Trial Outcomes & Findings for Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects (NCT NCT01766921)

Last Updated: 2019-01-30

Results Overview

The optimal aH5N1c vaccine formulation was evaluated in terms of percentages of subjects achieving HI titers ≥40 against homologous A/H5N1 strain, three weeks after second vaccination with either low dose or high dose of aH5N1c vaccine, according to the Center for Biologics Evaluation and Research (CBER) criterion. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% confidence interval (CI) for the percentages of subjects achieving HI titer ≥40 meets or exceeds 60%.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

1393 participants

Primary outcome timeframe

Baseline (day 1) and Three weeks after 2nd vaccination (day 43)

Results posted on

2019-01-30

Participant Flow

1393 subjects were enrolled at 12 centers in the US, 5 centers in Australia, 2 centers in New Zealand and 4 centers in Thailand.

All enrolled subjects were included in the trial.

Participant milestones

Participant milestones
Measure	High Dose Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.	Low Dose Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Overall Study STARTED	700	693
Overall Study COMPLETED	676	676
Overall Study NOT COMPLETED	24	17

Reasons for withdrawal

Reasons for withdrawal
Measure	High Dose Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.	Low Dose Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Overall Study Administrative Reason	5	5
Overall Study Death	1	1
Overall Study Lost to Follow-up	1	3
Overall Study Unclassified	2	2
Overall Study Protocol Violation	1	1
Overall Study Withdrawal by Subject	14	5

Baseline Characteristics

Safety and Immunogenicity of Two Doses of H5N1 Influenza Vaccine in Elderly Subjects

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dose n=700 Participants Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.	Low Dose n=693 Participants Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.	Total n=1393 Participants Total of all reporting groups
Age, Continuous	71.2 year STANDARD_DEVIATION 5.1 • n=5 Participants	70.7 year STANDARD_DEVIATION 4.7 • n=7 Participants	71.0 year STANDARD_DEVIATION 4.9 • n=5 Participants
Sex: Female, Male FEMALE	407 Participants n=5 Participants	418 Participants n=7 Participants	825 Participants n=5 Participants
Sex: Female, Male MALE	293 Participants n=5 Participants	275 Participants n=7 Participants	568 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (day 1) and Three weeks after 2nd vaccination (day 43)

Population: Analysis was done on the Full Analysis Set (FAS) i.e., subjects who actually receive at least one dose of study vaccination and provide at least one evaluable serum sample both before (baseline) and after vaccination.

Outcome measures

Outcome measures
Measure	High Dose n=693 Participants Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.	Low Dose n=683 Participants Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. Day 1	12 Percentages of subjects Interval 10.0 to 15.0	10 Percentages of subjects Interval 8.0 to 12.0
The Percentages Of Subjects Achieving Hemagglutination Inhibition (HI) Titers ≥40 Against A/H5N1 Strain. Day 43 (N=673,664)	81 Percentages of subjects Interval 78.0 to 84.0	63 Percentages of subjects Interval 59.0 to 66.0

PRIMARY outcome

Timeframe: Three weeks after 2nd vaccination (day 43)

Population: This analysis was done on the FAS.

Immunogenicity was measured in terms of the percentages of subjects achieving seroconversion or significant increase in HI titer against the vaccine strain, three weeks after receiving two injections of low dose or high dose of aH5N1c vaccine according to the CBER criterion. Seroconversion is defined as, a postvaccination titer ≥40 in subjects with a prevaccination HI titer \<10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The CBER criterion for the elderly population is met if the lower limit of the two-sided 95% CI for the percentages of subjects achieving seroconversion for HI antibody titer meets or exceeds 30%.

Outcome measures

Outcome measures
Measure	High Dose n=673 Participants Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.	Low Dose n=664 Participants Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain.	74 Percentages of subjects Interval 70.0 to 77.0	52 Percentages of subjects Interval 48.0 to 56.0

PRIMARY outcome

Timeframe: From day 1 through day 7 after any vaccination.

Population: Analysis was done on the solicited safety population, i.e. All subjects in the exposed set with solicited (local/systemic) AE data..

Safety was assessed as the number of subjects who reported solicited local and systemic adverse events following vaccination with either low or high dose of aH5N1c vaccine.

