Trial Outcomes & Findings for Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years (NCT NCT00616928)

Last Updated: 2018-06-08

Results Overview

A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination (Day 0) reciprocal HI titer \< 1:10 and a post-vaccination (Day 42) reciprocal titer ≥ 1:40, or a pre-vaccination reciprocal HI titer ≥ 1:10 and at least a 4-fold increase in post-vaccination reciprocal titer against A/Indonesia/5/05 virus 21 days after the second dose of Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

4561 participants

Primary outcome timeframe

At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

Results posted on

2018-06-08

Participant Flow

Participant milestones

Participant milestones
Measure	Influenza A (H5N1) 18-64Y Group Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Overall Study STARTED	2304	768	1118	371
Overall Study COMPLETED	2242	750	1101	364
Overall Study NOT COMPLETED	62	18	17	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Influenza A (H5N1) 18-64Y Group Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted vaccine formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Overall Study Adverse Event	6	3	2	2
Overall Study Other	51	8	15	5
Overall Study Lost to Follow-up	5	7	0	0

Baseline Characteristics

Immunogenicity & Safety of GSK's Influenza Vaccine 1557484A Given to Adults Aged ≥18 Years

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Influenza A (H5N1) 18-64Y Group n=2304 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=768 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=1118 Participants Influenza A (H5N1) \>64Y Group Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=371 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Total n=4561 Participants Total of all reporting groups
Age, Continuous	38.5 Years STANDARD_DEVIATION 13.64 • n=39 Participants	38.7 Years STANDARD_DEVIATION 13.58 • n=41 Participants	71.9 Years STANDARD_DEVIATION 5.49 • n=35 Participants	72.1 Years STANDARD_DEVIATION 5.41 • n=31 Participants	49.5 Years STANDARD_DEVIATION 19.50 • n=146 Participants
Sex: Female, Male Female	1328 Participants n=39 Participants	424 Participants n=41 Participants	621 Participants n=35 Participants	196 Participants n=31 Participants	2569 Participants n=146 Participants
Sex: Female, Male Male	976 Participants n=39 Participants	344 Participants n=41 Participants	497 Participants n=35 Participants	175 Participants n=31 Participants	1992 Participants n=146 Participants

PRIMARY outcome

Timeframe: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

Population: The analysis was based on the ATP cohort for analysis of immunogenicity, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=1571 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=76 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=396 Participants Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=40 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)	1427 Subjects	1 Subjects	293 Subjects	1 Subjects	—	—

PRIMARY outcome

Timeframe: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

A seroprotected subject was defined as a vaccinated subject with serum Hemagglutination Inhibition (HI) titer ≥ 1:40.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=1571 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=76 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=396 Participants Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=40 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1) Day 42	1467 Subjects	1 Subjects	334 Subjects	1 Subjects	—	—
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1) Day 0	5 Subjects	0 Subjects	9 Subjects	0 Subjects	—	—

PRIMARY outcome

Timeframe: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration

Population: The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.

Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=2267 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=754 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=1109 Participants Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=368 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group n=3376 Participants Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group n=1122 Participants Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Number of Subjects With Any Solicited Local Symptoms. Pain	2024 Subjects	171 Subjects	784 Subjects	53 Subjects	2808 Subjects	224 Subjects
Number of Subjects With Any Solicited Local Symptoms. Redness	181 Subjects	7 Subjects	106 Subjects	1 Subjects	287 Subjects	8 Subjects
Number of Subjects With Any Solicited Local Symptoms. Swelling	241 Subjects	7 Subjects	110 Subjects	1 Subjects	351 Subjects	8 Subjects

PRIMARY outcome

Timeframe: During a 7-day follow-up period (i.e., day of vaccination and 6 subsequent days) after each vaccine administration

Population: The analysis was based on the Total Vaccinated cohort, on subjects with symptom sheets completed.

Assessed solicited general symptoms were fatigue, headache, joint pain at other locations, muscle aches, shivering, sweating and temperature\[defined as axillary temperature equal to or above 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=2266 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=755 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=1109 Participants Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=368 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group n=3375 Participants Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group n=1123 Participants Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Number of Subjects With Any Solicited General Symptoms. Shivering	456 Subjects	87 Subjects	107 Subjects	22 Subjects	563 Subjects	109 Subjects
Number of Subjects With Any Solicited General Symptoms. Temperature	121 Subjects	32 Subjects	35 Subjects	6 Subjects	156 Subjects	109 Subjects
Number of Subjects With Any Solicited General Symptoms. Fatigue	890 Subjects	189 Subjects	258 Subjects	64 Subjects	1148 Subjects	253 Subjects
Number of Subjects With Any Solicited General Symptoms. Headache	932 Subjects	249 Subjects	247 Subjects	63 Subjects	1179 Subjects	312 Subjects
Number of Subjects With Any Solicited General Symptoms. Joint pain at other location	645 Subjects	97 Subjects	208 Subjects	39 Subjects	853 Subjects	136 Subjects
Number of Subjects With Any Solicited General Symptoms. Muscle aches	1188 Subjects	175 Subjects	338 Subjects	56 Subjects	1526 Subjects	231 Subjects
Number of Subjects With Any Solicited General Symptoms. Sweating	314 Subjects	67 Subjects	48 Subjects	15 Subjects	362 Subjects	109 Subjects

