Trial Outcomes & Findings for Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study (NCT NCT04657198)

Last Updated: 2022-06-29

Results Overview

Assessed solicited administration site AEs are erythema, pain and swelling. Any pain is defined as any pain regardless of intensity grade. Any injection site erythema/swelling is scored with a diameter larger than (\>) 20 millimeters (mm).

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

126 participants

Primary outcome timeframe

During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)

Results posted on

2022-06-29

Participant Flow

From a total of 126 participants enrolled in this study, 4 participants were withdrawn before vaccination. 122 participants received the study vaccination.

Participant milestones

Participant milestones
Measure	High Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Overall Study STARTED	40	39	43
Overall Study COMPLETED	39	39	43
Overall Study NOT COMPLETED	1	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	High Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Overall Study CONSENT WITHDRAWAL, NOT DUE TO A (S)AE	1	0	0

Baseline Characteristics

Extension Study to Evaluate the Safety and Immunogenicity of a Revaccination Dose of the RSVPreF3 OA Investigational Vaccine in Adults 60 Years and Older Who Participated in the RSV OA=ADJ-002 Study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	High Dose_AS01E Group n=40 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group n=39 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group n=43 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Total n=122 Participants Total of all reporting groups
Age, Continuous	68.3 Years STANDARD_DEVIATION 5.4 • n=5 Participants	69.1 Years STANDARD_DEVIATION 5.3 • n=7 Participants	66.6 Years STANDARD_DEVIATION 5.6 • n=5 Participants	68.0 Years STANDARD_DEVIATION 5.5 • n=4 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	21 Participants n=7 Participants	24 Participants n=5 Participants	72 Participants n=4 Participants
Sex: Female, Male Male	13 Participants n=5 Participants	18 Participants n=7 Participants	19 Participants n=5 Participants	50 Participants n=4 Participants
Race/Ethnicity, Customized American Indian Or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized Black Or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized White	38 Participants n=5 Participants	37 Participants n=7 Participants	42 Participants n=5 Participants	117 Participants n=4 Participants

PRIMARY outcome

Timeframe: During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)

Population: The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

Outcome measures

Outcome measures
Measure	High Dose_AS01E Group n=40 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group n=39 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group n=43 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Number of Participants With Any Solicited Administration Site Adverse Events (AEs) Any erythema	1 Participants	6 Participants	5 Participants
Number of Participants With Any Solicited Administration Site Adverse Events (AEs) Any pain	21 Participants	23 Participants	26 Participants
Number of Participants With Any Solicited Administration Site Adverse Events (AEs) Any swelling	0 Participants	2 Participants	4 Participants

PRIMARY outcome

Timeframe: During the 4-day follow-up period post-vaccination (i.e. on the day of vaccination [Day 1] and 3 subsequent days)

Population: The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

Assessed solicited systemic AE is fever (any temperature greater than or equal to 38.0 °C - the preferred location for measuring temperature being the oral cavity). Any is defined as occurrence of the symptom regardless of intensity grade or relation to study.

Outcome measures

Outcome measures
Measure	High Dose_AS01E Group n=40 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group n=39 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group n=43 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Number of Participants With Any Solicited Systemic AEs	1 Participants	1 Participants	4 Participants

PRIMARY outcome

Timeframe: During the 30-day follow-up period post-vaccination (i.e., on the day of vaccination [Day 1] and 29 subsequent days)

Population: The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms is reported as an unsolicited AE. Any is defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to study vaccination.

Outcome measures

Outcome measures
Measure	High Dose_AS01E Group n=40 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group n=39 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group n=43 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Number of Participants With Any Unsolicited AEs	5 Participants	11 Participants	12 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 30 days post-vaccination (Day 31)

Population: The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity. Any is defined as any occurrence of SAE regardless of intensity grade or relation to study vaccination.

Outcome measures

Outcome measures
Measure	High Dose_AS01E Group n=40 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group n=39 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group n=43 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Number of Participants With Any Serious Adverse Events (SAEs) up to 30 Days Post-vaccination	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From Day 1 up to 30 days post-vaccination (Day 31)

Population: The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology. Any is defined as the occurrence of any pIMD regardless of intensity grade or relation to study vaccination.

Outcome measures

Outcome measures
Measure	High Dose_AS01E Group n=40 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group n=39 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group n=43 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Number of Participants With Any Potential Immune-mediated Diseases (pIMDs) up to 30 Days Post-vaccination	0 Participants	0 Participants	0 Participants

PRIMARY outcome

Timeframe: At 30 days post-vaccination (Day 31)

Population: The analysis was performed on the Per Protocol Set (that included participants who received the study intervention dose and have post-vaccination data, minus participants with protocol deviations that led to exclusion), for the High Dose\_AS01E Group only (as per protocol).

