13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study

NCT01095471 | Completed Phase 4 DMC

• 1 other identifier: 2009/04
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 4

Brief Summary

This is a follow-on, multi-centre, open-label, clinical trial. The purpose of this trial is to investigate the concentrations of serotype-specific antibodies to IgG included in PCV13 in children who have received either the PCV7 or PCV13 primary immunisation at 2, 4 and 12 months of age. We intend to recruit all interested participants who completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at selected study sites (i.e. those that recruited the majority of the children in the original study). The study will start in March 2010, at which time the eldest participants in the 6096A1-007 study will be approximately 42 months of age. There will be two visits per participant, 1 month apart from each other. At visit one, all participants will have a blood test and receive a dose of PCV13. At visit 2, all participants will have a blood test and will be offered the remaining pre-school booster vaccinations unless they have already received them.

Conditions

Pneumococcal Disease

Keywords

7 valent Pneumococcal conjugate vaccine; 13 valent Pneumococcal conjugate vaccine; PCV13; PCV7

Outcome Measures

Primary Outcomes (1)

• To assess the effectiveness of PCV13 booster vaccinations

  To assess the proportion of participants, immunised with the 13-valent pneumococcal conjugate vaccine (PCV13) at 2, 4 and 12 months of age, who have IgG concentrations ≥ 0.35mcg/ml for PCV13 serotypes at the time when preschool booster vaccinations are due (at 40 months of age).

  1 month

Secondary Outcomes (6)

• To assess IgG concentrations for PCV13 serotypes in children immunised with PCV7 and PCV13

  1 month

• Compare PCV13 serotype-specific IgG geometric mean concentrations, opsonophagocytic activity geometric mean titres & the proportion of participants with PCV13 serotype-specific OPA titres ≥ 1:8 (at 40 months) when immunised in infancy with PCV7 or PCV13.

  1 month

• Compare PCV serotype-specific IgG GMCs, OPA GMTs & proportion of participants with IgG concs ≥ 0.35mcg/ml & OPA titres ≥ 1:8 one month after booster dose of PCV13 at 40 months in children previously immunised with PCV7 & PCV13 at 2,4 & 12 months.

  1 month

• To determine reactogenicity of the pre-school PCV13 booster in terms of rates of local and systemic reactions following vaccination.

  1 month

• Investigate influence of genetic polymorphisms on the above immunological markers following infant immunisation with PCV7/PCV13 & following booster dose of PCV13 at 40 months & on the nature of adverse reactions observed after booster.

  1 month

Study Arms (2)

PCV13

EXPERIMENTAL

Initial vaccination with PCV13

Biological: PCV13

PCV7

EXPERIMENTAL

Initial intervention with PCV7

Biological: PCV13

Interventions

PCV13 BIOLOGICAL

Immunisation with the 13-valent pneumococcal conjugate vaccine (PCV13) at approximately 40 months of age.

Also known as: 13-valent pneumococcal conjugate vaccine

PCV13; PCV7

Eligibility Criteria

• Age: 39 Months - 46 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Participant completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at one of the study sites participating in this follow-on study.
• Aged 39-46 months (inclusive) at time of enrolment.
• Available for entire study period and whose parent/legal guardian can be reached by telephone.
• Healthy children as determined by medical history, 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.

You may not qualify if:

• Has received further doses of pneumococcal vaccination with licensed or investigational pneumococcal vaccine other than those given as part of the Wyeth-sponsored PCV13 infant trial study (6096A1-007).
• 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; eg, synagisB).
• Participation in another investigational study other than the Wyeth-sponsored PCV13 infant trial study (6096A1-007). Participation in purely observational studies is acceptable.
• Child who is a direct descendant (child, grandchild) of the study site personnel.

Sponsors & Collaborators

• University of Oxford: lead
• University of Bristol: collaborator
• University of Southampton: collaborator
• University of London: collaborator

Study Sites (4)

Bristol Children's Vaccine Centre, University of Bristol

Bristol, United Kingdom

Location

St George's Vaccine Institute, University of London

London, United Kingdom

Location

Oxford Vaccine Group, Dept Paediatrics, University of Oxford

Oxford, OX3 7LJ, United Kingdom

Location

Wellcome Trust Clinical Research Facility, University of Southampton

Southampton, United Kingdom

Location

Related Publications (2)

• Truck J, Thompson A, Morales-Aza B, Clutterbuck EA, Voysey M, Clarke E, Snape MD, Kelly DF, Finn A, Pollard AJ. Memory B cell response to a PCV-13 booster in 3.5year old children primed with either PCV-7 or PCV-13. Vaccine. 2017 May 9;35(20):2701-2708. doi: 10.1016/j.vaccine.2017.03.079. Epub 2017 Apr 6.

  PMID: 28392142 DERIVED

• Truck J, Snape MD, Tatangeli F, Voysey M, Yu LM, Faust SN, Heath PT, Finn A, Pollard AJ. Pneumococcal serotype-specific antibodies persist through early childhood after infant immunization: follow-up from a randomized controlled trial. PLoS One. 2014 Mar 11;9(3):e91413. doi: 10.1371/journal.pone.0091413. eCollection 2014.

  PMID: 24618837 DERIVED

MeSH Terms

Conditions

Pneumococcal Infections

Condition Hierarchy (Ancestors)

Streptococcal Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Andrew Pollard, FRCPCH, PhD

  University of Oxford, Department of Paediatrics

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: March 26, 2010
• First Posted: March 30, 2010
• Study Start: April 1, 2010
• Primary Completion: December 1, 2010
• Study Completion: March 1, 2011
• Last Updated: March 22, 2011

Record last verified: 2011-03

Locations

GB (4)