Trial Outcomes & Findings for A Study To Learn About The Effects Of Pneumococcal Vaccine In People With HIV (NCT NCT05794191)

NCT ID: NCT05794191

Last Updated: 2025-10-17

Results Overview

VE:\[(1-hazard ratio (HR)\]\*100 and was obtained from marginal structural Cox models(Cox-MSM) after applying Inverse probability of treatment (IPT)\*Inverse probability of censoring(IPC)weights.IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD: based on International Classification of Diseases,9th revision, Clinical Modification(ICD-9-CM)or ICD-10-CM.Data for total number of participants with IPD is reported in descriptive and VE (IPTW\*IPCW+imbalanced variables) is reported in statistical section.PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

• Recruitment status: COMPLETED
• Target enrollment: 350399 participants
• Primary outcome timeframe: From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years)
• Results posted on: 2025-10-17

Participant Flow

Data was collected from participants living with human immunodeficiency virus (PLWH) having an HIV diagnosis code between January 1, 2014 and December 31, 2021. Data was analyzed over 73 weeks in this retrospective study from March 22, 2023 to August 15, 2024.

A total of 350399 participants were enrolled in the study. The six months of continuous enrollment in medical and pharmacy plans between 01-Jan-2014 and 31-Dec-2021 was considered the baseline period. The end of the study occurred on the last date that administrative claims data were available on September 30, 2022. Participants were followed up from index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years).

Participant milestones

Measure	PCV13-vaccinated Participants Participants with an HIV diagnosis code who received 13-valent pneumococcal conjugate vaccine (PCV13) were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
Overall Study STARTED	29435	320964
Overall Study COMPLETED	29435	320964
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	PCV13-vaccinated Participants n=29435 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=320964 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.	Total n=350399 Participants Total of all reporting groups
Age, Customized 18-49 Years	20571 Participants n=29435 Participants	189050 Participants n=320964 Participants	209621 Participants n=350399 Participants
Age, Customized 50-64 Years	7907 Participants n=29435 Participants	113632 Participants n=320964 Participants	121539 Participants n=350399 Participants
Age, Customized 65-74 Years	814 Participants n=29435 Participants	14617 Participants n=320964 Participants	15431 Participants n=350399 Participants
Age, Customized 75 Years or above	143 Participants n=29435 Participants	3665 Participants n=320964 Participants	3808 Participants n=350399 Participants
Sex/Gender, Customized Male	22736 Participants n=29435 Participants	221640 Participants n=320964 Participants	244376 Participants n=350399 Participants
Sex/Gender, Customized Female	6699 Participants n=29435 Participants	99319 Participants n=320964 Participants	106018 Participants n=350399 Participants
Sex/Gender, Customized Unknown	0 Participants n=29435 Participants	5 Participants n=320964 Participants	5 Participants n=350399 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years)

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'Overall Number of Participants Analyzed (N)' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this outcome measure (OM); N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline.

VE:[(1-hazard ratio (HR)]*100 and was obtained from marginal structural Cox models(Cox-MSM) after applying Inverse probability of treatment (IPT)*Inverse probability of censoring(IPC)weights.IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD: based on International Classification of Diseases,9th revision, Clinical Modification(ICD-9-CM)or ICD-10-CM.Data for total number of participants with IPD is reported in descriptive and VE (IPTW*IPCW+imbalanced variables) is reported in statistical section.PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=85584 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=320959 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
PCV13 Vaccine Effectiveness (VE) for First Event of Invasive Pneumococcal Disease (IPD): Overall Follow-up	167 Participants Interval 57.233 to 77.529	747 Participants Interval 91.165 to 105.226

PRIMARY outcome

Timeframe: 0 to 3 years of follow up

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'Overall Number of Participants Analyzed (N)' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline.

VE: [(1- hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of IPD is reported in the descriptive section and data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=75382 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=320959 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
VE for First Event of IPD at 0-3 Years of Follow-up	73 Participants Interval 47.288 to 74.868	566 Participants Interval 96.12 to 113.34

PRIMARY outcome

Timeframe: 3 to 5 years of follow up

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.

