Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.

A Phase 4, Randomized, Double-blind Trial To Evaluate The Immunogenicity And Safety Of A 13-valent Pneumococcal Conjugate Vaccine When Administered Concomitantly With Seasonal Inactivated Influenza Vaccine In Adults 50 Years And Older Who Received 1 Or More Doses Of 23-valent Pneumococcal Polysaccharide Vaccine Prior To Study Enrollment.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02124161

Enrollment

882

Registered

2014-04-28

Start date

2014-09-30

Completion date

2015-05-31

Last updated

2016-07-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PREVENTION OF INVASIVE PNEUMOCOCCAL DISEASE

Keywords

Pneumococcal polysaccharide vaccine, 13-valent pneumococcal conjugate vaccine, invasive pneumococcal disease, flu vaccine

Brief summary

The purpose of this study is to evaluate the immunogenicity and safety of 13-valent pneumococcal polysaccharide vaccine when given concomitantly with seasonal inactivated influenza vaccine to adults 50 years and older who have previously received 23-valent pneumococcal polysaccharide vaccine.

Interventions

BIOLOGICAL13-valent pneumococcal conjugate vaccine

One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.

BIOLOGICALSeasonal Inactivated Influenza Vaccine

One (1) dose of SIIV will be administered intramuscularly into the right deltoid of all subjects at Visit 1.

OTHERPlacebo

One (1) dose (0.5 mL) will be administered intramuscularly into the left deltoid either at Visit 1 or at Visit 2, depending on the randomization group assigned to the subject.

Study design

Allocation

RANDOMIZED

Primary purpose

BASIC_SCIENCE

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

1. Evidence of a personally signed and dated informed consent document (ICD) indicating that the subject has been informed of all pertinent aspects of the study. 2. Male or female adults 50 years of age or older. 3. Documented vaccination with 1 or more prior doses of 23vPS, the last given at least 1 year prior to study enrollment. 4. Negative urine pregnancy test for all female subjects who are of child bearing potential.

Exclusion criteria

1. Previous vaccination with Prevnar®, Prevnar 13®, or any other investigational pneumococcal conjugate vaccine. 2. History of severe adverse reactions associated with any vaccine or vaccine-related component. 3. Allergic to egg proteins (egg or egg products) and chicken proteins. 4. History of Guillain-Barré syndrome. 5. Vaccination with any influenza vaccine within 6 months (182 days) before investigational product administration. 6. Documented S pneumoniae infection within the past 5 years before investigational product administration.

Design outcomes

Primary

Measure	Time frame	Description
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up	Within 168 to 196 days after Vaccination 2	An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. 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-serious adverse events (Non-SAEs).
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC	Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint and n signifies participants with a determinate OPA titer to the given serotype.
Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)	1 month after Vaccination 1	HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, number of participants analyzed signifies participants with a determinate HAI titer to the given strain.
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1	Within 28 to 42 days after Vaccination 1	An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. 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-serious adverse events (Non-SAEs).
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2	Within 28 to 42 days after Vaccination 2	An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. 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-serious adverse events (Non-SAEs).
Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination	Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2	An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. 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-serious adverse events (Non-SAEs).

