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An Alternative Booster Vaccine Against Meningitis and Ear Infections

NCT01443416 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 178

Last updated 2015-11-09

No results posted yet for this study

Summary

This is a study to evaluate an alternative booster for pneumococcal conjugate vaccination (PCV) for children at 12 months of age. Currently in the UK, 3 doses of a vaccine called Prevenar 13 (PCV-13), which contains 13 pneumococcal serotypes attached to a carrier protein called CRM197, are given to children at 2, 4 and 12 months of age. There is some evidence that a vaccine called Synflorix (PHiD-CV) may be at least as good as the currently used vaccine when used as an alternative vaccine at 12 months of age. Although PHiD-CV contains only 10 serotypes, there is evidence that it generates cross-reactive antibodies against two of the three additional serotypes included in PCV-13 which might be enough to protect children against disease caused by these two serotypes. Furthermore, previous studies have shown that PHiD-CV confers protection against a common otitis media pathogen in children called nontypeable H. influenzae (NTHi) by attachment to a carrier protein called Protein D, which is derived from NTHi. In addition, the use of a carrier protein, which is not closely related to an antigen included in any coadministered or previously administered routine vaccine minimises the risk of interference related to it.

The investigators aim to recruit 168 healthy children at the age of 12 months who have already received two doses of PCV-13 according to the UK routine immunisation schedule at 2 and 4 months of age. Participants will then be randomised to receive a booster dose of either PCV-13 or PHiD-CV at 12 months of age.

Three visits will take place at their parents' home and will involve a blood test followed by a dose of PCV-13 or PHiD-CV on visit 1, and a blood test on each of the visits 2 (1 month after visit 1) and 3 (1 year after visit 1).

Conditions

  • Invasive Streptococcus Pneumoniae Disease

Interventions

BIOLOGICAL

13-valent pneumococcal conjugate vaccine

The vaccine will be given to 12 month old children who have had 2 doses of Prevenar at 2 and 4 months of age

BIOLOGICAL

10-valent pneumococcal conjugate vaccine

The vaccine will be given to 12 month old children who have had 2 doses of Prevenar at 2 and 4 months of age.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

  • Andrew Pollard · University of Oxford

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Months
Max Age
13 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-04-30
Primary Completion
2013-08-31

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01443416 on ClinicalTrials.gov