Clinical Trial Results:
Immunogenicity and Safety of Sanofi Pasteur’s AVAXIM 80U Pediatric Vaccine Administered in Healthy Adolescents, Children and Toddlers in People’s Republic of China Followed by a Booster Dose 6 Months after the Initial Dose Versus HAVRIX 720 Vaccine
Summary
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EudraCT number |
2015-005191-18 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
08 Mar 2008
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Mar 2016
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First version publication date |
26 Mar 2016
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Other versions |
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 |
HAF78
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT00483470 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Sanofi Pasteur SA
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Sponsor organisation address |
2, avenue Pont Pasteur, Lyon cedex 07, France, F-69367
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Public contact |
Responsible Medical Officer, Sanofi Pasteur SA, 33 4 37 37 73 84, Eric.desauziers@sanofipasteur.com
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Scientific contact |
Responsible Medical Officer, Sanofi Pasteur SA, 33 4 37 37 73 84, Eric.desauziers@sanofipasteur.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 |
25 Jun 2008
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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 |
08 Mar 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 |
1) To demonstrate the non-inferiority in terms of seroprotection rate of AVAXIM 80U Pediatric vaccine versus HAVRIX 720 vaccine 1 month after booster vaccination.
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Protection of trial subjects |
Only subjects that met all the study inclusion and none of the exclusion criteria were randomized and vaccinated in the study. Vaccinations were performed by qualified and trained study personnel. Subjects with allergy to any of the vaccine components were not vaccinated. After vaccination, subjects were also kept under clinical observation for 30 minutes to ensure their safety. Appropriate medical equipment was also available on site in case of any immediate allergic reactions.
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Background therapy |
Not applicable | ||
Evidence for comparator |
Not applicable | ||
Actual start date of recruitment |
30 May 2007
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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: 720
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Worldwide total number of subjects |
720
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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) |
78
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Children (2-11 years) |
376
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Adolescents (12-17 years) |
266
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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 |
The study subjects were enrolled from 06 June 2007 to 15 August 2007 at 1 clinic center in China. | |||||||||||||||||||||
Pre-assignment
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Screening details |
A total of 720 subjects who met all of the inclusion and none of the exclusion criteria were randomized and vaccinated in this study. | |||||||||||||||||||||
Period 1
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Period 1 title |
Overall trial (overall period)
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Is this the baseline period? |
Yes | |||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||||||||||||||
Blinding implementation details |
Not applicable
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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 A; AVAXIM 80U Pediatric | |||||||||||||||||||||
Arm description |
Subjects received AVAXIM 80U Pediatric vaccine at baseline and a booster dose 6 months after the primary injection. | |||||||||||||||||||||
Arm type |
Experimental | |||||||||||||||||||||
Investigational medicinal product name |
Hepatitis A vaccine (AVAXIM 80U Pediatric)
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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 |
0.5 mL, intramuscular into the left deltoid muscle, 1 injection on Day 0 and as a booster dose 6 months after the primary injection.
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Arm title
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Group B; HAVRIX 720 | |||||||||||||||||||||
Arm description |
Subjects received HAVRIX 720 vaccine at baseline and a booster dose 6 months after the primary injection. | |||||||||||||||||||||
Arm type |
Active comparator | |||||||||||||||||||||
Investigational medicinal product name |
Hepatitis A vaccine (HAVRIX 720)
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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 |
0.5 mL, intramuscular, 1 injection on Day 0 and as a booster dose 6 months after the primary injection.
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Baseline characteristics reporting groups
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Reporting group title |
Group A; AVAXIM 80U Pediatric
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Reporting group description |
Subjects received AVAXIM 80U Pediatric vaccine at baseline and a booster dose 6 months after the primary injection. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group B; HAVRIX 720
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Reporting group description |
Subjects received HAVRIX 720 vaccine at baseline and a booster dose 6 months after the primary injection. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Group A; AVAXIM 80U Pediatric
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Reporting group description |
Subjects received AVAXIM 80U Pediatric vaccine at baseline and a booster dose 6 months after the primary injection. | ||
Reporting group title |
Group B; HAVRIX 720
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Reporting group description |
Subjects received HAVRIX 720 vaccine at baseline and a booster dose 6 months after the primary injection. |
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End point title |
Percentage of Subjects With Seroprotection Against Inactivated Hepatitis A Antigen After Primary and Booster Vaccinations with Either AVAXIM™ 80U-Pediatric or HAVRIX 720 Vaccine | ||||||||||||||||||||||||
End point description |
Anti-Hepatitis A antibody titers were measured by enzyme-linked immunosorbent assay (ELISA). Seroprotection was defined as Anti-Hepatitis A virus antibody titers ≥ 20 mIU/mL on Day 210, 1 month after booster vaccination with study vaccines. Seroprotection is reported based on age group: Toddlers (12 to 23 months), Children (2 to 11 years), and Adolescents (12 to 15 years).
