Trial Outcomes & Findings for Safety and Immunogenicity of a Subunit Trivalent Influenza Vaccine, Northern Hemisphere Formulation 2013/2014, in Healthy Adults Aged 18 Years and Above (NCT NCT01879553)

Last Updated: 2014-03-12

Results Overview

Immunogenicity was assessed in terms of percentages of subjects in both age groups with SRH areas ≥25mm2 against each of the three vaccine strains, three weeks after receiving one dose of TIV . The related European Committee for Human Medicinal Products (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

126 participants

Primary outcome timeframe

Day 1 (baseline) and Day 22 (postvaccination)

Results posted on

2014-03-12

Participant Flow

Subjects recruited from a single center in Belgium

Participant milestones

Participant milestones
Measure	TIV (18 to ≤ 60 Years) Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	TIV (≥ 61 Years) Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
Overall Study STARTED	63	63
Overall Study COMPLETED	62	63
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	TIV (18 to ≤ 60 Years) Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	TIV (≥ 61 Years) Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Safety and Immunogenicity of a Subunit Trivalent Influenza Vaccine, Northern Hemisphere Formulation 2013/2014, in Healthy Adults Aged 18 Years and Above

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	TIV (18 to ≤ 60 Years) n=63 Participants Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	TIV (≥ 61 Years) n=63 Participants Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	Total n=126 Participants Total of all reporting groups
Age, Continuous	31.6 year STANDARD_DEVIATION 10.7 • n=5 Participants	70.2 year STANDARD_DEVIATION 5.7 • n=7 Participants	50.9 year STANDARD_DEVIATION 21.2 • n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants	29 Participants n=7 Participants	69 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants	34 Participants n=7 Participants	57 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 (baseline) and Day 22 (postvaccination)

Population: Analysis was done on the per-protocol population i.e all subjects who have received study vaccination and provided immunogenicity data both at baseline and after vaccination; did not withdraw informed consent and did not have RT-PCR confirmed influenza during the study

Outcome measures

Outcome measures
Measure	TIV (18 to ≤ 60 Years) n=61 Participants Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	TIV (≥ 61 Years) n=63 Participants Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV Day 1/baseline (H1N1 strain)	52 Percentage of subjects Interval 39.0 to 65.0	41 Percentage of subjects Interval 29.0 to 54.0
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV Day 22 (H1N1 strain)	100 Percentage of subjects Interval 94.0 to 100.0	78 Percentage of subjects Interval 66.0 to 87.0
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV Day 1/baseline (H3N2 strain)	31 Percentage of subjects Interval 20.0 to 44.0	46 Percentage of subjects Interval 33.0 to 59.0
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV Day 22 (H3N2 strain)	92 Percentage of subjects Interval 82.0 to 97.0	78 Percentage of subjects Interval 66.0 to 87.0
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV Day 1/baseline (B strain)	38 Percentage of subjects Interval 26.0 to 51.0	67 Percentage of subjects Interval 54.0 to 78.0
Percentages of Subjects With Single Radial Hemolysis (SRH) Areas ≥25mm2, Against Each of Three Vaccine Strains After Receiving One Dose of TIV Day 22 (B strain)	92 Percentage of subjects Interval 82.0 to 97.0	89 Percentage of subjects Interval 78.0 to 95.0

PRIMARY outcome

Timeframe: Day 22 (postvaccination) /Day 1 (baseline)

Population: Analysis was done on the per-protocol population

Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase by SRH area against each of the three vaccine strains, three weeks after receiving one dose of TIV. Seroconversion is defined as percentage of subjects with a pre vaccination SRH area ≤4mm2 achieving a post vaccination SRH area ≥25 mm2. Significant increase is defined as percentage of subjects with a pre-vaccination SRH area \>4mm2 achieving at least 50% increase in post vaccination SRH area. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving post vaccination SRH areas ≥ 25mm2 is \>40% for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years.

Outcome measures

Outcome measures
Measure	TIV (18 to ≤ 60 Years) n=61 Participants Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	TIV (≥ 61 Years) n=63 Participants Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV H1N1 strain	69 Percentages of subjects Interval 56.0 to 80.0	49 Percentages of subjects Interval 36.0 to 62.0
Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV H3N2 strain	70 Percentages of subjects Interval 57.0 to 81.0	43 Percentages of subjects Interval 30.0 to 56.0
Percentages of Subjects With Seroconversion or Significant Increase in SRH Area, Against Each of Three Vaccine Strains After Receiving One Dose of TIV B strain	70 Percentages of subjects Interval 57.0 to 81.0	30 Percentages of subjects Interval 19.0 to 43.0

PRIMARY outcome

Timeframe: Day 22 (postvaccination) / Day 1 (baseline)

Population: Analysis was done on the per-protocol population

The antibody responses were evaluated in terms of GMRs of post vaccination GMAs to pre vaccination GMAs against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 in for subjects aged ≥61 years.

