Trial Outcomes & Findings for Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam (NCT NCT02640404)

Last Updated: 2018-01-08

Results Overview

Solicited injection (Inj.) site reactions: Tenderness/Pain (Grade 1: minor reaction when Inj. site touched; Grade 2: cries/protests when Inj. site touched; Grade 3: cries when injected limb moved, or the movement of the injected limb is reduced), Erythema and Swelling (Grade 1: \>0 to \<25 mm, Grade 2: \>=25 to \<50 mm, Grade 3: \>=50 mm). Number of participants with any of the Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

224 participants

Primary outcome timeframe

Within 7 days post-vaccination 1, Within 7 days post-vaccination 2

Results posted on

2018-01-08

Participant Flow

Participants were enrolled from 06 June 2016 through 16 June 2016 at a single center in Vietnam.

A total of 224 participants (112 for each group) were enrolled and vaccinated in the study.

Participant milestones

Participant milestones
Measure	Menactra® Vaccine (9 to 23 Months) Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).	Menactra® Vaccine (2 to 55 Years) Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
Overall Study STARTED	112	112
Overall Study COMPLETED	110	112
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Menactra® Vaccine (9 to 23 Months) Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).	Menactra® Vaccine (2 to 55 Years) Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Safety of a Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine in Healthy Subjects in Vietnam

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Menactra® Vaccine (9 to 23 Months) n=112 Participants Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).	Menactra® Vaccine (2 to 55 Years) n=112 Participants Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.	Total n=224 Participants Total of all reporting groups
Age, Customized 9 to 23 months	112 Participants n=5 Participants	0 Participants n=7 Participants	112 Participants n=5 Participants
Age, Customized 2 to 11 years	0 Participants n=5 Participants	43 Participants n=7 Participants	43 Participants n=5 Participants
Age, Customized 12 to 17 years	0 Participants n=5 Participants	33 Participants n=7 Participants	33 Participants n=5 Participants
Age, Customized 18 to 55 years	0 Participants n=5 Participants	36 Participants n=7 Participants	36 Participants n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	57 Participants n=7 Participants	109 Participants n=5 Participants
Sex: Female, Male Male	60 Participants n=5 Participants	55 Participants n=7 Participants	115 Participants n=5 Participants
Region of Enrollment Vietnam	112 participants n=5 Participants	112 participants n=7 Participants	224 participants n=5 Participants

PRIMARY outcome

Timeframe: Within 7 days post-vaccination 1, Within 7 days post-vaccination 2

Population: Safety analysis set included all participants who received at least 1 dose of study vaccine.

Outcome measures

Outcome measures
Measure	Menactra® Vaccine (9 to 23 Months) n=112 Participants Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Inj. site pain (post-vaccination 1)	15 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Inj site pain (post-vaccination 1)	0 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Inj site pain (post-vaccination 2)	15 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Inj site pain (post-vaccination 2)	0 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Erythema (post-vaccination 1)	1 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Erythema (post-vaccination 1)	0 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Erythema (post-vaccination 2)	2 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Erythema (post-vaccination 2)	0 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Swelling (post-vaccination 1)	1 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Swelling (post-vaccination 1)	0 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Swelling (post-vaccination 2)	2 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Swelling (post-vaccination 2)	0 Participants

PRIMARY outcome

Timeframe: Within 7 days post-vaccination

Population: Safety analysis set included all participants who received at least 1 dose of study vaccine.

Solicited injection (Inj.) site reactions in children (2-11 years), adolescents and adults (12-55 years): Tenderness/Pain (Grade 1: easily tolerated \[children\], no interference with activity \[adolescents and adults\]; Grade 2: sufficiently discomforting \[children\], some interference\[adolescents and adults\]; Grade 3: unable to perform usual activities\[children\]; significant interference with daily activities \[adolescents and adults\]), Erythema and Swelling (Grade 1: \>0 to\<25 mm \[children\], \>=25 to \<=50 mm \[adolescents and adults\]; Grade 2: \>=25 to \<50 mm \[children\], \>=51 to \<=100 mm \[adolescents and adults\], Grade 3: \>=50 mm \[children\]; \>100 mm\[adolescents and adults\]). Number of participants with any of Grade 1, 2 or 3 solicited injection-site reactions and Grade 3 solicited injection-site reactions were reported.

Outcome measures

Outcome measures
Measure	Menactra® Vaccine (9 to 23 Months) n=112 Participants Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Grade 3 Swelling	0 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Any Inj site pain	28 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Grade 3 Inj site pain	1 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Any Erythema	2 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Grade 3 Erythema	0 Participants
Number of Participants Reporting Solicited Injection-Site Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Any Swelling	1 Participants

PRIMARY outcome

Timeframe: Within 7 days post-vaccination 1, Within 7 days post-vaccination 2

Population: Safety analysis set included all participants who received at least 1 dose of study vaccine.

Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius to \<=38.5 degree Celsius; Grade 2: \>38.5 degree Celsius to \<=39.5 degree Celsius; Grade 3: \>39.5 degree Celsius), Vomiting (Grade 1: 1 episode per 24 hours, Grade 2: 2-5 episodes per 24 hours, Grade 3: \>=6 episodes per 24 hours), Crying abnormal (Grade 1: \<1 hour; Grade 2: 1-3 hours; Grade 3: \>3 hours), Drowsiness (Grade 1: sleepier than usual or less interested in surroundings; Grade 2: Not interested in surroundings or did not wake up for a feed / meal; Grade 3: Sleeping most of the time or difficult to wake up), Appetite loss (Grade 1: eating less than normal; Grade 2: missed 1 or 2 feeds / meals completely; Grade 3: refuses \>=3 feeds / meals or refuses most feeds / meals), Irritability (Grade 1: easily consolable; Grade 2: requiring increased attention; Grade 3: inconsolable). Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.

Outcome measures

Outcome measures
Measure	Menactra® Vaccine (9 to 23 Months) n=112 Participants Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Fever (post-vaccination 1)	9 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Fever (post-vaccination 1)	1 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Fever (post-vaccination 2)	9 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Fever (post-vaccination 2)	0 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Vomiting (post-vaccination 1)	8 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Vomiting (post-vaccination 1)	0 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Vomiting (post-vaccination 2)	10 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Vomiting (post-vaccination 2)	1 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Crying Abnormal (post-vaccination 1)	9 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Crying Abnormal (post-vaccination 1)	0 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Crying Abnormal (post-vaccination 2)	8 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Crying Abnormal (post-vaccination 2)	1 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Drowsiness (post-vaccination 1)	6 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Drowsiness (post-vaccination 1)	0 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Drowsiness (post-vaccination 2)	5 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Drowsiness (post-vaccination 2)	0 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Appetite lost (post-vaccination 1)	22 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Appetite lost (post-vaccination 1)	0 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Appetite lost (post-vaccination 2)	17 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Appetite lost (post-vaccination 2)	0 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Irritability (post-vaccination 1)	13 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Irritability (post-vaccination 1)	1 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Any Irritability (post-vaccination 2)	7 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (9 to 23 Months) Grade 3 Irritability (post-vaccination 2)	1 Participants

PRIMARY outcome

Timeframe: Within 7 days post-vaccination

Population: Safety analysis set included all participants who received at least 1 dose of study vaccine.

Solicited systemic reactions: Fever (Grade 1: \>=38.0 degree Celsius to \<=38.4 degree Celsius; Grade 2: \>=38.5 degree Celsius to \<=38.9 degree Celsius; Grade 3: \>=39.0 degree Celsius), headache, malaise and myalgia (Grade 1: no interference with activity, Grade 2: some interference, Grade 3: significant interference). Number of participants with any of the Grade 1, 2 or 3 systemic reactions and Grade 3 systemic reactions were reported.

Outcome measures

Outcome measures
Measure	Menactra® Vaccine (9 to 23 Months) n=112 Participants Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Any Fever	5 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Grade 3 Fever	1 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Any Headache	17 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Grade 3 Headache	3 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Any Malaise	24 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Grade 3 Malaise	1 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Any Myalgia	20 Participants
Number of Participants Reporting Solicited Systemic Reactions Following Vaccination: Menactra® Vaccine (2 to 55 Years) Grade 3 Myalgia	1 Participants

Adverse Events

Menactra® Vaccine (9 to 23 Months)

Serious events: 16 serious events

Other events: 86 other events

Deaths: 0 deaths

Menactra® Vaccine (2 to 55 Years)

Serious events: 0 serious events

Other events: 49 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Menactra® Vaccine (9 to 23 Months) n=112 participants at risk Participants (infants and toddlers) received 2 doses of 0.5 mL Menactra® Vaccine, intramuscularly, with 3-month interval (first dose at Day 0 and second dose, 3 months after dose 1).	Menactra® Vaccine (2 to 55 Years) n=112 participants at risk Participants (children, adolescents and adults) received 1 dose of 0.5 mL Menactra® Vaccine, intramuscularly at Day 0.
Gastrointestinal disorders Diarrhoea	0.89% 1/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Bronchiolitis	2.7% 3/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Diarrhoea infectious	0.89% 1/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Gastrointestinal infection	0.89% 1/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Hand-foot-and-mouth disease	1.8% 2/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Pneumonia	2.7% 3/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Respiratory tract infection	0.89% 1/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Tonsillitis	0.89% 1/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Infections and infestations Viral infection	1.8% 2/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Nervous system disorders Febrile convulsion	1.8% 2/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Respiratory, thoracic and mediastinal disorders Asthma	0.89% 1/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.
Respiratory, thoracic and mediastinal disorders Respiratory tract inflammation	0.89% 1/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.	0.00% 0/112 • Non-serious Adverse Events (AEs) data were collected from Day 0 up to 28 days post-vaccination. Serious adverse event data were collected from Day 0 throughout the study (up to 135 days for participants 9 to 23 months of age and up to 28 days for participants 2 to 55 years of age). A solicited reaction is an AE that is prelisted in the electronic case report form (eCRF) and considered to be related to vaccination. A solicited reaction is therefore an adverse drug reaction (ADR) observed and reported under the conditions (nature and time to onset) prelisted (i.e., solicited) in the eCRF. An unsolicited AE is an observed AE that does not fulfill the conditions prelisted in the eCRF in terms of symptom and/or time to onset post-vaccination.

Other adverse events

Additional Information

Medical Director

Sanofi Pasteur Inc.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
Publication restrictions are in place

Restriction type: OTHER