Clinical Trial Results:
A phase I, single-arm, single-center study to investigate safety and reactogenicity of Vaxem HibTM in healthy children aged 16-20 months and infants aged 2-4 months.
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Summary
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EudraCT number |
2014-005036-33 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
20 Oct 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
11 May 2016
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First version publication date |
14 May 2015
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Other versions |
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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 |
M37P1
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00734565 | ||
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 |
KG, Postfach 1630, Marburg, Germany, 35006
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Public contact |
Novartis Vaccines, Posting Director, RegistryContactVaccinesUS@novartis.com
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Scientific contact |
Novartis Vaccines, Posting Director, 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 |
15 Jul 2009
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
20 Oct 2008
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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 determine safety and tolerability of Vaxem Hib (Novartis Vaccines) when given to 20 healthy children aged 16-20 months and subsequently to 20 healthy infants aged 2-4 months.
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Protection of trial subjects |
This clinical trial was carried out in accordance with relative requirements of Provisions for Drug Registration and Good Clinical Practice (GCP) and Guidelines on Clinical Evaluation of Vaccines issued by State Food and Drug Administration and under the principle of Helsinki Declaration. The study protocol and relevant documents was reviewed and approved by ethics committees in Heibei Provincial Center for Disease Prevention and Control on 25 Jun 2008.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
03 Jul 2008
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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 |
China: 40
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Worldwide total number of subjects |
40
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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) |
40
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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 |
Subjects were enrolled at 1 study center in China. | |||||||||
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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 |
Non-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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Vaxem Hib_16 to 20 months | |||||||||
Arm description |
one single dose of 0.5 mL administered by IM; | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Vaxem Hib
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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 |
one single dose of 0.5 mL adminstered by IM;
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Arm title
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Vaxem Hib_2 to 4 months | |||||||||
Arm description |
3 doses of 0.5 mL with a time interval of one month between each dose. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Vaxem Hib
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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 |
3 doses of 0.5 mL with a time interval of one month between each dose.
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Baseline characteristics reporting groups
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Reporting group title |
Vaxem Hib_16 to 20 months
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Reporting group description |
one single dose of 0.5 mL administered by IM; | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Vaxem Hib_2 to 4 months
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Reporting group description |
3 doses of 0.5 mL with a time interval of one month between each dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Vaxem Hib_16 to 20 months
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Reporting group description |
one single dose of 0.5 mL administered by IM; | ||
Reporting group title |
Vaxem Hib_2 to 4 months
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Reporting group description |
3 doses of 0.5 mL with a time interval of one month between each dose. | ||
Subject analysis set title |
Enrolled Population
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Subject analysis set type |
Intention-to-treat | ||
Subject analysis set description |
All subjects who have been enrolled.
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Subject analysis set title |
Exposed Population
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All enrolled subjects who actually received a study vaccination.
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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 enrolled who have received study vaccination and provided any post-baseline safety data.
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End point title |
Number of subjects reporting local and systemic reactions during 0-6 days after each vaccination. [1] | ||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Safety was evaluated as the number of subjects reporting local and systemic reactions occurring between 0-6 days after each vaccination.
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End point type |
Primary
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End point timeframe |
0-6 days after each vaccination
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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: no statistical analyses required for this endpoint. |
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| No statistical analyses for this end point | |||||||||||||||||||||||||||||||||||||||||||||||||
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End point title |
Number of unsolicited adverse events occurring throughout the study period. [2] | |||||||||||||||||||||||||||||||||
End point description |
Safety was evaluated as the number of subjects reported unsolicited adverse events throughout the study.
Category 1* (Title) : Withdrawl of study due to drug related adverse events.
Category 2* (Title) : Reduced dose of vaccine for vaccination or disruption and delay of vaccination time due to adverse events.
Category 3* (Title) : Reduced dose of vaccine for vaccination or disruption and delay of vaccination time due to drug-related adverse events.
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End point type |
Primary
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End point timeframe |
Day 1 to Day 90.
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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: no statistical analyses required 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 |
Solicited adverse events were collected from Day 0-6 after vaccination; Unsolicited adverse events were collected from day 1 to 90.
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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 |
17.1
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Reporting groups
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Reporting group title |
Vaxem Hib_16 to 20 months
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Reporting group description |
one single dose of 0.5 mL administered by IM; | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Vaxem Hib_2 to 4 months
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Reporting group description |
3 doses of 0.5 mL with a time interval of one month between each dose. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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? Yes | |||
Date |
Amendment |
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14 Jul 2008 |
Change in route of administration. |
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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. | |||
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