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End point type |
Primary
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End point timeframe |
Day 210 (1 month post booster vaccination)
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Statistical analysis title |
Non-inferiority (Group A - Group B); All Subjects | ||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority analysis of AVAXIM 80U Pediatric on HAVRIX 720 in all subjects assessed 1 month after booster vaccination.
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Comparison groups |
Group A; AVAXIM 80U Pediatric v Group B; HAVRIX 720
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Number of subjects included in analysis |
680
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [1] | ||||||||||||||||||||||||
Method |
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Parameter type |
Difference in AVAXIM 80U Ped.-HAVRIX 720 | ||||||||||||||||||||||||
Point estimate |
-0.2
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
-1.24 | ||||||||||||||||||||||||
upper limit |
1.46 | ||||||||||||||||||||||||
Notes [1] - The non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference was greater than -10%. The 95% CI was calculated with the Wilson score method without continuity correction. AVAXIM 80U Pediatric was non-inferior to HAVRIX 720. |
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Statistical analysis title |
Non-inferiority (Group A - Group B); Toddlers | ||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority analysis of AVAXIM 80U Pediatric on HAVRIX 720 in toddlers (12 to 23 months) assessed 1 month after booster vaccination.
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Comparison groups |
Group A; AVAXIM 80U Pediatric v Group B; HAVRIX 720
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Number of subjects included in analysis |
680
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [2] | ||||||||||||||||||||||||
Method |
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Parameter type |
Difference in AVAXIM 80U Ped.-HAVRIX 720 | ||||||||||||||||||||||||
Point estimate |
0
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
-7.41 | ||||||||||||||||||||||||
upper limit |
15.46 | ||||||||||||||||||||||||
Notes [2] - The non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference was greater than -10%. The 95% CI was calculated with the Wilson score method without continuity correction. AVAXIM 80U Pediatric was non-inferior to HAVRIX 720. |
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Statistical analysis title |
Non-inferiority (Group A - Group B); Children | ||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority analysis of AVAXIM 80U Pediatric on HAVRIX 720 in children (2 to 11 years) assessed 1 month after booster vaccination.
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Comparison groups |
Group A; AVAXIM 80U Pediatric v Group B; HAVRIX 720
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Number of subjects included in analysis |
680
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [3] | ||||||||||||||||||||||||
Method |
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Parameter type |
Difference in AVAXIM 80U Ped.-HAVRIX 720 | ||||||||||||||||||||||||
Point estimate |
0
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
-1.61 | ||||||||||||||||||||||||
upper limit |
2.98 | ||||||||||||||||||||||||
Notes [3] - The non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference was greater than -10%. The 95% CI was calculated with the Wilson score method without continuity correction. AVAXIM 80U Pediatric was non-inferior to HAVRIX 720. |
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Statistical analysis title |
Non-inferiority (Group A - Group B); Adolescents | ||||||||||||||||||||||||
Statistical analysis description |
Non-inferiority analysis of AVAXIM 80U Pediatric on HAVRIX 720 in adolescents (12 to 15 years) assessed 1 month after booster vaccination.
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Comparison groups |
Group A; AVAXIM 80U Pediatric v Group B; HAVRIX 720
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Number of subjects included in analysis |
680
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Analysis specification |
Pre-specified
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Analysis type |
non-inferiority [4] | ||||||||||||||||||||||||
Method |
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Parameter type |
Difference in AVAXIM 80U Ped.-HAVRIX 720 | ||||||||||||||||||||||||
Point estimate |
-0.6
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Confidence interval |
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level |
95% | ||||||||||||||||||||||||
sides |
2-sided
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lower limit |
-3.24 | ||||||||||||||||||||||||
upper limit |
4.02 | ||||||||||||||||||||||||
Notes [4] - The non-inferiority was demonstrated if the lower bound of the two-sided 95% confidence interval (CI) of the difference was greater than -10%. The 95% CI was calculated with the Wilson score method without continuity correction. AVAXIM 80U Pediatric was non-inferior to HAVRIX 720. |
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End point title |
Geometric Mean Titers (GMTs) of Hepatitis A Antibodies After Primary and Booster Vaccinations with Either AVAXIM™ 80U-Pediatric or HAVRIX 720 Vaccine | ||||||||||||||||||||||||
End point description |
Anti-Hepatitis A antibody titers were measured by enzyme-linked immunosorbent assay (ELISA). Geometric mean titers are reported based on age group: Toddlers (12 to 23 months), Children (2 to 11 years), and Adolescents (12 to 15 years).
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End point type |
Secondary
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End point timeframe |
Day 210 (1 month after booster vaccination)
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Reporting Solicited Injection-site Reaction After Any and Each Vaccination with Either AVAXIM™ 80U-Pediatric or HAVRIX 720 Vaccine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited injection site reactions: Tenderness (Toddlers), Pain (Children and Adolescents), Erythema, and Swelling. Grade 3 solicited injection site reactions: Tenderness, Cries when injected limb is moved or the movement of the injected limb is reduced; Pain, Incapacitating unable to perform usual activities; Erythema and Swelling > 3 cm.
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End point type |
Secondary
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End point timeframe |
Day 0 up to Day 7 post-any and each injection
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No statistical analyses for this end point |
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End point title |
Percentage of Subjects Reporting Solicited Systemic Reaction After Any and Each Vaccination with Either AVAXIM™ 80U-Pediatric or HAVRIX 720 Vaccine | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
End point description |
Solicited systemic reactions (Toddlers; 12 to 23 months of age): Pyrexia (Fever), Vomiting, Abnormal crying, Somnolence (Drowsiness), Anorexia (Loss of appetite), and Irritability. Solicited systemic reactions (Children and Adolescents; 2 to 15 years of age): Pyrexia (Fever), Headache, Malaise, Myalgia.
Grade 3 solicited systemic reactions (Toddlers): Pyrexia, > 39.0°C; Vomiting, ≥ 6 episodes per 24 hours or requiring parenteral hydration; Abnormal crying, > 3 hours; Somnolence, Sleeping most of the time or difficult to wake up; Anorexia, Refuses ≥ 3 feeds/meals or refuses most feeds/meals; Irritability, Inconsolable. Grade 3 solicited systemic reactions (Children and Adolescents): Pyrexia, > 39.0°C; Headache, Malaise, and Myalgia, Prevents daily activities.
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End point type |
Secondary
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End point timeframe |
Day 0 up to Day 7 post-any and each injection
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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 |
Adverse event data were collected from Day 0 up to Day 210 (1 month after booster vaccination).
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
10
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Reporting groups
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Reporting group title |
Group A; AVAXIM 80U Pediatric
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Reporting group description |
Subjects received AVAXIM 80U Pediatric vaccine at baseline and a booster dose 6 months after the primary injection. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Group B; HAVRIX 720
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Reporting group description |
Subjects received HAVRIX 720 vaccine at baseline and a booster dose 6 months after the primary injection. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Notes [1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (children and adolescents) for which the diary cards were returned and for which data were available for the event during the period. [2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (toddlers) for which the diary cards were returned and for which data were available for the event during the period. [3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (toddlers) for which the diary cards were returned and for which data were available for the event during the period. [4] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (children and adolescents) for which the diary cards were returned and for which data were available for the event during the period. [5] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (children and adolescents) for which the diary cards were returned and for which data were available for the event during the period. [6] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (toddlers) for which the diary cards were returned and for which data were available for the event during the period. [7] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (toddlers) for which the diary cards were returned and for which data were available for the event during the period. [8] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (toddlers) for which the diary cards were returned and for which data were available for the event during the period. [9] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (children and adolescents) for which the diary cards were returned and for which data were available for the event during the period. [10] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed for the reporting group. These numbers are expected to be equal. Justification: This was a solicited adverse event recorded in a diary card within 7 days after vaccination; the total number (N) reflects those subjects (toddlers) for which the diary cards were returned and for which data were available for the event during the period. |
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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 |