Trial Outcomes & Findings for Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children (NCT NCT00824655)

Last Updated: 2011-08-10

Results Overview

Antibody geometric mean concentration (GMC) as measured by micrograms per milliliter (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) were presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs were calculated using all participants with available data for the specified blood draw.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

234 participants

Primary outcome timeframe

1 month after the toddler dose (13 months of age)

Results posted on

2011-08-10

Participant Flow

Group 1 participants received 1 dose of Prevenar at least 42 days prior to study enrollment. Group 2 participants received 2 doses of Prevenar with the last dose at least 140 days prior to study enrollment.

Participant milestones

Participant milestones
Measure	13vPnC/13vPnC Participants received two doses of 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7-valent pneumococcal conjugate vaccine (7vPnC), at approximately 3 months of age prior to enrollment in the study.	13vPnC Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants had received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Infant Series (5 Months of Age) STARTED	118	0
Infant Series (5 Months of Age) COMPLETED	118	0
Infant Series (5 Months of Age) NOT COMPLETED	0	0
After Infant Dose (6 Months of Age) STARTED	118	0
After Infant Dose (6 Months of Age) COMPLETED	118	0
After Infant Dose (6 Months of Age) NOT COMPLETED	0	0
Toddler Dose (12 Months of Age) STARTED	118	116
Toddler Dose (12 Months of Age) COMPLETED	116	116
Toddler Dose (12 Months of Age) NOT COMPLETED	2	0

Reasons for withdrawal

Reasons for withdrawal
Measure	13vPnC/13vPnC Participants received two doses of 13-valent pneumococcal conjugate vaccine (13vPnC) 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7-valent pneumococcal conjugate vaccine (7vPnC), at approximately 3 months of age prior to enrollment in the study.	13vPnC Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants had received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Toddler Dose (12 Months of Age) Adverse Event	1	0
Toddler Dose (12 Months of Age) Parent/legal guardian request	1	0

Baseline Characteristics

Study Evaluating 13-valent Pneumococcal Conjugate Vaccine in Healthy Children

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	13vPnC/13vPnC n=118 Participants Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	13vPnC n=116 Participants Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.	Total n=234 Participants Total of all reporting groups
Age Continuous	5.1 months STANDARD_DEVIATION 0.37 • n=5 Participants	11.9 months STANDARD_DEVIATION 0.52 • n=7 Participants	8.5 months STANDARD_DEVIATION 3.42 • n=5 Participants
Sex/Gender, Customized Female	50 participants n=5 Participants	60 participants n=7 Participants	110 participants n=5 Participants
Sex/Gender, Customized Male	68 participants n=5 Participants	56 participants n=7 Participants	124 participants n=5 Participants

PRIMARY outcome

Timeframe: 1 month after the toddler dose (13 months of age)

Population: Evaluable Toddler Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC n=114 Participants Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	13vPnC n=115 Participants Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Common Serotype 18C	2.93 mcg/mL Interval 2.5 to 3.44	3.87 mcg/mL Interval 3.3 to 4.53
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Additional Serotype 3	1.85 mcg/mL Interval 1.59 to 2.15	1.34 mcg/mL Interval 1.13 to 1.58
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Additional Serotype 7F	5.86 mcg/mL Interval 5.11 to 6.72	3.55 mcg/mL Interval 3.09 to 4.08
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Additional Serotype 19A	7.25 mcg/mL Interval 6.14 to 8.57	13.16 mcg/mL Interval 11.26 to 15.38
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Common Serotype 4	5.27 mcg/mL Interval 4.43 to 6.26	5.06 mcg/mL Interval 4.22 to 6.06
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Common Serotype 6B	9.63 mcg/mL Interval 8.01 to 11.57	8.75 mcg/mL Interval 6.76 to 11.32
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Common Serotype 9V	3.50 mcg/mL Interval 3.01 to 4.07	3.33 mcg/mL Interval 2.88 to 3.84
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Common Serotype 14	9.22 mcg/mL Interval 7.66 to 11.09	9.30 mcg/mL Interval 7.9 to 10.95
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Common Serotype 19F	7.70 mcg/mL Interval 6.12 to 9.69	8.31 mcg/mL Interval 6.39 to 10.81
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Common Serotype 23F	3.27 mcg/mL Interval 2.68 to 3.99	4.40 mcg/mL Interval 3.7 to 5.22
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Additional Serotype 1	14.65 mcg/mL Interval 12.5 to 17.17	1.58 mcg/mL Interval 1.3 to 1.93
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Additional Serotype 5	7.02 mcg/mL Interval 5.98 to 8.25	1.44 mcg/mL Interval 1.21 to 1.72
Geometric Mean Concentration (GMC) of Serotype-Specific Pneumococcal Immunoglobulin G (IgG) Antibodies 1 Month After the Toddler Dose Additional Serotype 6A	6.14 mcg/mL Interval 5.08 to 7.43	2.48 mcg/mL Interval 1.89 to 3.26

