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

NCT01425372 | Completed DMC

• 1 other identifier: P13UK
• Study Type: observational
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Streptococcus Pneumoniae

Keywords

vaccine; pneumococcal conjugate vaccine; immune responses; primary immunisation; Vaccine responses to primary immunisation in the UK

Outcome Measures

Primary Outcomes (1)

• 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

  24 months

Secondary Outcomes (4)

• 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

  24 months

• 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

  24 months

• 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

  24 months

• 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

  24 months

Eligibility Criteria

• Age: Up to 6 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Male or female infants born at term (at least 37 weeks gestation) aged \<6 months:
• 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
• Who have received all their primary immunisations in the 1st 6 months of life, including:
• doses of Pediacel®
• 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
• doses of any MenC vaccine

You may not qualify if:

• Participant may not be included in the study if any of the following apply:
• History of invasive Haemophilus influenzae serotype b (Hib), pneumococcal or meningococcal disease
• Confirmed or suspected immunosuppressive or immunodeficient condition (including HIV)
• Bleeding disorders and/or prolonged bleeding time
• Major congenital defects or chronic disease
• Premature birth (\<37 weeks gestation at birth)

Sponsors & Collaborators

• Prof. Elizabeth Miller: lead

Study Sites (1)

Multiple GP surgeries

Hertfordshire and Gloucstershire, United Kingdom

Location

Related Publications (2)

• Andrews NJ, Waight PA, Burbidge P, Pearce E, Roalfe L, Zancolli M, Slack M, Ladhani SN, Miller E, Goldblatt D. Serotype-specific effectiveness and correlates of protection for the 13-valent pneumococcal conjugate vaccine: a postlicensure indirect cohort study. Lancet Infect Dis. 2014 Sep;14(9):839-46. doi: 10.1016/S1473-3099(14)70822-9. Epub 2014 Jul 17.

  PMID: 25042756 BACKGROUND

• Ladhani SN, Andrews NJ, Waight P, Hallis B, Matheson M, England A, Findlow H, Bai X, Borrow R, Burbidge P, Pearce E, Goldblatt D, Miller E. Interchangeability of meningococcal group C conjugate vaccines with different carrier proteins in the United Kingdom infant immunisation schedule. Vaccine. 2015 Jan 29;33(5):648-55. doi: 10.1016/j.vaccine.2014.12.018. Epub 2014 Dec 12.

  PMID: 25510388 RESULT

Related Links

• Published study results
• Published study results

Study Officials

• Elizabeth Coates, PhD

  Public Health England

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Epidemiologist

Study Record Dates

• First Submitted: August 26, 2011
• First Posted: August 30, 2011
• Study Start: November 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2013
• Last Updated: March 22, 2019

Record last verified: 2018-08

Locations

GB (1)