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OpenTrials
Completed

NCT Number: NCT01996007

Understanding Pneumococcal Carriage and Disease

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 PCV13 has superseded PCV7 in the routine immunisation schedule, however its impact on carriage and disease in this community is yet to be evaluated.

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Key information

Age range

6 month and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Oxford Vaccine Group

Oxford, Oxfordshire, OX3 7LE, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. The presence of serotype 19A pneumococci on children's swabs

    Time frame: 2 years

Secondary outcomes

  1. The presence of pneumococcal serotypes on children's swabs

    Time frame: 2 years

  2. The presence of pneumococcal serotypes on parents/legal guardians swabs

    Time frame: 2 years

  3. The molecular sequence type of nasopharyngeal carriage isolates from children and parents/legal guardians.

    Time frame: 2 years

  4. The serotype-specific and genotype-specific invasive disease potential of isolates recovered from children.

    Time frame: 2 years

  5. The serotype specific pneumococcal antibodies levels in children and their parents/legal guardians

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

University of Oxford

Other

Collaborators

  • Pfizer

Registry information

Official study 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.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2013
Registry last updated
Jul 8, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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