Immunogenicity of a Reduced Primary Schedule for Pneumococcal Conjugate Vaccine in UK Infants

Public Health England

Status and phase

Completed

Phase 2

Conditions

Streptococcus Pneumoniae

Treatments

Biological: 9 valent pneumococcal con jugate vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT00197769

PNC1/2

Details and patient eligibility

About

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

Full 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.

Sex

All

Ages

7 weeks to 18 months old

Volunteers

Accepts Healthy Volunteers

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