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

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. Identifier: NCT00197769
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : May 1, 2008
Information provided by:
Public Health England

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

Condition or disease Intervention/treatment Phase
Streptococcus Pneumoniae Biological: 9 valent pneumococcal con jugate vaccine Phase 2

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  (Clinical Trial)
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : September 2000
Study Completion Date : January 2004

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Ages Eligible for Study:   7 Weeks to 18 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00197769

Sponsors and Collaborators
Public Health England
Principal Investigator: Elizabeth Miller, MBBS FRCPath Heath Protection Agency

Publications of Results: Identifier: NCT00197769     History of Changes
Other Study ID Numbers: PNC1/2
First Posted: September 20, 2005    Key Record Dates
Last Update Posted: May 1, 2008
Last Verified: February 2008

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Heptavalent Pneumococcal Conjugate Vaccine
Immunologic Factors
Physiological Effects of Drugs