Trial Outcomes & Findings for A Phase 2 Bridging Study to Assess the New Formulation of ETVAX (NCT NCT05178134)
NCT ID: NCT05178134
Last Updated: 2025-08-19
Results Overview
The primary endpoint to be measured for each patient in the study is response (yes/no) to a vaccine. A vaccine responder will be defined by a ≥2-fold increase in IgA and/or IgG antibody levels against LTB in serum between post- compared to pre-immunization samples. The response rates (seroconversion rates) of IgA and/or IgG anti-LTB antibodies in serum will be derived and compared between the two treatment groups.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
280 participants
Primary outcome timeframe
3 weeks
Results posted on
2025-08-19
Participant Flow
Participant milestones
| Measure |
The Wet Formulation of ETVAX.
The wet formulation consists of a liquid suspension of inactivated bacteria (ETEX 21-24) and LCTBA in one vial, freeze-dried dmLT adjuvant in a second vial, and effervescent buffer granules in a separate sachet. Prior to administration, the buffer is dissolved in 150 ml tap water, followed by the addition of the content of the vaccine vial (inactivated bacteria mixed with LCTBA) and reconstituted and diluted adjuvant dmLT from the second vial.
Etvax: Preparation of complete Wet formulation. The vaccine supplied as a liquid, is mixed with the 150 ml of sodium bicarbonate buffer solution on the day of preparation for use on dosing day.
Just prior to administration 10 µg of dmLT is added by pipette (50 µl).
|
The Partially Dried Formulation of Selected Components of ETVAX.
The partially dried formulation, dmLT and LCTBA are spray-dried and mixed with the buffer granules and stabilizing excipients in a sachet. Prior to administration, the content of the buffer sachet (buffer, dmLT, and LCTBA) is dissolved in 150 ml tap water, followed by the addition of a liquid suspension of inactivated bacteria (ETEX 21-24).
Etvax: Preparation of partially dry formulation. The partially dry formulation of vaccine is prepared by adding the effervescent powder containing the dmLT and LCTBA to 150 ml of water. After mixing, the content of the vaccine vial is added to the mixture and the vaccine is administered to the volunteer within 30 minutes after adding the buffer powder to the water.
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|---|---|---|
|
Overall Study
STARTED
|
140
|
140
|
|
Overall Study
COMPLETED
|
139
|
139
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Phase 2 Bridging Study to Assess the New Formulation of ETVAX
Baseline characteristics by cohort
| Measure |
The Wet Formulation of ETVAX.
n=140 Participants
The wet formulation consists of a liquid suspension of inactivated bacteria (ETEX 21-24) and LCTBA in one vial, freeze-dried dmLT adjuvant in a second vial, and effervescent buffer granules in a separate sachet. Prior to administration, the buffer is dissolved in 150 ml tap water, followed by the addition of the content of the vaccine vial (inactivated bacteria mixed with LCTBA) and reconstituted and diluted adjuvant dmLT from the second vial.
Etvax: Preparation of complete Wet formulation. The vaccine supplied as a liquid, is mixed with the 150 ml of sodium bicarbonate buffer solution on the day of preparation for use on dosing day.
Just prior to administration 10 µg of dmLT is added by pipette (50 µl).
|
The Partially Dried Formulation of Selected Components of ETVAX.
n=140 Participants
The partially dried formulation, dmLT and LCTBA are spray-dried and mixed with the buffer granules and stabilizing excipients in a sachet. Prior to administration, the content of the buffer sachet (buffer, dmLT, and LCTBA) is dissolved in 150 ml tap water, followed by the addition of a liquid suspension of inactivated bacteria (ETEX 21-24).