Secondary

Measure	Time frame	Description
Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Immediately before Vaccination 1, 1 month after Vaccination 1	GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 1 to before Vaccination 1 were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 1 and 1 month after Vaccination 1 blood draws. Here, n signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 1 were analyzed.
Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Immediately before Vaccination 2, 1 month after Vaccination 2	GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 2 to before Vaccination 2 (1 month after Vaccination 1) were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 2 and 1 month after Vaccination 2 blood draws. Here, number of participants analyzed signifies total participants who were evaluable at this timepoint and n signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 2 were analyzed.
Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers	Immediately before Vaccination 1, 1 month after Vaccination 1	Percentage of participants achieving seroconversion in HAI titers was defined as the percentage of participants with either before Vaccination 1 (pre-vaccination 1) HAI titer less than \<1:10 and after Vaccination 1 (post-vaccination 1) HAI titer \>=1:40 or before Vaccination 1 (pre-vaccination 1) HAI titer \>=1:10 and a minimum 4-fold rise in after Vaccination 1 (post-vaccination 1) HAI antibody titer with respect to before Vaccination 1 (pre-vaccination) titer for influenza virus strains. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint.
Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1	Immediately before Vaccination 1, 1 month after Vaccination 1	Fold rise 1 month after Vaccination 1 to before Vaccination 1 was calculated for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). GMFRs were calculated using all participants with available data from both the specified blood draws. CI for the GMFRs were back transformations of a CI based on the Student t distribution for mean fold rise. Here, number of participants analyzed signifies participants with valid and determinate assay results for specified strain at both the specified blood draws.
Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	1 Month After Vaccination 1 for 13vPnC+QIV/Placebo, 1 month after Vaccination 2 for Placebo+QIV/13vPnC	Percentage of participants achieving predefined OPA antibody titer \>= LLOQ for each of the 13 pneumococcal serotypes (LLOQs for each serotype OPA were set as- serotype 1: 18; serotype 3: 12; serotype 4: 21; serotype 5: 29; serotype 6A: 37; serotype 6B: 43; serotype 7F: 210; serotype 9V: 345; serotype 14: 35; serotype 18C: 31; serotype 19A: 18; serotype 19F: 48; and serotype 23F: 13) determined in blood samples of all participants were calculated. Exact, 2-sided 95% CIs based on the observed percentage of participants were determined by using Clopper and Pearson method. OPA titers were calculated using all participants with available data from 1 month after 13vPnC vaccination blood draw. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint and n signifies participants with valid and determinate assay results to the specified serotype.

Countries

United States

Participant flow

Pre-assignment details

882 participants who were greater than or equal to (\>=) 50 years of age and previously vaccinated with at least 1 dose of 23-valent pneumococcal polysaccharide vaccine (23vPS) were randomized in this study but 6 participants (2 participants in 13vPnC+QIV/Placebo arm and 4 participants in Placebo+QIV/13vPnC arm) were randomized but not vaccinated.

Participants by arm

Arm	Count
13vPnC+QIV/Placebo Participants received 0.5 milliliter (mL) single dose of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly along with a dose of quadrivalent influenza vaccine (QIV, as per official recommendations) intramuscularly at Day 1 (Vaccination 1) followed by 0.5 mL placebo matched to 13vPnC vaccine intramuscularly 1 month after Vaccination 1.	439
Placebo+QIV/13vPnC Participants received 0.5 mL placebo matched to 13vPnC vaccine intramuscularly along with a dose of QIV intramuscular injection as per official recommendations at Day 1 (Vaccination 1) followed by 0.5 mL single dose of 13vPnC vaccine intramuscularly 1 month after Vaccination 1.	437
Total	876

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Adverse Event	2	0
Overall Study	Death	1	0
Overall Study	Does not meet entrance criteria	2	3
Overall Study	Lost to Follow-up	3	4
Overall Study	No longer meets eligibility criteria	5	4
Overall Study	Other unspecified	0	1
Overall Study	Protocol Violation	2	1
Overall Study	Withdrawal by Subject	1	2

Baseline characteristics

Characteristic	13vPnC+QIV/Placebo	Placebo+QIV/13vPnC	Total
Age, Continuous	66.9 years STANDARD_DEVIATION 9	66.4 years STANDARD_DEVIATION 8.85	66.7 years STANDARD_DEVIATION 8.93
Sex: Female, Male Female	234 Participants	249 Participants	483 Participants
Sex: Female, Male Male	205 Participants	188 Participants	393 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk	EG003 affected / at risk	EG004 affected / at risk	EG005 affected / at risk	EG006 affected / at risk	EG007 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —	— / —	— / —	— / —	— / —	— / —
other Total, other adverse events	62 / 439	52 / 437	42 / 431	51 / 432	62 / 439	51 / 432	6 / 439	6 / 437
serious Total, serious adverse events	6 / 439	0 / 437	7 / 431	6 / 432	6 / 439	6 / 432	5 / 439	6 / 437

Outcome results

Primary

Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)

HAI GMTs were computed for assay titers collected 1 month after Vaccination 1 by vaccine sequence for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). CIs were back-transformations of a CI based on the Student t distribution for the mean logarithm of the titers. HAI GMTs were calculated using all participants with available data for the specified blood draw. Here, number of participants analyzed signifies participants with a determinate HAI titer to the given strain.

