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Assessment of Novel Pneumococcal Conjugate Vaccination Scheduled in UK Infants (PINC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02918708
Recruitment Status : Withdrawn (funding channel amended by UK department of health)
First Posted : September 29, 2016
Last Update Posted : August 28, 2019
Sponsor:
Collaborators:
Imperial College London
Institute of Child Health
Information provided by (Responsible Party):
Public Health England

Brief Summary:

The National Vaccine Evaluation Consortium conducts Department of Health funded trials trials to provide information to underpin changes to the national immunisation and vaccination schedule.

This study will assess how different schedules of pneumococcal conjugate vaccines work in providing protection to young infants. It is well established that vaccines can behave differently depending on which order they are given and alongside which other immunisations. This has been shown for Hib and MenC vaccines, which are similar in structure to the pneumococcal vaccines that will be studied here. The investigators will measure responses to the pneumococcal vaccines as well as to other routine immunisations, all of which will be provided by our study team. Infants will be recruited by dedicated study staff through primary care and will participate from their first vaccinations at 2 months of age, until the blood sample taken a month after their boosters at a year old, i.e. until 13 months of age.

Any child found to have antibody levels below that which indicates protection for Hib, MenC, MenB or pneumococcal in the blood sample taken at 13 months of age will be offered an extra dose of the relevant vaccine(s).


Condition or disease Intervention/treatment Phase
Vaccination Immunization Biological: Synflorix Biological: Prevenar13 Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Assessment of Antibody Responses in UK Infants Given Two Doses of 10 or 13 Valent Pneumococcal Conjugate Vaccine (PCV) in Infancy and PCV13 in the Second Year of Life (Study Code: Pneumococcal in New Combinations (PINC))
Actual Primary Completion Date : January 1, 2017


Arm Intervention/treatment
Active Comparator: group 2 (Synflorix then Prevenar13)
PCV10 given at 2 and 4 months of age, PCV13 given at 12 months of age
Biological: Synflorix
10-valent pneumococcal conjugate vaccine
Other Name: PCV10

Biological: Prevenar13
13-valent pneumococcal conjugate vaccine
Other Name: PCV13

Active Comparator: group 1 (Prevenar13 only)
PCV13 given at 2,4 and 13 months of age
Biological: Prevenar13
13-valent pneumococcal conjugate vaccine
Other Name: PCV13




Primary Outcome Measures :
  1. pneumococcal proportions [ Time Frame: 13 months of age ]
    proportions with protective antibody levels to each serotype in the pneumococcal conjugate vaccine


Secondary Outcome Measures :
  1. pneumococcal GMC [ Time Frame: 13 months of age ]
    geometric mean concentration of each serotype included in pneumococcal conjugate vaccine

  2. pneumococcal fold rise [ Time Frame: 13 months of age ]
    to estimate fold rises in antibody for each serotype included in pneumococcal conjugate vaccine

  3. Men B proportions [ Time Frame: 5 and 13 months of age ]
    to estimate proportions with protective antibody levels against the three strains included in the vaccine

  4. Men B GMT [ Time Frame: 5 and 13 months of age ]
    to estimate the geometric mean titres of serum bactericidal antibody levels

  5. tetanus proportions [ Time Frame: 5 months of age ]
    to estimate proportions achieving the protective antibody levels

  6. tetanus GMC [ Time Frame: 5 months of age ]
    to estimate the geometric mean concentration of antibody levels against tetanus

  7. diphtheria GMC [ Time Frame: 5 months of age ]
    to estimate the geometric mean concentration of antibody levels against diphtheria

  8. diphtheria proportions [ Time Frame: 5 months of age ]
    to estimate proportions achieving the protective antibody levels

  9. pertussis GMC [ Time Frame: 5 months of age ]
    to estimate the geometric mean titres of antibody levels against pertussis components

  10. MenC proportions [ Time Frame: 13 months of age ]
    to estimate proportions achieving the protective antibody levels

  11. MenC GMT [ Time Frame: 13 months of age ]
    to estimate the geometric mean titres of antibody levels against MenC

  12. Hib proportions [ Time Frame: 5 and 13 months of age ]
    to estimate proportions achieving the protective antibody levels

  13. Hib GMC [ Time Frame: 5 and 13 months of age ]
    to estimate the geometric mean concentration of antibody levels against Hib

  14. reactogenicity [ Time Frame: one week after each vaccination ]
    Assessment of reactogenicity of vaccines from parent completed health diaries for the week following each vaccination



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Months to 2 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Infants due to receive their primary immunisations , aged up to 13 weeks on first vaccinations.
  • Written informed consent given by mother who is aged ≥>= 16 years [NB mother is preferable as consent also allows permission to record the date of pertussis immunisation in pregnancy, which may need to be verified in her medical record. Where mother is not available, consent may be taken from father or legal guardian and maternal pertussis status noted as not known]

Exclusion Criteria:

  • Bleeding disorder
  • Fulfil any of the contraindications to vaccination as specified in The Green Book [https://www.gov.uk/government/organisations/public-health-england/series/immunisation-against-infectious-disease-the-green-book]

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02918708


Locations
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United Kingdom
Hertfordshire primary care
Hertfordshire, United Kingdom
Imperial Healthcare NHS Trust
London, United Kingdom
Sponsors and Collaborators
Public Health England
Imperial College London
Institute of Child Health
Investigators
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Study Chair: Elizabeth Coates, PhD Public Health England
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Responsible Party: Public Health England
ClinicalTrials.gov Identifier: NCT02918708    
Other Study ID Numbers: PINC trial
First Posted: September 29, 2016    Key Record Dates
Last Update Posted: August 28, 2019
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Public Health England:
vaccination
immunisation
pneumococcal
conjugate
Additional relevant MeSH terms:
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Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs