Evaluating Vaccine Responses in Healthy Infants Receiving Their Routine Primary Immunisation According to the Accelerated United Kingdom Schedule at 2, 3 and 4 Months (P13UK)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Prof. Elizabeth Miller, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier:
NCT01425372
First received: August 26, 2011
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

Streptococcus pneumoniae is a major cause of serious bacterial infections, particularly among young children. Over 30 different types of the pneumococcus germ can cause invasive disease, but 7 types (namely serotypes 4, 6B, 9V, 14, 18C, 19F and 23F) are responsible for around 75% of cases in young children. A pneumococcal conjugate vaccine against these 7 serotypes (PCV7; Prevenar ®, Wyeth Vaccines) was introduced into the UK national immunisation programme in September 2006 and has resulted in a rapid reduction in pneumococcal disease caused by the 7 serotypes among both vaccinated children and older unvaccinated children and adults through herd immunity. By 2009, over half of all invasive pneumococcal cases in young children were caused by six other pneumococcal serotypes (1, 3, 5, 6A, 7F and 19A) that are included in a newly licensed 13 valent pneumococcal vaccine (PCV13; Prevenar 13®, Wyeth Vaccines). In April 2010, PCV13 replaced PCV7 in the UK immunisation programme with the aim of further reducing cases of invasive pneumococcal disease. The antibody responses induced by the 7 serotypes in both PCV13 and PCV7 have been shown to be comparable, but the protection offered by the additional 6 serotypes in PCV13 merits further study. Also, it is possible that the use of PCV13 instead of PCV7 may interfere with immune responses to other vaccines, such as Haemophilus influenzae serotype b (Hib), which are given to infants at the same time as PCV13. The proposed study will aim to collect one blood sample from infants after they receive their routine vaccinations at 2, 3 and 4 months in order to their measure immune responses to routine vaccines. The investigators hope that their results will help us better understand the added protection offered by the 13valent pneumococcal vaccine and ensure that children are adequately protected by the other vaccines they receive.


Condition
Streptococcus Pneumoniae

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Study to Evaluate the Immune Response of UK Infants Receiving the 13-valent Pneumococcal Conjugate Vaccine as Part of Their Routine Primary Immunisation Schedule at 2 and 4 Months

Resource links provided by NLM:


Further study details as provided by Health Protection Agency, United Kingdom:

Primary Outcome Measures:
  • 1. To determine the proportion of infants with pneumococcal serotype-specific IgG antibody concentrations ≥0.35 μg/ml for the 13 serotypes included in Prevenar13 at one month after completion of primary immunisation [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. To determine the geometric mean concentrations (GMCs) of pneumococcal serotype-specific IgG antibody concentrations for each of the 13 serotypes in Prevenar13 one month after primary immunisation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 2. To determine, using a functional opsonophagocytic assay (OPA), the proportion of infants with geometric mean titres (GMT) ≥1:8 for the 13 serotypes in Prevenar13 one month after primary immunisation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 3. To determine serum bactericidal assay (SBA) titres with 95%CI for MenC and the proportion of infants achieving SBA titres ≥8 or ≥128 one month after primary immunisation [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • 4. To determine Hib GMC with 95%CI and proportions of infants with Hib antibody concentrations ≥0.15 μg/ml or ≥1.0 μg/ml one month after primary immunisation [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: November 2010
Study Completion Date: June 2013
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Detailed Description:

This study will aim to prospectively recruit infants in the first 6 months of life who are either due to receive or in the process of receiving their routine infant immunisation and request one blood sample one month after completing their primary immunisation schedule, which will be at around 5 months of age, if they fulfil the inclusion criteria for the study.

NUMBER OF SUBJECTS AND DURATION OF STUDY

A total of 200 infants will be recruited in two centres - Hertfordshire and Gloucestershire.

  Eligibility

Ages Eligible for Study:   up to 6 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy infants who have received their primary immunisation schedule at appropriate intervals

Criteria

Inclusion Criteria:

Male or female infants born at term (at least 37 weeks gestation) aged <6 months:

  1. With written informed consent obtained from the parent or legal guardian of the infant to participate in the study and to allow the infant's General Practitioner (GP) to be informed of participation in the study and be contacted, if required, for confirmation of the vaccination history
  2. Who have received all their primary immunisations in the 1st 6 months of life, including:

    • 3 doses of Pediacel®
    • 2 doses of Prevenar13®, with the 1st dose given at 6-12 weeks of age and the 2nd dose at 8-12 weeks after the 1st dose
    • 2 doses of any MenC vaccine
  3. Do not fulfil any of the Exclusion Criteria

Exclusion Criteria:

Participant may not be included in the study if any of the following apply:

  1. History of invasive Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease
  2. Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV)
  3. Bleeding disorders and/or prolonged bleeding time
  4. Major congenital defects or chronic disease
  5. Premature birth (<37 weeks gestation at birth)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01425372

Locations
United Kingdom
Multiple GP surgeries
Hertfordshire and Gloucsstershire, United Kingdom
Sponsors and Collaborators
Prof. Elizabeth Miller
Investigators
Study Chair: Elizabeth Miller, PhD Health Protection Agency, United Kingdom
  More Information

No publications provided

Responsible Party: Prof. Elizabeth Miller, Consultant Epidemiologist, Health Protection Agency, United Kingdom
ClinicalTrials.gov Identifier: NCT01425372     History of Changes
Other Study ID Numbers: P13UK
Study First Received: August 26, 2011
Last Updated: March 19, 2014
Health Authority: United Kingdom: National Research Ethics Service (NRES)
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Health Protection Agency, United Kingdom:
vaccine
pneumococcal conjugate vaccine
immune responses
primary immunisation
Vaccine responses to primary immunisation in the UK

Additional relevant MeSH terms:
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 16, 2014