Vaccine effectiveness was calculated as [(1- hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of IPD is reported in the descriptive section and data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=47501 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=98677 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
VE for First Event of IPD at 3-5 Years of Follow-up	59 Participants Interval 65.536 to 109.273	116 Participants Interval 69.578 to 100.157

PRIMARY outcome

Timeframe: 5 to 7 years of follow up

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.

Vaccine effectiveness was calculated as [(1- hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. IPD was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of IPD is reported in the descriptive section and data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=31770 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=48523 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
VE for First Event of IPD at 5-7 Years of Follow-up	32 Participants Interval 48.64 to 97.486	54 Participants Interval 61.365 to 104.724

PRIMARY outcome

Timeframe: From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years)

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'Overall Number of Participants Analyzed (N)' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this outcome measure (OM); N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline.

Vaccine effectiveness was calculated as [(1- hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. PP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of PP is reported in the descriptive section and data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=85487 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=320959 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
PCV13 VE for First Event of Pneumococcal Pneumonia (PP): Overall Follow-up	309 Participants Interval 110.734 to 138.408	1362 Participants Interval 169.723 to 188.744

PRIMARY outcome

Timeframe: 0 to 3 years of follow up

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'Overall Number of Participants Analyzed (N)' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this outcome measure (OM); N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline.

Vaccine effectiveness was calculated as [(1- hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. PP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of PP is reported in the descriptive section data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=75322 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=320959 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
VE for First Event of PP at 0-3 Years of Follow-up	161 Participants Interval 113.143 to 154.129	1092 Participants Interval 190.119 to 214.066

PRIMARY outcome

Timeframe: 3 to 5 years of follow up

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.

Vaccine effectiveness was calculated as [(1- hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. PP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of PP is reported in the descriptive section and data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=47365 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=98430 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
VE for First Event of PP at 3-5 Years of Follow-up	94 Participants Interval 110.92 to 166.264	184 Participants Interval 115.149 to 153.758

PRIMARY outcome

Timeframe: 5 to 7 years of follow up

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.

Vaccine effectiveness was calculated as [(1- hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. PP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of PP is reported in the descriptive section and data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=31660 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=48369 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
VE for First Event of PP at 5-7 Years of Follow-up	49 Participants Interval 80.542 to 141.172	69 Participants Interval 81.402 to 130.586

PRIMARY outcome

Timeframe: From index date to the earliest of death, end of health plan enrollment or end of study period (maximum up to 8.25 years)

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'Overall Number of Participants Analyzed (N)' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this outcome measure (OM); N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline.

Vaccine effectiveness was calculated as [(1- hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. ACP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of ACP is reported in the descriptive section and data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=80591 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=320959 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
PCV13 VE for First Event of All-cause Pneumonia (ACP): Overall Follow-up	8098 Participants Interval 3637.505 to 3799.459	34498 Participants Interval 4922.665 to 5027.661

PRIMARY outcome

Timeframe: 0 to 3 years of follow up

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.

Vaccine effectiveness was calculated as [(1- hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. ACP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of ACP is reported in the descriptive section and data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=72303 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=320959 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
VE for First Event of ACP at 0-3 Years of Follow-up	4543 Participants Interval 3903.147 to 4136.881	27984 Participants Interval 5433.501 to 5562.327

PRIMARY outcome

Timeframe: 3 to 5 years of follow up

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.

Vaccine effectiveness was calculated as [(1- hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. ACP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of ACP is reported in the descriptive section and data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=41296 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=86841 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
VE for First Event of ACP at 3-5 Years of Follow-up	2079 Participants Interval 3405.879 to 3711.656	4437 Participants Interval 3636.291 to 3856.707

PRIMARY outcome

Timeframe: 5 to 7 years of follow up

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=number of participants unvaccinated at start of specified follow-up time evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up time for this OM; hence, N is different from those reported under participant flow and baseline.

Vaccine effectiveness was calculated as [(1- hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. ACP was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of ACP is reported in the descriptive section and data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up.

