Clinical Trial Results:
A phase III randomised, open label clinical trial evaluating the immunogenicity of a 10-valent pneumococcal conjugate vaccine booster compared to the standard 13-valent pneumococcal conjugate vaccine booster given at 12 months of age to healthy children who have received the 13-valent pneumococcal conjugate vaccine at 2 and 4 months of age.
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Summary
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EudraCT number |
2011-005102-30 |
Trial protocol |
GB |
Global end of trial date |
13 Oct 2014
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Jul 2019
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First version publication date |
28 Jul 2019
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Other versions |
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Summary report(s) |
PCV10 Booster Clinical Study Report |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
OVG2011/05
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01443416 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
University of Oxford
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Sponsor organisation address |
CTRG, Old Road, Oxford, United Kingdom, OX3 7LE
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Public contact |
Prof. Andrew Pollard, Oxford Vaccine Group, +44 01865857420, andrew.pollard@paediatrics.ox.ac.uk
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Scientific contact |
Prof. Andrew Pollard, Oxford Vaccine Group, +44 01865857420, andrew.pollard@paediatrics.ox.ac.uk
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
20 Jul 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
13 Oct 2014
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Global end of trial reached? |
Yes
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Global end of trial date |
13 Oct 2014
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
The primary objective of this study is to assess whether the study vaccine (PHiD-CV) is as good as the standard vaccine (PCV-13) in terms of percentage of participants who have antibody concentrations above the protective threshold (≥0.35mcg/ml) for the 10 serotypes included in PHiD-CV (serotypes 1, 4, 5, 6B, 7F, 9V, 14, 18C, 19F, 23F) one month following booster vaccination at 12 months of age with PHiD-CV or PCV-13.
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Protection of trial subjects |
All study procedures were performed by qualified, trained staff delegated by the PI. Standard practice equivalent to clinical care is used for vaccination and venepuncture in all paediatric studies.
All serious adverse events were reported to the sponsor, who provided safety oversight and ensured that all SAEs were reviewed by a medical monitor on a regular basis.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
05 Apr 2012
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United Kingdom: 178
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Worldwide total number of subjects |
178
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EEA total number of subjects |
178
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
178
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
177 healthy children who have been vaccinated according to the routine immunisation schedule and received the 13-valent pneumococcal conjugate vaccine at 2 and 4 months of age were enrolled during a 6 month period starting in April 2012. | ||||||||||||||||||
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Pre-assignment
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Screening details |
No screening visit was performed. Enrolment was performed during the first study visit at which randomisation was performed and IMP was administered. | ||||||||||||||||||
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Period 1
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Period 1 title |
Vaccine Administration and Randomisation
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Is this the baseline period? |
Yes | ||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1 | ||||||||||||||||||
Arm description |
Booster vaccination with PHiD-CV (Synflorix®, GSK Biologicals) | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Synflorix®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Suspension for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Administer a single 0.5-ml dose of PHiD-CV or PCV-13 via intramuscular injection into
the anterolateral aspect of either thigh.
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Arm title
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Group 2 | ||||||||||||||||||
Arm description |
Booster vaccination with PCV-13 (Prevenar 13®, Pfizer) | ||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||
Investigational medicinal product name |
Prevenar 13®
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection in pre-filled syringe
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Routes of administration |
Intramuscular use
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Dosage and administration details |
Administer a single 0.5-ml dose of PHiD-CV or PCV-13 via intramuscular injection into
the anterolateral aspect of either thigh. .
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| Notes [1] - The number of subjects reported to be in the baseline period are not the same as the worldwide number enrolled in the trial. It is expected that these numbers will be the same. Justification: One participant withdrew consent prior to vaccination. |
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Period 2
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Period 2 title |
Visit 2 and 3 - Follow up
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Is this the baseline period? |
No | ||||||||||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||||||||||
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Group 1 - Follow up | ||||||||||||||||||
Arm description |
Visit 2 All participants receive routine immunisations (MMR, Hib-MenC) and blood sample collected. AE data reviewed. Visit 3 Blood sample collected. SAE data reviewed. | ||||||||||||||||||
Arm type |
Sample collection | ||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Arm title
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Group 2 - Follow up | ||||||||||||||||||
Arm description |
Visit 2 All participants receive routine immunisations (MMR, Hib-MenC) and blood sample collected. AE data reviewed. Visit 3 Blood sample collected. SAE data reviewed. | ||||||||||||||||||
Arm type |
Sample collection | ||||||||||||||||||
Investigational medicinal product name |
No investigational medicinal product assigned in this arm
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Baseline characteristics reporting groups
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Reporting group title |
Group 1
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Reporting group description |
Booster vaccination with PHiD-CV (Synflorix®, GSK Biologicals) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2
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Reporting group description |
Booster vaccination with PCV-13 (Prevenar 13®, Pfizer) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group 1
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Reporting group description |
Booster vaccination with PHiD-CV (Synflorix®, GSK Biologicals) | ||
Reporting group title |
Group 2
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Reporting group description |
Booster vaccination with PCV-13 (Prevenar 13®, Pfizer) | ||
Reporting group title |
Group 1 - Follow up
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Reporting group description |
Visit 2 All participants receive routine immunisations (MMR, Hib-MenC) and blood sample collected. AE data reviewed. Visit 3 Blood sample collected. SAE data reviewed. | ||
Reporting group title |
Group 2 - Follow up
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Reporting group description |
Visit 2 All participants receive routine immunisations (MMR, Hib-MenC) and blood sample collected. AE data reviewed. Visit 3 Blood sample collected. SAE data reviewed. | ||
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End point title |
The proportion of participants with serotype-specific IgG concentrations ≥0.35mcg/ml to PCV-10 serotypes at 12 months of age one month following a booster with either PCV-10 or PCV-13. [1] | |||||||||
End point description |
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End point type |
Primary
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End point timeframe |
Visit 2. One month post booster dose.
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| Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Statistical analysis is provided in the clinical study report which is attached. |
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| No statistical analyses for this end point | ||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
All AEs occurring in the first 4 days after booster immunisation, and all AEs resulting in an
unscheduled visits to a physician or emergency department or withdrawal from the study
occurring within 1 month after vaccination were collected.
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
Protocol | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
4.0
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Reporting groups
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Reporting group title |
Group 1
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Reporting group description |
Booster vaccination with PHiD-CV (Synflorix®, GSK Biologicals) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group 2
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Reporting group description |
Booster vaccination with PCV-13 (Prevenar 13®, Pfizer) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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28 May 2012 |
Protocol
Both vaccines in the study (Prevenar13 and Synflorix) can be given in either the arms or legs, as specified in the Summary of Product Characteristics. For ease of administration in infants injection into the leg (thigh) is preferred, in practice. The change to the procotol is to clarify that the anterolateral aspect of either thigh will be used as an injection site for either of the two vaccines administered. Whether the right or left leg is used will be documented in the diary card, as is being done currently, for information of the parents.
Information Booklet
Clarification that anonymised participants' information will be shared, as and when required by the Sponsor's contractual agreements, with GlaxoSmithKline who manufacture the PCV10 vaccine and fund the study.
Consent Form
Seeking consent for the changes made to the information booklet that clarify that anonymised participants' information will be shared, as and when required by the Sponsor's contractual agreements, with GlaxoSmithKline who manufacture the PCV10 vaccine and fund the study.
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
