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A Clinical Trial of CSL's 2009 H1N1 Influenza Vaccine (CSL425) in Healthy Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seqirus
ClinicalTrials.gov Identifier:
NCT00940108
First received: July 13, 2009
Last updated: July 17, 2016
Last verified: October 2013
Results First Received: July 9, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza Caused by the Novel Influenza A (H1N1) Virus
Intervention: Biological: CSL425

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
One randomized participant withdrew consent prior to vaccine administration and was not included in the participant flow data or in any analysis population.

Reporting Groups
  Description
CSL425 (15 mcg) Cohort A Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
CSL425 (30 mcg) Cohort A Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
CSL425 (15 mcg) Cohort B Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
CSL425 (30 mcg) Cohort B Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

Participant Flow:   Overall Study
    CSL425 (15 mcg) Cohort A   CSL425 (30 mcg) Cohort A   CSL425 (15 mcg) Cohort B   CSL425 (30 mcg) Cohort B
STARTED   82   80   103   104 
COMPLETED   77   71   100   99 
NOT COMPLETED   5   9   3   5 
Adverse Event                2                4                0                2 
Withdrew Consent                2                1                0                1 
Dose 2 contraindicated                1                1                0                1 
Declined further vaccination                0                1                3                0 
Refused - pyrexia after Dose 1                0                1                0                0 
Viral illness after Dose 1                0                1                0                0 
Diagnosed with H1N1                0                0                0                1 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
CSL425 (15 mcg) Cohort A Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
CSL425 (30 mcg) Cohort A Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
CSL425 (15 mcg) Cohort B Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
CSL425 (30 mcg) Cohort B Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
Total Total of all reporting groups

Baseline Measures
   CSL425 (15 mcg) Cohort A   CSL425 (30 mcg) Cohort A   CSL425 (15 mcg) Cohort B   CSL425 (30 mcg) Cohort B   Total 
Overall Participants Analyzed 
[Units: Participants]
 82   80   103   104   369 
Age 
[Units: Years]
Mean (Standard Deviation)
 1.68  (0.67)   1.73  (0.74)   5.78  (1.69)   5.66  (1.74)   3.96  (2.42) 
Gender 
[Units: Participants]
         
Female   41   41   53   49   184 
Male   41   39   50   55   185 


  Outcome Measures
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1.  Primary:   Haemagglutination Inhibition (HI) Antibody Titre Seroconversion Rate After the First Vaccination   [ Time Frame: Before and 21 days after the first vaccination ]

2.  Primary:   HI Antibody Titre Seroconversion Rate After the Second Vaccination   [ Time Frame: Before and 21 days after the second vaccination ]

3.  Primary:   Geometric Mean Fold Increase (GMFI) in the HI Antibody Titre After the First Vaccination   [ Time Frame: Before and 21 days after the first vaccination ]

4.  Primary:   GMFI in the HI Antibody Titre After the Second Vaccination   [ Time Frame: Before and 21 days after the second vaccination ]

5.  Primary:   Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the First Vaccination   [ Time Frame: 21 days after the first vaccination ]

6.  Primary:   Percentage of Participants Achieving a HI Antibody Titre of 1:40 or More After the Second Vaccination   [ Time Frame: 21 days after the second vaccination ]

7.  Secondary:   Frequency and Intensity of Solicited Adverse Events (AEs) After the First or Second Vaccination   [ Time Frame: During the 7 days after each vaccination ]

8.  Secondary:   Duration of Solicited AEs After the First Vaccination   [ Time Frame: During the 7 days after the first vaccination and up to Day 20 after the first vaccination if AE is ongoing at Day 7. ]

9.  Secondary:   Duration of Solicited AEs After the Second Vaccination   [ Time Frame: During the 7 days after the second vaccination and up to Day 20 after the second vaccination if AE was ongoing at Day 7. ]

10.  Secondary:   Incidence of Serious Adverse Events (SAEs), Adverse Events of Special Interest (AESIs), and New Onset of Chronic Illnesses (NOCIs)   [ Time Frame: Up to 180 days after the last vaccination ]

11.  Secondary:   Frequency and Intensity of Unsolicited Adverse Events After the First or Second Vaccination   [ Time Frame: During the 21 days after each vaccination; up to 180 days after the last vaccination for SAEs, AESIs, and NOCIs ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame For SAEs: up to 180 days after the last vaccination. For Other AEs: solicited AEs: during the 7 days after each vaccination; unsolicited AEs: during the 21 days after each vaccination; up to 180 days after the last vaccination for AESIs and NOCIs.
Additional Description Unsolicited AEs presented in the organ system "General disorders" with a footnote of "MedDRA V13.0", were collected under the MedDRA System Organ Class (SOC) 'General disorders and administration site conditions'. Solicited AEs are presented in the organ system "General disorders" and were not collected under the MedDRA SOC.

Frequency Threshold
Threshold above which other adverse events are reported   2  

Reporting Groups
  Description
CSL425 (15 mcg) Cohort A Participants aged 6 months to less than 3 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
CSL425 (30 mcg) Cohort A Participants aged 6 months to less than 3 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
CSL425 (15 mcg) Cohort B Participants aged 3 years to less than 9 years received two doses of CSL425 (15 mcg of haemagglutinin antigen per 0.25 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.
CSL425 (30 mcg) Cohort B Participants aged 3 years to less than 9 years received two doses of CSL425 (30 mcg of haemagglutinin antigen per 0.5 mL dose) by intramuscular injection into the deltoid region of the arm on Day 0 and Day 21.

Other Adverse Events
    CSL425 (15 mcg) Cohort A   CSL425 (30 mcg) Cohort A   CSL425 (15 mcg) Cohort B   CSL425 (30 mcg) Cohort B
Total, other (not including serious) adverse events         
# participants affected / at risk   81/82 (98.78%)   78/80 (97.50%)   91/103 (88.35%)   96/104 (92.31%) 
Ear and labyrinth disorders         
Ear pain † 1         
# participants affected / at risk   0/82 (0.00%)   2/80 (2.50%)   8/103 (7.77%)   4/104 (3.85%) 
# events   0   2   8   5 
Gastrointestinal disorders         
Abdominal pain † 1         
# participants affected / at risk   1/82 (1.22%)   0/80 (0.00%)   4/103 (3.88%)   1/104 (0.96%) 
# events   1   0   4   1 
Diarrhoea † 1         
# participants affected / at risk   3/82 (3.66%)   3/80 (3.75%)   3/103 (2.91%)   2/104 (1.92%) 
# events   3   3   3   2 
Abdominal pain upper † 1         
# participants affected / at risk   0/82 (0.00%)   1/80 (1.25%)   1/103 (0.97%)   3/104 (2.88%) 
# events   0   1   1   3 
Teething † 1         
# participants affected / at risk   14/82 (17.07%)   12/80 (15.00%)   0/103 (0.00%)   0/104 (0.00%) 
# events   18   19   0   0 
Vomiting † 1         
# participants affected / at risk   0/82 (0.00%)   4/80 (5.00%)   2/103 (1.94%)   2/104 (1.92%) 
# events   0   4   2   2 
General disorders         
Influenza-like illness † 1         
# participants affected / at risk   12/82 (14.63%)   10/80 (12.50%)   7/103 (6.80%)   9/104 (8.65%) 
# events   14   10   8   9 
Pyrexia † 1         
# participants affected / at risk   10/82 (12.20%)   4/80 (5.00%)   3/103 (2.91%)   2/104 (1.92%) 
# events   10   4   4   2 
Malaise † 1         
# participants affected / at risk   0/82 (0.00%)   2/80 (2.50%)   3/103 (2.91%)   0/104 (0.00%) 
# events   0   2   3   0 
Fatigue † 1         
# participants affected / at risk   0/82 (0.00%)   2/80 (2.50%)   0/103 (0.00%)   0/104 (0.00%) 
# events   0   2   0   0 
Pain at Injection Site †         
# participants affected / at risk   40/82 (48.78%)   35/80 (43.75%)   61/103 (59.22%)   67/104 (64.42%) 
# events   52   47   96   105 
Redness at Injection Site †         
# participants affected / at risk   44/82 (53.66%)   31/80 (38.75%)   39/103 (37.86%)   39/104 (37.50%) 
# events   66   44   53   52 
Swelling/Induration at Injection Site †         
# participants affected / at risk   25/82 (30.49%)   26/80 (32.50%)   26/103 (25.24%)   28/104 (26.92%) 
# events   35   33   32   40 
Nausea/Vomiting †         
# participants affected / at risk   11/82 (13.41%)   24/80 (30.00%)   16/103 (15.53%)   21/104 (20.19%) 
# events   15   26   18   28 
Diarrhoea †         
# participants affected / at risk   22/82 (26.83%)   26/80 (32.50%)   13/103 (12.62%)   13/104 (12.50%) 
# events   28   32   14   15 
Loss of Appetite † [3]         
# participants affected / at risk   33/82 (40.24%)   40/80 (50.00%)   0/0   0/0 
# events   48   55   0   0 
Irritability † [3]         
# participants affected / at risk   52/82 (63.41%)   58/80 (72.50%)   0/0   0/0 
# events   92   99   0   0 
Fever †         
# participants affected / at risk   41/82 (50.00%)   57/80 (71.25%)   21/103 (20.39%)   31/104 (29.81%) 
# events   51   75   28   37 
Headache † [4]         
# participants affected / at risk   0/0   0/0   28/103 (27.18%)   24/104 (23.08%) 
# events   0   0   42   38 
Muscle Ache (Myalgia) † [4]         
# participants affected / at risk   0/0   0/0   16/103 (15.53%)   23/104 (22.12%) 
# events   0   0   21   28 
Malaise † [4]         
# participants affected / at risk   0/0   0/0   20/103 (19.42%)   28/104 (26.92%) 
# events   0   0   25   39 
Immune system disorders         
Seasonal allergy † 1         
# participants affected / at risk   1/82 (1.22%)   0/80 (0.00%)   3/103 (2.91%)   3/104 (2.88%) 
# events   1   0   3   3 
Infections and infestations         
Upper respiratory tract infection † 1         
# participants affected / at risk   22/82 (26.83%)   28/80 (35.00%)   22/103 (21.36%)   24/104 (23.08%) 
# events   28   31   26   26 
Viral infection † 1         
# participants affected / at risk   4/82 (4.88%)   0/80 (0.00%)   3/103 (2.91%)   9/104 (8.65%) 
# events   4   0   4   9 
Croup infectious † 1         
# participants affected / at risk   3/82 (3.66%)   1/80 (1.25%)   4/103 (3.88%)   0/104 (0.00%) 
# events   3   1   4   0 
Tonsillitis † 1         
# participants affected / at risk   1/82 (1.22%)   1/80 (1.25%)   1/103 (0.97%)   3/104 (2.88%) 
# events   1   1   1   3 
Nasopharyngitis † 1         
# participants affected / at risk   1/82 (1.22%)   1/80 (1.25%)   3/103 (2.91%)   0/104 (0.00%) 
# events   1   1   3   0 
Otitis media † 1         
# participants affected / at risk   4/82 (4.88%)   1/80 (1.25%)   3/103 (2.91%)   0/104 (0.00%) 
# events   5   1   3   0 
Hand-foot-and-mouth disease † 1         
# participants affected / at risk   4/82 (4.88%)   3/80 (3.75%)   1/103 (0.97%)   0/104 (0.00%) 
# events   4   3   1   0 
Gastroenteritis † 1         
# participants affected / at risk   2/82 (2.44%)   3/80 (3.75%)   1/103 (0.97%)   2/104 (1.92%) 
# events   2   3   1   2 
Viral upper respiratory tract infection † 1         
# participants affected / at risk   1/82 (1.22%)   2/80 (2.50%)   0/103 (0.00%)   2/104 (1.92%) 
# events   1   2   0   2 
Ear infection † 1         
# participants affected / at risk   2/82 (2.44%)   0/80 (0.00%)   1/103 (0.97%)   0/104 (0.00%) 
# events   2   0   1   0 
Lower respiratory tract infection † 1         
# participants affected / at risk   0/82 (0.00%)   2/80 (2.50%)   0/103 (0.00%)   0/104 (0.00%) 
# events   0   2   0   0 
Rhinitis † 1         
# participants affected / at risk   2/82 (2.44%)   0/80 (0.00%)   0/103 (0.00%)   1/104 (0.96%) 
# events   2   0   0   1 
Injury, poisoning and procedural complications         
Fall † 1         
# participants affected / at risk   3/82 (3.66%)   6/80 (7.50%)   4/103 (3.88%)   7/104 (6.73%) 
# events   3   6   5   7 
Excoriation † 1         
# participants affected / at risk   2/82 (2.44%)   1/80 (1.25%)   3/103 (2.91%)   6/104 (5.77%) 
# events   2   1   3   8 
Contusion † 1         
# participants affected / at risk   1/82 (1.22%)   1/80 (1.25%)   0/103 (0.00%)   6/104 (5.77%) 
# events   1   1   0   6 
Injury † 1         
# participants affected / at risk   1/82 (1.22%)   0/80 (0.00%)   1/103 (0.97%)   4/104 (3.85%) 
# events   1   0   1   5 
Accident † 1         
# participants affected / at risk   1/82 (1.22%)   0/80 (0.00%)   1/103 (0.97%)   3/104 (2.88%) 
# events   1   0   1   4 
Head injury † 1         
# participants affected / at risk   0/82 (0.00%)   3/80 (3.75%)   0/103 (0.00%)   4/104 (3.85%) 
# events   0   5   0   5 
Musculoskeletal and connective tissue disorders         
Arthralgia † 1         
# participants affected / at risk   0/82 (0.00%)   0/80 (0.00%)   3/103 (2.91%)   1/104 (0.96%) 
# events   0   0   3   1 
Nervous system disorders         
Headache † 1         
# participants affected / at risk   1/82 (1.22%)   2/80 (2.50%)   4/103 (3.88%)   4/104 (3.85%) 
# events   1   2   4   4 
Lethargy † 1         
# participants affected / at risk   1/82 (1.22%)   3/80 (3.75%)   1/103 (0.97%)   0/104 (0.00%) 
# events   1   3   1   0 
Respiratory, thoracic and mediastinal disorders         
Cough † 1         
# participants affected / at risk   6/82 (7.32%)   11/80 (13.75%)   13/103 (12.62%)   11/104 (10.58%) 
# events   6   12   13   12 
Rhinorrhea † 1         
# participants affected / at risk   8/82 (9.76%)   17/80 (21.25%)   4/103 (3.88%)   8/104 (7.69%) 
# events   8   17   4   10 
Oropharyngeal pain † 1         
# participants affected / at risk   2/82 (2.44%)   0/80 (0.00%)   4/103 (3.88%)   4/104 (3.85%) 
# events   2   0   6   4 
Asthma † 1         
# participants affected / at risk   2/82 (2.44%)   4/80 (5.00%)   3/103 (2.91%)   3/104 (2.88%) 
# events   2   4   4   4 
Nasal congestion † 1         
# participants affected / at risk   0/82 (0.00%)   3/80 (3.75%)   2/103 (1.94%)   2/104 (1.92%) 
# events   0   4   4   2 
Skin and subcutaneous tissue disorders         
Rash † 1         
# participants affected / at risk   7/82 (8.54%)   3/80 (3.75%)   0/103 (0.00%)   2/104 (1.92%) 
# events   7   3   0   2 
Dermatitis diaper † 1         
# participants affected / at risk   7/82 (8.54%)   1/80 (1.25%)   0/103 (0.00%)   0/104 (0.00%) 
# events   7   1   0   0 
Dermatitis † 1         
# participants affected / at risk   1/82 (1.22%)   2/80 (2.50%)   0/103 (0.00%)   2/104 (1.92%) 
# events   1   2   0   3 
Eczema † 1         
# participants affected / at risk   1/82 (1.22%)   2/80 (2.50%)   0/103 (0.00%)   0/104 (0.00%) 
# events   1   3   0   0 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA V13.0
[3] Not solicited for in Cohort B.
[4] Not solicited for in Cohort A.



  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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