Trial Outcomes & Findings for Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED) (NCT NCT00393523)
NCT ID: NCT00393523
Last Updated: 2017-04-12
Results Overview
Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1478 participants
Primary outcome timeframe
4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-B
Results posted on
2017-04-12
Participant Flow
This study was conducted at 77 primary study sites in Spain and 1 study site in Canada. Date of first subject visit: 26-Sep-2006; Date of last subject visit: 23-June-2008
To be eligible for enrollment in the study, participants were to have received a primary series of 3 doses of the same type of hepatitis B vaccine (either RECOMBIVAX HB or ENGERIX-B) during the first year of life.
Participant milestones
| Measure |
Modified Process Hepatitis B Vaccine (Group 5)
Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
|
Modified Process Hepatitis B Vaccine Booster (Group 1)
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
Modified Process Hepatitis B Vaccine Booster (Group 3)
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
20
|
376
|
375
|
353
|
354
|
|
Overall Study
Vaccination Visit 1
|
20
|
374
|
375
|
349
|
352
|
|
Overall Study
COMPLETED
|
19
|
364
|
366
|
349
|
348
|
|
Overall Study
NOT COMPLETED
|
1
|
12
|
9
|
4
|
6
|
Reasons for withdrawal
| Measure |
Modified Process Hepatitis B Vaccine (Group 5)
Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
|
Modified Process Hepatitis B Vaccine Booster (Group 1)
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
Modified Process Hepatitis B Vaccine Booster (Group 3)
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
2
|
|
Overall Study
Protocol Violation
|
0
|
6
|
2
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
6
|
7
|
2
|
3
|
|
Overall Study
Difficulties in specimen collection
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Vaccine supply issue
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Hepatitis B Vaccine Booster Study (V232-058)(COMPLETED)
Baseline characteristics by cohort
| Measure |
Modified Process Hepatitis B Vaccine Booster (Group 1)
n=376 Participants
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
n=375 Participants
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
Modified Process Hepatitis B Vaccine Booster (Group 3)
n=353 Participants
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)
n=354 Participants
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
Modified Process Hepatitis B Vaccine (Group 5)
n=20 Participants
Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
|
Total
n=1478 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
5.7 years
STANDARD_DEVIATION 0.92 • n=5 Participants
|
5.7 years
STANDARD_DEVIATION 0.92 • n=7 Participants
|
5.3 years
STANDARD_DEVIATION 1.05 • n=5 Participants
|
5.4 years
STANDARD_DEVIATION 0.98 • n=4 Participants
|
4.3 years
STANDARD_DEVIATION 0.66 • n=21 Participants
|
5.5 years
STANDARD_DEVIATION 0.98 • n=8 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
179 Participants
n=5 Participants
|
161 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
711 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
204 Participants
n=5 Participants
|
189 Participants
n=7 Participants
|
174 Participants
n=5 Participants
|
193 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
767 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-BPopulation: Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
Number of subjects who received a 3-dose primary series of RECOMBIVAX HB™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine Booster (Group 1)
n=340 Participants
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
n=333 Participants
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
|---|---|---|
|
Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy
|
323 Participants
|
305 Participants
|
SECONDARY outcome
Timeframe: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-BPopulation: Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
Number of subjects who received a 3-dose primary series of ENGERIX-B ™ in infancy and who demonstrated antibodies to hepatitis B surface antigen ≥10 mIU/mL at 4 weeks after receiving a booster dose of modified process hepatitis B vaccine or ENGERIX-B™.
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine Booster (Group 1)
n=338 Participants
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
n=328 Participants
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
|---|---|---|
|
Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy
|
329 Participants
|
313 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-BPopulation: Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of RECOMBIVAX HB™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine Booster (Group 1)
n=340 Participants
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
n=333 Participants
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
|---|---|---|
|
Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of RECOMBIVAX HB in Infancy
|
476.9 mIU/mL
Interval 380.7 to 597.3
|
561.2 mIU/mL
Interval 435.6 to 723.1
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 4 weeks after vaccination with either modified process hepatitis B vaccine or ENGERIX-BPopulation: Per-protocol population (defined as the subjects that completed the study as defined by the protocol). Subjects were excluded from the analysis population mainly because they did not receive the primary series vaccination series as defined in the protocol or the study vaccine was not maintained at proper temperature as defined in the protocol.
Geometric Mean Titer (GMT) for all subjects who completed a 3-dose primary vaccination series of ENGERIX-B™ and who received a booster dose of either modified process hepatitis B vaccine or ENGERIX-B™
Outcome measures
| Measure |
Modified Process Hepatitis B Vaccine Booster (Group 1)
n=338 Participants
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
n=328 Participants
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
|---|---|---|
|
Antibody Response to Hepatitis B Surface Antigen in Subjects Who Received a 3-dose Primary Series of ENGERIX-B in Infancy
|
1424.0 mIU/mL
Interval 1131.1 to 1792.8
|
1216.1 mIU/mL
Interval 923.6 to 1601.2
|
Adverse Events
Modified Process Hepatitis B Vaccine Booster (Group 1)
Serious events: 0 serious events
Other events: 214 other events
Deaths: 0 deaths
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
Serious events: 0 serious events
Other events: 192 other events
Deaths: 0 deaths
Modified Process Hepatitis B Vaccine Booster (Group 3)
Serious events: 0 serious events
Other events: 198 other events
Deaths: 0 deaths
ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)
Serious events: 2 serious events
Other events: 194 other events
Deaths: 0 deaths
Modified Process Hepatitis B Vaccine (Group 5)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Modified Process Hepatitis B Vaccine Booster (Group 1)
n=369 participants at risk
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
n=368 participants at risk
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
Modified Process Hepatitis B Vaccine Booster (Group 3)
n=344 participants at risk
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)
n=342 participants at risk
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
Modified Process Hepatitis B Vaccine (Group 5)
n=19 participants at risk
Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
Other adverse events
| Measure |
Modified Process Hepatitis B Vaccine Booster (Group 1)
n=369 participants at risk
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (RECOMBIVAX-HB™ in Infancy) (Group 2)
n=368 participants at risk
Participants received a primary series of 3 doses of RECOMBIVAX HB™ (5 µg (micrograms) per dose) during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
Modified Process Hepatitis B Vaccine Booster (Group 3)
n=344 participants at risk
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms) (Booster Dose)
|
ENGERIX-B™ Booster (ENGERIX-B™ in Infancy) (Group 4)
n=342 participants at risk
Participants received a primary series of 3 doses of ENGERIX-B™ (10 µg (micrograms) per dose).during the first year of life outside of the context of the study; During the study, participants received one dose of ENGERIX-B™ (10 µg (micrograms) per dose) (Booster Dose)
|
Modified Process Hepatitis B Vaccine (Group 5)
n=19 participants at risk
Participants did not receive a prior vaccination with a hepatitis B vaccine; During the study, participants received one dose of Modified Process Hepatitis B Vaccine, 5 µg (micrograms)
|
|---|---|---|---|---|---|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.54%
2/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Metabolism and nutrition disorders
Arthralgia
|
1.4%
5/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
5.3%
1/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Metabolism and nutrition disorders
Bone pain
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Metabolism and nutrition disorders
Epiphysiolysis
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Metabolism and nutrition disorders
Musculoskeletal stiffness
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Metabolism and nutrition disorders
Myalgia
|
0.54%
2/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Metabolism and nutrition disorders
Neck pain
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Metabolism and nutrition disorders
Pain in extremity
|
1.4%
5/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.87%
3/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Nervous system disorders
Aphonia
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Nervous system disorders
Headache
|
4.3%
16/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
4.9%
18/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
5.5%
19/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
4.1%
14/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Psychiatric disorders
Nightmare
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.87%
3/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.88%
3/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.5%
13/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
2.7%
10/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
6.4%
22/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
3.5%
12/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
5.3%
1/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Respiratory, thoracic and mediastinal disorders
Increased upper airway secretion
|
0.81%
3/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.88%
3/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.81%
3/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
1.9%
7/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.6%
6/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
2.6%
9/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.5%
5/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis seasonal
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Scarlet fever
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Ear and labyrinth disorders
Ear Pain
|
1.4%
5/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.4%
5/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.7%
6/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.2%
4/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Ear and labyrinth disorders
Motion Sickness
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Eye disorders
Conjunctivitis
|
0.54%
2/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Eye disorders
Conjunctivitis allergic
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Eye disorders
Eye Discharge
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Rhinitis
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Endocrine disorders
Eye Swelling
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.54%
2/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
2.4%
9/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.2%
4/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.8%
6/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
5.3%
1/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.81%
3/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
5.3%
1/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.88%
3/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Diarrhea
|
2.4%
9/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
2.3%
8/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
2.3%
8/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Gastritis
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Lip dry
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Nausea
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Odynophagia
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Stomatitis
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Toothache
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Gastrointestinal disorders
Vomiting
|
3.5%
13/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
2.0%
7/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
3.8%
13/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Asthenia
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Discomfort
|
0.81%
3/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Fatigue
|
0.54%
2/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.82%
3/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Hypothermia
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Irritability
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Malaise
|
0.54%