Time frame: 1 month after Vaccination 1

Population: Evaluable immunogenicity population: eligible, randomized participants of 50 years of age or above, received all study vaccinations in assigned sequence with expected concomitant vaccination, had at least 1 valid, determinate assay results, had pre and post vaccination blood drawn within protocol-specified time frames, no major protocol violations.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC+QIV/Placebo	Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)	Strain: A/H1N1	115 titer
13vPnC+QIV/Placebo	Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)	Strain: A/H3N2	226 titer
13vPnC+QIV/Placebo	Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)	Strain: B/Brisbane	28 titer
13vPnC+QIV/Placebo	Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)	Strain: B/Massachusetts	45 titer
Placebo+QIV/13vPnC	Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)	Strain: B/Massachusetts	43 titer
Placebo+QIV/13vPnC	Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)	Strain: A/H1N1	113 titer
Placebo+QIV/13vPnC	Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)	Strain: B/Brisbane	26 titer
Placebo+QIV/13vPnC	Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)	Strain: A/H3N2	196 titer

Comparison: Strain A/H1N1: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.88, 1.18]

Comparison: Strain A/H3N2: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [1.01, 1.32]

Comparison: Strain B/Brisbane: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.95, 1.24]

Comparison: Strain B/Massachusetts: CIs for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.9, 1.21]

Primary

Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination

An AE was any untoward medical occurrence in a participant who received vaccine without regard to possibility of causal relationship. 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-serious adverse events (Non-SAEs).

Time frame: Baseline (Vaccination 1) up to 28 to 42 Days after Vaccination 2

Population: Safety population included all participants who received at least 1 dose of vaccination. Here, number of participants analyzed signifies participants who were evaluable at this timepoint.

Arm	Measure	Group	Value (NUMBER)
13vPnC+QIV/Placebo	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination	AE	15.3 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination	SAE	1.4 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination	AE	12.5 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination	SAE	1.4 percentage of participants

Comparison: AE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.95% CI: [-1.9, 7.4]

Comparison: SAE: Exact 2-sided confidence interval (based on Chan and Zhang) for the difference in proportions, 13vPnC+QIV /placebo - placebo+QIV/13vPnC, expressed as a percentage.95% CI: [-1.8, 1.7]

Primary

Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1

Time frame: Within 28 to 42 days after Vaccination 1

Population: Safety population included all participants who received at least 1 dose of vaccination.

Arm	Measure	Group	Value (NUMBER)
13vPnC+QIV/Placebo	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1	AE	15.3 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1	SAE	1.4 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1	AE	11.9 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1	SAE	0 percentage of participants

Primary

Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2

Time frame: Within 28 to 42 days after Vaccination 2

Population: Safety population included all participants who received at least 1 dose of vaccination. Here, number of participants analyzed signifies participants who were evaluable at this timepoint.

Arm	Measure	Group	Value (NUMBER)
13vPnC+QIV/Placebo	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2	AE	10.4 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2	SAE	1.6 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2	AE	12.5 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2	SAE	1.4 percentage of participants

Primary

Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up

Time frame: Within 168 to 196 days after Vaccination 2

Population: Safety population included all participants who received at least 1 dose of vaccination.

Arm	Measure	Group	Value (NUMBER)
13vPnC+QIV/Placebo	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up	AE	2.5 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up	SAE	1.1 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up	AE	2.7 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up	SAE	1.4 percentage of participants

Primary

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes

Serotype-specific OPA GMTs for each of the 13 pneumococcal common serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were logarithmically transformed for analysis. Confidence intervals (CIs) for GMT were back-transformed based on the Student t distribution for the mean logarithm of the titers. GMTs were calculated using all participants with available data for the specified blood draw. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint and n signifies participants with a determinate OPA titer to the given serotype.