Outcome measures

Outcome measures
Measure	TIV (18 to ≤ 60 Years) n=61 Participants Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	TIV (≥ 61 Years) n=63 Participants Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIV H1N1 strain	3.41 Ratio Interval 2.51 to 4.63	1.85 Ratio Interval 1.52 to 2.25
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIV H3N2 strain	3.07 Ratio Interval 2.45 to 3.85	1.74 Ratio Interval 1.46 to 2.08
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination Geometric Mean Areas (GMAs), After One Dose of TIV B strain	2.06 Ratio Interval 1.75 to 2.42	1.49 Ratio Interval 1.29 to 1.73

PRIMARY outcome

Timeframe: Day 1 (baseline) and Day 22 (postvaccination)

Population: Analysis was done on the per-protocol population.

Immunogenicity was assessed in terms of percentages of subjects in both age groups with HI titers ≥40, against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the percentage of subjects achieving HI titers ≥ 40 is \>70% for adults aged 18 to ≤60 years and \>60% for subjects aged ≥61 years.

Outcome measures

Outcome measures
Measure	TIV (18 to ≤ 60 Years) n=61 Participants Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	TIV (≥ 61 Years) n=63 Participants Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV Day 1 (H1N1 strain)	59 Percentages of subjects Interval 46.0 to 71.0	60 Percentages of subjects Interval 47.0 to 72.0
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV Day 22 (H1N1 strain)	100 Percentages of subjects Interval 94.0 to 100.0	90 Percentages of subjects Interval 80.0 to 96.0
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV Day 1 (H3N2 strain)	66 Percentages of subjects Interval 52.0 to 77.0	86 Percentages of subjects Interval 75.0 to 93.0
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV Day 22 (H3N2 strain)	100 Percentages of subjects Interval 94.0 to 100.0	98 Percentages of subjects Interval 91.0 to 100.0
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV Day 1 (B strain)	66 Percentages of subjects Interval 52.0 to 77.0	70 Percentages of subjects Interval 57.0 to 81.0
Percentages of Subjects With Haemagglutination Inhibition (HI) Titers ≥40, Against Each of Three Vaccine Strains After Receiving One Dose of TIV Day 22 (B strain)	98 Percentages of subjects Interval 91.0 to 100.0	89 Percentages of subjects Interval 78.0 to 95.0

PRIMARY outcome

Timeframe: Day 22 (postvaccination) / Day 1 (baseline)

Population: Analysis was done on the per-protocol population

Immunogenicity was assessed in terms of percentages of subjects in both age groups achieving seroconversion or significant increase in HI antibody titers after receiving one dose of TIV. Seroconversion is defined as percentage of subjects with a pre vaccination HI titer \<10 to a post vaccination titer ≥40. Significant increase is defined as percentage of subjects with a pre vaccination HI titer ≥10 to at least a 4-fold increase in post vaccination HI antibody titers. The related European (CHMP) criterion for the assessment of immunogenicity is met if \>40% for adults aged 18 to ≤60 years and \>30% for subjects aged ≥61 years achieve seroconversion or significant increase in post-vaccination HI titers.

Outcome measures

Outcome measures
Measure	TIV (18 to ≤ 60 Years) n=61 Participants Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	TIV (≥ 61 Years) n=63 Participants Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV H1N1 strain	64 Percentages of subjects Interval 51.0 to 76.0	32 Percentages of subjects Interval 21.0 to 45.0
Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV H3N2 strain	64 Percentages of subjects Interval 51.0 to 76.0	16 Percentages of subjects Interval 8.0 to 27.0
Percentages of Subjects With Seroconversion or Significant Increase in HI Antibody Titers After Receiving One Dose of TIV B strain	52 Percentages of subjects Interval 39.0 to 65.0	13 Percentages of subjects Interval 6.0 to 23.0

PRIMARY outcome

Timeframe: Day 22 (postvaccination)/ Day 1 (baseline)

Population: Analysis was done on the per-protocol population

The antibody responses following one dose of TIV were evaluated in terms of GMRs of post vaccination against pre vaccination geometric mean HI titers against each of the three vaccine strains, three weeks after receiving one dose of TIV. The related European (CHMP) criterion for the assessment of immunogenicity is met if the GMR day 22/day 1 is \>2.5 for adults aged 18 to ≤60 years and \> 2.0 for subjects aged ≥61 years.