Etvax: Preparation of partially dry formulation. The partially dry formulation of vaccine is prepared by adding the effervescent powder containing the dmLT and LCTBA to 150 ml of water. After mixing, the content of the vaccine vial is added to the mixture and the vaccine is administered to the volunteer within 30 minutes after adding the buffer powder to the water.
|
Total
n=280 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.0 Years
STANDARD_DEVIATION 9.70 • n=93 Participants
|
32.2 Years
STANDARD_DEVIATION 9.54 • n=4 Participants
|
31.6 Years
STANDARD_DEVIATION 9.62 • n=27 Participants
|
|
Sex: Female, Male
Female
|
86 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
173 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=93 Participants
|
53 Participants
n=4 Participants
|
107 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
139 Participants
n=93 Participants
|
139 Participants
n=4 Participants
|
278 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Sweden
|
140 participants
n=93 Participants
|
140 participants
n=4 Participants
|
280 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 weeksPopulation: Per Protocol population
The primary endpoint to be measured for each patient in the study is response (yes/no) to a vaccine. A vaccine responder will be defined by a ≥2-fold increase in IgA and/or IgG antibody levels against LTB in serum between post- compared to pre-immunization samples. The response rates (seroconversion rates) of IgA and/or IgG anti-LTB antibodies in serum will be derived and compared between the two treatment groups.
Outcome measures
| Measure |
The Wet Formulation of ETVAX.
n=137 Participants
The wet formulation consists of a liquid suspension of inactivated bacteria (ETEX 21-24) and LCTBA in one vial, freeze-dried dmLT adjuvant in a second vial, and effervescent buffer granules in a separate sachet. Prior to administration, the buffer is dissolved in 150 ml tap water, followed by the addition of the content of the vaccine vial (inactivated bacteria mixed with LCTBA) and reconstituted and diluted adjuvant dmLT from the second vial.
Etvax: Preparation of complete Wet formulation. The vaccine supplied as a liquid, is mixed with the 150 ml of sodium bicarbonate buffer solution on the day of preparation for use on dosing day.
Just prior to administration 10 µg of dmLT is added by pipette (50 µl).
|
The Partially Dried Formulation of Selected Components of ETVAX.
n=133 Participants
The partially dried formulation, dmLT and LCTBA are spray-dried and mixed with the buffer granules and stabilizing excipients in a sachet. Prior to administration, the content of the buffer sachet (buffer, dmLT, and LCTBA) is dissolved in 150 ml tap water, followed by the addition of a liquid suspension of inactivated bacteria (ETEX 21-24).
Etvax: Preparation of partially dry formulation. The partially dry formulation of vaccine is prepared by adding the effervescent powder containing the dmLT and LCTBA to 150 ml of water. After mixing, the content of the vaccine vial is added to the mixture and the vaccine is administered to the volunteer within 30 minutes after adding the buffer powder to the water.
|
|---|---|---|
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Vaccine Response
|
116 Participants
|
110 Participants
|
SECONDARY outcome
Timeframe: 3 weeksPopulation: 140 subjects in each group received one vaccine dose and 139 subjects in each group received two vaccine doses.
Occurrence of solicited symptoms for six days after each vaccination (day of vaccination and five subsequent days).
Outcome measures
| Measure |
The Wet Formulation of ETVAX.
n=140 Participants
The wet formulation consists of a liquid suspension of inactivated bacteria (ETEX 21-24) and LCTBA in one vial, freeze-dried dmLT adjuvant in a second vial, and effervescent buffer granules in a separate sachet. Prior to administration, the buffer is dissolved in 150 ml tap water, followed by the addition of the content of the vaccine vial (inactivated bacteria mixed with LCTBA) and reconstituted and diluted adjuvant dmLT from the second vial.
Etvax: Preparation of complete Wet formulation. The vaccine supplied as a liquid, is mixed with the 150 ml of sodium bicarbonate buffer solution on the day of preparation for use on dosing day.
Just prior to administration 10 µg of dmLT is added by pipette (50 µl).
|
The Partially Dried Formulation of Selected Components of ETVAX.
n=140 Participants
The partially dried formulation, dmLT and LCTBA are spray-dried and mixed with the buffer granules and stabilizing excipients in a sachet. Prior to administration, the content of the buffer sachet (buffer, dmLT, and LCTBA) is dissolved in 150 ml tap water, followed by the addition of a liquid suspension of inactivated bacteria (ETEX 21-24).
