Trial Outcomes & Findings for Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067) (NCT NCT00312858)
NCT ID: NCT00312858
Last Updated: 2017-04-13
Results Overview
Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
653 participants
Primary outcome timeframe
4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)
Results posted on
2017-04-13
Participant Flow
39 clinical sites in the United States Date first participant visit: 14-Apr-2006 Date last participant visit: 25-Mar-2008
Participant milestones
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Overall Study
STARTED
|
330
|
323
|
|
Overall Study
Visit 1
|
330
|
323
|
|
Overall Study
Visit 2
|
305
|
294
|
|
Overall Study
Visit 3
|
273
|
261
|
|
Overall Study
Visit 4
|
262
|
240
|
|
Overall Study
COMPLETED
|
262
|
230
|
|
Overall Study
NOT COMPLETED
|
68
|
93
|
Reasons for withdrawal
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
25
|
42
|
|
Overall Study
Protocol Violation
|
3
|
8
|
|
Overall Study
Withdraw by Participant
|
20
|
20
|
|
Overall Study
Participant Moved
|
11
|
10
|
|
Overall Study
Other
|
9
|
12
|
Baseline Characteristics
Concomitant Use of Hepatitis A Vaccine With Measles, Mumps, Rubella and Varicella Vaccine and Pneumococcal 7-Valent Conjugate Vaccine in Healthy 12-Month-Old Children (V251-067)
Baseline characteristics by cohort
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=330 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=323 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
Total
n=653 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.4 months
STANDARD_DEVIATION 0.80 • n=5 Participants
|
12.5 months
STANDARD_DEVIATION 0.89 • n=7 Participants
|
12.4 months
STANDARD_DEVIATION 0.85 • n=5 Participants
|
|
Sex: Female, Male
Female
|
156 Participants
n=5 Participants
|
166 Participants
n=7 Participants
|
322 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
174 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
331 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)Population: Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures.
Number of participants with titer ≥10 mIU/mL, i.e., seropositive for hepatitis A antibody, regardless of initial serostatus
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=182 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=159 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Antibody Response to Hepatitis A - Participants With a Serological Response
|
182 Participants
|
158 Participants
|
PRIMARY outcome
Timeframe: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)Population: Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures.
Participants with varicella baseline antibody titer \<1.25 gpELISA units/mL and Postdose 1 titers ≥1.25 gpELISA units/mL (seroconversion) and ≥5 gpELISA units/mL (seroprotection)
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=225 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=232 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Antibody Response to Varicella - Participants With a Serological Response
Number of participants ≥1.25 gpELISA units/mL
|
222 Participants
|
231 Participants
|
|
Antibody Response to Varicella - Participants With a Serological Response
Number of participants ≥5 gpELISA units/mL
|
210 Participants
|
228 Participants
|
PRIMARY outcome
Timeframe: 6 weeks Postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)Population: Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures
Serum antibodies to serotype-specific pneumococcal polysaccharides were determined by enzyme-linked immunosorbent assay
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=330 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=323 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Serotype 4 (n=246, 247)
|
1.8 mcg/mL
Interval 1.6 to 2.1
|
1.6 mcg/mL
Interval 1.4 to 1.8
|
|
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Serotype 6B (n=246, 246)
|
9.5 mcg/mL
Interval 8.3 to 11.0
|
9.6 mcg/mL
Interval 8.5 to 10.8
|
|
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Serotype 9V (n=247, 247)
|
3.7 mcg/mL
Interval 3.2 to 4.2
|
4.1 mcg/mL
Interval 3.7 to 4.7
|
|
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Serotype 14 (n=248, 247)
|
7.7 mcg/mL
Interval 6.8 to 8.8
|
7.4 mcg/mL
Interval 6.5 to 8.4
|
|
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Serotype 18C (n=247, 247)
|
2.9 mcg/mL
Interval 2.6 to 3.3
|
2.6 mcg/mL
Interval 2.3 to 3.0
|
|
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Serotype 19F (n=248, 248)
|
4.0 mcg/mL
Interval 3.5 to 4.5
|
3.8 mcg/mL
Interval 3.3 to 4.3
|
|
Antibody Response to Streptococcus Pneumoniae - Geometric Mean Titers
Serotype 23F (n=247, 247)
|
4.9 mcg/mL
Interval 4.3 to 5.6
|
4.5 mcg/mL
Interval 3.9 to 5.1
|
PRIMARY outcome
Timeframe: 6 weeks post dose 1Population: Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 6 week study period.