Time frame: 1 month after Vaccination 1 for 13vPnC+QIV/Placebo, 1 Month After Vaccination 2 for Placebo+QIV/13vPnC

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 4 (n= 412, 417)	587 titer
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 5 (n= 423, 414)	97 titer
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 6A (n= 420, 415)	953 titer
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 6B (n= 414, 405)	867 titer
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 7F (n= 424, 419)	651 titer
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 9V (n= 419, 415)	699 titer
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 14 (n= 421, 416)	574 titer
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 18C (n= 420, 414)	713 titer
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 19A (n= 425, 419)	337 titer
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 19F (n= 423, 416)	324 titer
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 23F (n= 421, 417)	278 titer
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 1 (n= 419, 417)	75 titer
13vPnC+QIV/Placebo	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 3 (n= 422, 418)	41 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 23F (n= 421, 417)	364 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 18C (n= 420, 414)	865 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 5 (n= 423, 414)	101 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 3 (n= 422, 418)	49 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 6A (n= 420, 415)	1413 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 19A (n= 425, 419)	390 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 6B (n= 414, 405)	1041 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 1 (n= 419, 417)	83 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 7F (n= 424, 419)	670 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 19F (n= 423, 416)	360 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 9V (n= 419, 415)	838 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 4 (n= 412, 417)	824 titer
Placebo+QIV/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes	Serotype 14 (n= 421, 416)	760 titer

Comparison: Serotype 1: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.74, 1.12]

Comparison: Serotype 3: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.7, 0.98]

Comparison: Serotype 4: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.55, 0.91]

Comparison: Serotype 5: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.78, 1.18]

Comparison: Serotype 6A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.53, 0.85]

Comparison: Serotype 6B: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.64, 1.08]

Comparison: Serotype 7F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.83, 1.14]

Comparison: Serotype 9V: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.69, 1]

Comparison: Serotype 14: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.62, 0.92]

Comparison: Serotype 18C: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.64, 1.06]

Comparison: Serotype 19A: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.72, 1.04]

Comparison: Serotype 19F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.71, 1.14]

Comparison: Serotype 23F: Confidence Intervals (CIs) for the ratio were back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC+QIV/placebo - placebo+QIV/13vPnC).95% CI: [0.56, 1.03]

Secondary

Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 1 to before Vaccination 1 were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 1 and 1 month after Vaccination 1 blood draws. Here, n signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 1 were analyzed.

Time frame: Immediately before Vaccination 1, 1 month after Vaccination 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 1 (n= 417)	3.6 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 3 (n= 419)	3.4 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 4 (n= 399)	9.1 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 5 (n= 422)	3.0 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 6A (n= 408)	13.7 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 6B (n= 391)	8.9 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 7F (n= 417)	2.7 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 9V (n= 405)	2.1 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 14 (n= 411)	2.0 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 18C (n= 417)	4.0 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 19A (n= 424)	3.7 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 19F (n= 419)	4.2 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1	Serotype 23F (n= 418)	8.7 fold rise

Secondary

Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2

GMFR for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) 1 month after Vaccination 2 to before Vaccination 2 (1 month after Vaccination 1) were computed using the logarithmically transformed assay results. CIs for GMFR were back transformations of a CI based on the Student t distribution for the mean logarithm of the mean fold rise. GMFRs were calculated using all participants with available data from both before Vaccination 2 and 1 month after Vaccination 2 blood draws. Here, number of participants analyzed signifies total participants who were evaluable at this timepoint and n signifies participants with valid and determinate assay results for specified serotype at both the given visits. Number of participants who received at least 1 dose of 13vPnC during Vaccination 2 were analyzed.

Time frame: Immediately before Vaccination 2, 1 month after Vaccination 2

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 1 (n =413)	3.6 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 3 (n= 414)	3.9 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 4 (n= 391)	10.4 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 5 (n= 411)	3.3 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 6A (n= 399)	17.9 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 6B (n= 382)	9.5 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 7F (n= 407)	2.7 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 9V (n= 399)	2.4 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 14 (n= 406)	2.3 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 18C (n= 408)	6.3 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 19A (n= 416)	4.6 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 19F (n= 410)	4.8 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2	Serotype 23F (n= 412)	12.9 fold rise

Secondary

Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1

Fold rise 1 month after Vaccination 1 to before Vaccination 1 was calculated for each influenza virus strain (A/H1N1, A/H3N2, B/Brisbane and B/Massachusetts). GMFRs were calculated using all participants with available data from both the specified blood draws. CI for the GMFRs were back transformations of a CI based on the Student t distribution for mean fold rise. Here, number of participants analyzed signifies participants with valid and determinate assay results for specified strain at both the specified blood draws.