SECONDARY outcome

Timeframe: 1 Month after the infant series (6 months of age)

Population: Evaluable Infant Immunogenicity Population: eligible participants who received study vaccine at the expected dose(s), blood drawn within specified timeframes, at least 1 valid and determinate assay result for proposed analysis, and no major protocol violations.

Percentage of participants achieving predefined antibody threshold ≥0.35 mcg/mL along with the corresponding 95% CI for the 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. Exact 2-sided CI based on the observed proportion of participants.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC n=115 Participants Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	13vPnC Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Common Serotype 9V	99.1 Percentage of participants Interval 95.3 to 100.0	—
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Common Serotype 14	96.5 Percentage of participants Interval 91.3 to 99.0	—
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Additional Serotype 3	100.0 Percentage of participants Interval 96.8 to 100.0	—
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Additional Serotype 5	83.5 Percentage of participants Interval 75.4 to 89.7	—
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Additional Serotype 6A	36.8 Percentage of participants Interval 28.0 to 46.4	—
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Additional Serotype 7F	93.0 Percentage of participants Interval 86.8 to 96.9	—
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Additional Serotype 19A	87.8 Percentage of participants Interval 80.4 to 93.2	—
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Common Serotype 4	99.1 Percentage of participants Interval 95.3 to 100.0	—
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Common Serotype 6B	53.0 Percentage of participants Interval 43.5 to 62.4	—
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Common Serotype 18C	95.7 Percentage of participants Interval 90.1 to 98.6	—
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Common Serotype 19F	92.2 Percentage of participants Interval 85.7 to 96.4	—
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Common Serotype 23F	62.6 Percentage of participants Interval 53.1 to 71.5	—
Percentage of Participants Achieving a Serotype-specific IgG Antibody Greater Than or Equal To (≥) 0.35 Mcg/mL, 1 Month After the Infant Dose Additional Serotype 1	80.9 Percentage of participants Interval 72.5 to 87.6	—

SECONDARY outcome

Timeframe: 1 Month after the infant series (6 months of age)

Population: Evaluable Infant Immunogenicity Population

Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% confidence intervals (CI) were evaluated. GMCs calculated using all participants with available data for the specified blood draw.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC n=115 Participants Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	13vPnC Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Common Serotype 4	2.90 mcg/mL Interval 2.48 to 3.4	—
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Common Serotype 6B	0.40 mcg/mL Interval 0.32 to 0.5	—
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Common Serotype 9V	1.73 mcg/mL Interval 1.5 to 1.99	—
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Common Serotype 14	4.70 mcg/mL Interval 3.72 to 5.92	—
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Common Serotype 18C	1.56 mcg/mL Interval 1.29 to 1.89	—
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Common Serotype 19F	3.01 mcg/mL Interval 2.34 to 3.88	—
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Common Serotype 23F	0.57 mcg/mL Interval 0.46 to 0.7	—
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Additional Serotype 1	0.89 mcg/mL Interval 0.73 to 1.08	—
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Additional Serotype 3	1.88 mcg/mL Interval 1.65 to 2.14	—
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Additional Serotype 5	0.72 mcg/mL Interval 0.62 to 0.84	—
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Additional Serotype 6A	0.28 mcg/mL Interval 0.23 to 0.34	—
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Additional Serotype 7F	1.78 mcg/mL Interval 1.48 to 2.15	—
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured 1 Month After the Infant Dose Additional Serotype 19A	0.85 mcg/mL Interval 0.73 to 0.99	—

SECONDARY outcome

Timeframe: 12 months of age (prior to toddler dose)

Population: Evaluable Toddler Immunogenicity Population

Antibody GMC 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) presented. GMC (13vPnC) and corresponding 2-sided 95% CIs evaluated. GMCs calculated using all participants with available data for the specified blood draw.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC n=114 Participants Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	13vPnC n=115 Participants Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Common Serotype 4	0.66 mcg/mL Interval 0.57 to 0.77	0.62 mcg/mL Interval 0.53 to 0.72
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Common Serotype 6B	0.83 mcg/mL Interval 0.67 to 1.02	0.65 mcg/mL Interval 0.51 to 0.82
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Common Serotype 9V	0.74 mcg/mL Interval 0.65 to 0.85	0.70 mcg/mL Interval 0.6 to 0.82
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Common Serotype 14	1.99 mcg/mL Interval 1.63 to 2.42	2.23 mcg/mL Interval 1.85 to 2.69
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Common Serotype 18C	0.35 mcg/mL Interval 0.3 to 0.41	0.44 mcg/mL Interval 0.38 to 0.51
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Common Serotype 19F	0.85 mcg/mL Interval 0.7 to 1.03	0.81 mcg/mL Interval 0.66 to 1.0
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Common Serotype 23F	0.33 mcg/mL Interval 0.27 to 0.39	0.41 mcg/mL Interval 0.34 to 0.49
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Additional Serotype 1	0.46 mcg/mL Interval 0.4 to 0.53	0.01 mcg/mL Interval 0.01 to 0.02
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Additional Serotype 3	0.40 mcg/mL Interval 0.34 to 0.47	0.05 mcg/mL Interval 0.04 to 0.07
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Additional Serotype 5	1.18 mcg/mL Interval 1.02 to 1.36	0.33 mcg/mL Interval 0.26 to 0.42
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Additional Serotype 6A	0.71 mcg/mL Interval 0.6 to 0.85	0.24 mcg/mL Interval 0.19 to 0.31
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Additional Serotype 7F	1.08 mcg/mL Interval 0.95 to 1.23	0.02 mcg/mL Interval 0.02 to 0.02
GMC of Serotype-Specific Pneumococcal IgG Antibodies Measured Before the Toddler Dose Additional Serotype 19A	1.06 mcg/mL Interval 0.88 to 1.28	1.55 mcg/mL Interval 1.32 to 1.81

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 through Day 7 after vaccination

Population: Safety Population: all participants who received at least 1 dose of the study vaccine; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic

Local reactions were reported using an electronic diary. Tenderness was scaled as Any (tenderness present); Significant (present and interfered with limb movement). Swelling and redness were scaled as Any (swelling or redness present); Mild (0.5 centimeters \[cm\] to 2.0 cm); Moderate (2.5 to 7.0 cm); Severe (\> 7.0 cm). Participants may have been represented in more than 1 category.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC n=113 Participants Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	13vPnC Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) Tenderness: Any (n=108)	36.1 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) Tenderness: Significant (n=99)	3.0 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) Swelling: Any (n=104)	33.7 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) Swelling: Mild (n=104)	31.7 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) Swelling: Moderate (n=101)	9.9 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) Swelling: Severe (n=99)	0.0 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) Redness: Any (n=107)	40.2 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) Redness: Mild (n=107)	36.4 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) Redness: Moderate (n=99)	4.0 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Local Reactions: Infant Series Dose 1 (5 Months of Age) Redness: Severe (n=99)	0.0 Percentage of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 through Day 7 after vaccination

Population: Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC n=108 Participants Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	13vPnC n=115 Participants Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) Tenderness: Significant (n=96,103)	5.2 Percentage of participants	7.8 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) Swelling: Any (n=104,110)	53.8 Percentage of participants	54.5 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) Swelling: Mild (n=104,109)	50.0 Percentage of participants	52.3 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) Swelling: Moderate (n=100,105)	24.0 Percentage of participants	29.5 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) Swelling: Severe (n=95,101)	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) Redness: Any (n=104,113)	62.5 Percentage of participants	59.3 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) Redness: Mild (n=103,113)	52.4 Percentage of participants	51.3 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) Redness: Moderate (n=98,106)	20.4 Percentage of participants	26.4 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) Redness: Severe (n=95,101)	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Pre-specified Local Reactions Within 7 Days of the Toddler Dose (12 Months of Age) Tenderness: Any (n=104,110)	59.6 Percentage of participants	52.7 Percentage of participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 through 7 after vaccination

