Trial Outcomes & Findings for Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos (NCT NCT01396434)

Last Updated: 2017-01-30

Results Overview

All observed or volunteered AEs and SAEs regardless of treatment group or suspected causal relationship to 13vPnC were reported. An AE was any untoward medical occurrence in a participant who received 13vPnC. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. AEs included both SAEs and non-SAEs.

Recruitment status

COMPLETED

Target enrollment

3006 participants

Primary outcome timeframe

Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period

Results posted on

2017-01-30

Participant Flow

Participant milestones

Participant milestones
Measure	13vPnC (Prevenar 13), Cohort 1 Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.	13vPnC (Prevenar 13), Cohort 2 13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.	13vPnC (Prevenar 13), Cohort 3 13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
Overall Study STARTED	2817	175	14
Overall Study COMPLETED	2806	175	14
Overall Study NOT COMPLETED	11	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	13vPnC (Prevenar 13), Cohort 1 Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.	13vPnC (Prevenar 13), Cohort 2 13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.	13vPnC (Prevenar 13), Cohort 3 13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
Overall Study Lost to Follow-up	1	0	0
Overall Study Other	10	0	0

Baseline Characteristics

Safety Surveillance of Pneumococcal 13-valent Conjugate Vaccine Among Filipinos

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	13vPnC (Prevenar 13), Cohort 1 n=2817 Participants Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.	13vPnC (Prevenar 13), Cohort 2 n=175 Participants 13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.	13vPnC (Prevenar 13), Cohort 3 n=14 Participants 13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.	Total n=3006 Participants Total of all reporting groups
Age, Continuous Age at enrollment (years)	0.5 years STANDARD_DEVIATION 0.94 • n=5 Participants	65.1 years STANDARD_DEVIATION 10.60 • n=7 Participants	0.7 years STANDARD_DEVIATION 1.54 • n=5 Participants	4.3 years STANDARD_DEVIATION 15.37 • n=4 Participants
Gender Female	1402 Participants n=5 Participants	115 Participants n=7 Participants	6 Participants n=5 Participants	1523 Participants n=4 Participants
Gender Male	1415 Participants n=5 Participants	60 Participants n=7 Participants	8 Participants n=5 Participants	1483 Participants n=4 Participants
Race/Ethnicity, Customized Asian	2783 participants n=5 Participants	175 participants n=7 Participants	14 participants n=5 Participants	2972 participants n=4 Participants
Race/Ethnicity, Customized Other	24 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	24 participants n=4 Participants
Race/Ethnicity, Customized White	8 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	8 participants n=4 Participants
Race/Ethnicity, Customized Black	2 participants n=5 Participants	0 participants n=7 Participants	0 participants n=5 Participants	2 participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline through and including 28 calendar days after the last administration of study vaccine within the observation period

Population: Participants who received at least 1 dose of 13vPnC.

Outcome measures

Outcome measures
Measure	13vPnC (Prevenar 13), Cohort 1 n=2817 Participants Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.	13vPnC (Prevenar 13), Cohort 2 n=175 Participants 13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.	13vPnC (Prevenar 13), Cohort 3 n=14 Participants 13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) AEs	68 participants	5 participants	0 participants
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) SAEs	1 participants	0 participants	0 participants

Adverse Events

13vPnC (Prevenar 13), Cohort 1

Serious events: 1 serious events

Other events: 68 other events

Deaths: 0 deaths

13vPnC (Prevenar 13), Cohort 2

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

13vPnC (Prevenar 13), Cohort 3

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	13vPnC (Prevenar 13), Cohort 1 n=2817 participants at risk Pneumococcal 13-valent conjugate vaccine (13vPnC) as prescribed by the physician based on approved product indication for infants and children 6 weeks through 5 years of age.	13vPnC (Prevenar 13), Cohort 2 n=175 participants at risk 13vPnC as prescribed by the physician based on approved product indication for adults 50 years and older.	13vPnC (Prevenar 13), Cohort 3 n=14 participants at risk 13vPnC as prescribed by the physician based on approved product indication. These participants may have had incorrect documentation of their 13vPnC vaccine date(s) and were neither included in the 6 weeks through 5 years of age nor 50 years and older indication group.
Infections and infestations Bronchopneumonia	0.04% 1/2817 • Number of events 1 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/175 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.	0.00% 0/14 The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60