PCV7 in the Prevention of Nasopharyngeal Carriage of Vaccine Serotype (VT) Streptococcus Pneumoniae (NCT02133469) | Clinical Trial Compass
CompletedNot Applicable
PCV7 in the Prevention of Nasopharyngeal Carriage of Vaccine Serotype (VT) Streptococcus Pneumoniae
China3,281 participantsStarted 2012-06
Plain-language summary
A parallel-group, randomized, open-label study will be performed in subjects receiving PCV7 and subjects receiving controlled vaccine Hib vaccine, to claim the efficacy of PCV7 in the prevention of NP carriage of vaccine-serotype S. pneumoniae (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F combined) in 2 to 5 years old healthy Chinese children.
Who can participate
Age range2 Years – 5 Years
SexALL
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Inclusion criteria
✓. Healthy children aged 2 to 5 years.
✓. Evidence of a personally signed and dated informed consent document indicating that the parent(s) (or legal guardian) has been informed of all pertinent aspects of the study.
✓. Subjects and parents / legal guardian/ adult caregiver who are willing and able to comply with scheduled visits, treatment plan, and other study procedures.
✓. Available for entire study period and whose parent/legal guardian/adult caregiver can be reached by telephone.
✓. Healthy child as determined by medical history, physical examination, and judgment of the investigator.
Exclusion criteria
✕. Previous vaccination with licensed or investigational pneumococcal vaccine.
✕. Receipt of a full series or catch-up dose of licensed or investigational Hib vaccinations.
✕. Contraindication to vaccination with a pneumococcal conjugate vaccine or Hib.
✕. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
✕. Known or suspected immune deficiency or suppression including treatment with systemic steroids, anti-metabolites, chemotherapy and immunomodulatory agents.
✕. Major known congenital malformation or serious chronic disorder.
What they're measuring
1
Carriage Rate of Vaccine-Serotype S. pneumoniae at 180days after vaccination
Timeframe: 6 months
Trial details
NCT IDNCT02133469
SponsorCenters for Disease Control and Prevention, China
. Malformation or injury of the nasopharynx that makes the procedure of taking a nasopharyngeal swab impossible.
✕. Significant neurologic disorder including congenital neurological disease in sibling of the subject or history of seizure including febrile seizure, or significant stable or evolving disorder such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder. Does not include resolving syndromes due to birth trauma such as Erb's palsy.