Outcome measures

Outcome measures
Measure	High Dose n=693 Participants Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.	Low Dose n=683 Participants Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Any Local	314 Number of subjects	212 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Injection site Erythema (N=693,681)	17 Number of subjects	5 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Injection site Induration (N=693,683)	20 Number of subjects	11 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Injection site Ecchymosis (N=692,682)	7 Number of subjects	10 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Injection site Pain (N=693,681)	309 Number of subjects	203 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Any Systemic	250 Number of subjects	228 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Nausea (N=692,681)	45 Number of subjects	44 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Myalgia (N=691,681)	91 Number of subjects	85 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Arthralgia (N=692,681)	65 Number of subjects	69 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Headache (N=692,678)	92 Number of subjects	89 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Fatigue (N=692,681)	116 Number of subjects	112 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Loss of Appetite (N=683,673)	40 Number of subjects	42 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Malaise (N=692,680)	116 Number of subjects	117 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Fever (≥38°C; N=693,681)	16 Number of subjects	4 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Prevention of Pain and (or) Fever (N=691,682)	18 Number of subjects	26 Number of subjects
Number of Subjects Reporting Solicited Local and Systemic Adverse Events, After Any Vaccination. Treatment of Pain and (or) Fever (N=691,682)	56 Number of subjects	46 Number of subjects

PRIMARY outcome

Timeframe: Day 1 through day 387 after any vaccination

Population: Analysis was done unsolicited safety population, i.e. subjects in the exposed set with unsolicited AE data.

Safety was assessed using the number of subjects who reported any unsolicited adverse events, adverse events possibly or probably related to study vaccine, serious adverse events (SAEs), new onset of chronic diseases (NOCDs), medically attended AEs, AEs of special interest (AESIs), AEs leading to withdrawal from study following vaccination with aH5N1c vaccine

Outcome measures

Outcome measures
Measure	High Dose n=694 Participants Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.	Low Dose n=686 Participants Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. Any AEs (Day 1 to 22; N=694,685)	147 Number of subjects	149 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. At least possibly related AEs(Day1to22;N=694,685)	56 Number of subjects	61 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. Any AEs (Day 23 to 43; N=689,681)	101 Number of subjects	123 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. At least possibly related AEs(Day23to43;N=689,681)	21 Number of subjects	37 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. Any SAEs	43 Number of subjects	53 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. Deaths	1 Number of subjects	1 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. Medically attended AEs	383 Number of subjects	373 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. Premature withdrawal from study	1 Number of subjects	1 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. AESIs	2 Number of subjects	0 Number of subjects
Number of Subjects Reporting Unsolicited Adverse Events After Any Vaccination. NOCD	108 Number of subjects	92 Number of subjects

SECONDARY outcome

Timeframe: Day 1; day 22; day 43 and day 387

Population: Analysis was done on the FAS.

Immunogenicity was measured as the GMR. The ratio of postvaccination to prevaccination HI geometric mean titers (GMTs) is reported. The criterion is met according to the European Committee for Medicinal Products for Human Use (CHMP) criterion if the geometric mean increase GMR (day 43/day 1) in HI antibody titer is \>2.0 for subjects \>60 years of age.

Outcome measures

Outcome measures
Measure	High Dose n=681 Participants Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.	Low Dose n=673 Participants Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. A/H5N1 (Day22/Day1)	3.21 Ratio Interval 2.85 to 3.62	2.01 Ratio Interval 1.78 to 2.26
Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. A/H5N1 (Day43/Day1; N=673,664)	16 Ratio Interval 14.0 to 18.0	5.72 Ratio Interval 4.94 to 6.63
Geometric Mean Ratios (GMR) Against A/H5N1 Strain Following 2-dose Vaccination Schedule of Either Low Dose or High Dose aH5N1c Vaccine. A/H5N1 (Day387/Day1; N=658,651)	1.97 Ratio Interval 1.79 to 2.17	1.3 Ratio Interval 1.18 to 1.44

SECONDARY outcome

Timeframe: Day 1, day 22, day 43 and day 387.

Population: Analysis was done on the FAS.

Immunogenicity was assessed in terms of percentage of subjects achieving HI titers \>40, three weeks after second vaccination with aH5N1c according to the CHMP criterion. The European Licensure (CHMP) criterion is met if the percentage of subjects achieving HI titers ≥40 is \>60%.