PRIMARY outcome

Timeframe: During a 21-day follow-up period for each vaccine administration, as well as overall (Day 0 through Day 84)

An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=2304 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=768 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=1118 Participants Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=371 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Number of Subjects With Any Unsolicited Adverse Events (AEs). Unsolicited AEs Days 0-21	914 Subjects	289 Subjects	399 Subjects	113 Subjects	—	—
Number of Subjects With Any Unsolicited Adverse Events (AEs). Unsolicited AEs Days 0-84	1017 Subjects	321 Subjects	467 Subjects	130 Subjects	—	—

PRIMARY outcome

Timeframe: From Day 0 through Day 182 and through Day 379.

Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=2304 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=768 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=1118 Participants Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=371 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Number of Subjects With Serious Adverse Events (SAEs) Subjects with SAEs Days 0-379	46 Subjects	15 Subjects	65 Subjects	30 Subjects	—	—
Number of Subjects With Serious Adverse Events (SAEs) Subjects with SAEs Days 0-182	24 Subjects	7 Subjects	43 Subjects	14 Subjects	—	—

PRIMARY outcome

Timeframe: From Day 0 through Day 182 and through Day 364.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=2304 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=768 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=1118 Participants Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=371 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Number of Subjects With Medically Attended Events (MAEs) Subjects with MAEs Days 0-182	480 Subjects	154 Subjects	298 Subjects	92 Subjects	—	—
Number of Subjects With Medically Attended Events (MAEs) Subjects with MAEs Days 0-379	627 Subjects	212 Subjects	400 Subjects	134 Subjects	—	—

SECONDARY outcome

Timeframe: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=1488 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=68 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=479 Participants Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=48 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Number of Subjects With Serum Reciprocal HI Antibodies Against A/Indonesia/5/2005 Equal to or Above (≥) 1:10	1391 Subjects	1 Subjects	410 Subjects	1 Subjects	—	—

SECONDARY outcome

Timeframe: At Month 6 (Day 182) post Dose 1

Population: The analysis was based on the ATP cohort for analysis of immunogenicity - Month 6, which included all evaluable subjects (meeting all eligibility criteria, complying with the procedures in the protocol, with no elimination criteria during the study) with a complete set of data concerning immunogenicity primary outcome variables available at Month 6

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=366 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=37 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=91 Participants Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=19 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Number of Subjects With A/Indonesia/5/05 Antibody Titers ≥ 1:10	258 Subjects	2 Subjects	77 Subjects	1 Subjects	—	—

SECONDARY outcome

Timeframe: At Month 6 (Day 182) after Dose 1

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=366 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=37 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=91 Participants Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=19 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Number of Seroconverted Subjects Against A/Indonesia/5/2005 (H5N1)	225 Subjects	1 Subjects	59 Subjects	0 Subjects	—	—

SECONDARY outcome

Timeframe: At Month 6 (Day 182) after Dose 1

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=366 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=37 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=91 Participants Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=19 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Number of Seroprotected Subjects Against A/Indonesia/5/2005 (H5N1)	225 Subjects	1 Subjects	60 Subjects	0 Subjects	—	—

SECONDARY outcome

Timeframe: At Month 6 (Day 182) after Dose 1

Titers are presented as geometric mean titers (GMTs). The reference seropositivity cut-off value was ≥ 1:10.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=366 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=37 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=40 Participants Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=19 Participants Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Titers for Serum HI Antibodies Against A/Indonesia/5/05 (H5N1)	36.2 Titers Interval 31.0 to 42.2	5.5 Titers Interval 4.8 to 6.5	44.8 Titers Interval 33.3 to 60.4	5.4 Titers Interval 4.6 to 6.3	—	—

SECONDARY outcome

Timeframe: At Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

Virus antibody response rates were defined as the number of subjects with antibody titers at Day 42 ≥ 4-fold the pre-vaccination antibody titers. The 2 strains assessed were Flu A/Indonesia/5/05 and Flu A/Vietnam/1194/04.

