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Evaluation of Different Infant Vaccination Schedules Incorporating Pneumococcal Vaccination
NCT01953510Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2013
- Primary completion
- Jan 2016
- Countries
- 1
- Sponsor
- Murdoch Children's Research Institute
- Modality
- Split/Subunit Vaccines
- Conditions
- pneumococcal infection
01
Overview
Phase 3, randomised, open-label trial of pneumococcal conjugate vaccine in pneumococcal infection (7 arms), sponsored by Murdoch Children's Research Institute. Primary endpoint: Proportion of children with antibody concentration ≥0.35µg/mL for individual pneumococcal serotypes. Started Sep 2013; status: completed.
02
Design
7 arms- Study design
- RandomizedOpen-label
3+1 PCV10
PCV10 at 2, 3, 4, 9 months
3+0 PCV10
PCV10 at 2, 3, 4 months
2+1 PCV10
PCV10 at 2, 4, 9 months
1+1 PCV10
PCV10 at 2, 6 months
2+1 PCV13
PCV13 at 2, 4, 9 months
Control
PCV10 at 18, 24 months
1 more in the full profile.
03
Who it enrols
Healthy infants aged 2 months (or 18 months for Arm G) born at or after 36 weeks gestation, without significant medical history or prior PCV vaccination.
04
Endpoints
Primary
Proportion of children with antibody concentration ≥0.35µg/mL for individual pneumococcal serotypes
Secondary
Geometric mean concentration (GMC) of pneumococcal serotype-specific IgG
Proportion of children with pneumococcal serotype-specific opsonisation index (OI) ≥8
NP carriage rate of VT S. pneumoniae, non-VT S. pneumoniae, NTHi, and H. influenzae
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