Clinical Trial Results:
A Post Marketing Surveillance Study to monitor the reactogenicity and safety of Vaxem™Hib when administered according to the prescribing information in Korea.
Due to a system error, the data reported in v1 is not correct and has been removed from public view.
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Summary
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EudraCT number |
2014-005203-24 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
29 Jul 2012
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Results information
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Results version number |
v2(current) |
This version publication date |
03 Jun 2016
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First version publication date |
21 Mar 2015
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Other versions |
v1 (removed from public view) |
Version creation reason |
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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 |
V37_11
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01404962 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Novartis Vaccines and Diagnostics
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Sponsor organisation address |
Via Fiorentina 1, Siena, Italy, 53100
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Public contact |
Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
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Scientific contact |
Posting Director, Novartis Vaccines and Diagnostics, RegistryContactVaccinesUS@novartis.com
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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? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
19 Aug 2015
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
29 Jul 2012
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Global end of trial reached? |
Yes
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Global end of trial date |
29 Jul 2012
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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 |
To evaluate the safety and reactogenicity profile of VaxemHib in Korean children.
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Protection of trial subjects |
Study vaccines were not administered to individuals with known hypersensitivity to any component of the vaccines. An oral temperature ≥38.0°C (≥100.4°F) or serious active infection was a reason for delaying vaccination. Standard immunization practices were observed and care was taken to administer the injection intramuscularly. As with all injectable vaccines, appropriate medical treatment and supervision was readily available in case of rare anaphylactic reactions following administration of the study vaccine. Epinephrine 1:1000 and diphenhydramine was available in case of any anaphylactic reactions. Care was taken to ensure that the vaccine is not injected into a blood vessel.
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Background therapy |
N/A | ||
Evidence for comparator |
N/A | ||
Actual start date of recruitment |
16 Jun 2011
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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 |
Korea, Republic of: 764
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Worldwide total number of subjects |
764
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EEA total number of subjects |
0
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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) |
761
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Children (2-11 years) |
3
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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 |
Subjects were enrolled from 23 centres in Korea. | ||||||||||
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Pre-assignment
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Screening details |
All enrolled subjects were included in the trial. | ||||||||||
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Period 1
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||
Allocation method |
Not applicable
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Blinding used |
Not blinded | ||||||||||
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Arms
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Arm title
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VaxemHib Vaccine | ||||||||||
Arm description |
Subjects received 0.5 mL of VaxemHib vaccine as part of primary series or as a booster. | ||||||||||
Arm type |
post marketing safety study | ||||||||||
Investigational medicinal product name |
Haemophilus influenza type b conjugate vaccine
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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 |
Single dose, pre-filled syringe containing 0.5 mL of liquid vaccine for intramuscular administration.
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Baseline characteristics reporting groups
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Reporting group title |
VaxemHib Vaccine
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Reporting group description |
Subjects received 0.5 mL of VaxemHib vaccine as part of primary series or as a booster. | |||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
VaxemHib Vaccine
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Reporting group description |
Subjects received 0.5 mL of VaxemHib vaccine as part of primary series or as a booster. | ||
Subject analysis set title |
All enrolled Population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who have signed an informed consent and undergone procedure(s) for eligibility check for Post Marketing Surveillance
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Subject analysis set title |
Safety Population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who receive at least one vaccination and provide some safety data will be considered evaluable for the safety analyses.
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End point title |
Number of subjects who reported solicited local and systemic adverse events after vaccination with vaxemHib. [1] | ||||||||||||||||||||||||||||||||||
End point description |
Safety was assessed in terms of number of subjects who reported solicited local and systemic adverse events collected for 7 days after each vaccination.
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End point type |
Primary
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End point timeframe |
Days 1 to 7
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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 analyses not applicable for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||
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End point title |
Number of subjects reporting unsolicited AEs after vaccination with VaxemHib. [2] | ||||||||||||||||||
End point description |
Safety was assessed as the number of subjects who reported unsolicited AEs for 28 days after vaccination with VaxemHib.
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End point type |
Primary
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End point timeframe |
Days 1 to 28
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| Notes [2] - 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 analyses not applicable for this endpoint. |
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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 |
Day 1 to day 28 after vaccination.
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Adverse event reporting additional description |
For occurrences table MedDRA 17.1 version was used.
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Assessment type |
Non-systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
15.1
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Reporting groups
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Reporting group title |
VaxemHib Vaccine
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Reporting group description |
Subjects received 0.5 mL of VaxemHib vaccine as part of primary series or as a booster. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? No | |||
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 | |||