Time frame: Immediately before Vaccination 1, 1 month after Vaccination 1

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1	Strain: A/H1N1	2.4 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1	Strain: A/H3N2	2.3 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1	Strain: B/Brisbane	2.1 fold rise
13vPnC+QIV/Placebo	Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1	Strain: B/Massachusetts	2.2 fold rise
Placebo+QIV/13vPnC	Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1	Strain: B/Massachusetts	2.1 fold rise
Placebo+QIV/13vPnC	Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1	Strain: A/H1N1	2.2 fold rise
Placebo+QIV/13vPnC	Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1	Strain: B/Brisbane	2.2 fold rise
Placebo+QIV/13vPnC	Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1	Strain: A/H3N2	2.4 fold rise

Secondary

Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)

Percentage of participants achieving predefined OPA antibody titer \>= LLOQ for each of the 13 pneumococcal serotypes (LLOQs for each serotype OPA were set as- serotype 1: 18; serotype 3: 12; serotype 4: 21; serotype 5: 29; serotype 6A: 37; serotype 6B: 43; serotype 7F: 210; serotype 9V: 345; serotype 14: 35; serotype 18C: 31; serotype 19A: 18; serotype 19F: 48; and serotype 23F: 13) determined in blood samples of all participants were calculated. Exact, 2-sided 95% CIs based on the observed percentage of participants were determined by using Clopper and Pearson method. OPA titers were calculated using all participants with available data from 1 month after 13vPnC vaccination blood draw. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint and n signifies participants with valid and determinate assay results to the specified serotype.

Time frame: 1 Month After Vaccination 1 for 13vPnC+QIV/Placebo, 1 month after Vaccination 2 for Placebo+QIV/13vPnC

Arm	Measure	Group	Value (NUMBER)
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 4 (n= 412, 417)	88.6 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 9V (n= 419, 415)	65.2 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 6A (n= 420, 415)	90.5 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 14 (n= 421, 416)	91.4 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 3 (n= 422, 418)	79.4 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 18C (n= 420, 414)	88.8 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 6B (n= 414, 405)	85.0 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 19A (n= 425, 419)	95.5 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 5 (n= 423, 414)	74.5 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 19F (n= 423, 416)	79.9 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 7F (n= 424, 419)	82.3 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 23F (n= 421, 417)	80.3 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 1 (n= 419, 417)	77.3 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 23F (n= 421, 417)	84.2 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 1 (n= 419, 417)	80.1 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 3 (n= 422, 418)	83.7 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 4 (n= 412, 417)	92.1 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 5 (n= 423, 414)	72.7 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 6A (n= 420, 415)	94.2 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 6B (n= 414, 405)	86.4 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 7F (n= 424, 419)	83.5 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 9V (n= 419, 415)	71.3 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 14 (n= 421, 416)	95.2 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 18C (n= 420, 414)	91.3 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 19A (n= 425, 419)	97.4 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)	Serotype 19F (n= 423, 416)	79.6 percentage of participants

Comparison: Serotype 1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.33395% CI: [-8.3, 2.8]Chan and Zhang method

Comparison: Serotype 3: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.10595% CI: [-9.6, 0.9]Chan and Zhang method

Comparison: Serotype 4: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.0995% CI: [-7.6, 0.6]Chan and Zhang method

Comparison: Serotype 5: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.5995% CI: [-4.2, 7.8]Chan and Zhang method

Comparison: Serotype 6A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.04495% CI: [-7.5, -0.1]Chan and Zhang method

Comparison: Serotype 6B: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.57495% CI: [-6.2, 3.4]Chan and Zhang method

Comparison: Serotype 7F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.64895% CI: [-6.3, 3.9]Chan and Zhang method

