Trial Outcomes & Findings for A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children (NCT NCT01349829)
NCT ID: NCT01349829
Last Updated: 2013-12-17
Results Overview
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration \>=10 mIU/ml)
COMPLETED
PHASE4
251 participants
Month 1
2013-12-17
Participant Flow
Recruitment period: 25 March 2010 to 18 April 2011; outpatient study
Participant milestones
| Measure |
HAVpur
|
Havrix
|
|---|---|---|
|
Overall Study
STARTED
|
126
|
125
|
|
Overall Study
COMPLETED
|
117
|
102
|
|
Overall Study
NOT COMPLETED
|
9
|
23
|
Reasons for withdrawal
| Measure |
HAVpur
|
Havrix
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
8
|
|
Overall Study
Consent withdrawal
|
3
|
8
|
|
Overall Study
Migrated/moved
|
2
|
7
|
Baseline Characteristics
A Study to Evaluate the Safety and Immunogenicity of the Hepatitis A Virus Vaccine HAVpur in Healthy Young Children
Baseline characteristics by cohort
| Measure |
HAVpur
n=126 Participants
|
Havrix
n=125 Participants
|
Total
n=251 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
126 Participants
n=5 Participants
|
125 Participants
n=7 Participants
|
251 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age Continuous
|
27.6 months
STANDARD_DEVIATION 8.45 • n=5 Participants
|
27.9 months
STANDARD_DEVIATION 8.23 • n=7 Participants
|
27.8 months
STANDARD_DEVIATION 8.33 • n=5 Participants
|
|
Sex: Female, Male
Female
|
59 Participants
n=5 Participants
|
68 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 1Population: Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity
Proportion of subjects seroprotected (seroprotection defined as anti-HAV antibody concentration \>=10 mIU/ml)
Outcome measures
| Measure |
HAVpur
n=122 Participants
|
Havrix
n=117 Participants
|
|---|---|---|
|
Seroprotection at Month 1
|
95.9 percentage of participants
Interval 90.7 to 98.7
|
96.6 percentage of participants
Interval 91.5 to 99.1
|
SECONDARY outcome
Timeframe: Month 6Population: Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentrations at screening, no major protocol violations and whose serum sample was available for measurement of immunogenicity
Proportion of subjects seroprotected (\>=10 mIU/ml)
Outcome measures
| Measure |
HAVpur
n=115 Participants
|
Havrix
n=105 Participants
|
|---|---|---|
|
Seroprotection at Month 6
|
98.3 percentage of participants
Interval 93.9 to 99.8
|
99.0 percentage of participants
Interval 94.8 to 100.0
|
SECONDARY outcome
Timeframe: Month 7Population: Results are for the ATP population included all randomized subjects who received the first and second vaccination and had negative anti-HAV antibody concentrations at baseline, no major protocol violations and whose serum sample after the second vaccination was available for measurement of immunogenicity
Proportion of subjects seroprotected (\>=10 mIU/ml)
Outcome measures
| Measure |
HAVpur
n=112 Participants
|
Havrix
n=94 Participants
|
|---|---|---|
|
Seroprotection at Month 7
|
100 percentage of participants
Interval 96.8 to 100.0
|
100 percentage of participants
Interval 96.2 to 100.0
|
SECONDARY outcome
Timeframe: Month 1Population: Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentration at screening, and who had no major protocol violations and whose serum sample after the first vaccination was available for measurement of immunogenicity
GMCs of anti-HAV antibodies will be measured from blood samples
Outcome measures
| Measure |
HAVpur
n=122 Participants
|
Havrix
n=117 Participants
|
|---|---|---|
|
Geometric Mean Concentrations (GMCs)
|
51.5 mIU/mL
Interval 41.5 to 64.0
|
53.3 mIU/mL
Interval 42.8 to 66.5
|
SECONDARY outcome
Timeframe: Month 6Population: Results are for the ATP population included all randomized subjects who received the first vaccination and had negative anti-HAV antibody concentrations at screening, no major protocol violations and whose serum sample was available for measurement of immunogenicity
GMCs of anti-HAV antibodies will be measured from blood samples
Outcome measures
| Measure |
HAVpur
n=115 Participants
|
Havrix
n=105 Participants
|
|---|---|---|
|
Geometric Mean Concentrations (GMCs)
|
96.0 mIU/mL
Interval 71.8 to 128.4
|
113.0 mIU/mL
Interval 83.7 to 152.5
|
SECONDARY outcome
Timeframe: Month 7Population: Results are for the ATP population included all randomized subjects who received the first and second vaccination and had negative anti-HAV antibody concentrations at baseline, no major protocol violations and whose serum sample after the second vaccination was available for measurement of immunogenicity
GMCs of anti-HAV antibodies will be measured from blood samples
Outcome measures
| Measure |
HAVpur
n=112 Participants
|
Havrix
n=94 Participants
|
|---|---|---|
|
Geometric Mean Concentrations (GMCs)
|
1712.4 mIU/mL
Interval 1377.1 to 2129.3
|
2226.4 mIU/mL
Interval 1758.4 to 2819.1
|
Adverse Events
HAVpur - First Vaccination
Havrix - First Vaccination
HAVPur - Second Vaccination
Havrix - Second Vaccination
Serious adverse events
| Measure |
HAVpur - First Vaccination
n=126 participants at risk
|
Havrix - First Vaccination
n=125 participants at risk
|
HAVPur - Second Vaccination
n=118 participants at risk
|
Havrix - Second Vaccination
n=108 participants at risk
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/126
|
0.00%
0/125
|
0.85%
1/118 • Number of events 1
|
0.00%
0/108
|
|
Infections and infestations
Typhoid fever
|
0.00%
0/126
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
Other adverse events
| Measure |
HAVpur - First Vaccination
n=126 participants at risk
|
Havrix - First Vaccination
n=125 participants at risk
|
HAVPur - Second Vaccination
n=118 participants at risk
|
Havrix - Second Vaccination
n=108 participants at risk
|
|---|---|---|---|---|
|
Infections and infestations
Bronchitis
|
0.79%
1/126 • Number of events 1
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/126
|
1.6%
2/125 • Number of events 2
|
0.00%
0/118
|
0.00%
0/108
|
|
General disorders
Injection site pain (solicited)
|
1.6%
2/126 • Number of events 2
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.93%
1/108 • Number of events 1
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/126
|
0.00%
0/125
|
0.00%
0/118
|
0.93%
1/108 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
0.79%
1/126 • Number of events 1
|
0.80%
1/125 • Number of events 1
|
0.85%
1/118 • Number of events 1
|
0.00%
0/108
|
|
Gastrointestinal disorders
Vomiting
|
0.79%
1/126 • Number of events 1
|
0.00%
0/125
|
0.00%
0/118
|
0.00%
0/108
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/126
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
|
General disorders
Pyrexia (solicited)
|
0.00%
0/126
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
|
General disorders
Injection site swelling (solicited)
|
2.4%
3/126 • Number of events 3
|
0.00%
0/125
|
0.00%
0/118
|
0.00%
0/108
|
|
General disorders
Injection site erythema (solicited)
|
1.6%
2/126 • Number of events 2
|
0.00%
0/125
|
0.85%
1/118 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
General disorders
Pyrexia (unsolicited)
|
4.0%
5/126 • Number of events 5
|
4.0%
5/125 • Number of events 6
|
0.85%
1/118 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
Immune system disorders
Allergy to arthropod bite
|
0.79%
1/126 • Number of events 1
|
0.00%
0/125
|
0.00%
0/118
|
0.00%
0/108
|
|
Infections and infestations
Upper respiratory tract infection
|
4.8%
6/126 • Number of events 6
|
2.4%
3/125 • Number of events 3
|
0.00%
0/118
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Nasopharyngitis
|
1.6%
2/126 • Number of events 2
|
4.0%
5/125 • Number of events 5
|
0.85%
1/118 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
Infections and infestations
Respiratory tract infection
|
1.6%
2/126 • Number of events 2
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
|
Infections and infestations
Gastroenteritis
|
0.79%
1/126 • Number of events 1
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
|
Infections and infestations
Pyoderma
|
1.6%
2/126 • Number of events 2
|
0.00%
0/125
|
0.00%
0/118
|
0.00%
0/108
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/126
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
|
Infections and infestations
Helminthic infection
|
0.00%
0/126
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
|
Infections and infestations
Malaria
|
0.79%
1/126 • Number of events 1
|
0.00%
0/125
|
0.00%
0/118
|
0.00%
0/108
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/126
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/126
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
|
Infections and infestations
Varicella
|
0.00%
0/126
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/126
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.6%
2/126 • Number of events 2
|
4.0%
5/125 • Number of events 5
|
0.85%
1/118 • Number of events 1
|
0.93%
1/108 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/126
|
0.80%
1/125 • Number of events 1
|
0.00%
0/118
|
0.00%
0/108
|
|
Skin and subcutaneous tissue disorders
Heat rash
|
0.79%
1/126 • Number of events 1
|
0.00%
0/125
|
0.00%
0/118
|
0.00%
0/108
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place