2/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Pain
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Pyrexia
|
6.0%
22/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
5.4%
20/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
4.9%
17/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
9.4%
32/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
5.3%
1/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Vessel puncture site pain
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Bronchitis
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Cystitis
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Ear infection
|
0.81%
3/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.87%
3/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.8%
6/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Enterobiasis
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Fungal infection
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Gastroenteritis
|
0.81%
3/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.1%
4/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
2.6%
9/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.88%
3/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Herpes virus infection
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Impetigo
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Infectious mononucleosis
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Influenza
|
1.1%
4/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Laryngitis
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Nasopharyngitis
|
4.6%
17/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
3.3%
12/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
3.5%
12/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
3.8%
13/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Otitis media
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Otitis media acute
|
0.54%
2/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.87%
3/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Pharyngitis
|
3.0%
11/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.1%
4/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.5%
5/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.2%
4/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.54%
2/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Sinusitis
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Skin infection
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Tonsillitis
|
1.9%
7/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
3.0%
11/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
2.0%
7/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Tonsillitis streptococcal
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.54%
2/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
2.3%
8/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
2.3%
8/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Varicella
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Viral infection
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
10.5%
2/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.81%
3/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Infections and infestations
Vulvovaginitis
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Injury, poisoning and procedural complications
Bite
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Injury, poisoning and procedural complications
Chillblains
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.81%
3/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Injury, poisoning and procedural complications
Face injury
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Injury, poisoning and procedural complications
Joint sprain
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Injury, poisoning and procedural complications
Open wound
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Skin and subcutaneous tissue disorders
Prurigo
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.54%
2/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.87%
3/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
1.2%
4/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.54%
2/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.81%
3/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
5.3%
1/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Vascular disorders
Hematoma
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
Vascular disorders
Pallor
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Bruising, Injection site for hepatitis B vaccine
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Erythema, Injection site for hepatitis B vaccine
|
10.0%
37/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
10.1%
37/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
8.7%
30/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
7.6%
26/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
10.5%
2/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Hematoma, Injection site for hepatitis B vaccine
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.82%
3/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.87%
3/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.88%
3/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Hypersensitivity, Injection site for hepatitis B vaccine
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.54%
2/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.87%
3/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Induration, Injection site for hepatitis B vaccine
|
0.81%
3/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.27%
1/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.58%
2/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Edema, Injection site for hepatitis B vaccine
|
0.27%
1/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Pain, Injection site for hepatitis B vaccine
|
35.0%
129/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
29.1%
107/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
27.0%
93/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
27.8%
95/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
31.6%
6/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Paraesthesia, Injection site for hepatitis B vaccine
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Pruritus, Injection site for hepatitis B vaccine
|
1.6%
6/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.82%
3/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.87%
3/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.88%
3/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Scar, Injection site for hepatitis B vaccine
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Swelling, Injection site for hepatitis B vaccine
|
14.6%
54/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
10.3%
38/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
11.6%
40/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
7.3%
25/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
15.8%
3/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Vesicles, Injection site for hepatitis B vaccine
|
0.00%
0/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.29%
1/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
|
General disorders
Warmth, Injection site for hepatitis B vaccine
|
0.81%
3/369
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/368
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/344
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/342
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
0.00%
0/19
Of the 1478 total participants in this study, 8 did not receive study vaccine, 17 received the incorrect study vaccine (different than what they were supposed to receive as part of the study), and 11 did not have safety follow-up information available. Thus, the total number of participants included in the safety analyses is 1442.
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1-800-672-6372
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