Population: Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic

Systemic events (any fever ≥ 38 degrees Celsius \[C\], decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC n=117 Participants Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	13vPnC Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) Fever ≥38 degrees C but ≤39 degrees C (n=103)	26.2 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) Fever >39 degrees C but ≤40 degrees C (n=99)	2.0 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) Fever >40 degrees C (n=99)	0.0 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) Decreased appetite (n=107)	36.4 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) Irritability (n=114)	80.7 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) Increased sleep (n=106)	50.9 Percentage of participants	—
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Infant Dose (5 Months of Age) Decreased sleep (n=112)	39.3 Percentage of participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Day 1 through 7 after vaccination

Population: Safety Population; n = number of participants reporting yes for at least 1 day or no for all days for the specific characteristic

Systemic events (any fever ≥ 38 degrees C, decreased appetite, irritability, increased sleep, and decreased sleep) were reported using an electronic diary. Participants may have been represented in more than 1 category.

Outcome measures

Outcome measures
Measure	13vPnC/13vPnC n=113 Participants Participants received two doses of 13vPnC 0.5 milliliter (mL) intramuscularly (IM) at 5 months (Infant dose) and 12 months (Toddler dose) of age. Participants had received a single dose of Prevenar, 7vPnC, at approximately 3 months of age prior to enrollment in the study.	13vPnC n=114 Participants Participants received one dose of 13vPnC 0.5 mL IM at 12 months (Toddler dose) of age. Participants received Prevenar, 7vPnC, at approximately 3 and 5 months of age prior to enrollment in the study.
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) Fever ≥38 degrees C but ≤39 degrees C (n=99,105)	31.3 Percentage of participants	32.4 Percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) Fever >39 degrees C but ≤40 degrees C (n=96,102)	5.2 Percentage of participants	3.9 Percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) Fever >40 degrees C (n=95,101)	0.0 Percentage of participants	0.0 Percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) Decreased appetite (n=103,109)	46.6 Percentage of participants	44.0 Percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) Irritability (n=111,113)	82.0 Percentage of participants	76.1 Percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) Increased sleep (n=101,108)	49.5 Percentage of participants	38.9 Percentage of participants
Percentage of Participants Reporting Pre-specified Systemic Events Within 7 Days of the Toddler Dose (12 Months of Age) Decreased sleep (n=105,106)	36.2 Percentage of participants	33.0 Percentage of participants

Adverse Events

13vPnC/13vPnC at 5 Months

Serious events: 1 serious events

Other events: 92 other events

Deaths: 0 deaths

13vPnC/13vPnC at 6 Months of Age

Serious events: 4 serious events

Other events: 4 other events

Deaths: 0 deaths

13vPnC/13vPnC at 12 Months

Serious events: 1 serious events

Other events: 91 other events

Deaths: 0 deaths

13vPnC at 12 Months

Serious events: 0 serious events

Other events: 86 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	13vPnC/13vPnC at 5 Months n=118 participants at risk 13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose)	13vPnC/13vPnC at 6 Months of Age n=118 participants at risk 13vPnC 0.5 mL dose administered IM at 5 months of age (infant dose); assessment 1 month after the infant series (6 months of age).	13vPnC/13vPnC at 12 Months n=116 participants at risk 13vPnC 0.5 mL dose administered IM at 5 months (infant dose) and 12 months of age (toddler dose).	13vPnC at 12 Months n=116 participants at risk 13vPnC 0.5 mL dose administered IM at 12 months of age (toddler dose).
Gastrointestinal disorders Diarrhoea	0.85% 1/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.86% 1/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Intussusception	0.00% 0/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.85% 1/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Gastroenteritis	0.00% 0/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	3.4% 4/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Injury, poisoning and procedural complications Foreign body	0.00% 0/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.85% 1/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Gastrointestinal disorders Vomiting	0.00% 0/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.86% 1/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Infections and infestations Bronchitis	0.00% 0/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.86% 1/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/118 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.86% 1/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.	0.00% 0/116 The same event may appear as both an adverse event (AE) and a serious adverse event (SAE). However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Other adverse events

Additional Information

Pfizer ClinicalTrials.gov Call Center

Pfizer, Inc.

Phone: 1-800-718-1021

Email: [email protected]

Results disclosure agreements

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

Restriction type: OTHER