Serological assays for the determination of functional antibodies against RSV-A are performed by neutralization assay. Anti RSV-A neutralizing antibody titers are given as Geometric Mean Titers (GMTs) and expressed as Estimated Dose: serum dilution giving a 60% reduction of the signal compared to a control without serum (ED60).

Outcome measures

Outcome measures
Measure	High Dose_AS01E Group n=34 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Humoral Immune Response in Terms of Neutralizing Antibody Titers Against Respiratory Syncytial Virus (RSV)-Serotype A	4394.9 Titers Interval 3191.3 to 6052.5	—	—

PRIMARY outcome

Timeframe: At 30 days post-vaccination (Day 31)

Serological assays for the determination of functional antibodies against RSV-B are performed by neutralization assay. Anti RSV-B neutralizing antibody titers are given as GMTs and expressed as ED60.

Outcome measures

Outcome measures
Measure	High Dose_AS01E Group n=34 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Humoral Immune Response in Terms of Neutralizing Antibody Titers Against RSV-serotype B	6094.3 Titers Interval 4476.8 to 8296.4	—	—

SECONDARY outcome

Timeframe: At 30 days post-vaccination (Day 31)

The detection and the quantification of total IgG antibodies directed against RSVPreF3 in human serum samples were based on an indirect Enzyme-Linked Immunosorbent Assay (ELISA). Anti RSVPreF3 antibody concentration is given in geometric mean concentration (GMC) and is expressed in ELISA Laboratory Units per milliliter (ELU/mL).

Outcome measures

Outcome measures
Measure	High Dose_AS01E Group n=34 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Humoral Immune Response in Terms of RSVPreF3-specific Immunoglobulin G (IgG) Antibody Concentrations	46276.5 ELU/mL Interval 36821.3 to 58159.6	—	—

SECONDARY outcome

Timeframe: At 30 days post-vaccination (Day 31)

Among markers expressed are interleukin-2 (IL2), cluster of 40 ligand (CD40L), tumour necrosis factor alpha (TNF α) and interferon gamma (IFN γ), in vitro upon stimulation with RSVPreF3 peptide preparations.

Outcome measures

Outcome measures
Measure	High Dose_AS01E Group n=31 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Frequency of RSVPreF3-specific Cluster of Differentiation 4+ (CD4+) T-cells Identified as Expressing at Least Two Markers	1601 cells per million CD4+ T Cells Interval 1174.0 to 2541.0	—	—

SECONDARY outcome

Timeframe: From Day 1 up to the end of follow-up period (Month 6)

Population: The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization or results in disability/incapacity.

Outcome measures

Outcome measures
Measure	High Dose_AS01E Group n=40 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group n=39 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group n=43 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Number of Participants With Any SAEs, up the End of Follow-up Study Period (Month 6)	1 Participants	1 Participants	2 Participants

SECONDARY outcome

Timeframe: From Day 1 up to the end of follow-up period (Month 6)

Population: The analysis was performed on the Exposed Set that included all participants who received the study intervention dose.

pIMDs are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune etiology.

Outcome measures

Outcome measures
Measure	High Dose_AS01E Group n=40 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group n=39 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group n=43 Participants Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Number of Participants Reporting pIMDs up to the End of Follow-up Study Period (Month 6)	0 Participants	0 Participants	0 Participants

Adverse Events

High Dose_AS01E Group

Serious events: 1 serious events

Other events: 22 other events

Deaths: 0 deaths

Low Dose_AS01E Group

Serious events: 1 serious events

Other events: 25 other events

Deaths: 0 deaths

Medium Dose_AS01E Group

Serious events: 2 serious events

Other events: 29 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	High Dose_AS01E Group n=40 participants at risk Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Low Dose_AS01E Group n=39 participants at risk Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) low dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.	Medium Dose_AS01E Group n=43 participants at risk Participants received 1 dose of the RSV Vaccine (GSK3844766A) high dose adjuvanted with AS01E in the current study after having received 2 doses of the RSV Vaccine (GSK3844766A) medium dose adjuvanted with AS01E in the RSV OA=ADJ-002 (NCT03814590) parent study.
Infections and infestations Diverticulitis	0.00% 0/40 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).	2.6% 1/39 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).	0.00% 0/43 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).
Injury, poisoning and procedural complications Limb traumatic amputation	0.00% 0/40 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).	0.00% 0/39 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).	2.3% 1/43 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Prostate cancer	2.5% 1/40 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).	0.00% 0/39 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).	0.00% 0/43 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).
Reproductive system and breast disorders Benign prostatic hyperplasia	0.00% 0/40 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).	0.00% 0/39 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).	2.3% 1/43 • Number of events 1 • Solicited AEs were collected during the 4-day follow-up period after vaccination. Unsolicited AEs were collected during the 30-day follow-up period after vaccination. SAEs and pIMDs were collected throughout the study period (from Day 1 to Month 6).

Other adverse events

Additional Information

GSK Response Center

GlaxoSmithKline

Phone: 866-435-7343

Email: [email protected]

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

Restriction type: OTHER