13 Valent Pneumococcal Conjugate Vaccine - Follow-on Study

NCT ID: NCT01095471

Last Updated: 2011-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-04-30
• Study Completion Date: 2011-03-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

PCV13

Initial vaccination with PCV13

Group Type: EXPERIMENTAL

PCV13

Intervention Type: BIOLOGICAL

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

PCV7

Initial intervention with PCV7

Group Type: EXPERIMENTAL

PCV13

Intervention Type: BIOLOGICAL

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

Interventions

PCV13

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

Intervention Type: BIOLOGICAL

Other Intervention Names

13-valent pneumococcal conjugate vaccine

Eligibility Criteria

Inclusion Criteria

1. Participant completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007) at one of the study sites participating in this follow-on study.

2. Aged 39-46 months (inclusive) at time of enrolment.

3. Available for entire study period and whose parent/legal guardian can be reached by telephone.

4. 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.

5. Parent/legal guardian must be able to complete all relevant study procedures during study participation.

Exclusion Criteria

1. 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).

2. A previous anaphylactic reaction to any vaccine or vaccine-related component.

3. Contraindication to vaccination with pneumococcal conjugate vaccine.

4. Bleeding diathesis or condition associated with prolonged bleeding time that would contraindicate intramuscular injection.

5. Known or suspected immune deficiency or suppression.

6. History of culture-proven invasive disease caused by S pneumoniae.

7. Major known congenital malformation or serious chronic disorder.

8. 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.

9. Receipt of blood products or gamma-globulin (including hepatitis B immunoglobulin and monoclonal antibodies; eg, synagisB).

10. Participation in another investigational study other than the Wyeth-sponsored PCV13 infant trial study (6096A1-007). Participation in purely observational studies is acceptable.

11. Child who is a direct descendant (child, grandchild) of the study site personnel.

• Minimum Eligible Age: 39 Months
• Maximum Eligible Age: 46 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Bristol

OTHER

Sponsor Role: collaborator

University of Southampton

OTHER

Sponsor Role: collaborator

University of London

OTHER

Sponsor Role: collaborator

University of Oxford

OTHER

Sponsor Role: lead

Responsible Party

University of Oxford

Principal Investigators

Andrew Pollard, FRCPCH, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oxford, Department of Paediatrics

Locations

Bristol Children's Vaccine Centre, University of Bristol

Bristol, , United Kingdom

St George's Vaccine Institute, University of London

London, , United Kingdom

Oxford Vaccine Group, Dept Paediatrics, University of Oxford

Oxford, , United Kingdom

Wellcome Trust Clinical Research Facility, University of Southampton

Southampton, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: DERIVED

PMID: 28392142 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 24618837 (View on PubMed)

Other Identifiers

2009/04

Identifier Type: -

Identifier Source: org_study_id