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=188 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=46 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays. A/Indonesia/5/05	177 Subjects	36 Subjects	—	—	—	—
Number of Subjects With a Vaccine Response to the Vaccine-homologous Virus and Drift Variant H5N1 Virus, as Assessed by Microneutralization Assays. A/Vietnam/1194/04	113 Subjects	12 Subjects	—	—	—	—

SECONDARY outcome

Timeframe: At Day 0 and Day 42 post Dose 1 (Day 42 post Dose 1 = Day 21 post Dose 2)

Titers were expressed as Geometric Mean Titers (GMTs).

Outcome measures

Outcome measures
Measure	Influenza A (H5N1) 18-64Y Group n=188 Participants Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=46 Participants Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) Group Pooled group of subjects aged \>18 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A. B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo Group Pooled group of subjects aged \>18 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays A/Indonesia/5/05, Day 0	22.4 Titers Interval 19.9 to 25.3	52.4 Titers Interval 39.2 to 69.8	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays A/Indonesia/5/05, Day 42	1450.6 Titers Interval 1266.9 to 1660.9	631.1 Titers Interval 444.5 to 896.1	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays A/Vietnam/1194/04, Day 0	29.9 Titers Interval 25.7 to 34.9	94.4 Titers Interval 68.4 to 130.3	—	—	—	—
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against A/Vietnam/1194/2004 (H5N1) and A/Indonesia/5/2005 (H5N1) as Assessed by Microneutralization Assays A/Vietnam/1194/04, Day 42	163.1 Titers Interval 145.6 to 182.8	213.4 Titers Interval 165.5 to 275.1	—	—	—	—

Adverse Events

Influenza A (H5N1) 18-64Y Group

Serious events: 24 serious events

Other events: 2087 other events

Deaths: 0 deaths

Placebo 18-64Y Group

Serious events: 7 serious events

Other events: 405 other events

Deaths: 0 deaths

Influenza A (H5N1) >64Y Group

Serious events: 43 serious events

Other events: 866 other events

Deaths: 0 deaths

Placebo >64Y Group

Serious events: 14 serious events

Other events: 141 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Influenza A (H5N1) 18-64Y Group n=2304 participants at risk Subjects aged 18-64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo 18-64Y Group n=768 participants at risk Subjects aged 18-64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Influenza A (H5N1) >64Y Group n=1118 participants at risk Subjects aged \> 64 years, who received 2 doses of the Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted, formulations A, B, or C in approximately equal proportions, at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.	Placebo >64Y Group n=371 participants at risk Subjects aged \> 64 years, who received 2 doses of placebo at Days 0 and 21. The first dose was administered in the deltoid region of the non-dominant arm. The second dose was administered in the deltoid region of the dominant arm.
General disorders Pain	89.3% 2024/2267 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	22.7% 171/754 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	70.7% 784/1109 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	14.4% 53/368 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.
General disorders Redness	8.0% 181/2267 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	0.93% 7/754 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	9.6% 106/1109 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	0.27% 1/368 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.
General disorders Swelling	10.6% 241/2267 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	0.93% 7/754 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	9.9% 110/1109 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	0.27% 1/368 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.
General disorders Fatigue	39.3% 890/2266 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	25.0% 189/755 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	23.3% 258/1109 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	17.3% 64/371 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.
General disorders Headache	41.1% 932/2266 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	33.0% 249/755 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	22.3% 247/1109 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	17.0% 63/371 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.
General disorders Joint pain at other location	28.5% 645/2266 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	12.8% 97/755 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	18.8% 208/1109 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	10.5% 39/371 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.
General disorders Muscle aches	52.4% 1188/2266 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	23.2% 175/755 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	30.5% 338/1109 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	15.1% 56/371 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.
General disorders Shivering	20.1% 456/2266 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	11.5% 87/755 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	9.6% 107/1109 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	5.9% 22/371 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.
General disorders Sweating	13.9% 314/2266 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	8.9% 67/755 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	4.3% 48/1109 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	4.0% 15/371 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.
General disorders Temperature (Oral)	5.3% 121/2266 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	4.2% 32/755 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	3.2% 35/1109 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	1.6% 6/371 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.
Infections and infestations Nasopharyngitis	5.0% 116/2304 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	3.8% 29/768 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	3.6% 40/1118 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	3.0% 11/371 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	3.9% 91/2304 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	5.1% 39/768 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	3.0% 34/1118 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.	3.2% 12/371 • SAEs were collected up to Day 182 and up to study end at Day 379. Unsolicited AEs were collected up to Day 20 and up to Day 84. Systematically-assessed symptoms were collected up to Day 6 post vaccination.

Additional Information

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GlaxoSmithKline

Phone: 866-435-7343

Results disclosure agreements

Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Publication restrictions are in place

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