Etvax: Preparation of partially dry formulation. The partially dry formulation of vaccine is prepared by adding the effervescent powder containing the dmLT and LCTBA to 150 ml of water. After mixing, the content of the vaccine vial is added to the mixture and the vaccine is administered to the volunteer within 30 minutes after adding the buffer powder to the water.
|
|---|---|---|
|
Solicited Symptoms After Vaccination
Subjects who experienced solicited AEs within 6 days after second dose · Loose stools/Diarrhea
|
27 Participants
|
24 Participants
|
|
Solicited Symptoms After Vaccination
Subjects who experienced solicited AEs within 6 days after first dose · Abdominal pain
|
23 Participants
|
22 Participants
|
|
Solicited Symptoms After Vaccination
Subjects who experienced solicited AEs within 6 days after first dose · Nausea
|
17 Participants
|
20 Participants
|
|
Solicited Symptoms After Vaccination
Subjects who experienced solicited AEs within 6 days after first dose · Vomiting
|
3 Participants
|
3 Participants
|
|
Solicited Symptoms After Vaccination
Subjects who experienced solicited AEs within 6 days after first dose · Loose stools/Diarrhea
|
24 Participants
|
33 Participants
|
|
Solicited Symptoms After Vaccination
Subjects who experienced solicited AEs within 6 days after first dose · Fever
|
3 Participants
|
0 Participants
|
|
Solicited Symptoms After Vaccination
Subjects who experienced solicited AEs within 6 days after first dose · No solicited symptom
|
70 Participants
|
62 Participants
|
|
Solicited Symptoms After Vaccination
Subjects who experienced solicited AEs within 6 days after second dose · Abdominal pain
|
24 Participants
|
12 Participants
|
|
Solicited Symptoms After Vaccination
Subjects who experienced solicited AEs within 6 days after second dose · Nausea
|
22 Participants
|
20 Participants
|
|
Solicited Symptoms After Vaccination
Subjects who experienced solicited AEs within 6 days after second dose · Vomiting
|
4 Participants
|
5 Participants
|
|
Solicited Symptoms After Vaccination
Subjects who experienced solicited AEs within 6 days after second dose · Fever
|
3 Participants
|
0 Participants
|
|
Solicited Symptoms After Vaccination
Subjects who experienced solicited AEs within 6 days after second dose · No solicited symptom
|
59 Participants
|
78 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 3 monthsEvaluation if ETVAX® vaccination induces circulating antigen specific memory B- and/or T cells.
Outcome measures
Outcome data not reported
Adverse Events
The Wet Formulation of ETVAX.
Serious events: 0 serious events
Other events: 107 other events
Deaths: 0 deaths
The Partially Dried Formulation of Selected Components of ETVAX.
Serious events: 0 serious events
Other events: 102 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
The Wet Formulation of ETVAX.
n=140 participants at risk
The wet formulation consists of a liquid suspension of inactivated bacteria (ETEX 21-24) and LCTBA in one vial, freeze-dried dmLT adjuvant in a second vial, and effervescent buffer granules in a separate sachet. Prior to administration, the buffer is dissolved in 150 ml tap water, followed by the addition of the content of the vaccine vial (inactivated bacteria mixed with LCTBA) and reconstituted and diluted adjuvant dmLT from the second vial.
Etvax: Preparation of complete Wet formulation. The vaccine supplied as a liquid, is mixed with the 150 ml of sodium bicarbonate buffer solution on the day of preparation for use on dosing day.
Just prior to administration 10 µg of dmLT is added by pipette (50 µl).
|
The Partially Dried Formulation of Selected Components of ETVAX.
n=140 participants at risk
The partially dried formulation, dmLT and LCTBA are spray-dried and mixed with the buffer granules and stabilizing excipients in a sachet. Prior to administration, the content of the buffer sachet (buffer, dmLT, and LCTBA) is dissolved in 150 ml tap water, followed by the addition of a liquid suspension of inactivated bacteria (ETEX 21-24).