Outcome measures

Outcome measures
Measure	TIV (18 to ≤ 60 Years) n=61 Participants Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	TIV (≥ 61 Years) n=63 Participants Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV H1N1 strain	9.65 Ratio Interval 5.96 to 16.0	2.6 Ratio Interval 1.97 to 3.45
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV H3N2 strain	8.47 Ratio Interval 5.44 to 13.0	1.85 Ratio Interval 1.37 to 2.5
Geometric Mean Ratio (GMR) of Post Vaccination Versus Pre Vaccination HI Antibody Titers, After Receiving One Dose of TIV B strain	4.56 Ratio Interval 3.26 to 6.37	1.49 Ratio Interval 1.22 to 1.83

PRIMARY outcome

Timeframe: Day 1 to Day 4 post vaccination

The number of adult and elderly subjects reporting solicited local and systemic adverse events and other solicited adverse events after receiving one dose of TIV are reported.

Outcome measures

Outcome measures
Measure	TIV (18 to ≤ 60 Years) n=62 Participants Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	TIV (≥ 61 Years) n=63 Participants Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Any Local	38 Number of subjects	18 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Injection site induration	13 Number of subjects	9 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Injection site erythema	10 Number of subjects	8 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Injection site ecchymosis	4 Number of subjects	1 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Injection site pain	34 Number of subjects	12 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Any Systemic	17 Number of subjects	10 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Shivering/chills	0 Number of subjects	0 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Prophylactic use of analgesics/antipyretics	0 Number of subjects	0 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Therapeutic use of analgesics/antipyretics	2 Number of subjects	0 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Myalgia	1 Number of subjects	1 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Arthralgia	0 Number of subjects	1 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Fatigue	15 Number of subjects	8 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Headache	5 Number of subjects	3 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Malaise	2 Number of subjects	4 Number of subjects
Number of Subjects Reporting Solicited Adverse Events After Receiving One Dose of TIV Fever (≥ 38°C)	0 Number of subjects	0 Number of subjects

PRIMARY outcome

Timeframe: Day 1 through Day 22 post vaccination

Population: Analysis was done on the unsolicited safety set population i.e all subjects who have post vaccination unsolicited adverse event data

The number of subjects in both age groups reporting any unsolicited AEs (between Day 1 to 4), serious adverse events (SAEs), medically attended AEs, AEs leading to premature withdrawal (Day 1 to Day 22), after receiving one dose of TIV is reported.

Outcome measures

Outcome measures
Measure	TIV (18 to ≤ 60 Years) n=63 Participants Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	TIV (≥ 61 Years) n=63 Participants Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV Any AE (Day 1 to 4)	10 Number of subjects	8 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV At least possibly related AE	9 Number of subjects	6 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV Any SAE	0 Number of subjects	0 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV At least possibly related SAE	0 Number of subjects	0 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV Medically attended AE	0 Number of subjects	0 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV AE leading to discontinuation	0 Number of subjects	0 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Receiving One Dose of TIV Death	0 Number of subjects	0 Number of subjects

Adverse Events

TIV (18 to ≤ 60 Years)

Serious events: 0 serious events

Other events: 41 other events

Deaths: 0 deaths

TIV (≥ 61 Years)

Serious events: 0 serious events

Other events: 27 other events

Deaths: 0 deaths

Total

Serious events: 0 serious events

Other events: 68 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	TIV (18 to ≤ 60 Years) n=63 participants at risk Adult subjects 18 to ≤60 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	TIV (≥ 61 Years) n=63 participants at risk Adult subjects ≥61 years received one dose of a trivalent, surface antigen inactivated subunit influenza virus vaccine (TIV) formulation 2013/2014 Northern Hemisphere	Total n=126 participants at risk Total
General disorders Fatigue	23.8% 15/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	12.7% 8/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	18.3% 23/126 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22
General disorders Injection site erythema	14.3% 9/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	14.3% 9/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	14.3% 18/126 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22
General disorders Injection site haemorrhage	6.3% 4/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	1.6% 1/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	4.0% 5/126 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22
General disorders Injection site induration	17.5% 11/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	12.7% 8/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	15.1% 19/126 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22
General disorders Injection site pain	55.6% 35/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	25.4% 16/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	40.5% 51/126 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22
General disorders Malaise	3.2% 2/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	7.9% 5/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	5.6% 7/126 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22
Nervous system disorders Headache	7.9% 5/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	4.8% 3/63 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22	6.3% 8/126 • All solicited AEs and unsolicited AEs were collected from Day1 to Day 4; all unsolicited SAEs, medically attended AEs, AEs leading to withdrawal from the study were collected from Day 1 to Day 22

Additional Information

Posting Director

Novartis Vaccines and Diagnostics

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60