A follow-on, multi-centre, open-label, clinical, phase 3 trial to investigate the persistence of serotype-specific antibodies at 40 months of age in children who have received either the 7-valent or the 13-valent pneumococcal conjugate vaccine at 2, 4 and 12 months of age and assessing the immunogenicity of a 13-valent pneumococcal conjugate vaccine booster dose given at 40 months of age

Phase 1

• Conditions: Active immunisation for the prevention of invasive disease, pneumonia and acute otitis media caused by Streptococcus pneumoniae in infants and children from 6 weeks to 5 years of age.; MedDRA version: 12.1Level: LLTClassification code 10042193Term: Streptococcus pneumoniae acute exacerbation of chronic bronchitis; MedDRA version: 12.1Level: LLTClassification code 10042194Term: Streptococcus pneumoniae meningitis; MedDRA version: 12.1Level: LLTClassification code 10042195Term: Streptococcus pneumoniae pneumonia; MedDRA version: 12.1Level: LLTClassification code 10042196Term: Streptococcus pneumoniae secondary bacterial infection of acute bronchitis; MedDRA version: 12.1Level: LLTClassification code 10042197Term: Streptococcus pneumoniae septicaemia

• Registration Number: EUCTR2009-017498-39-GB
• Lead Sponsor: niversity of Oxford

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-17
• Study Completion: 2012-12-10
• Last Update Posted: 13 October 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.Participant completed the Wyeth-sponsored PCV13 infant trial study (6096A1-007)
2.Aged 39-44 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.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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.

6.3.4Temporary exclusion criteria

1.In the event of systemic illness or fever > 38 degrees centigrade at the time of the visit, immunisation will be deferred and rearranged as appropriate when the participant is recovered.

2.Any live immunisation within 28 days prior to enrolment, or any other (non-live) vaccine within the 7 days prior to enrolment.Any immunisation within 28 days of enrolment.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified