Trial Outcomes & Findings for A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069) (NCT NCT00835380)
NCT ID: NCT00835380
Last Updated: 2017-04-13
Results Overview
Seroconversion rate = (number of subjects with seronegative at baseline and developed seropositive at Month 7)/(number of subjects with seronegative at baseline regardless HAV serum status at Month 7). Measure serum HAV (hepatitis A virus) antibody at Day 0 prior to vaccination and at Month 7 after administration of a 2-dose regimen of vaccines. HAV antibody titers were determined by Wantai ELISA kit for serum antibody response to HAV. Seropositive was defined as HAV antibody titer ≥ 50 mIU/mL. Seronegative was defined as HAV antibody titer \< 50 mIU/mL.
COMPLETED
PHASE3
80 participants
Collect blood sample for HAV antibody testing at Day 0 prior to vaccination, and Month 7 (4 weeks after administration of a 2-dose regimen of vaccines at Month 6)
2017-04-13
Participant Flow
114 subjects were enrolled for vaccination screening. Subject eligibility was reviewed according to the inclusion/exclusion criteria, and blood samples were collected for HAV (hepatitis A virus) antibody and ALT (alanine aminotransferase) testing. Finally 80 HAV-susceptible subjects with normal ALT were administered vaccines at the Day 1
Participant milestones
| Measure |
VAQTA™
Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
|
|---|---|
|
Overall Study
STARTED
|
80
|
|
Overall Study
COMPLETED
|
78
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
VAQTA™
Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Study of 2 Doses of VAQTA™ in Healthy Children 12 to 23 Months of Age (V251-069)
Baseline characteristics by cohort
| Measure |
VAQTA™
n=80 Participants
Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
|
|---|---|
|
Age, Continuous
|
14.7 Months
STANDARD_DEVIATION 1.6 • n=99 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=99 Participants
|
|
Body Temperature
|
35.56 Degrees Celsius
STANDARD_DEVIATION 0.31 • n=99 Participants
|
|
Pulse
|
80.05 Beats per minute (BPM)
STANDARD_DEVIATION 5.04 • n=99 Participants
|
PRIMARY outcome
Timeframe: Collect blood sample for HAV antibody testing at Day 0 prior to vaccination, and Month 7 (4 weeks after administration of a 2-dose regimen of vaccines at Month 6)Population: Per-protocol population, defined as all HAV-susceptible subjects who completed the vaccination regimen within acceptable day ranges, had 2 valid serology results on Day 0 and Month 7, and met all inclusion/exclusion criteria.
Seroconversion rate = (number of subjects with seronegative at baseline and developed seropositive at Month 7)/(number of subjects with seronegative at baseline regardless HAV serum status at Month 7). Measure serum HAV (hepatitis A virus) antibody at Day 0 prior to vaccination and at Month 7 after administration of a 2-dose regimen of vaccines. HAV antibody titers were determined by Wantai ELISA kit for serum antibody response to HAV. Seropositive was defined as HAV antibody titer ≥ 50 mIU/mL. Seronegative was defined as HAV antibody titer \< 50 mIU/mL.
Outcome measures
| Measure |
VAQTA™
n=70 Participants
Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
|
|---|---|
|
Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines.
Seronegative at Month 7
|
2 Percentage of Participants
|
|
Hepatitis A Virus (HAV) Seroconversion Rate, i.e. the Percentage of Subjects Who Were Seronegative at Baseline and Developed Seropositive at Month 7 After Administration of a 2-dose Regime of Vaccines.
Seropositive at Month 7
|
68 Percentage of Participants
|
SECONDARY outcome
Timeframe: For serious adverse experiences and systemic adverse experiences: 14 days follow-up after each dose of vaccination; For injection-site adverse experiences: 5 days follow-up after each dose of vaccinationPopulation: Safety population, defined as all subjects who were vaccinated at least one dose and had safety follow-up data
All adverse experiences were collected from the time the consent form was signed through 14 days following the first vaccination(s) and from the time of the second vaccination through 14 days thereafter. The parent/legal guardian of each participant were requested to record injection-site adverse experiences and monitor the subject's temperature daily on the Vaccination Report Card for Day 1 thereafter for 4 additional calendar days, and record all systemic adverse experiences that occur during the 14-day period after each injection.
Outcome measures
| Measure |
VAQTA™
n=80 Participants
Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
|
|---|---|
|
Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination
Serious adverse experiences
|
0 participants
|
|
Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination
Injection-site adverse experiences
|
10 participants
|
|
Serious Adverse Experiences and Systemic Adverse Experiences Occurring Within 14 Days After Each Vaccination, and Injection-site Complaints Occurring Day 1 Through Day 5 After Each Vaccination
Systemic adverse experiences
|
54 participants
|
Adverse Events
VAQTA™
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
VAQTA™
n=80 participants at risk
Subjects be given a 25-U/0.5-ml intramuscular injection of VAQTA™ at the Day 1 and Month 6 visits respectively.
|
|---|---|
|
General disorders
Injection site redness
|
6.2%
5/80 • Number of events 6
|
|
General disorders
Injection site pain
|
6.2%
5/80 • Number of events 6
|
|
General disorders
Injection site induration
|
5.0%
4/80 • Number of events 4
|
|
General disorders
Injection site swelling
|
5.0%
4/80 • Number of events 4
|
|
General disorders
Injection site pruritus
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Hypersomnia
|
1.2%
1/80 • Number of events 1
|
|
Nervous system disorders
Fidgety
|
2.5%
2/80 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
5.0%
4/80 • Number of events 4
|
|
Gastrointestinal disorders
Abdominal pain
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Diarrhea
|
18.8%
15/80 • Number of events 16
|
|
Gastrointestinal disorders
Vomiting
|
3.8%
3/80 • Number of events 3
|
|
Gastrointestinal disorders
Inappetency
|
1.2%
1/80 • Number of events 1
|
|
Gastrointestinal disorders
Anorexia
|
1.2%
1/80 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Coughing
|
15.0%
12/80 • Number of events 12
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
|
20.0%
16/80 • Number of events 28
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopenumonia
|
1.2%
1/80 • Number of events 1
|
|
General disorders
Allergic reaction
|
2.5%
2/80 • Number of events 2
|
|
General disorders
Fever
|
42.5%
34/80 • Number of events 38
|
|
General disorders
Fatigue
|
1.2%
1/80 • Number of events 1
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee Merck agreements may vary with individual investigators, but will not prohibit any investigator from publishing. Merck supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER