Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.

Conditions

13-valent Pneumococcal Vaccine, Antibody Response, Immunization, Safety

Keywords

Pneumococcal vaccine 13-valent

Brief summary

This is an open-label study (a study in which the doctors and participants know which drug or vaccine is being administered) in children who previously received a 4-dose series of a pneumococcal conjugate vaccine (PnC) during infancy in Study 6096A1-008-EU (NCT00366678). In this study, participants will receive an additional dose of 13-valent pneumococcal conjugate vaccine. The purpose of this study is to evaluate persistence, if any, of the antibody response by measuring any remaining pneumococcal antibodies since the previous study. This study will also evaluate the safety and immunogenicity of 13-valent pneumococcal conjugate vaccine when administered at least 24 months after the last dose of pneumococcal conjugate vaccine.

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Interventions

BIOLOGICAL13-valent pneumococcal conjugate vaccine

All subjects will receive 1 dose (0.5 mL), IM of 13vPnC vaccine. (at least 24 months after toddler dose).

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

3 Years to No maximum

Healthy volunteers

Yes

Inclusion criteria

* Healthy subjects at least 3 years of age, who received all 4 assigned doses of pneumococcal conjugate vaccine and completed Study 6096A1-008-EU (NCT00366678) for at least 24 months

Exclusion criteria

* Vaccination with any licensed or investigational pneumococcal vaccine since completion of Study 6096A1-008-EU(NCT00366678). * History of culture-proven invasive disease caused by S pneumoniae since the completion of Study 6096A1-008-EU (NCT00366678). * Previous anaphylactic reaction to any vaccine or vaccine-related component. * Contraindication to vaccination

Design outcomes

Primary

Measure	Time frame	Description
Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	One month after vaccination	Antibody GMC as measured by microgram/millilitre (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.
Percentage of Participants With Prespecified Local Reactions	Seven days after vaccination	Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm. Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (\>7.0 cm; \>14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Participants may be reported in more than 1 category.
Percentage of Participants With Prespecified Systemic Events	Seven days after vaccination	Systemic events (any fever \>= 38 degree celsius \[C\], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as \>=38 to \<=39 degree C; \>39 to \<=40 degree C; \>40 degree C. Vomiting: mild (1-2 times/day ); moderate (\>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (\>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Participants may be reported in more than 1 category.

Secondary

Measure	Time frame	Description
Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	One month after vaccination	Serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.
Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	Up to 7 days before vaccination	IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA). CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine	One month after vaccination	Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants.
Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine	One month after vaccination	Percentage of participants with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all participants.
Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	Four to seven days after vaccination	IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG ELISA. CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.
Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	Up to 7 days before vaccination	Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Countries

France

Participant flow

Pre-assignment details

A total of 263 participants who had received a 4-dose vaccination series of pneumococcal conjugate vaccine as part of study 6096A1-008 (NCT00366678) were enrolled for this study. Out of those 1 participant was a screen failure and was not included in results.

Participants by arm

Arm	Count
13vPnC/13vPnC/13vPnC Single dose (0.5 milliliter \[mL\]) of 13-valent pneumococcal conjugate (13vPnC) vaccine intramuscularly (IM), 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 13vPnC/13vPnC vaccine.	130
7vPnC/7vPnC/13vPnC Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7-valent pneumococcal conjugate (7vPnC)/7vPnC vaccine.	65
7vPnC/13vPnC/13vPnC Single dose (0.5 mL) of 13vPnC vaccine IM, 2 years after receiving a full schedule (3 infant doses/1 toddler dose) of 7vPnC/13vPnC vaccine.	67
Total	262

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Lost to Follow-up	1	1	0

Baseline characteristics

Characteristic	13vPnC/13vPnC/13vPnC	7vPnC/7vPnC/13vPnC	7vPnC/13vPnC/13vPnC	Total
Age Continuous	3.4 Years STANDARD_DEVIATION 0.25	3.4 Years STANDARD_DEVIATION 0.24	3.5 Years STANDARD_DEVIATION 0.25	3.4 Years STANDARD_DEVIATION 0.25
Sex: Female, Male Female	70 Participants	29 Participants	40 Participants	139 Participants
Sex: Female, Male Male	60 Participants	36 Participants	27 Participants	123 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	82 / 130	36 / 64	39 / 64
serious Total, serious adverse events	0 / 130	0 / 64	0 / 64

Outcome results

Primary

Percentage of Participants With Prespecified Local Reactions

Local reactions (redness, swelling and pain) were reported using electronic diary. Redness and swelling were recorded in caliper units (range 1 to 14+), each caliper unit represented 0.5 cm. Categorized as any, absent (no redness or swelling present; 0 caliper units), mild (0.5 to 2.0 cm; 1 to 4 caliper units); moderate (2.5 to 7.0 cm; 5 to 14 caliper units); or severe (\>7.0 cm; \>14 caliper units). Pain was categorized as any, mild: does not interfere with activity; moderate: interferes with activity; severe: prevents daily activity. Participants may be reported in more than 1 category.