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=311 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=274 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Participants With 1 or More Systemic Adverse Experience
|
178 Participants
|
80 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post dose 2Population: Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. They are collected the first 14 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 14) within the 4 week study period.
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=263 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=251 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Participants With 1 or More Systemic Adverse Experience
|
88 Participants
|
77 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)
Systemic adverse experiences are unfavorable or unintended changes in the body after getting study vaccine. Collected the first 14 days after each of the 2 doses of hepatitis A vaccine (VAQTA™) (Days 1 to 14), given 6 months apart
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=330 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=286 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Participants With 1 or More Systemic Adverse Experience.
|
204 Participants
|
133 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post dose 1Population: Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)
Injection-site adverse experiences collected the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=311 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=274 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Participants With 1 or More Injection-site Adverse Experience
|
83 Participants
|
61 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post dose 2Population: Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)
Injection-site adverse experiences collected the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=263 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=251 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Participants With 1 or More Injection-site Adverse Experience
|
54 Participants
|
66 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)
Injection-site adverse experiences collected the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=330 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=286 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Participants With 1 or More Injection-site Adverse Experience
|
105 Participants
|
95 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post dose 1Population: Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)
Elevated temperatures measured the first 5 days after receipt of dose 1 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 6 week study period.
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=285 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=243 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
|
10 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post dose 2Population: Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)
Elevated temperatures measured the first 5 days after receipt of dose 2 of hepatitis A vaccine (VAQTA™) (Days 1 to 5) within the 4 week study period.
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=237 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=221 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
|
6 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)
Elevated temperatures measured the first 5 days after receipt of each dose of hepatitis A vaccine (VAQTA™) (Days 1 to 5) over the 6 months in which the 2 doses of vaccine were administered.
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=293 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=257 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Participants With Elevated Temperature (≥102.2F/ ≥39.0C)
|
16 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 6 weeks post dose 1Population: Includes all participants who provided safety follow-up after receipt of Dose 1 of VAQTA™ (hepatitis A vaccine)
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=311 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=274 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Participants With 1 or More Serious Vaccine-related Adverse Experience
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 4 weeks post dose 2Population: Includes all participants who provided safety follow-up after receipt of Dose 2 of VAQTA™ (hepatitis A vaccine)
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=263 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=251 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Participants With 1 or More Serious Vaccine-related Adverse Experience
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: Includes all participants who provided safety follow-up after receipt of any dose of VAQTA™ (hepatitis A vaccine)
Serious vaccine-related adverse experience causes death, persistent or significant disability, causes or prolong a hospital stay, is a cancer, an overdose, or life-threatening. They were collected during the entire study and believed due to study vaccine
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=330 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=286 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Participants With 1 or More Serious Vaccine-related Adverse Experience
|
0 Participants
|
1 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks Postdose 2 of hepatitis A vaccine (VAQTA™)Population: Per-protocol analysis set includes participants who received 2 doses of VAQTA™ (hepatitis A vaccine), had a Postdose 2 serology results, and followed the protocol procedures
Geometric Mean Titer of hepatitis A antibody, regardless of initial serostatus
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=182 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=159 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Antibody Response to Hepatitis A - Geometric Mean Titer
|
4976.6 mIU/mL
Interval 4067.6 to 6088.6
|
6123.2 mIU/mL
Interval 4825.6 to 7769.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks Postdose 1 of varicella-containing vaccine (ProQuad™)Population: Per-protocol analysis set includes participants who received the initial dose of ProQuad™ (varicella-containing vaccine), had a Postdose 1 serology result, and followed the protocol procedures
Geometric Mean Titer of varicella antibody, baseline antibody titer was \<1.25 gpELISA units/mL
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=225 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=232 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Antibody Response to Varicella - Geometric Mean Titer
|
14.6 gpELISA units/mL
Interval 13.3 to 16.1
|
16.4 gpELISA units/mL
Interval 15.1 to 17.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)Population: Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 4 is one of 7 individual serotypes contained in Prevnar™.
Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 4
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=246 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=247 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Antibody Response to S. Pneumoniae Serotype 4 - Participants With a Serological Response
|
241 Participants
|
237 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)Population: Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 6B is one of 7 individual serotypes contained in Prevnar™.
Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 6B
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=246 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=246 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Antibody Response to S. Pneumoniae Serotype 6B - Participants With a Serological Response
|
242 Participants
|
245 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)Population: Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 9V is one of 7 individual serotypes contained in Prevnar™.
Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 9V
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=247 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=247 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Antibody Response to S. Pneumoniae Serotype 9V - Participants With a Serological Response
|
243 Participants
|
245 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)Population: Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 14 is one of 7 individual serotypes contained in Prevnar™.
Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 14
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=248 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=247 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Antibody Response to S. Pneumoniae Serotype 14 - Participants With a Serological Response
|
245 Participants
|
244 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)Population: Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 18C is one of 7 individual serotypes contained in Prevnar™.
Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 18C
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=247 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=247 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Antibody Response to S. Pneumoniae Serotype 18C - Participants With a Serological Response
|
245 Participants
|
243 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)Population: Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 19F is one of 7 individual serotypes contained in Prevnar™.
Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 19F
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=248 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=248 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Antibody Response to S. Pneumoniae Serotype 19F - Participants With a Serological Response
|
245 Participants
|
244 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 6 weeks postvaccination of pneumococcal 7-valent conjugate vaccine (Prevnar™)Population: Per-protocol analysis set includes participants who received Prevnar™ (pneumococcal 7-valent conjugate vaccine), had a postvaccination serology result, and followed the protocol procedures. Serotype 23F is one of 7 individual serotypes contained in Prevnar™.
Number of participants with a postvaccination titer \>=0.2 mcg/mL for S. pneumoniae serotype 23F
Outcome measures
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
n=247 Participants
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
n=247 Participants
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Antibody Response to S. Pneumoniae Serotype 23F - Participants With a Serological Response
|
245 Participants
|
246 Participants
|
Adverse Events
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
Serious events: 2 serious events
Other events: 231 other events
Deaths: 0 deaths
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
Serious events: 6 serious events
Other events: 172 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Infections and infestations
Pneumonia
|
0.30%
1/330 • Number of events 1
|
0.00%
0/323
|
|
Infections and infestations
Cellulitis
|
0.30%
1/330 • Number of events 1
|
0.00%
0/323
|
|
Infections and infestations
Perineal Abscess
|
0.30%
1/330 • Number of events 1
|
0.00%
0/323
|
|
Infections and infestations
Genital Abscess
|
0.00%
0/330
|
0.31%
1/323 • Number of events 1
|
|
Infections and infestations
Bronchopneumonia
|
0.00%
0/330
|
0.31%
1/323 • Number of events 1
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/330
|
0.62%
2/323 • Number of events 2
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/330
|
0.62%
2/323 • Number of events 2
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/330
|
0.31%
1/323 • Number of events 1
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.00%
0/330
|
0.31%
1/323 • Number of events 1
|
Other adverse events
| Measure |
Arm 1: VAQTA™ + ProQuad™ + Prevnar™
VAQTA™ (hepatitis A vaccine) + ProQuad™ (measles, mumps, rubella, and varicella vaccine) + Prevnar™ (pneumococcal 7-valent conjugate vaccine) administered at the same time at first study visit. Second doses of VAQTA™ and ProQuad™ administered together 24 weeks later at third study visit.