Outcome measures

Measure	PCV13-vaccinated Participants n=25890 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=40301 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
VE for First Event of ACP at 5-7 Years of Follow-up	1200 Participants Interval 3132.249 to 3507.557	1757 Participants Interval 3101.962 to 3406.066

SECONDARY outcome

Timeframe: 0 to 3 years, 3 to 5 years and 5 to 7 years of follow-up (maximum up to 8.25 years)

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline. ."n":number of participants evaluable for specified rows.

Vaccine effectiveness was calculated as [(1- hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. Data for total number of participants with episodes of pneumococcal pneumonia or pneumonia with unspecified causes are reported in the descriptive section and data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=81338 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=320959 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
PCV13 VE for First Event of Pneumococcal Pneumonia or Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up 0-3 Years	3996 Participants Interval 3384.055 to 3600.551	24423 Participants Interval 4694.78 to 4814.028
PCV13 VE for First Event of Pneumococcal Pneumonia or Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up 3-5 Years	1886 Participants Interval 3016.434 to 3301.388	3979 Participants Interval 3193.903 to 3398.684
PCV13 VE for First Event of Pneumococcal Pneumonia or Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up 5-7 Years	1031 Participants Interval 2597.852 to 2935.209	1460 Participants Interval 2496.416 to 2766.14
PCV13 VE for First Event of Pneumococcal Pneumonia or Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up Overall follow up	7155 Participants Interval 3147.928 to 3297.244	30139 Participants Interval 4242.686 to 4339.574

SECONDARY outcome

Timeframe: 0 to 3 years, 3 to 5 years and 5 to 7 years of follow-up (maximum up to 8.25 years)

Population: PCV13 vaccination status was a time varying exposure and participants could be counted in both PCV13 vaccinated or unvaccinated arms, depending on vaccination status during follow-up. Here, 'N' for Unvaccinated arm=participants unvaccinated at start of study evaluable for this OM; N for vaccinated arm=participants vaccinated by end of follow up for this OM; hence, N is different from those reported under participant flow and baseline. ."n":number of participants evaluable for specified rows.

VE was calculated as [(1-hazard ratio (HR)] * 100 and was obtained from Cox-MSM after applying the IPT *IPC weights. IPTW was generated from predicted probabilities of vaccination status (propensity scores) to create pseudo-populations where any imbalances in the potential confounders by vaccination status were reduced. IPCW was used to adjust for informative censoring. Pneumonia with unspecified causes was identified based on ICD-9-CM or ICD-10-CM codes. Data for total number of participants with episodes of pneumonia with unspecified causes are reported in the descriptive section and data for vaccine effectiveness (IPTW*IPCW + imbalanced variables) is reported in statistical analysis section. PCV13 vaccination status was a time varying exposure (i.e.,vaccination status was not fixed at start of follow-up and participants could receive PCV13 during follow-up).

Outcome measures

Measure	PCV13-vaccinated Participants n=81361 Participants Participants with an HIV diagnosis code who received PCV13 were included. The participants were followed up in the databases from 14 days after their PCV13 or index date if vaccinated during the baseline period, until the earliest occurrence of outcome, death, end of health plan enrollment, or end of study period.	Unvaccinated Participants n=320959 Participants Participants with an HIV diagnosis code who did not receive PCV13 were included. The participants were followed in the databases from index date until the earliest occurrence of PCV13 vaccination, death, end of health plan enrollment or end of study period.
PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up 0-3 Years	3980 Participants Interval 3368.927 to 3584.902	24302 Participants Interval 4669.755 to 4788.667
PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up 3-5 Years	1881 Participants Interval 3006.512 to 3290.923	3970 Participants Interval 3184.563 to 3388.983
PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up 5-7 Years	1030 Participants Interval 2593.321 to 2930.264	1461 Participants Interval 2496.054 to 2765.642
PCV13 VE for First Event of Pneumonia With Unspecified Causes at 0-3, 3-5, 5-7 and Overall Years of Follow-up Overall follow up	7133 Participants Interval 3136.465 to 3285.472	30010 Participants Interval 4222.55 to 4319.187

Adverse Events

PCV13-vaccinated Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unvaccinated Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer Inc.

Phone: 18007181021

Email: ClinicalTrials.gov_Inquiries@pfizer.com

Results disclosure agreements

• Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publication until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
• Publication restrictions are in place

Restriction type: OTHER