Time frame: Seven days after vaccination

Population: Safety population: all participants who received the single dose of 13vPnC vaccination. n is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively.

Arm	Measure	Group	Value (NUMBER)
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Pain: Any (n= 112, 52, 53)	55.4 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Pain: Mild (n= 109, 51, 51)	50.5 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Pain: Moderate (n= 95, 47, 48)	17.9 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Pain: Severe (n= 90, 43, 45)	1.1 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Swelling: Any (101, 48, 47)	39.6 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Swelling: Mild (n= 96, 48, 47)	28.1 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Swelling: Moderate (n= 97, 44, 46)	24.7 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Swelling: Severe (n= 90, 43, 45)	0.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Redness: Any (n= 105, 50, 50)	48.6 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Redness: Mild (n= 101, 49, 48)	38.6 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Redness: Moderate (n= 95, 45, 47)	22.1 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Redness: Severe (n= 90, 43, 45)	0.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Redness: Severe (n= 90, 43, 45)	2.3 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Pain: Any (n= 112, 52, 53)	55.8 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Swelling: Moderate (n= 97, 44, 46)	20.5 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Redness: Any (n= 105, 50, 50)	54.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Pain: Mild (n= 109, 51, 51)	49.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Swelling: Mild (n= 96, 48, 47)	35.4 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Redness: Moderate (n= 95, 45, 47)	31.1 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Pain: Moderate (n= 95, 47, 48)	25.5 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Swelling: Severe (n= 90, 43, 45)	2.3 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Swelling: Any (101, 48, 47)	41.7 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Pain: Severe (n= 90, 43, 45)	2.3 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Redness: Mild (n= 101, 49, 48)	40.8 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Pain: Severe (n= 90, 43, 45)	2.2 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Swelling: Any (101, 48, 47)	27.7 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Redness: Mild (n= 101, 49, 48)	37.5 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Swelling: Mild (n= 96, 48, 47)	23.4 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Swelling: Moderate (n= 97, 44, 46)	10.9 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Swelling: Severe (n= 90, 43, 45)	0.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Redness: Moderate (n= 95, 45, 47)	17.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Pain: Any (n= 112, 52, 53)	64.2 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Pain: Mild (n= 109, 51, 51)	56.9 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Redness: Any (n= 105, 50, 50)	46.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Pain: Moderate (n= 95, 47, 48)	20.8 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Local Reactions	Redness: Severe (n= 90, 43, 45)	0.0 Percentage of Participants

Comparison: Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.429Fisher Exact

Comparison: Pain (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.314Fisher Exact

Comparison: Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.552Fisher Exact

Comparison: Pain (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.499Fisher Exact

Comparison: Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.376Fisher Exact

Comparison: Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.633Fisher Exact

Comparison: Pain (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.658Fisher Exact

Comparison: Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.544Fisher Exact

Comparison: Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Pain (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.859Fisher Exact

Comparison: Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.197Fisher Exact

Comparison: Swelling (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.198Fisher Exact

Comparison: Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.443Fisher Exact

Comparison: Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.261Fisher Exact

Comparison: Swelling (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.687Fisher Exact

Comparison: Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.671Fisher Exact

Comparison: Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.253Fisher Exact

Comparison: Swelling (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.074Fisher Exact

Comparison: Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.323Fisher Exact

Comparison: Swelling (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.489Fisher Exact

Comparison: Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.607Fisher Exact

Comparison: Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.549Fisher Exact

Comparison: Redness (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.864Fisher Exact

Comparison: Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.859Fisher Exact

Comparison: Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.836Fisher Exact

Comparison: Redness (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.297Fisher Exact

Comparison: Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.145Fisher Exact

Comparison: Redness (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.517Fisher Exact

Comparison: Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.323Fisher Exact

Comparison: Redness (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.489Fisher Exact

Primary

Percentage of Participants With Prespecified Systemic Events

Systemic events (any fever \>= 38 degree celsius \[C\], vomiting, diarrhea, and fatigue) were reported using electronic diary. Fever categorized as \>=38 to \<=39 degree C; \>39 to \<=40 degree C; \>40 degree C. Vomiting: mild (1-2 times/day ); moderate (\>2 times/day); severe (requires intravenous hydration). Diarrhea: mild (2-3 loose stools/day); moderate (4-5 stools/day); severe (\>=6 loose stools/day). Fatigue: mild (does not interfere with activity); moderate (some interference with activity); severe (prevents daily routine activity). Participants may be reported in more than 1 category.