|
Arm 2: VAQTA™ Separate From ProQuad™ and Prevnar™
VAQTA™ (hepatitis A vaccine) dose 1 administered separately from ProQuad™ (measles, mumps, rubella, and varicella vaccine) and Prevnar™ (pneumococcal 7-valent conjugate vaccine). A second dose of VAQTA™ administered 24 weeks after the first dose at third study visit.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.30%
1/330
|
0.00%
0/286
|
|
Ear and labyrinth disorders
Ear Pain
|
0.61%
2/330
|
0.70%
2/286
|
|
Ear and labyrinth disorders
Otorrhea
|
0.00%
0/330
|
0.35%
1/286
|
|
Eye disorders
Conjunctivitis
|
0.91%
3/330
|
1.4%
4/286
|
|
Eye disorders
Eye Discharge
|
0.61%
2/330
|
0.00%
0/286
|
|
Eye disorders
Eye Swelling
|
0.00%
0/330
|
0.35%
1/286
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.30%
1/330
|
0.00%
0/286
|
|
Gastrointestinal disorders
Constipation
|
0.61%
2/330
|
0.35%
1/286
|
|
Gastrointestinal disorders
Diarrhea
|
4.8%
16/330
|
2.8%
8/286
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/330
|
0.35%
1/286
|
|
Gastrointestinal disorders
Gastroesophageal Reflux Disease
|
0.30%
1/330
|
0.00%
0/286
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/330
|
0.35%
1/286
|
|
Gastrointestinal disorders
Oral Pain
|
0.00%
0/330
|
0.35%
1/286
|
|
Gastrointestinal disorders
Teething
|
0.00%
0/330
|
0.35%
1/286
|
|
Gastrointestinal disorders
Vomiting
|
3.0%
10/330
|
2.1%
6/286
|
|
General disorders
Body Temperature
|
0.30%
1/330
|
0.00%
0/286
|
|
General disorders
Fatigue
|
0.30%
1/330
|
0.35%
1/286
|
|
General disorders
Irritability
|
7.3%
24/330
|
5.9%
17/286
|
|
General disorders
Pain
|
0.00%
0/330
|
0.35%
1/286
|
|
General disorders
Pyrexia
|
38.2%
126/330
|
18.5%
53/286
|
|
Immune system disorders
Drug Hypersensitivity
|
0.30%
1/330
|
0.00%
0/286
|
|
Immune system disorders
Multiple Allergies
|
0.91%
3/330
|
0.00%
0/286
|
|
Immune system disorders
Seasonal Allergy
|
0.00%
0/330
|
0.35%
1/286
|
|
Infections and infestations
Acute Sinusitis
|
0.30%
1/330
|
0.00%
0/286
|
|
Infections and infestations
Adenovirus Infection
|
0.00%
0/330
|
0.35%
1/286
|
|
Infections and infestations
Body Tinea
|
0.30%
1/330
|
0.00%
0/286
|
|
Infections and infestations
Bronchitis
|
0.30%
1/330
|
0.35%
1/286
|
|
Infections and infestations
Candida Nappy Rash
|
0.61%
2/330
|
0.35%
1/286
|
|
Infections and infestations
Candidiasis
|
0.00%
0/330
|
0.35%
1/286
|
|
Infections and infestations
Conjunctivitis Bacterial
|
0.00%
0/330
|
0.35%
1/286
|
|
Infections and infestations
Conjunctivitis Infective
|
0.91%
3/330
|
0.35%
1/286
|
|
Infections and infestations
Conjunctivitis Viral
|
0.30%
1/330
|
0.00%
0/286
|
|
Infections and infestations
Croup Infectious
|
0.91%
3/330
|
1.4%
4/286
|
|
Infections and infestations
Ear Infection
|
1.8%
6/330
|
0.35%
1/286
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/330
|
0.35%
1/286
|
|
Infections and infestations
Eye Infection
|
0.61%
2/330
|
0.00%
0/286
|
|
Infections and infestations
Gastroenteritis
|
0.91%
3/330
|
0.70%
2/286
|
|
Infections and infestations
Gastroenteritis Viral
|
0.61%
2/330
|
1.0%
3/286
|
|
Infections and infestations
Impetigo
|
0.30%
1/330
|
0.00%
0/286
|
|
Infections and infestations
Influenza
|
0.30%
1/330
|
0.70%
2/286
|
|
Infections and infestations