Etvax: Preparation of partially dry formulation. The partially dry formulation of vaccine is prepared by adding the effervescent powder containing the dmLT and LCTBA to 150 ml of water. After mixing, the content of the vaccine vial is added to the mixture and the vaccine is administered to the volunteer within 30 minutes after adding the buffer powder to the water.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
1.4%
2/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Ear and labyrinth disorders
Inner ear inflammation
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Ear and labyrinth disorders
Vertigo
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Eye disorders
Eye inflammation
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Eye disorders
Visual impairment
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
1.4%
2/140 • Number of events 3 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
2/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
2.1%
3/140 • Number of events 4 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
2/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
3/140 • Number of events 3 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
4.3%
6/140 • Number of events 6 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Eructation
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Faeces hard
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Flatulence
|
13.6%
19/140 • Number of events 21 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
10.0%
14/140 • Number of events 18 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Gastric dilatation
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Gastrointestinal hypermotility
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.71%
1/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Toothache
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Vomiting
|
5.0%
7/140 • Number of events 8 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
4.3%
6/140 • Number of events 8 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
General disorders
Asthenia
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
General disorders
Chest discomfort
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
General disorders
Chest pain
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
General disorders
Chills
|
2.1%
3/140 • Number of events 3 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
General disorders
Fatigue
|
5.0%
7/140 • Number of events 8 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
3.6%
5/140 • Number of events 5 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
General disorders
Feeling cold
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
General disorders
Hunger
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
General disorders
Malaise
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
1.4%
2/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
General disorders
Pain
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
General disorders
Pyrexia
|
5.0%
7/140 • Number of events 7 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
General disorders
Sensation of foreign body
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
General disorders
Thirst
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Infections and infestations
COVID-19
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Infections and infestations
Candida infection
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Infections and infestations
Gastroenteritis
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Infections and infestations
Herpes Simplex
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
12/140 • Number of events 12 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
7.9%
11/140 • Number of events 13 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Infections and infestations
Ophthalmic herpes simplex
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Infections and infestations
Otosalpingitis
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Injury, poisoning and procedural complications
Limb injury
|
2.1%
3/140 • Number of events 3 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Metabolism and nutrition disorders
Appetite disorder
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.9%
4/140 • Number of events 5 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.71%
1/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
1.4%
2/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Musculoskeletal and connective tissue disorders
Spondylolisthesis
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Papilloma conjunctival
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Nervous system disorders
Dizziness
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
2.9%
4/140 • Number of events 4 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Nervous system disorders
Exertional headache
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Nervous system disorders
Headache
|
30.7%
43/140 • Number of events 59 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
28.6%
40/140 • Number of events 55 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Nervous system disorders
Migraine
|
0.71%
1/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
1.4%
2/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Nervous system disorders
Tremor
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
1.4%
2/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Psychiatric disorders
Disorientation
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Reproductive system and breast disorders
Cervical polyp
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
9.3%
13/140 • Number of events 14 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
3.6%
5/140 • Number of events 5 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Reproductive system and breast disorders
Premenstrual dysphoric disorder
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
1.4%
2/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
2.1%
3/140 • Number of events 3 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
Dry throat
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
1.4%
2/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.4%
2/140 • Number of events 2 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
3.6%
5/140 • Number of events 5 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Skin and subcutaneous tissue disorders
Cold sweat
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.71%
1/140 • Number of events 1 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
0.00%
0/140 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Abdominal pain
|
25.7%
36/140 • Number of events 62 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
21.4%
30/140 • Number of events 38 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Diarrhoea
|
29.3%
41/140 • Number of events 67 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
30.0%
42/140 • Number of events 71 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
|
Gastrointestinal disorders
Nausea
|
22.9%
32/140 • Number of events 47 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
23.6%
33/140 • Number of events 46 • Collection of unsolicited AEs started with the first intervention with the study vaccine and continued until the last follow-up assessment 7 days (6-10 days) after study vaccine dose 2.
Collection of Adverse Events: * Diary solicited: Registration of solicited symptoms for 6 days after each vaccination through a diary where questions about solicited symptoms were included. The occurrence of solicited symptoms for 6 days after each vaccination was defined as secondary outcome measure in this study. * Other: Unsolicited adverse events where the collection was not primarily through diaries. The collection period for unsolicited adverse events was the entire study period.
|
Additional Information
Head of Clinical Development
Scandinavian Biopharma Holding AB
Phone: +4684705600
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place