NCT02918708

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).

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

2 active sites

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 29, 2016

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Last Updated

August 28, 2019

Status Verified

January 1, 2017

First QC Date

September 12, 2016

Last Update Submit

August 27, 2019

Conditions

VaccinationImmunization

Keywords

vaccinationimmunisationpneumococcalconjugate

Outcome Measures

Primary Outcomes (1)

  • pneumococcal proportions

    proportions with protective antibody levels to each serotype in the pneumococcal conjugate vaccine

    13 months of age

Secondary Outcomes (14)

  • pneumococcal GMC

    13 months of age

  • pneumococcal fold rise

    13 months of age

  • Men B proportions

    5 and 13 months of age

  • Men B GMT

    5 and 13 months of age

  • tetanus proportions

    5 months of age

  • +9 more secondary outcomes

Study Arms (2)

group 2 (Synflorix then Prevenar13)

ACTIVE COMPARATOR

PCV10 given at 2 and 4 months of age, PCV13 given at 12 months of age

Biological: SynflorixBiological: Prevenar13

group 1 (Prevenar13 only)

ACTIVE COMPARATOR

PCV13 given at 2,4 and 13 months of age

Biological: Prevenar13

Interventions

SynflorixBIOLOGICAL

10-valent pneumococcal conjugate vaccine

Also known as: PCV10
group 2 (Synflorix then Prevenar13)
Prevenar13BIOLOGICAL

13-valent pneumococcal conjugate vaccine

Also known as: PCV13
group 1 (Prevenar13 only)group 2 (Synflorix then Prevenar13)

Eligibility Criteria

Age2 Months - 2 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • 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 \[NB mother is preferable as consent also allows permission to record the date of pertussis immunisation in pregnancy, which may need to be verified in her medical record. Where mother is not available, consent may be taken from father or legal guardian and maternal pertussis status noted as not known\]

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hertfordshire primary care

Hertfordshire, Hertfordshire, United Kingdom

Location

Imperial Healthcare NHS Trust

London, United Kingdom

Location

MeSH Terms

Interventions

PHiD-CV vaccine10-valent pneumococcal conjugate vaccine13-valent pneumococcal vaccine

Study Officials

  • Elizabeth Coates, PhD

    Public Health England

    STUDY CHAIR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 29, 2016

Primary Completion

January 1, 2017

Last Updated

August 28, 2019

Record last verified: 2017-01

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)