Outcome measures

Outcome measures
Measure	High Dose n=693 Participants Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.	Low Dose n=683 Participants Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain Day 1	12 Percentages of subjects Interval 10.0 to 15.0	10 Percentages of subjects Interval 8.0 to 12.0
Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain Day 22 (N=681,673)	49 Percentages of subjects Interval 45.0 to 52.0	32 Percentages of subjects Interval 28.0 to 35.0
Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain Day 43 (N=673,664)	81 Percentages of subjects Interval 78.0 to 84.0	63 Percentages of subjects Interval 59.0 to 66.0
Percentages Of Subjects With HI Titers ≥40 Against A/H5N1 Strain Day 387 (N=658,651)	35 Percentages of subjects Interval 31.0 to 39.0	16 Percentages of subjects Interval 13.0 to 19.0

SECONDARY outcome

Timeframe: Day 22, day 43 and day 387

Population: Analysis was done on the FAS.

Immunogenicity was assessed in terms of percentages of subjects achieving seroconversion in HI titers, three weeks after receiving two injections of either low dose or high dose aH5N1c vaccine according to the CHMP criterion. Seroconversion is defined as a postvaccination titer ≥40 in subjects with a prevaccination HI titer \<10; or in subjects with prevaccination HI titer ≥10, a minimum four-fold rise in postvaccination HI antibody titer. The criterion is met according to the European (CHMP) guideline if the percentage of subjects achieving seroconversion is \>30%.

Outcome measures

Outcome measures
Measure	High Dose n=681 Participants Subjects received 2 injections of a high dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.	Low Dose n=673 Participants Subjects received 2 injections of a low dose of cell culture-derived adjuvanted monovalent inactivated subunit H5N1 vaccine three weeks apart.
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain Day 22	36 Percentages of subjects Interval 32.0 to 40.0	21 Percentages of subjects Interval 18.0 to 25.0
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain Day 43 (N=673,664)	74 Percentages of subjects Interval 70.0 to 77.0	52 Percentages of subjects Interval 48.0 to 56.0
The Percentages Of Subjects Achieving Seroconversion Against A/H5N1 Strain Day 387 (N=658,651)	23 Percentages of subjects Interval 20.0 to 27.0	10 Percentages of subjects Interval 8.0 to 12.0

Adverse Events

High Dose

Serious events: 43 serious events

Other events: 481 other events

Deaths: 0 deaths

Low Dose

Serious events: 51 serious events

Other events: 427 other events

Deaths: 0 deaths

Total

Serious events: 94 serious events

Other events: 908 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	High Dose n=699 participants at risk Subjects received 2 injections of a high dose MF59 adjuvanted cell-culture derived monovalent H5N1 vaccine three weeks apart.	Low Dose n=689 participants at risk Subjects received 2 injections of a low dose MF59 adjuvanted cell-culture derived monovalent H5N1 three weeks apart.	Total n=1388 participants at risk Total of subjects in both high and low dose groups.
Psychiatric disorders EATING DISORDER	5.7% 40/699 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	6.2% 43/689 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	6.0% 83/1388 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689
Gastrointestinal disorders NAUSEA	6.9% 48/699 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	6.8% 47/689 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	6.8% 95/1388 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689
General disorders FATIGUE	17.0% 119/699 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	17.0% 117/689 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	17.0% 236/1388 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689
General disorders INJECTION SITE PAIN	45.4% 317/699 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	30.5% 210/689 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	38.0% 527/1388 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689
General disorders MALAISE	16.6% 116/699 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	17.3% 119/689 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	16.9% 235/1388 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689
Infections and infestations UPPER RESPIRATORY TRACT INFECTION	4.6% 32/699 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	5.2% 36/689 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	4.9% 68/1388 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689
Musculoskeletal and connective tissue disorders ARTHRALGIA	12.4% 87/699 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	12.6% 87/689 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	12.5% 174/1388 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689
Musculoskeletal and connective tissue disorders MYALGIA	14.7% 103/699 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	13.5% 93/689 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	14.1% 196/1388 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689
Nervous system disorders HEADACHE	15.5% 108/699 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	15.1% 104/689 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689	15.3% 212/1388 • Solicited local and systemic adverse events were collected from day 1 to 7. Unsolicited AEs (other than SAEs) and SAEs were collected from day 1 to 387. All Solicited AEs-systematic assessment and all unsolicited AEs-non-systematic assessment. Type II reactions are reported for solicited AEs. Total number of subjects enrolled was - High dose: 700 and Low dose: 693. Total number of subjects who received a study vaccination and included in safety set was - High dose: 699 and Low dose: 689

Additional Information

Posting Director

Novartis Vaccines

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place