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CompletedNCT00197769Updated Aug 29, 2018

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

A Phase 2 interventional study of 9 valent pneumococcal con jugate vaccine in Streptococcus Pneumoniae, sponsored by Public Health England. Completed. Open to participants aged 7 Weeks to 18 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-08-29.

Sponsored by Public Health England · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
7 Weeks to 18 Months
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Streptococcus Pneumoniae
03

In context

Pneumonia, Pneumococcal

121 studies on the registry are indexed under Pneumonia, Pneumococcal; 7 are open to participants now.

Browse Pneumonia, Pneumococcal studies →

Lead sponsor

Public Health England is the lead sponsor of 36 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
7 Weeks to 18 Months
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)

Interventions

  • Biological9 valent pneumococcal con jugate vaccine
06

Study locations

No study locations are listed for this record.

07

References and documents

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. PubMed 16567982 ↗
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 29, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00197769
Lead sponsor
Public Health England
First posted
Sep 20, 2005
Start date
Sep 2000
Completion
Jan 2004
Last update
Aug 29, 2018

Study contacts

Elizabeth Miller, MBBS FRCPath
principal investigator · Public Health England
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2008. You cannot join it, but the record below documents what was studied.

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