Time frame: Seven days after vaccination

Population: Safety population: all participants who received the single dose of 13vPnC vaccination. n is signifying number of participants reporting yes for at least 1 day or no for all days, for each group, respectively.

Arm	Measure	Group	Value (NUMBER)
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fever >39 to <=40 degree C (n= 92, 43, 46)	2.2 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fever >=38 to <=39 degree C (n= 93, 49, 46)	15.1 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Vomiting: Moderate (n= 90, 43, 45)	0.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fatigue: Moderate (n= 96, 49, 46)	16.7 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Diarrhea: Mild (n= 90, 45, 47)	8.9 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Vomiting: Severe (n= 90, 43, 45)	0.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fatigue: Any (n= 103, 54, 48)	40.8 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Diarrhea: Any (n= 90, 45, 47)	8.9 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fever >40 degree C (n= 90, 43, 45)	0.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fatigue: Severe (n= 92, 43, 45)	3.3 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Diarrhea: Severe (n= 90, 43, 45)	0.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Vomiting: Any (n= 91, 44, 45)	3.3 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fatigue: Mild (n= 100, 49, 48)	34.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Diarrhea: Moderate (n= 90, 43, 45)	1.1 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Vomiting: Mild (n= 91, 44, 45)	3.3 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Diarrhea: Mild (n= 90, 45, 47)	17.8 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fever >=38 to <=39 degree C (n= 93, 49, 46)	28.6 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fever >39 to <=40 degree C (n= 92, 43, 46)	4.7 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fever >40 degree C (n= 90, 43, 45)	0.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Vomiting: Any (n= 91, 44, 45)	9.1 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Vomiting: Mild (n= 91, 44, 45)	9.1 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Vomiting: Moderate (n= 90, 43, 45)	0.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Vomiting: Severe (n= 90, 43, 45)	0.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Diarrhea: Any (n= 90, 45, 47)	17.8 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Diarrhea: Moderate (n= 90, 43, 45)	0.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Diarrhea: Severe (n= 90, 43, 45)	0.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fatigue: Any (n= 103, 54, 48)	51.9 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fatigue: Mild (n= 100, 49, 48)	34.7 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fatigue: Moderate (n= 96, 49, 46)	30.6 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fatigue: Severe (n= 92, 43, 45)	2.3 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fatigue: Moderate (n= 96, 49, 46)	15.2 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Diarrhea: Moderate (n= 90, 43, 45)	0.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fever >40 degree C (n= 90, 43, 45)	2.2 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fatigue: Mild (n= 100, 49, 48)	20.8 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Diarrhea: Severe (n= 90, 43, 45)	0.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fever >39 to <=40 degree C (n= 92, 43, 46)	2.2 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fatigue: Severe (n= 92, 43, 45)	2.2 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fatigue: Any (n= 103, 54, 48)	31.3 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Vomiting: Severe (n= 90, 43, 45)	0.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Fever >=38 to <=39 degree C (n= 93, 49, 46)	19.6 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Diarrhea: Any (n= 90, 45, 47)	8.5 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Vomiting: Moderate (n= 90, 43, 45)	0.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Vomiting: Mild (n= 91, 44, 45)	6.7 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Diarrhea: Mild (n= 90, 45, 47)	8.5 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants With Prespecified Systemic Events	Vomiting: Any (n= 91, 44, 45)	6.7 Percentage of Participants

Comparison: Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnCp-value: 0.075Fisher Exact

Comparison: Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnCp-value: 0.345Fisher Exact

Comparison: Fever (\>=38 degree C to \<=39 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnCp-value: 0.628Fisher Exact

Comparison: Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.592Fisher Exact

Comparison: Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.608Fisher Exact

Comparison: Fever (\>=39 degree C to \<=40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Fever (\>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Fever (\>40 degree C): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.333Fisher Exact

Comparison: Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.215Fisher Exact

Comparison: Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.714Fisher Exact

Comparison: Vomiting (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.397Fisher Exact

Comparison: Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.215Fisher Exact

Comparison: Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.714Fisher Exact

Comparison: Vomiting (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.397Fisher Exact

Comparison: Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.161Fisher Exact

Comparison: Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.226Fisher Exact

Comparison: Diarrhea (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.161Fisher Exact

Comparison: Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.226Fisher Exact

Comparison: Diarrhea (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Diarrhea (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.237Fisher Exact

Comparison: Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.045Fisher Exact

Comparison: Fatigue (Any): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.285Fisher Exact

Comparison: Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.174Fisher Exact

Comparison: Fatigue (Mild): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.125Fisher Exact

Comparison: Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: 0.058Fisher Exact

Comparison: Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: 0.092Fisher Exact

Comparison: Fatigue (Moderate): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/7vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 7vPnC/7vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: >0.99Fisher Exact

Comparison: Fatigue (Severe): Fisher exact test, 2-sided was used. Pairwise comparison was made between 13vPnC/13vPnC/13vPnC and 7vPnC/13vPnC/13vPnC.p-value: >0.99Fisher Exact

Primary

Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine

Antibody GMC as measured by microgram/millilitre (mcg/mL) for 7 common pneumococcal serotypes (serotypes 4, 6B, 9V, 14, 18C, 19F, and 23F) and 6 additional pneumococcal serotypes specific to 13vPnC (Serotypes 1, 3, 5, 6A, 7F, and 19A) are presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. Geometric means (GMs) were calculated using all participants with available data for the specified blood draw.

Time frame: One month after vaccination

Population: Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	7F	8.23 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	14	21.55 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	19A	17.10 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	23F	8.68 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	4	10.34 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	6B	31.62 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	9V	6.76 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	18C	4.56 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	1	10.72 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	3	1.81 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	5	10.00 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	19F	16.59 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	6A	23.09 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	19F	12.07 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	7F	5.04 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	5	2.86 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	1	2.96 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	19A	8.58 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	18C	6.12 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	6A	14.38 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	4	12.79 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	23F	10.87 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	3	1.60 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	6B	51.07 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	14	21.15 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	9V	6.50 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	3	2.07 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	9V	6.19 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	14	20.73 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	18C	5.35 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	19F	15.09 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	23F	9.10 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	1	20.69 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	6B	35.38 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	5	19.20 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	6A	18.60 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	7F	8.02 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	19A	16.46 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine	4	8.98 mcg/mL

Comparison: Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.61, 1.07]

Comparison: Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.87, 1.52]

Comparison: Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [1.03, 1.96]

Comparison: Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.46, 0.84]

Comparison: Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.66, 1.2]

Comparison: Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [1.02, 2.04]

Comparison: Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.82, 1.32]

Comparison: Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.86, 1.39]

Comparison: Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.79, 1.39]

Comparison: Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.77, 1.34]

Comparison: Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.79, 1.37]

Comparison: Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.74, 1.4]

Comparison: Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.57, 0.97]

Comparison: Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.65, 1.11]

Comparison: Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.84, 1.56]

Comparison: Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.97, 1.94]

Comparison: Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.78, 1.55]

Comparison: Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.54, 1.19]

Comparison: Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.61, 1.05]

Comparison: Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.73, 1.25]

Comparison: Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.87, 1.64]

Comparison: Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [2.76, 4.74]

Comparison: Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.4, 0.68]

Comparison: Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.1, 0.2]

Comparison: Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.8, 1.59]

Comparison: Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.62, 1.23]

Comparison: Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.52, 1.15]

Comparison: Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [2.68, 4.54]

Comparison: Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.4, 0.68]

Comparison: Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.11, 0.2]

Comparison: Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [1.15, 2.23]

Comparison: Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.89, 1.72]

Comparison: Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.53, 1.13]

Comparison: Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [1.28, 2.08]

Comparison: Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.81, 1.3]

Comparison: Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.47, 0.83]

Comparison: Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [1.51, 2.63]

Comparison: Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.79, 1.37]

Comparison: Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.38, 0.72]

Secondary

Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine

Percentage of participants with at least 1/2048 serotype-specific pneumococcal OPA GMTs for serotype 7F determined in the blood samples of all participants.

Time frame: One month after vaccination

Population: The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/2048 for serotype 7F for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.

Secondary

Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine

Percentage of participants with at least 1/8 serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) determined in the blood samples of all participants.

Time frame: One month after vaccination

Population: The data was not collected as planned as the additional, more stringent qualification and validation of the improved mcOPA assays used in this study did not support 1/8 for the quantitation of a serum response and thus the established LLOQ was used for the mcOPA assay.

Secondary

Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine

Serotype-specific pneumococcal OPA GMTs for the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using mcOPA assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Time frame: One month after vaccination

Population: Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	6A (n= 117, 55, 55)	5580 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	23F (n= 118, 53, 56)	2427 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	6B (n= 117, 57, 56)	6684 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	7F (n= 118, 56, 54)	4323 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	18C (n= 117, 54, 57)	7711 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	4 (n= 117, 53, 55)	5465 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	19A (n= 116, 53, 54)	1212 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	3 (n= 118, 56, 58)	244 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	19F (n= 118, 57, 57)	1319 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	14 (n= 115, 54, 55)	2780 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	5 (n= 118, 55, 54)	455 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	1 (n= 119, 56, 57)	613 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	9V (n= 116, 54, 55)	5120 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	9V (n= 116, 54, 55)	4052 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	23F (n= 118, 53, 56)	2411 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	1 (n= 119, 56, 57)	197 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	3 (n= 118, 56, 58)	173 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	5 (n= 118, 55, 54)	390 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	6A (n= 117, 55, 55)	5596 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	7F (n= 118, 56, 54)	8048 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	19A (n= 116, 53, 54)	1249 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	4 (n= 117, 53, 55)	5208 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	6B (n= 117, 57, 56)	10042 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	14 (n= 115, 54, 55)	3079 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	18C (n= 117, 54, 57)	7091 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	19F (n= 118, 57, 57)	1721 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	18C (n= 117, 54, 57)	8431 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	6B (n= 117, 57, 56)	8983 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	5 (n= 118, 55, 54)	728 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	9V (n= 116, 54, 55)	5221 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	3 (n= 118, 56, 58)	291 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	23F (n= 118, 53, 56)	2673 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	14 (n= 115, 54, 55)	2979 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	1 (n= 119, 56, 57)	1212 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	19A (n= 116, 53, 54)	1568 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	7F (n= 118, 56, 54)	4056 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	19F (n= 118, 57, 57)	1914 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	4 (n= 117, 53, 55)	5487 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine	6A (n= 117, 55, 55)	5982 Geometric mean titers

Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.8, 1.38]

Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.76, 1.3]

Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.69, 1.3]

Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.49, 0.9]

Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.55, 1.01]

Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.79, 1.59]

Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.98, 1.63]

Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.76, 1.27]

Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.58, 1.05]

Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.67, 1.21]

Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.7, 1.25]

Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.73, 1.46]

Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.83, 1.43]

Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.7, 1.2]

Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.61, 1.15]

Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.51, 1.15]

Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.46, 1.03]

Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.56, 1.44]

Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.74, 1.37]

Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.67, 1.23]

Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.63, 1.29]

Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [2.4, 4.06]

Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.39, 0.66]

Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.12, 0.22]

Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [1.11, 1.78]

Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.66, 1.06]

Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.45, 0.78]

Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.84, 1.62]

Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.45, 0.87]

Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.36, 0.79]

Comparison: Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.71, 1.4]

Comparison: Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.66, 1.31]

Comparison: Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.63, 1.39]

Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.41, 0.7]

Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.82, 1.38]

Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [1.46, 2.69]

Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.74, 1.28]

Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.59, 1.02]

Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.58, 1.1]

Secondary

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine

Pneumococcal OPA GMTs for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a microcolony OPA (mcOPA) assay. CIs for GMT are back transformations of a CI based on the Student t distribution for the mean logarithm of the titers.

Time frame: Up to 7 days before vaccination

Population: Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	4 (n= 40, 14, 19)	8 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	18C (n= 42, 17, 19)	14 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	1 (n= 44, 18, 22)	6 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	3 (n= 42, 17, 21)	20 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	5 (n= 44, 18, 22)	4 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	6A (n= 44, 16, 21)	170 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	19A (n= 41, 18, 20)	118 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	6B (n= 38, 16, 21)	245 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	9V (n= 40, 18, 21)	43 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	14 (n= 39, 16, 20)	98 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	19F (n= 43, 17, 21)	48 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	23F (n= 43, 16, 21)	52 Geometric mean titers
13vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	7F (n= 39, 16, 21)	60 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	9V (n= 40, 18, 21)	36 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	4 (n= 40, 14, 19)	46 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	7F (n= 39, 16, 21)	47 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	19F (n= 43, 17, 21)	49 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	6A (n= 44, 16, 21)	10 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	23F (n= 43, 16, 21)	61 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	19A (n= 41, 18, 20)	25 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	14 (n= 39, 16, 20)	40 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	6B (n= 38, 16, 21)	247 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	1 (n= 44, 18, 22)	5 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	3 (n= 42, 17, 21)	10 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	5 (n= 44, 18, 22)	4 Geometric mean titers
7vPnC/7vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	18C (n= 42, 17, 19)	76 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	3 (n= 42, 17, 21)	18 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	19A (n= 41, 18, 20)	124 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	4 (n= 40, 14, 19)	45 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	6B (n= 38, 16, 21)	332 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	6A (n= 44, 16, 21)	75 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	9V (n= 40, 18, 21)	52 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	14 (n= 39, 16, 20)	49 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	18C (n= 42, 17, 19)	28 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	19F (n= 43, 17, 21)	40 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	23F (n= 43, 16, 21)	178 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	7F (n= 39, 16, 21)	389 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	1 (n= 44, 18, 22)	10 Geometric mean titers
7vPnC/13vPnC/13vPnC	Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine	5 (n= 44, 18, 22)	4 Geometric mean titers

Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.04, 0.73]

Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.04, 0.64]

Comparison: Serotype 4: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.19, 5.46]

Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.17, 5.85]

Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.15, 3.72]

Comparison: Serotype 6B: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.1, 5.37]

Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.23, 6.25]

Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.17, 3.92]

Comparison: Serotype 9V: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.11, 4.43]

Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.13, 5.14]

Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.48, 12.35]

Comparison: Serotype 14: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.45, 9.05]

Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.04, 0.8]

Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.12, 2.03]

Comparison: Serotype 18C: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.48, 14.92]

Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.23, 4.36]

Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.31, 4.84]

Comparison: Serotype 19F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.23, 6.65]

Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.17, 4.17]

Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.07, 1.24]

Comparison: Serotype 23F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.06, 2.08]

Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.79, 1.97]

Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.38, 0.88]

Comparison: Serotype 1: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.27, 0.77]

Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.85, 4.9]

Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.49, 2.48]

Comparison: Serotype 3: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.2, 1.45]

Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.87, 1.15]

Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.79, 1.03]

Comparison: Serotype 5: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.76, 1.06]

Comparison: Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [3.56, 76.14]

Comparison: Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.56, 9.06]

Comparison: Serotype 6A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.02, 0.78]

Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.22, 7.07]

Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.03, 0.74]

Comparison: Serotype 7F: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.02, 0.84]

Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [1.35, 16.98]

Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.28, 3.23]

Comparison: Serotype 19A: CI for the GMT ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.05, 0.85]

Secondary

Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine

IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG ELISA. CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Time frame: Four to seven days after vaccination

Population: Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	19F	11.70 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	23F	5.24 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	9V	3.49 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	18C	2.31 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	4	2.96 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	19A	13.07 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	14	5.55 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	6B	17.78 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	6A	13.86 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	1	4.24 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	7F	3.55 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	5	6.00 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	3	1.24 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	6B	19.15 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	9V	3.15 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	19F	6.88 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	23F	5.82 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	1	0.56 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	7F	1.23 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	19A	5.09 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	4	4.66 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	14	5.67 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	18C	3.34 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	3	1.12 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	5	1.43 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	6A	4.46 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	18C	2.51 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	19F	8.51 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	7F	3.08 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	6A	7.37 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	3	1.24 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	1	8.00 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	14	4.52 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	5	9.81 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	9V	3.20 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	4	3.85 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	23F	6.28 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	19A	10.50 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine	6B	16.26 mcg/mL

Comparison: Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.23, 1.76]

Comparison: Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.3, 1.99]

Comparison: Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.38, 3.86]

Comparison: Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.43, 1.99]

Comparison: Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.54, 2.22]

Comparison: Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.5, 2.79]

Comparison: Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.56, 2.19]

Comparison: Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.58, 2.06]

Comparison: Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.46, 2.13]

Comparison: Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.38, 2.55]

Comparison: Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.5, 3]

Comparison: Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.42, 3.72]

Comparison: Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.29, 1.68]

Comparison: Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.4, 2.1]

Comparison: Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.49, 3.64]

Comparison: Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.7, 4.12]

Comparison: Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.6, 3.14]

Comparison: Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.3, 2.21]

Comparison: Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.43, 1.89]

Comparison: Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.42, 1.67]

Comparison: Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.4, 2.16]

Comparison: Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [2.86, 19.78]

Comparison: Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.22, 1.31]

Comparison: Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.02, 0.21]

Comparison: Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.53, 2.3]

Comparison: Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.5, 1.97]

Comparison: Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.39, 2.07]

Comparison: Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [2.18, 8.09]

Comparison: Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.33, 1.13]

Comparison: Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.07, 0.31]

Comparison: Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [1.51, 6.4]

Comparison: Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.96, 3.69]

Comparison: Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.27, 1.37]

Comparison: Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [1.39, 5.98]

Comparison: Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.58, 2.28]

Comparison: Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.17, 0.92]

Comparison: Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [1.5, 4.39]

Comparison: Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.75, 2.05]

Comparison: Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.26, 0.89]

Secondary

Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine

IgG GMC to the 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, and 23F) were determined in the blood samples of all the participants using a standardized anti-pneumococcal IgG enzymelinked immunosorbent assay (ELISA). CIs for GMC are back transformations of a CI based on the Student t distribution for the mean logarithm of the concentrations.

Time frame: Up to 7 days before vaccination

Population: Evaluable immunogenicity population: eligible participants, randomized, blood drawn within required timeframes, at least 1 valid and determinate assay result for proposed analysis, received no prohibited vaccines, no major protocol violations. N= number of participants with determinate IgG antibody concentration to serotype.

Arm	Measure	Group	Value (GEOMETRIC_MEAN)
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	19A	6.16 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	14	0.77 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	6A	4.05 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	5	1.28 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	18C	0.21 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	4	0.17 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	19F	2.22 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	9V	0.72 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	23F	1.26 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	7F	0.65 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	3	0.50 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	1	0.35 mcg/mL
13vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	6B	2.86 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	1	0.14 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	3	0.47 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	5	1.12 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	6B	4.10 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	6A	1.89 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	7F	0.21 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	9V	0.92 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	14	0.74 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	19A	3.38 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	19F	2.11 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	23F	1.56 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	4	0.23 mcg/mL
7vPnC/7vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	18C	0.36 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	19A	4.63 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	19F	1.44 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	7F	0.77 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	4	0.18 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	9V	0.71 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	14	0.59 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	18C	0.23 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	23F	1.18 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	1	0.28 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	3	0.42 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	5	1.41 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	6A	2.47 mcg/mL
7vPnC/13vPnC/13vPnC	Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine	6B	3.21 mcg/mL

Comparison: Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.56, 1]

Comparison: Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.73, 1.28]

Comparison: Serotype 4: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.92, 1.79]

Comparison: Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.49, 1]

Comparison: Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.62, 1.27]

Comparison: Serotype 6B: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.84, 1.94]

Comparison: Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.58, 1.03]

Comparison: Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.76, 1.33]

Comparison: Serotype 9V: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.93, 1.8]

Comparison: Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.69, 1.58]

Comparison: Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.86, 1.97]

Comparison: Serotype 14: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.77, 2.03]

Comparison: Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.42, 0.78]

Comparison: Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.67, 1.23]

Comparison: Serotype 18C: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [1.11, 2.25]

Comparison: Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.66, 1.68]

Comparison: Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.97, 2.44]

Comparison: Serotype 19F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.85, 2.51]

Comparison: Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.56, 1.15]

Comparison: Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.74, 1.52]

Comparison: Serotype 23F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.87, 2.01]

Comparison: Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [1.8, 3.73]

Comparison: Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.88, 1.79]

Comparison: Serotype 1: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.32, 0.74]

Comparison: Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.61, 1.87]

Comparison: Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.68, 2.09]

Comparison: Serotype 3: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.59, 2.15]

Comparison: Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [0.87, 1.52]

Comparison: Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.69, 1.2]

Comparison: Serotype 5: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.57, 1.1]

Comparison: Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [1.52, 3.02]

Comparison: Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [1.16, 2.3]

Comparison: Serotype 6A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.51, 1.14]

Comparison: Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [2.23, 4.33]

Comparison: Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.61, 1.17]

Comparison: Serotype 7F: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.19, 0.4]

Comparison: Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/7vPnC/13vPnC).95% CI: [1.25, 2.66]

Comparison: Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (13vPnC/13vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.91, 1.94]

Comparison: Serotype 19A: CI for the GMC ratio was calculated by the back transformations of CI based on the Student t distribution for the mean difference of the logarithms of the measures (7vPnC/7vPnC/13vPnC - 7vPnC/13vPnC/13vPnC).95% CI: [0.47, 1.13]

Post Hoc

Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine

Percentage of participants achieving OPA GMTs with at least LLOQ for 13 pneumococcal serotypes (1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F and 23F) determined in blood samples of all participants using mcOPA assay. Exact 2-sided CI based on observed proportion of participants. LLOQ in titers for each serotype was: Pn001, 18; Pn003, 12; Pn004, 21; Pn005, 29; Pn06A, 37; Pn06B, 43; Pn7F, 210; Pn09V, 345; Pn014, 35; Pn18C, 31; Pn19A, 18; Pn19F, 48; Pn23F, 13. LOD established as lowest titer possible in assay, which was 8. OPA titers below LLOQ set to 0.5\*LOD for analysis.

Time frame: One month after vaccination

Population: Evaluable immunogenicity population. N= number of participants analyzed within a given treatment group. n= number of participants with a determinate OPA antibody titer to the given serotype.

Arm	Measure	Group	Value (NUMBER)
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	14 (n= 115, 54, 55)	100.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	18C (n= 117, 54, 57)	100.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	19A (n= 116, 53, 54)	100.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	4 (n= 117, 53, 55)	100.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	6A (n= 117, 55, 55)	100.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	1 (n= 119, 56, 57)	100.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	6B (n= 117, 57, 56)	100.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	9V (n= 116, 54, 55)	100.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	19F (n= 118, 57, 57)	98.3 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	5 (n= 118, 55, 54)	99.2 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	23F (n= 118, 53, 56)	100.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	3 (n= 118, 56, 58)	100.0 Percentage of Participants
13vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	7F (n= 118, 56, 54)	100.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	6B (n= 117, 57, 56)	100.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	9V (n= 116, 54, 55)	100.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	18C (n= 117, 54, 57)	100.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	1 (n= 119, 56, 57)	100.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	3 (n= 118, 56, 58)	98.2 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	5 (n= 118, 55, 54)	96.4 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	6A (n= 117, 55, 55)	100.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	4 (n= 117, 53, 55)	100.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	14 (n= 115, 54, 55)	100.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	19F (n= 118, 57, 57)	100.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	23F (n= 118, 53, 56)	100.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	7F (n= 118, 56, 54)	100.0 Percentage of Participants
7vPnC/7vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	19A (n= 116, 53, 54)	100.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	1 (n= 119, 56, 57)	100.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	23F (n= 118, 53, 56)	100.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	3 (n= 118, 56, 58)	100.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	19F (n= 118, 57, 57)	98.2 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	5 (n= 118, 55, 54)	100.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	18C (n= 117, 54, 57)	100.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	6A (n= 117, 55, 55)	100.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	9V (n= 116, 54, 55)	100.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	19A (n= 116, 53, 54)	100.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	14 (n= 115, 54, 55)	100.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	7F (n= 118, 56, 54)	100.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	6B (n= 117, 57, 56)	100.0 Percentage of Participants
7vPnC/13vPnC/13vPnC	Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine	4 (n= 117, 53, 55)	100.0 Percentage of Participants

Comparison: Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.5, 6.7]

Comparison: Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.6, 6.5]

Comparison: Serotype 4: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-6.8, 6.6]

Comparison: Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.7, 6.3]

Comparison: Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.6, 6.4]

Comparison: Serotype 6B: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-6.4, 6.5]

Comparison: Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.6, 6.6]

Comparison: Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.6, 6.5]

Comparison: Serotype 9V: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-6.7, 6.5]

Comparison: Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.7, 6.6]

Comparison: Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.7, 6.5]

Comparison: Serotype 14: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-6.7, 6.5]

Comparison: Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.6, 6.6]

Comparison: Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.7, 6.3]

Comparison: Serotype 18C: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-6.6, 6.4]

Comparison: Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-6.2, 4.5]

Comparison: Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-4.8, 7.5]

Comparison: Serotype 19F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-4.8, 9.5]

Comparison: Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.5, 6.7]

Comparison: Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.6, 6.4]

Comparison: Serotype 23F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-6.7, 6.5]

Comparison: Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.5, 6.4]

Comparison: Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.6, 6.3]

Comparison: Serotype 1: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-6.5, 6.3]

Comparison: Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-1.7, 9.6]

Comparison: Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.7, 6.2]

Comparison: Serotype 3: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-9.6, 4.5]

Comparison: Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-2, 11.3]

Comparison: Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-4.9, 5.6]

Comparison: Serotype 5: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-12.5, 3.2]

Comparison: Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.6, 6.5]

Comparison: Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.6, 6.5]

Comparison: Serotype 6A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-6.6, 6.6]

Comparison: Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.6, 6.4]

Comparison: Serotype 7F: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.5, 6.6]

Comparison: Serotype 7F:Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-6.5, 6.7]

Comparison: Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.6, 6.7]

Comparison: Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 13vPnC/13vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-3.6, 6.6]

Comparison: Serotype 19A: Difference in proportion, expressed as percentage, was calculated by percentage of participants achieving at least LLOQ in 7vPnC/7vPnC/13vPnC minus the percentage of participants achieving at least LLOQ in 7vPnC/13vPnC/13vPnC along with exact 2-sided 95% CI.95% CI: [-6.8, 6.6]

Study Evaluating Antibody Response Of 13-Valent Pneumococcal Conjugate Vaccine (13vPnC) 24 Months After Toddler Dose.

Conditions

Keywords

Brief summary

Related papers

Interventions

Sponsors

Study design

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Countries

Participant flow

Pre-assignment details

Participants by arm

Withdrawals & dropouts

Baseline characteristics

Adverse events

Outcome results

Percentage of Participants With Prespecified Local Reactions

Percentage of Participants With Prespecified Systemic Events

Serotype-specific Pneumococcal Immunoglobulin G (IgG) Geometric Mean Concentration (GMC) 1 Month After Single Dose of 13 Valent Pneumococcal Conjugate (13vPnC) Vaccine

Percentage of Participants With at Least 1/2048 OPA GMTs for Serotype 7F After Single Dose of 13vPnC Vaccine

Percentage of Participants With at Least 1/8 Serotype-specific OPA GMTs After Single Dose of 13vPnC Vaccine

Serotype-specific OPA GMTs 1 Month After Single Dose of 13vPnC Vaccine

Serotype-specific Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMT) Prior to Single Dose of 13vPnC Vaccine

Serotype-specific Pneumococcal IgG GMC at 4 to 7 Days After the Single Dose of 13vPnC Vaccine

Serotype-specific Pneumococcal IgG GMC Prior to Single Dose of 13vPnC Vaccine

Percentage of Participants Achieving OPA GMTs With at Least Lower Limit of Quantification (LLOQ) 1 Month After Single Dose of 13vPnC Vaccine