Comparison: Serotype 9V: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.05795% CI: [-12.5, 0.2]Chan and Zhang method

Comparison: Serotype 14: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.0395% CI: [-7.3, -0.3]Chan and Zhang method

Comparison: Serotype 18C: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.23395% CI: [-6.6, 1.6]Chan and Zhang method

Comparison: Serotype 19A: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.15295% CI: [-4.5, 0.7]Chan and Zhang method

Comparison: Serotype 19F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.92695% CI: [-5.1, 5.8]Chan and Zhang method

Comparison: Serotype 23F: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.14395% CI: [-9.1, 1.3]Chan and Zhang method

Secondary

Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers

Percentage of participants achieving seroconversion in HAI titers was defined as the percentage of participants with either before Vaccination 1 (pre-vaccination 1) HAI titer less than \<1:10 and after Vaccination 1 (post-vaccination 1) HAI titer \>=1:40 or before Vaccination 1 (pre-vaccination 1) HAI titer \>=1:10 and a minimum 4-fold rise in after Vaccination 1 (post-vaccination 1) HAI antibody titer with respect to before Vaccination 1 (pre-vaccination) titer for influenza virus strains. Here, number of participants analyzed signifies the participants who were evaluable at this timepoint.

Time frame: Immediately before Vaccination 1, 1 month after Vaccination 1

Arm	Measure	Group	Value (NUMBER)
13vPnC+QIV/Placebo	Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers	Strain: A/H1N1	29.3 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers	Strain: A/H3N2	27.9 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers	Strain: B/Brisbane	21.3 percentage of participants
13vPnC+QIV/Placebo	Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers	Strain: B/Massachusetts	23.2 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers	Strain: B/Massachusetts	24.7 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers	Strain: A/H1N1	24.2 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers	Strain: B/Brisbane	22.3 percentage of participants
Placebo+QIV/13vPnC	Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers	Strain: A/H3N2	31.6 percentage of participants

Comparison: Strain A/H1N1: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.09495% CI: [-0.9, 11]Chan and Zhang method

Comparison: Strain A/H3N2: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.23295% CI: [-9.9, 2.4]Chan and Zhang method

Comparison: Strain B/Brisbane: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.73495% CI: [-6.6, 4.5]Chan and Zhang method

Comparison: Strain B/Massachusetts: Exact 2-sided CI and corresponding p-value (based on Chan and Zhang) for the difference in proportions, (13vPnC+QIV/placebo - placebo+QIV/13vPnC), expressed as a percentage.p-value: 0.62795% CI: [-7.2, 4.3]Chan and Zhang method

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026

Concomitant Administration of 13-valent Pneumococcal Conjugate Vaccine (13vPnC) With Influenza Vaccine in 23-valent Pneumococcal Polysaccharide (23vPS) Pre-vaccinated Adults.

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Participant flow

Pre-assignment details

Participants by arm

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Outcome results

Hemagglutination Inhibition Assay (HAI) Geometric Mean Titers (GMTs) for Each Influenza Virus Strain in Quadrivalent Influenza Vaccine (QIV)

Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After 13vPnC Vaccination

Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 1

Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) After Vaccination 2

Percentage of Participants With Treatment--Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs) at the 6-Month Follow-up

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) for 13 Pneumococcal Serotypes

Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 1 to Immediately Before 13vPnC Vaccination 1

Geometric Mean Fold Rise (GMFR) for Pneumococcal Serotype-Specific Opsonophagocytic Activity (OPA) Titers 1 Month After 13vPnC Vaccination 2 to Immediately Before 13vPnC Vaccination 2

Geometric Mean Fold Rise (GMFR) in Hemagglutination Inhibition Assay (HAI) 1 Month After Vaccination 1 to Immediately Before Vaccination 1

Percentage of Participants Achieving Pneumococcal Serotype-specific Opsonophagocytic Activity (OPA) Antibody Titer Greater Than or Equal to (>=) Lower Limit of Quantitation (LLOQ)

Percentage of Participants Achieving Seroconversion in Hemagglutination Inhibition Assay (HAI) Titers