Mycoplasma Infection
|
0.00%
0/330
|
0.35%
1/286
|
|
Infections and infestations
Nasopharyngitis
|
3.6%
12/330
|
2.4%
7/286
|
|
Infections and infestations
Otitis Media
|
7.6%
25/330
|
5.9%
17/286
|
|
Infections and infestations
Otitis Media Acute
|
0.61%
2/330
|
1.0%
3/286
|
|
Infections and infestations
Pharyngitis
|
0.91%
3/330
|
1.0%
3/286
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.61%
2/330
|
1.0%
3/286
|
|
Infections and infestations
Pharyngotonsillitis
|
0.30%
1/330
|
0.00%
0/286
|
|
Infections and infestations
Pneumonia
|
0.00%
0/330
|
0.35%
1/286
|
|
Infections and infestations
Respiratory Syncytial Virus Infection
|
0.00%
0/330
|
0.35%
1/286
|
|
Infections and infestations
Rhinitis
|
2.1%
7/330
|
2.4%
7/286
|
|
Infections and infestations
Roseola
|
1.5%
5/330
|
0.35%
1/286
|
|
Infections and infestations
Sinusitis
|
0.91%
3/330
|
0.00%
0/286
|
|
Infections and infestations
Skin Infection
|
0.30%
1/330
|
0.00%
0/286
|
|
Infections and infestations
Tinea Pedis
|
0.00%
0/330
|
0.35%
1/286
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
10.3%
34/330
|
6.6%
19/286
|
|
Infections and infestations
Viraemia
|
0.30%
1/330
|
0.00%
0/286
|
|
Infections and infestations
Viral Infection
|
2.7%
9/330
|
0.35%
1/286
|
|
Infections and infestations
Viral Pharyngitis
|
0.30%
1/330
|
0.00%
0/286
|
|
Infections and infestations
Viral Skin Infection
|
0.61%
2/330
|
0.70%
2/286
|
|
Infections and infestations
Viral upper respiratory tract Infection
|
0.00%
0/330
|
0.70%
2/286
|
|
Injury, poisoning and procedural complications
Arthropod Bite
|
0.61%
2/330
|
0.70%
2/286
|
|
Injury, poisoning and procedural complications
Arthropod Sting
|
0.30%
1/330
|
0.00%
0/286
|
|
Injury, poisoning and procedural complications
Contusion
|
0.30%
1/330
|
0.00%
0/286
|
|
Injury, poisoning and procedural complications
Head Injury
|
0.30%
1/330
|
0.00%
0/286
|
|
Injury, poisoning and procedural complications
Lower Limb Fracture
|
0.30%
1/330
|
0.00%
0/286
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.30%
1/330
|
0.00%
0/286
|
|
Injury, poisoning and procedural complications
Thermal Burn
|
0.00%
0/330
|
0.35%
1/286
|
|
Metabolism and nutrition disorders
Anorexia
|
0.61%
2/330
|
0.35%
1/286
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
0.30%
1/330
|
0.00%
0/286
|
|
Metabolism and nutrition disorders
Hypervitaminosis A
|
0.30%
1/330
|
0.00%
0/286
|
|
Metabolism and nutrition disorders
Iron Deficiency
|
0.00%
0/330
|
0.35%
1/286
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.30%
1/330
|
0.00%
0/286
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.30%
1/330
|
0.00%
0/286
|
|
Nervous system disorders
Febrile Convulsion
|
0.30%
1/330
|
0.00%
0/286
|
|
Nervous system disorders
Headache
|
0.30%
1/330
|
0.35%
1/286
|
|
Nervous system disorders
Lethargy
|
0.30%
1/330
|
0.35%
1/286
|
|
Nervous system disorders
Tremor
|
0.30%
1/330
|
0.00%
0/286
|
|
Psychiatric disorders
Crying
|
0.30%
1/330
|
0.00%
0/286
|
|
Psychiatric disorders
Insomnia
|
0.30%
1/330
|
0.35%
1/286
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/330
|
0.70%
2/286
|
|
Psychiatric disorders
Sleep Disorder
|
0.00%
0/330
|
0.35%
1/286
|
|
Reproductive system and breast disorders
Penile Discharge
|
0.00%
0/330
