9 valent pneumococcal con jugate vaccine in Streptococcus Pneumoniae - Clinical Trials Registry

Study Overview

Status

Completed

Conditions

Streptococcus Pneumoniae

Intervention / Treatment

Biological: 9 valent pneumococcal con jugate vaccine

Detailed Description

A new vaccine against pneumococcal infection is now available in the UK and has already been in routine use in the US for five years. The purpose of the trial is to determine the minimum number of does required to protect UK infants and toddlers, and to assess the compatibility of the pneumococcal vaccine with the other vaccines given in the UK childhood immunisation programme. The vaccine used in the US protects against seven strains of pnemococcus whereas the vaccine used in this trial protects against nine strains. Infants received either two doses at two and four months or three doses at two, three and four months of age, the latter comprising the routine infant schedule for other paediatric vaccines in the UK. The infants also received the usual vaccines against diphtheria , tetanus, polio, whooping cough and Hib together with meningitis C vaccine which is currently only used in the UK and a few other countries worldwide. A group of toddlers aged twelve to fifteen months also took apart and received either one or two doses of pneumococcal vaccine around the same time as their MMR vaccine. All children in the study received a booster dose some months later. The response to the vaccine is assessed by measuring levels of protective antibodies to the pneumococcal strains in blood samples taken at various times during the immunisation schedule.

Study Type

Interventional

Phase

Phase 2

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 1 year (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Public Health England

Investigators

Principal Investigator: Elizabeth Miller, MBBS FRCPath, Public Health England

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2000

Study Completion

January 1, 2004

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria