Clinical Trial Results:
A phase II, randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted pandemic H1N1 influenza candidate vaccine following a 0-28 day or 0-4 month vaccination schedule in subjects aged 8 to 12 weeks.
Summary
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EudraCT number |
2009-015174-35 |
Trial protocol |
NO |
Global end of trial date |
25 Nov 2010
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Results information
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Results version number |
v2(current) |
This version publication date |
14 Jul 2021
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First version publication date |
13 Jun 2015
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Other versions |
v1 |
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 |
113629
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01003418 | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
GlaxoSmithKline Biologicals
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Sponsor organisation address |
Rue de l'Institut 89, Rixensart, Belgium,
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Public contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.com
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Scientific contact |
Clinical Trials Call Center, GlaxoSmithKline Biologicals, 044 2089-904466, GSKClinicalSupportHD@gsk.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 Nov 2010
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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 |
25 Nov 2010
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Was the trial ended prematurely? |
Yes
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General information about the trial
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Main objective of the trial |
To evaluate the safety and reactogenicity of the H1N1 candidate vaccine in terms of solicited local and general symptoms, unsolicited adverse events (AEs) and serious adverse events (SAEs) two weeks post Dose 1.
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Protection of trial subjects |
The vaccinees were observed closely for at least 30 minutes, with appropriate medical treatment readily available in case of anaphylaxis following the administration of vaccines.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
17 Nov 2009
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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 |
Norway: 8
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Worldwide total number of subjects |
8
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EEA total number of subjects |
8
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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) |
8
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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 |
Only 8 subjects were enrolled in the study as the study was prematurely terminated for logistic reasons, not related to safety or efficacy of the vaccine | |||||||||
Pre-assignment
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Screening details |
Subjects who were enrolled completed the study but the lack of data due to the small enrollment number prevented any statistical analyses to be performed. No statistical analyses were performed as per planned in the protocol. All study results summarized below are based solely on individual data listings generated. | |||||||||
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 |
Randomised - controlled
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Blinding used |
Not blinded | |||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Flu A Group | |||||||||
Arm description |
Subjects received 2 primary doses of H1N1 vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Pandemrix™
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Investigational medicinal product code |
GSK2340272A
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Other name |
A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03, Split virion, inactivated A/California/7/2009 (H1N1)v-like
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Pharmaceutical forms |
Emulsion for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
2 primary doses of H1N1 vaccine administered intramuscularly in the anterolateral region of the left thigh at Day 0 and right thigh at Day 28.
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Investigational medicinal product name |
Infanrix™ -IPV+HIB
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Investigational medicinal product code |
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Other name |
DTPa-IPV/Hib
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3 doses administered intramuscularly at Day 14, Month 3 and Month 10 in anterolateral region of right thigh.
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Investigational medicinal product name |
Prevenar™
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Investigational medicinal product code |
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Other name |
7-valent pneumococcal conjugate vaccine
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3 doses administered intramuscularly in the anterolateral region of left thigh at at Day 14, Month 3 and Month 10.
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Arm title
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Flu B Group | |||||||||
Arm description |
Subjects received 2 primary doses of H1N1 vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10. | |||||||||
Arm type |
Experimental | |||||||||
Investigational medicinal product name |
Pandemrix™
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Investigational medicinal product code |
GSK2340272A
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Other name |
A/California/7/2009 (H1N1)v-like vaccine adjuvanted with AS03, Split virion, inactivated A/California/7/2009 (H1N1)v-like
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Pharmaceutical forms |
Emulsion for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
2 primary doses of H1N1 vaccine administered intramuscularly in the anterolateral region of the left thigh at Day 0 and right thigh at Month 4.
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Investigational medicinal product name |
Infanrix™ -IPV+HIB
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Investigational medicinal product code |
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Other name |
DTPa-IPV/Hib
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3 doses administered intramuscularly at Day 14, Month 3 and Month 10 in anterolateral region of right thigh.
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Investigational medicinal product name |
Prevenar™
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Investigational medicinal product code |
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Other name |
7-valent pneumococcal conjugate vaccine
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Intramuscular use
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Dosage and administration details |
3 doses administered intramuscularly in the anterolateral region of left thigh at at Day 14, Month 3 and Month 10.
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Baseline characteristics reporting groups
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Reporting group title |
Flu A Group
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Reporting group description |
Subjects received 2 primary doses of H1N1 vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Flu B Group
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Reporting group description |
Subjects received 2 primary doses of H1N1 vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Flu A Group
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Reporting group description |
Subjects received 2 primary doses of H1N1 vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10. | ||
Reporting group title |
Flu B Group
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Reporting group description |
Subjects received 2 primary doses of H1N1 vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10. |
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End point title |
Number of subjects with any, grade 3 and related unsolicited adverse events (AEs). [1] | ||||||||||||||||||
End point description |
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination.
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End point type |
Primary
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End point timeframe |
During the 2 weeks post-Dose 1 (Day 0-13)
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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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Any Solicited Local or General Symptoms [2] | ||||||||||||||||||||||||||||||
End point description |
Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite.
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End point type |
Primary
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End point timeframe |
During the 7-days post-Dose 1 period (Days 0-6)
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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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Number of Subjects With Any Solicited Local or General Symptoms [3] | ||||||||||||||||||||||||||||||
End point description |
Assessed solicited local symptoms were pain, redness and swelling. Assessed solicited general symptoms were drowsiness, fever, irritability and loss of appetite.
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End point type |
Primary
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End point timeframe |
During the 7-days post-Dose 2 period (Days 28 + 7 days for Group 1; Month 4 + 7 days for Group 2)
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Notes [3] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Number of subjects with Serious Adverse Events (SAEs) [4] | |||||||||
End point description |
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity.
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End point type |
Primary
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End point timeframe |
During the 2-weeks post-Dose 1 period (Days 0-13)
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Notes [4] - 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: The analysis of the primary endpoint was descriptive i.e. no statistical hypothesis test was performed. |
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No statistical analyses for this end point |
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End point title |
Number of subjects with any, grade 3 and related unsolicited AEs | ||||||||||||||||||
End point description |
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any AE reported in addition to those solicited during the clinical study. Also any ‘solicited’ symptom with onset outside the specified period of follow-up for solicited symptoms will be reported as an unsolicited AE.
Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination. Grade 3 AE = an AE which prevented normal, everyday activities/crying that cannot be comforted. Related = AE assessed by the investigator as related to the vaccination.
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End point type |
Secondary
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End point timeframe |
During the 28-day (Days 0-27) follow-up period after each study vaccine administration.
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No statistical analyses for this end point |
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End point title |
Number of subjects with serious adverse events (SAEs). | ||||||||||||
End point description |
SAEs assessed included medical occurrences that resulted in death, were life threatening, required hospitalization or prolongation of hospitalization or resulted in disability/incapacity. Results about SAEs were based on individual listings.
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End point type |
Secondary
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End point timeframe |
During the entire study period (Day 0 - Month 11)
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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 symptoms: Within 7 days (Day 0-6) follow up period after each study vaccination. Unsolicited AEs: Within 28-day follow-up period after each H1N1 vaccination. SAEs: Throughout the entire study (Day 0 to Month 11).
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Assessment type |
Non-systematic | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.1
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Reporting groups
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Reporting group title |
Flu A Group
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Reporting group description |
Subjects received 2 primary doses of H1N1 vaccine, according to a 0-28 day schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Flu B Group
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Reporting group description |
Subjects received 2 primary doses of H1N1 vaccine, according to a 0-4 month schedule. Subjects also received routine infant immunisation (DTPa-IPV/Hib) and 7Pn vaccine at Day 14, Month 3 and Month 10. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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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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01 Dec 2009 |
On request of Paediatric Committee (PDCO)/Committee for Medicinal Products for Human Use (CHMP), reporting of vaccine effectiveness and vaccine failure were incorporated. One telephone contact per group was added after the second dose to monitor fever, based on previous paediatric study results. |
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Interruptions (globally) |
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Were there any global interruptions to the trial? Yes | |||||||
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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 |