|
0.35%
1/286
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.30%
1/330
|
0.35%
1/286
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Hyperreactivity
|
0.30%
1/330
|
0.70%
2/286
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
4.5%
15/330
|
3.1%
9/286
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
2.1%
7/330
|
1.0%
3/286
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal Sinus Hypersecretion
|
0.30%
1/330
|
0.35%
1/286
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
0.30%
1/330
|
0.00%
0/286
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Tract Congestion
|
0.91%
3/330
|
0.70%
2/286
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/330
|
0.35%
1/286
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
0.61%
2/330
|
0.35%
1/286
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhea
|
4.8%
16/330
|
3.1%
9/286
|
|
Respiratory, thoracic and mediastinal disorders
Sinus Congestion
|
0.61%
2/330
|
0.35%
1/286
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.61%
2/330
|
0.35%
1/286
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/330
|
0.35%
1/286
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.30%
1/330
|
0.00%
0/286
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.30%
1/330
|
0.70%
2/286
|
|
Skin and subcutaneous tissue disorders
Dermatitis Atopic
|
0.30%
1/330
|
0.35%
1/286
|
|
Skin and subcutaneous tissue disorders
Dermatitis Contact
|
0.30%
1/330
|
0.00%
0/286
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
7.9%
26/330
|
3.1%
9/286
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.91%
3/330
|
1.0%
3/286
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.61%
2/330
|
0.00%
0/286
|
|
Skin and subcutaneous tissue disorders
Erythema Multiforme
|
0.30%
1/330
|
0.00%
0/286
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.0%
10/330
|
1.4%
4/286
|
|
Skin and subcutaneous tissue disorders
Rash Macular
|
0.30%
1/330
|
0.00%
0/286
|
|
Skin and subcutaneous tissue disorders
Rash Maculo-papular
|
0.30%
1/330
|
0.00%
0/286
|
|
Skin and subcutaneous tissue disorders
Rash Morbilliform
|
2.4%
8/330
|
0.35%
1/286
|
|
Skin and subcutaneous tissue disorders
Rash Rubelliform
|
0.30%
1/330
|
0.00%
0/286
|
|
Skin and subcutaneous tissue disorders
Rash Vesicular
|
1.2%
4/330
|
0.70%
2/286
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/330
|
0.35%
1/286
|
|
General disorders
Bruising, Injection site for VAQTA™
|
1.8%
6/330
|
2.4%
7/286
|
|
General disorders
Erythema, Injection site for VAQTA™
|
13.6%
45/330
|
17.8%
51/286
|
|
General disorders
Haemorrhage, Injection site for VAQTA™
|
0.30%
1/330
|
0.00%
0/286
|
|
General disorders
Nodule, Injection site for VAQTA™
|
0.30%
1/330
|
0.00%
0/286
|
|
General disorders
Pain, Injection site for VAQTA™
|
26.1%
86/330
|
25.5%
73/286
|
|
General disorders
Rash, Injection site for VAQTA™
|
1.5%
5/330
|
0.35%
1/286
|
|
General disorders
Reaction, Injection site for VAQTA™
|
0.30%
1/330
|
0.00%
0/286
|
|
General disorders
Swelling, Injection site for VAQTA™
|
9.7%
32/330
|
13.3%
38/286
|
|
General disorders
Warmth, Injection site for VAQTA™
|
0.61%
2/330
|
0.00%
0/286
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
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