkok, Krung Thep Maha Nakhon 10700
ThailandSite Not Available
CM Clinical Trial Unit-CM Clinical Trial Unit ( Site 0061)
Chiang Mai, 50200
ThailandSite Not Available
Community Instit Dnipropetrovsk Municipal clinical Hospital #21 ( Site 0088)
Dnipro, Dnipropetrovska Oblast 49006
UkraineSite Not Available
Dnipropetrovsk Regional Center of Socially Significant Diseases ( Site 0082)
Dnipro, Dnipropetrovska Oblast 49115
UkraineSite Not Available
Odesa Regional Center of Socially Significant Diseases ( Site 0083)
Odesa, Odeska Oblast 65014
UkraineSite Not Available
Vinnitsa Reg Cntr for AIDS Prevention-Control-Outpatient clinic dept ( Site 0086)
Vinnytsia, Vinnytska Oblast 21000
UkraineSite Not Available
Zaporizhzhya Regional Clinical Children's Hospital ( Site 0089)
Zaporizhzhya, Zaporizka Oblast 69063
UkraineSite Not Available

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