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Trial record 1 of 1 for:    NCT01996007
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Understanding Pneumococcal Carriage and Disease

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ClinicalTrials.gov Identifier: NCT01996007
Recruitment Status : Completed
First Posted : November 27, 2013
Last Update Posted : July 8, 2019
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
University of Oxford

Tracking Information
First Submitted Date November 21, 2013
First Posted Date November 27, 2013
Last Update Posted Date July 8, 2019
Actual Study Start Date March 2014
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 21, 2013)
The presence of serotype 19A pneumococci on children's swabs [ Time Frame: 2 years ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 21, 2013)
  • The presence of pneumococcal serotypes on children's swabs [ Time Frame: 2 years ]
  • The presence of pneumococcal serotypes on parents/legal guardians swabs [ Time Frame: 2 years ]
  • The molecular sequence type of nasopharyngeal carriage isolates from children and parents/legal guardians. [ Time Frame: 2 years ]
  • The serotype-specific and genotype-specific invasive disease potential of isolates recovered from children. [ Time Frame: 2 years ]
  • The serotype specific pneumococcal antibodies levels in children and their parents/legal guardians [ Time Frame: 2 years ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Understanding Pneumococcal Carriage and Disease
Official Title Cross-sectional Study to Establish the Point Prevalence of Serotype 19A Pneumococcal Nasopharyngeal Carriage of Fully Vaccinated Children Aged 13-48 Months Following Introduction of PCV13.
Brief Summary Pneumococcus is a bacteria that causes disease of the respiratory tract (pneumonia and middle ear infections), blood poisoning, and meningitis. It is frequently carried by people in back of the throat without symptoms. Pneumococcal carriage in the Thames Valley region has been studied over the last 12 years with carriage rates having been shown to be reflective of disease potential and hence vaccine effect. During this time pneumococcal vaccines have been introduced into the routine immunisation schedules of this community. The PCV7 (A vaccine against 7 types of pneumococcus) vaccine has subsequently been noted to have had a significant impact in reducing vaccine serotype carriage and disease. Herd protection (indirect protection of unvaccinated individuals) has also been implicated with vaccine serotypes not being carried in parents of vaccinated children. The most common serotype carried since the introduction of PCV7 is 19A, which is included in the PCV13 vaccine (A vaccine against 13 types of pneumococcus). PCV13 has superseded PCV7 in the routine immunisation schedule, however its impact on carriage and disease in this community is yet to be evaluated.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Bacteria grown from nasopharyngeal swabs Serum
Sampling Method Non-Probability Sample
Study Population One thousand healthy children aged 6-48 months, of which at least 600 will be aged 21-48 months, who have received 3 doses of PCV13 will be recruited along with a subset (200) of their parents/legal guardians
Condition
  • Meningitis
  • Septicaemia
  • Pneumonia
Intervention Not Provided
Study Groups/Cohorts
  • Children
    Pneumococcal nasopharyngeal carriage and immunogenicity in children aged 6-48 months who have previously received PCV13
  • Parents
    Pneumococcal nasopharyngeal carriage and immunogenicity in parents of children also participating in the study
Publications * Kandasamy R, Voysey M, Collins S, Berbers G, Robinson H, Noel I, Hughes H, Ndimah S, Gould K, Fry N, Sheppard C, Ladhani S, Snape MD, Hinds J, Pollard AJ. Persistent Circulation of Vaccine Serotypes and Serotype Replacement After 5 Years of Infant Immunization With 13-Valent Pneumococcal Conjugate Vaccine in the United Kingdom. J Infect Dis. 2020 Mar 28;221(8):1361-1370. doi: 10.1093/infdis/jiz178.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 21, 2013)
1200
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

Children

  • Parent/guardian of participant is willing and able to give informed consent for participation in the study.
  • In good health as determined by a brief medical history and/or clinical judgement of the investigator
  • Have received three doses of PCV13 as per infant immunisation schedule (as confirmed by red book or through vaccination history and age). Vaccination history will be confirmed by the child's GP or CHCD. The visit and sampling may still proceed if the vaccination history has not been confirmed beforehand and the participant subsequently excluded if they are found to not have received all three doses of PCV13.Aged 6-48 months and at least 28 days since their third PCV13 vaccination.
  • Able (in the Investigators opinion) and willing to comply with all study requirements.

Parents/ Legal guardians

  • Participant is willing and able to give informed consent for participation in the study.
  • Is the child's legal guardian and lives in the same household with the child participating in the same study.
  • In good health as determined by clinical judgement of the research staff
  • Able (in the investigators opinion) and willing to comply with all study requirements.

Exclusion Criteria:

The participant may not enter the study if ANY of the following apply:

Children

  • Parent/legal guardian unwilling or unable to give written informed consent to participate in the study.
  • Parent/legal guardian less than 18 years of age at time of enrolment.
  • Parent/legal guardian is listed on the study delegation log.
  • Children who are unimmunised or have an incomplete course of PCV13.
  • Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
  • Febrile illness or temperature of 38°C on the day of the visit or in the preceding 24 hours.
  • Respiratory illness on the day of the study visit or in the preceding 24 hours. A respiratory illness will be classified as a combination of at least two of the following symptoms: cough, sore throat, and runny nose.
  • Administration of antibiotics in the month prior to sampling.
  • A risk of nose bleed, including; a recent (within the last 24 hours) nose bleed, history of a bleeding disorder, history of severe nose bleeds or recent (within the last 3 months) nasal/craniofacial surgery.
  • Receipt of blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days.

Parents/ Legal guardians

  • Participants who are unwilling or unable to give written informed consent to participate in the study.
  • Less than 18 years of age at time of enrolment
  • Is listed on the study delegation log
  • Previous immunisation with pneumococcal conjugate vaccine.
  • Participants who in the opinion of the investigator are unable to comply with study procedures or may be put at risk by participation in the study.
  • Febrile illness or temperature of 38°C on the day of the visit or in the preceding 24 hours.
  • Respiratory illness on the day of the study visit or in the preceding 24 hours. A respiratory illness will be classified as a combination of at least two of the following symptoms: cough, sore throat, and runny nose.
  • Administration of antibiotics in the month prior to sampling.
  • A risk of nose bleed, including; a recent (within the last 24 hours) nose bleed, history of a bleeding disorder, a history of severe nose bleeds or recent (within the last 3 months) nasal/craniofacial surgery.
  • Receipt of blood products and/or plasma derivatives or any parenteral immunoglobulin preparation within 90 days.
Sex/Gender
Sexes Eligible for Study: All
Ages 6 Months and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number NCT01996007
Other Study ID Numbers OVG 2013/05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party University of Oxford
Study Sponsor University of Oxford
Collaborators Pfizer
Investigators
Principal Investigator: Andrew J Pollard, PhD Oxford Vaccine Group
PRS Account University of Oxford
Verification Date November 2015