An Alternative Booster Vaccine Against Meningitis and Ear Infections

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
University of Oxford
ClinicalTrials.gov Identifier:
NCT01443416
First received: September 27, 2011
Last updated: August 12, 2013
Last verified: August 2013
  Purpose

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).


Condition Intervention Phase
Invasive Pneumococcal Disease
Biological: 13-valent pneumococcal conjugate vaccine
Biological: 10-valent pneumococcal conjugate vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Phase III Randomised, Open Label Clinical Trial Evaluating the Immunogenicity of a 10-valent Pneumococcal Conjugate Vaccine Booster Compared to the Standard 13-valent Pneumococcal Conjugate Vaccine Booster Given at 12 Months of Age to Healthy Children Who Have Received the 13-valent Pneumococcal Conjugate Vaccine at 2 and 4 Months of Age.

Resource links provided by NLM:


Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Proportions of participants who have IgG concentrations ≥0.35mcg/ml for 14 pneumococcal serotypes following vaccination with either Prevenar or Synflorix [ Time Frame: One month after a 12 month booster vaccination ] [ Designated as safety issue: No ]
    To demonstrate non-inferiority (10% level) of a booster dose of PCV-10 compared to a booster dose of PCV-13 for proportion of participants who have serotype-specific IgG concentrations ≥0.35mcg/ml for the PHiD-CV serotypes (1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) 1 month following booster vaccination.


Estimated Enrollment: 168
Study Start Date: April 2012
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Prevenar
12 month booster dose of Prevenar
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
Experimental: Synflorix
12 month booster dose of Synflorix
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.

  Eligibility

Ages Eligible for Study:   12 Months to 13 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Aged 12 months (-2 weeks to +6 weeks) at time of enrolment.
  • Have received two doses of PCV-13 at less than 6 months of age with a gap of at least 6 weeks between the two vaccinations.
  • Have received all primary vaccines according to the UK routine immunisation schedule (up to, but not including, 12 months of age).
  • Available for the entire study period and whose parent/legal guardian can be reached by telephone.
  • Healthy children as determined by medical history and physical examination, done by a study nurse (and/or study doctor if required, depending on the medical history of the participant and physical assessment), and judgment of the investigator.
  • Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion Criteria:

  • Previous receipt of pneumococcal vaccine other than the 13-valent pneumococcal conjugate vaccine (Prevenar 13®, Pfizer).
  • Receipt of the routine 12 month immunisations (PCV13 (3rd dose), combined Haemophilus influenzae type b and serogroup C meningococcal glyco-conjugate vaccine (Hib-MenC) or measles, mumps and rubella vaccine (MMR)).
  • A previous anaphylactic reaction to any vaccine or vaccine-related component.
  • Contraindication to vaccination with pneumococcal conjugate vaccine.
  • Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.
  • Known or suspected immune deficiency or suppression.
  • History of culture-proven invasive disease caused by S. pneumoniae.
  • Major known congenital malformation or serious chronic disorder.
  • Significant neurologic disorder or history of seizures including febrile seizure, or significant stable or evolving disorders such as cerebral palsy, encephalopathy, hydrocephalus, or other significant disorder.
  • Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; e.g., Synagis B).
  • Parents who plan to move out of the geographical area where the study would be conducted.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01443416

Locations
United Kingdom
Oxford Vaccine Group
Oxford, United Kingdom
Sponsors and Collaborators
University of Oxford
  More Information

No publications provided

Responsible Party: University of Oxford
ClinicalTrials.gov Identifier: NCT01443416     History of Changes
Other Study ID Numbers: OVG 2011/05
Study First Received: September 27, 2011
Last Updated: August 12, 2013
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
pneumococcal conjugate vaccine
invasive pneumococcal disease
vaccination
children

ClinicalTrials.gov processed this record on July 09, 2014