NCT00197769

Brief Summary

The purpose of the trial is to determine the minimum of doses of a new nine valent pneumococcal conjugate vaccine required to protect UK infants and toddlers

Trial Health

100
On Track

Trial Health Score

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

Timeline
Completed

Started Sep 2000

Typical duration for phase_2

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2000

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
Last Updated

August 29, 2018

Status Verified

February 1, 2008

First QC Date

September 12, 2005

Last Update Submit

August 28, 2018

Conditions

Streptococcus Pneumoniae

Interventions

9 valent pneumococcal con jugate vaccineBIOLOGICAL

Eligibility Criteria

Age7 Weeks - 18 Months
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Informed consent by parent/guardian for receipt of study vaccines and for blood samples
  • Age at first dose: Infants 7-11 weeks; toddlers 12-18 months

You may not qualify if:

  • Previous bacteriologically confirmed pneumococcal or meningococcal disease
  • Contraindications for pneumococcal, meningococcal, Hib, DTP, MMR immunisations as listed in the UK handbook, "Immunisation Against Infectious Disease" Edition 1996.
  • Language difficulty in parents sufficient to preclude adequate comprehension of the information sheet, consent form and study nurses' explanation of the study
  • Children participating in any other clinical trial
  • Immunocompromised
  • Acute systemic illness or fever \> 38C on day of vaccination - deferral

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Goldblatt D, Southern J, Ashton L, Richmond P, Burbidge P, Tasevska J, Crowley-Luke A, Andrews N, Morris R, Borrow R, Cartwright K, Miller E. Immunogenicity and boosting after a reduced number of doses of a pneumococcal conjugate vaccine in infants and toddlers. Pediatr Infect Dis J. 2006 Apr;25(4):312-9. doi: 10.1097/01.inf.0000207483.60267.e7.

    PMID: 16567982RESULT

Study Officials

  • Elizabeth Miller, MBBS FRCPath

    Public Health England

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 1, 2000

Study Completion

January 1, 2004

Last Updated

August 29, 2018

Record last verified: 2008-02